chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
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 a 37-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 4:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:27 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, 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 37.29  Concomitant products were not provided.   On 07-Jan-2021, Excursion time was 9A, 10A temperature was 34, 34 total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 18 vials were sent to clinic. Vaccine BUD date was 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 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.  Treatment medications were not reported.
Age: 48.0
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 a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 12:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 12:20 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, 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 patient was provided as 48.73  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  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.  Treatment medications were not reported. .
Age: 44.0
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 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Oct-2021 at 1:13 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:13 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. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature range of 29 and 32 degrees Fahrenheit at 09:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021, beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov-2021. Product moved to clinic on 27-Oct-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 brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 48.0
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 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:14 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.   The age of patient was provided as 48.78.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 09 AM, 10 AM temperature was 34, 37 respectively total doses given for the day was 184 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 08-Apr-2021.  On 20-Mar-202, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 PM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44 and 5 PM : 43.  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: 46.0
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 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 a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:56 AM, 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 46.67  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9A temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-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 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.  Treatment medications were not reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Doses administered after more than 1 temperature excursion; Doses 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 (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 46-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 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Mar-2021 at 11:15 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses 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 46.40  Concomitant medication was not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  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.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Liver function test increased, Vaccination site pain
Clinical narrative: ACHINESS IN ARM WITH FIRST COVID VACCINE; LIVER NUMBERS WERE ELEVATED; This spontaneous case was reported by a consumer and describes the occurrence of LIVER FUNCTION TEST INCREASED (LIVER NUMBERS WERE ELEVATED) and VACCINATION SITE PAIN (ACHINESS IN ARM WITH FIRST COVID VACCINE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (ACHINESS IN ARM WITH FIRST COVID VACCINE). In 2021, the patient experienced LIVER FUNCTION TEST INCREASED (LIVER NUMBERS WERE ELEVATED). In 2021, VACCINATION SITE PAIN (ACHINESS IN ARM WITH FIRST COVID VACCINE) had resolved. At the time of the report, LIVER FUNCTION TEST INCREASED (LIVER NUMBERS WERE ELEVATED) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported. The action taken for Humira was unknown.  On 29Nov2021, the patient received Tozinameran (Pfizer Biontech Covid-19 Vaccine) for COVID-19 vaccination via intramuscular route as booster dose. The causality between co-suspect Humira and event Liver numbers were elevated was provided as not reported and dechallenge was N/A. The causality between co-suspect Humira and event Achiness in arm with first COVID vaccine was provided as not related and dechallenge was N/A. No treatment medication was reported.   This case was linked to MOD-2022-577125 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood test, Blood test abnormal, Pain
Clinical narrative: ACHES/PAINS; Blood work levels high; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (ACHES/PAINS) and BLOOD TEST ABNORMAL (Blood work levels high) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 24-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 12-Jan-2022, the patient received third dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (ACHES/PAINS) and BLOOD TEST ABNORMAL (Blood work levels high). At the time of the report, PAIN (ACHES/PAINS) was resolving and BLOOD TEST ABNORMAL (Blood work levels high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product reported by reporter. On an unknown date in 2022, patient had the event of aches/pains. No treatment medication reported by reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter causality with respect to Humira for event of aches/pains was reported as probable and for event of blood work levels high was not reported.  The reporter causality with respect to JANSSEN COVID-19 VACCINE for blood work levels was reported as possible and for event of aches/pains was not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: doses administered after more than 1 temperature excursion; doses 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 (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 55-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 28-Feb-2021 at 11:38 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 11:38 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses 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.   Concomitant medication was not reported. On 28-Feb-2021, Excursion time was 09 AM and temperature was 27,excursion time was 1PM and temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43, 4 PM: 45. 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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient medical history reported as no chronic health conditions and patient received unknown historical drug with reaction of allergy.  Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE on 31-Mar-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.). At the time of the report, COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid. Recurrence was reported. No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred 4 days after the patient completed a 5-day course of Paxlovid. The patient received had received a dose of mRNA-1273 (Spikevax) on unknown date. The patient also had taken Pfizer BioNTech covid-19 vaccine on 31-Mar-2022. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred 4 days after the patient completed a 5-day course of Paxlovid. The patient received had received a dose of mRNA-1273 (Spikevax) on unknown date. The patient also had taken Pfizer BioNTech covid-19 vaccine on 31-Mar-2022. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Patient medical history reported as no chronic health conditions and patient received unknown historical drug with reaction of allergy.  Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE on 31-Mar-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 16-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.). At the time of the report, COVID-19 (I'm reporting that my Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. Covid symptoms re-occurred 4 days after I completed a 5-day course of Paxlovid. Recurrence was reported. No treatment medication was reported.  Company comment: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred 4 days after the patient completed a 5-day course of Paxlovid. The patient received had received a dose of mRNA-1273 (Spikevax) on unknown date. The patient also had taken Pfizer BioNTech covid-19 vaccine on 31-Mar-2022. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 71-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. It was reported that Covid symptoms re-occurred 4 days after the patient completed a 5-day course of Paxlovid. The patient received had received a dose of mRNA-1273 (Spikevax) on unknown date. The patient also had taken Pfizer BioNTech covid-19 vaccine on 31-Mar-2022. Outcome of the event was unknown at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna vaccine administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna vaccine administered to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.  The reporter was not sure about the date of administration of vaccine and was willing to provide more information once the reporter gets back to the office.   This case was linked to MOD-2022-577156 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022; received Moderna COVID-19 vaccine after the manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 vaccine after the manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received Moderna COVID-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (The vial wasfirst punctured on 25-Oct-2021 and the dose was administered on 31-Jan-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  It was not known on which arm the patient received her first and second dose.  The vial was punctured on 25-Oct-2021 and 31-Jan-2022. The vaccine provider was not aware that a punctured vial was only good for 12 hours and expired vaccine was administered to the patient. The vial did not undergo any temperature excursions.  No adverse reactions or side effects were reported after both the doses.  No treatment information was provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured; The patient received Moderna Covid-19 vaccine after the manufacturer expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine after the manufacturer expiration date) and PRODUCT STORAGE ERROR (Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured) in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine after the manufacturer expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received Moderna Covid-19 vaccine after the manufacturer expiration date) and PRODUCT STORAGE ERROR (Dose of Moderna COVID-19 may have been administered to patient greater than 12 hours after the vaccine has been punctured) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccine administrator was not sure when the vial was initially stored in the refrigerator and thought that vaccine was stored in the freezer and possibly thawed on the dates of administration. Date the vial was first punctured were: 25-Oct-2021 (time not known), 31-Jan-2022 (time not provided) and 22-Apr-2022 (time not provided). No concomitant drug was reported. The vaccine specialist (reporter) had a provider who vaccinated 6 patients with expired Moderna COVID-19 vaccine. The provider was not aware that a punctured vial was only good for 12 hours and expired vaccine was administered to at least 6 patients and 7 doses of vaccine past manufacturers expiration date were administered. The vial had not undergone any temperature excursions. No adverse reactions or side effects were reported. No treatment drug was reported.   This case was linked to MOD-2022-577155, MOD-2022-577164, MOD-2022-577166, MOD-2022-577168, MOD-2022-577176 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was administered more than 12 hours after the puncture; Patient received Moderna Covid-19 vaccine after the manufacturers expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered more than 12 hours after the puncture) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered more than 12 hours after the puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the manufacturers expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered more than 12 hours after the puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The date of the vial initially stored in refrigerator was unknown. It was reported that the provider was not aware that a punctured vial was only good for 12 hours and expired vaccine was administered to the patient. It was reported that vial did not undergo any temperature excursions. No adverse reactions or side effects were reported. No treatment drug was reported.   This case was linked to MOD-2022-577155 (Patient Link).   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 Patients.received Moderna Covid-19 vaccine after the manufacturers expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 Patients.received Moderna Covid-19 vaccine after the manufacturers expiration date.) in a 39-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 026D21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 Patients.received Moderna Covid-19 vaccine after the manufacturers expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 Patients.received Moderna Covid-19 vaccine after the manufacturers expiration date.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Treatment information was not reported   This case was linked to MOD-2022-577155 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Covid-19; Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035f21A, 024M20A and 032M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) from 01-May-2022 to 02-May-2022 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021). On 15-May-2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 12-FEB-2021 and Dose 2 3-MAR-2021) outcome was unknown.            Company comment- This spontaneous concerns a 66-year-old female with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 6 months and 4 days after the third dose of mRNA-1273. Inappropriate schedule of vaccine administration was noted in the case (19 days between dose 1 and 2). No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. report.   This case was linked to MOD-2022-577163 (Patient Link).; Sender's Comments: This spontaneous concerns a 66-year-old female with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 6 months and 4 days after the third dose of mRNA-1273. Inappropriate schedule of vaccine administration was noted in the case (19 days between dose 1 and 2). No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. report.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022; greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccineon 31 Jan 2022 and 26 Apr 2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days in between first two  doses of the Moderna Covid-19 vaccine.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported.  Patient received her first dose 31-JAN-2022 31-DEC-2021 lot number 026D21A expiration date 26-JAN-2022.  Event expired vaccine received onset dates were reported as 31 Jan 2022 and 26 Apr 2022.  No Adverse Reactions or Side Effects were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial left in fridge and was not thrown out after 30 day beyond use date; Dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (vial left in fridge and was not thrown out after 30 day beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial left in fridge and was not thrown out after 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) and PRODUCT STORAGE ERROR (vial left in fridge and was not thrown out after 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the vial was initially stored in refrigerator on 22-Mar-2022.  The vial did not undergo any temperature excursion. It was also reported that the vials were un-opened but administered to 7 patients 11 days after the beyond use date on different dates of 3 doses administered on 28-Apr-2022, 1 dose administered on 03-May-2022 and 3 doses were administered on 05-May-2022.   This case was linked to MOD-2022-577179, MOD-2022-577174 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 / COVID Rebound; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 / COVID Rebound) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Disorder thyroid (thyroid) and Drug allergy (sulfa).    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022 at 10:00 PM, the patient experienced COVID-19 (COVID-19 / COVID Rebound). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 / COVID Rebound) had not resolved. Not provided.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2022, SARS-CoV-2 test: positive (Positive) 4 days after completing paxlovid. On an unknown date, SARS-CoV-2 test: positive (Positive) Covid Rebound 10 days after testing positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Vaccine administration time of suspect vaccine was reported as 01:00 PM. It was reported that Co-suspect drug Pfizer was used for the treatment of COVID-19 from 16 May 2022 to 20 May 2022. Company comment- This spontaneous case concerns a 65-year-old female patient, with no relevant medical history reported, who experienced the unexpected  COVID-19. A dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on vaccination date. It was reported that patient experienced COVID rebound 10 days after testing positive, 4 days after completing treatment with paxlovid. Patient tested positive at home antigen test and developed COVID symptoms as well. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 65-year-old female patient, with no relevant medical history reported, who experienced the unexpected  COVID-19. A dose of mRNA-1273 vaccine, given as a fourth dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on vaccination date. It was reported that patient experienced COVID rebound 10 days after testing positive, 4 days after completing treatment with paxlovid. Patient tested positive at home antigen test and developed COVID symptoms as well. The benefit risk relationship of mRNA-1273 is not affected by this report.