chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Developed COVID-19 after Moderna Dose 3; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Developed COVID-19 after Moderna Dose 3) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included Drug allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from an unknown date to 12-May-2022 for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Developed COVID-19 after Moderna Dose 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2021 to 17-May-2021 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Developed COVID-19 after Moderna Dose 3) outcome was unknown.            The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Concomitant product reported also included Lexipro [sic].  Device Date was reported as '23May2022'.  Company Comment: This spontaneous case concerns a 55-year-old, female patient with past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, no symptoms were reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 13May2022 to 17May2022. It was reported that the patient developed rebound COVID-19 unknown number of days after treatment with Paxlovid. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-576751 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55-year-old, female patient with past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred approximately 6 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed COVID-19, however, no symptoms were reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 13May2022 to 17May2022. It was reported that the patient developed rebound COVID-19 unknown number of days after treatment with Paxlovid. No additional details were provided at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Age: 41.0
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 41-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 1:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:54 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.   The age of patient was provided as 41.58 years. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. The vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. 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.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 30.0
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 30-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 13-Feb-2021 at 2:55 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 2:55 PM, 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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 30.78.  No concomitant medications were reported.  Batch number 031L20A administered on 13-Feb-2021 underwent temperature excursion with temperature 32 degrees Fahrenheit at 9:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-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 traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patients where 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 19-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 3:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:53 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients where 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 (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patients where administered with vaccines that experienced more than 1 temperature excursion during 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 19.04 years.   No concomitant medications information was reported.  On 03-Apr-2021, at 09:00 AM, vial underwent excursion with temperature of 34. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Condition of vaccine prior to administration was not frozen.  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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine 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 vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 34-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 9:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 9:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine 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 vaccine 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 vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine 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 34.84 years.  Concomitant products were not provided.  On 27-Feb-2021, 20 vials were moved to clinic of batch number 014M20A. On 24-Feb-2021, the vaccines of same batch were moved to fridge and proposed beyond use date was 26-Mar-2021 for batch number 014M20A.  For batch number: 014M20A On 28-Feb-2021, at 09:00 A.M. the temperature recorded was 27 Fahrenheit and on same date, at 01:00 P.M. the temperature recorded was 26 Fahrenheit that has been reached by the vial.  The vials were only punctured right before administration and both the doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 Fahrenheit.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 45.0
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 45-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 14-Feb-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 2:18 PM, 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.   Concomitant products were not provided.  Number of vials sent to clinic were 30. Vial moved to fridge on 09-Feb-2021 and beyond use date for these vials was reported as 10-Mar-2021. Vial was moved to clinic on 13-Jan-2021. Batch number 031L20A administered on 14-Feb-201 underwent temperature excursion with temperature of 32 degrees Fahrenheit at 09:00 am, 32 degrees Fahrenheit at 10:00 am, 32 degrees Fahrenheit at 11:00 am, and 35 degrees Fahrenheit at 02:00 and 03:00 pm.  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.  Treatment products were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Soreness in her left arm; Some slight nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her left arm) and NAUSEA (Some slight nausea) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Soreness in her left arm). In 2021, the patient experienced NAUSEA (Some slight nausea). At the time of the report, PAIN IN EXTREMITY (Soreness in her left arm) and NAUSEA (Some slight nausea) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided.   This case was linked to MOD-2022-576700, MOD-2022-576759, MOD-2022-576600 (Patient Link).
Age: 27.0
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 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:51 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:51 AM, 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 27.93  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at  09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-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.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 30.0
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 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 2:19 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 2:19 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 30.66 for dose administered on 07-Jan-2021. No concomitant medications were reported.  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 11-Feb-22 and second dose on 4-Mar-21; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Feb-22 and second dose on 4-Mar-21) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CEFALEXIN MONOHYDRATE (LEXIPRON) and ATORVASTATIN CALCIUM (LIPITOR) from 12-May-2022 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Feb-22 and second dose on 4-Mar-21). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 11-Feb-22 and second dose on 4-Mar-21) outcome was unknown.            The patient had no known allergies.  The indication for Paxlovid (treatment medication) was reported as Treatment of COVID-19.   This case was linked to MOD-2022-576716 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19
Clinical narrative: Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19 (experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion, altered sense of taste)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) nothing over 100.         No concomitant medication information provided.  Caller stated he have had Moderna shots and both boosters. Caller were experiencing low grade temperatures, nothing over 100, bodyaches, coughing, headache, congestion. Other possible side effects included altered sense of taste.  Company Comment: This is a spontaneous case concerning  a  74-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred unknown day after the third  dose of mRNA-1273 COVID 19 Vaccine. Patient was treated with nirmatrelvir,  ritonavir tablet of unspecified dose and frequency. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  74-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred unknown day after the third  dose of mRNA-1273 COVID 19 Vaccine.Patient was treated with nirmatrelvir,  ritonavir tablet of unspecified dose and frequency. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccine 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine 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 vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine 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.   Age of the patient was reported as 30.90.  Concomitant products were not provided.  It was reported that patients were 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.  Vial was stored on cooler 1 , on 15-Apr-2021, Excursion duration At 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM : 43, 2 PM : 44, 3 PM: 44, 4 PM: 42 and 5 PM : 42.  On 15-Apr-2021, excursion time was 09 AM, temp was 34, total doses given for the day were 188, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were moved to clinic. Vaccine BUD date was 09-May-2021. Vials only punctured right before administration.   Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19/ developed foul taste; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19/ developed foul taste) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19/ developed foul taste). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19/ developed foul taste) outcome was unknown.            No concomitant drug information was provided. It was reported that patient had developed foul taste after taking Paxlovid which subsided overnight but upon taking next dose at 7:30, foul taste resumed and was more worse than the previous day. It was also reported that the patient experienced low grade temperatures (nothing over 100) body aches, coughing, headache and congestion. Patient had Moderna shots and both boosters.  No treatment drug information was provided.  Company comment: This is a spontaneous case concerning a 72-year-old, female patient with no reported medical history and with vaccine history of receiving mRNA-1273, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, patient experienced low grade temperatures, body aches, coughing, headache and congestion. Patient took Paxlovid (Nirmatrelvir + Ritonavir) and developed foul taste. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 72-year-old, female patient with no reported medical history and with vaccine history of receiving mRNA-1273, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred after the unknown dose number of mRNA-1273 vaccine administration. Allegedly the event was described as, patient experienced low grade temperatures, body aches, coughing, headache and congestion. Patient took Paxlovid (Nirmatrelvir + Ritonavir) and developed foul taste. No other information surrounding the event was reported. The outcome of the event was unknown. The current Covid-19 pandemic remain confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Mobility decreased
Clinical narrative: couldn't move; Covid-19(Fatigue and bad headache); This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (couldn't move) and COVID-19 (Covid-19(Fatigue and bad headache)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fall. Concurrent medical conditions included MS, Asthma, Seasonal allergy and Allergy to animal (Pet Allergy). Concomitant products included DULOXETINE, GABAPENTIN, BACLOFEN, MULTIVITAMINS [VITAMINS NOS], VITAMIN D NOS, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (couldn't move) and COVID-19 (Covid-19(Fatigue and bad headache)). At the time of the report, MOBILITY DECREASED (couldn't move) and COVID-19 (Covid-19(Fatigue and bad headache)) outcome was unknown.            Treatment information was not provided.  Company comment: This is a spontaneous case reported by a patient. A 43-year-old male patient received two doses of mRNA-1273 vaccine with an interval of 35 days between doses and, on an unknown date, experienced non serious events of COVID-19 (AESI) and mobility decreased. Relevant concurrent medical conditions included multiple sclerosis which could be a contributory factor for mobility decreased. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a patient. A 43-year-old male patient received two doses of mRNA-1273 vaccine with an interval of 35 days between doses and, on an unknown date, experienced non serious events of COVID-19 (AESI) and mobility decreased. Relevant concurrent medical conditions included multiple sclerosis which could be a contributory factor for mobility decreased. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Post my Covid vaccine my allergies have gotten worse; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Post my Covid vaccine my allergies have gotten worse) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Post my Covid vaccine my allergies have gotten worse). At the time of the report, HYPERSENSITIVITY (Post my Covid vaccine my allergies have gotten worse) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided by the reporter  No treatment medications were provided by the reporter
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Continued ringing in the ears following the initial two doses of the COVID 19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Continued ringing in the ears following the initial two doses of the COVID 19 vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039M21A, 030M20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Idiopathic thrombocytopenic purpura (history of ITP) and Autoimmune hemolytic anemia (history of autoimmune hemolytic anemia). Concurrent medical conditions included Seasonal allergy, Long QT syndrome and Asthma (controlled asthma without medication).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Continued ringing in the ears following the initial two doses of the COVID 19 vaccine) (seriousness criterion medically significant). At the time of the report, TINNITUS (Continued ringing in the ears following the initial two doses of the COVID 19 vaccine) had not resolved.            No concomitant medications were reported.   It was reported that patient experienced continued ringing in the ears following the initial two doses of the COVID 19 vaccine.  Company comment: This spontaneous case concerns a 43-year-old, male patient with no relevant medical history who experienced the unexpected, serious(medically significant) event of Tinnitus which occurred on an unspecified date after receiving the third dose of mRNA-1273 vaccine. It was reported that patient experienced continued ringing in the ears following the initial two doses of the COVID 19 vaccine. Further details on the clinical course, diagnostic test done or any treatment regimen was not provided in the case.  The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. No treatment medication was provided.; Sender's Comments: This spontaneous case concerns a 43-year-old, male patient with no relevant medical history who experienced the unexpected, serious(medically significant) event of Tinnitus which occurred on an unspecified date after receiving the third dose of mRNA-1273 vaccine. It was reported that patient experienced continued ringing in the ears following the initial two doses of the COVID 19 vaccine. Further details on the clinical course, diagnostic test done or any treatment regimen was not provided in the case.  The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 18.0
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 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 2:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 2:37 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. 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 18.94. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM, with temperature as 34. Total doses given for the day was 188 vials. Condition of vaccine prior to administration was not frozen. Vaccine was moved to fridge on 06-Apr-2021 and. Vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. 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: 49.0
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 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-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 49.16    Concomitant products were not provided.  On 22-Jun-2021,, Excursion time was 08 AM, 10 AM temperature was 35, total doses given for the day was 36, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 27-Myr-2021, vial was moved to clinic on 20-Mar-2021. 19 vials were sent to clinic. Vaccine BUD date was 22-JUn-2021  On 22-Jun-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 35, 9 AM: 39, 10 AM: 47, 11 AM: 36, 12 AM: 42, 1PM: 43, 2 PM: 43, 3 PM: 43, 4 PM: 43 and 5 PM: 00.  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  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).