chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-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 03-Nov-2021 at 11:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:29 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, 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.   Patient age was reported as 68.97.  Concomitant products were not provided.  On 03-Nov-2021 vials were moved to clinic. On 05-Oct-2021 the vaccines were moved to fridge. On 03-Nov-2021, the vial underwent the excursion on the following timing: at 10 AM temperature was 35. The vaccine beyond use date was reported as 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 10:47 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 10:47 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 73.55.  Concomitant products were not provided.  On 27-Feb-2021, 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.  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 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.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cyst, Lethargy, Neck mass, Onychomycosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), ASTHENIA (Weakness), ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass) and SKIN ODOUR ABNORMAL (Skin odor abnormal) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. The patient's past medical history included Cyst removal (cyst on back of neck removed). Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced LETHARGY (Lethargy), ASTHENIA (Weakness), ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass), SKIN ODOUR ABNORMAL (Skin odor abnormal), VITAMIN B COMPLEX DEFICIENCY (Unspecified vitamin B deficiency) and CYST (Cyst). At the time of the report, LETHARGY (Lethargy) and ASTHENIA (Weakness) had resolved, ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass), SKIN ODOUR ABNORMAL (Skin odor abnormal) and VITAMIN B COMPLEX DEFICIENCY (Unspecified vitamin B deficiency) had not resolved and CYST (Cyst) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. Concomitant product use was not provided by the reporter. It was reported that on unknown dates, the patient experienced lump on neck that had odor like was infected, weak and lethargic after Moderna COVID vaccine, vitamin B was low, had cyst on back of neck removed and left foot fourth toe toenail had fungus and infection. The patient had a lump on the back of neck that had an odor like it was infected. Patient took the Moderna Covid vaccine and it made patient weak and lethargic. Patient had been feeling lethargic. Physician said that Patient's vitamin B was low, and patient was needed to increase it. Patient had cyst on back of neck removed. Patient's left foot fourth toe toenail had fungus and infection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up received included new events, laboratory data was added and outcome of the events was updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Skin odour abnormal, Vitamin B complex deficiency
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), ASTHENIA (Weakness), ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass) and SKIN ODOUR ABNORMAL (Skin odor abnormal) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis. The patient's past medical history included Cyst removal (cyst on back of neck removed). Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS). On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced LETHARGY (Lethargy), ASTHENIA (Weakness), ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass), SKIN ODOUR ABNORMAL (Skin odor abnormal), VITAMIN B COMPLEX DEFICIENCY (Unspecified vitamin B deficiency) and CYST (Cyst). At the time of the report, LETHARGY (Lethargy) and ASTHENIA (Weakness) had resolved, ONYCHOMYCOSIS (Fungal infection of nail), NECK MASS (Neck mass), SKIN ODOUR ABNORMAL (Skin odor abnormal) and VITAMIN B COMPLEX DEFICIENCY (Unspecified vitamin B deficiency) had not resolved and CYST (Cyst) was resolving. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. Concomitant product use was not provided by the reporter. It was reported that on unknown dates, the patient experienced lump on neck that had odor like was infected, weak and lethargic after Moderna COVID vaccine, vitamin B was low, had cyst on back of neck removed and left foot fourth toe toenail had fungus and infection. The patient had a lump on the back of neck that had an odor like it was infected. Patient took the Moderna Covid vaccine and it made patient weak and lethargic. Patient had been feeling lethargic. Physician said that Patient's vitamin B was low, and patient was needed to increase it. Patient had cyst on back of neck removed. Patient's left foot fourth toe toenail had fungus and infection. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2022: Follow-up received included new events, laboratory data was added and outcome of the events was updated.
Age: 60.0
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 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 2:16 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 60.46.  No concomitant medications were reported.  Vial was moved to fridge on 09-Feb-2021. Product moved to clinic on 12-Feb-2021. Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 35 degrees Fahrenheit from 10 AM to 11 AM. Beyond use date for the vial was reported as 10-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 57.0
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 57-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 9:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:46 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, 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.   Patient age was reported as 57.96 No concomitant medications were reported. The vial underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit and the vial was initially moved to the fridge on 30-Mar-2021 and proposed beyond use date was 29-Apr-2021. The vial got moved to clinic on 03-Apr-2021. The vials were only punctured right before administration and all 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 degree Fahrenheit. On the date of administration, at 08:00 A.M., the temperature recorded was 38 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a 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.
Age: 68.0
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 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 4:37 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. 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). On 27-Oct-2021 at 4:37 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). 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 68.90 for dose administered on 27-Oct-2021.  No concomitant medications were reported.  2 vials with temperature 29 degrees Fahrenheit at 09:00 AM which were moved to fridge on 29-Sept-2021. Batch number 035C21A underwent temperature excursion on 27-Oct-2021. Product moved to clinic on 27-Oct-2021. Beyond used date was 29-Oct-2021. 4 vials with temperature 32 degrees Fahrenheit at 10:00 AM which were moved to fridge on 05-Oct-2021 and beyond used date was 04-Nov-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 67.0
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 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021 at 1:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 1:32 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 66.41 on 13-Feb-2021 and 67.13 on dose given on 03-Nov-2021. Concomitant products were not provided.  On 13-Feb-2021, excursion time was 09 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021, 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. On 03-Nov-2021, excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021, 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 72.0
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 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:12 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, 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.   The age of patient was provided as 72.29.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 8 AM, temp was 32 and at 9 AM temp was 32; total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a 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.  It was reported that unknown number of 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.  Treatment medications were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccines administered after more than 1 temperature excursion; Vaccines 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 (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion) in a 60-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 11:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:58 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines 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.   No concomitant product use was reported.  The patient age was reported as 60.55 years.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 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 in cooler 1, on 20-Mar-2021, Excursion temperature at 9 am: 34, at 10 am 30, at 11 am 41, at 12 am 45, at 1 pm 44, at 2 pm 44, at 3 pm 44, at 4 pm 44 and at 5 pm 43.  On 20-Mar-2021, Excursion time at 09 AM temp was 34 and at 10AM temp was 37, total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic. Vaccine BUD date was 08-Apr-2021.  Temperature recordings were taken by using a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Age: 71.0
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 71-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 10:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 10:19 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.50 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Vial was moved to fridge on 30-Mar-2021. Product moved to clinic on 03-Apr-2021. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. Beyond use date for the vial was reported as 29-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 72.0
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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 1:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). On 03-Nov-2021 at 1:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses 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.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 10am, temperature was 35, total 117 doses were administered for that day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 05-Oct-2021 and moved to clinic on 03-Nov-2021. 06 vials were sent to the clinic. BUD date was 05-Nov-2021. Vials only punctured right before administration.  Vial was stored on cooler 1 , on 22-Oct-2021, Excursion duration At 8 AM: 32, 9 AM: 32 and 10 AM: 32.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male 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 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 10:02 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, 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.   Age of patient was reported as 68.24.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 10:00 A.M., temperature was 37 degrees Fahrenheit, 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.  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 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.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 1:52 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:34 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 85.47 for dose administered on 28-Feb-2021 and 85.55 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 26 degrees Fahrenheit from 01:00 PM to 02:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-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: 85.0
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 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:02 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:44 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 85.97 for dose administered on 28-Feb-2021 and 86.05 for dose administered on 28-Mar-2021.  The age of patient was provided as 61.04 for 2nd dose LOT 007C21A and 60.97 for 1st dose LOT 030B21A.  Concomitant products were not provided.  On 27-Feb-2021 vials were moved to clinic. On 24-Feb-2021 the vaccines were moved to fridge. On 28-Feb-2021, the vial underwent the excursion. The vaccine beyond use date was reported as 26-Mar-2021.  On 27-Mar-2021 vials were moved to clinic. On 23-Mar-2021 the vaccines were moved to fridge. On 28-Mar-2021, the vial underwent the excursion on the following timings: at 10 AM temperature was 35. The vaccine beyond use date was reported as 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration. It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 85-year-old male 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 3:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:39 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.   Age of patient was reported as 85.59 for dose administered on  14-Feb-202.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 03:00 P.M., temperature was 35 degrees Fahrenheit, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-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 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.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 86.0
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 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 3:04 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.   Age of patient was reported as 86.23 for dose administered on 03-NOV-2021.  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10:00 A.M., temperature was 35 degrees Fahrenheit, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 20 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks 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.   This case was linked to MOD-2022-566976 (Patient Link).