chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Freezer temperature warm by atleast 2 degree C for 4 days; Possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature warm by atleast 2 degree C for 4 days) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  It was reported that there are 4 days temperature data(between 4/1/2022 and 4/4/2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 2/22/21 to 4/26/22 there is no other temperature data available. Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period and LOT numbers were provided(057M21A, 025L21B, 066H21A, 069H21A, 027H21B, 032F21A, 011F21A, 004F21A, 025C21A, 017C21A, 002C21A, 042B21A, 031B21A, 027B21A, 026B21A, 016B21A, 008B21A, 045A21A, 001B21A, 029A21A, 025A21A, 001A21A).Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Product storage error
Clinical narrative: Product storage error; possible administration of invalid dose to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients). At the time of the report, PRODUCT STORAGE ERROR (Product storage error) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possible administration of invalid dose to patients) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   There are 4 days temperature data for the freezer storage unit is between 1-Apr-2022 and 4-Apr-2022 however it never reached an acceptable range and was always warm by at least 2 degrees Celsius.  Between 22-feb-21 through 4/26/22 there is no other temperature data other than what is listed above. 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period. Some vials may have been moved to a refrigerator at some point. There is no temperature data for that storage unit.  The concomitant history was not reported. The treatment history was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Rebound of Covid symptoms day 12 after taking Paxlovid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of Covid symptoms day 12 after taking Paxlovid) in a 61-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Blood pressure high, Asthma, Pollen allergy, Allergy to animal dander (cat/dog dander) and Fruit allergy (drupes).   On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 21-May-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Rebound of Covid symptoms day 12 after taking Paxlovid). At the time of the report, COVID-19 (Rebound of Covid symptoms day 12 after taking Paxlovid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: positive (Positive) Rebound of COVID symptoms day 12 after taking Paxlovid. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication information was provided.  No treatment medications were provided for Rebound of Covid symptoms. Company comment This regulatory authority case concerns a 61-year-old female patient, with medical history of Blood pressure high, Asthma and allergy, who experienced the unexpected non-serious AESI of COVID-19, which occurred after receiving the first dose of mRNA-1273 vaccine. Patient received second dose with TOZINAMERAN. Vaccination dates were not provided; hence, latency cannot be assessed. It was reported that patient experienced rebound of Covid symptoms the 12thday after taking Paxlovid (nirmatrelvir, ritonavir). No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 61-year-old female patient, with medical history of Blood pressure high, Asthma and allergy, who experienced the unexpected non-serious AESI of COVID-19, which occurred after receiving the first dose of mRNA-1273 vaccine. Patient received second dose with TOZINAMERAN. Vaccination dates were not provided; hence, latency cannot be assessed. It was reported that patient experienced rebound of Covid symptoms the 12thday after taking Paxlovid (nirmatrelvir, ritonavir). No further information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Histamine level, Pruritus, Rash, Urticaria
Clinical narrative: Across upper torso a little itchy; rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body; rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (Across upper torso a little itchy), URTICARIA (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) and RASH (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (cillin medications) and Hashimoto's thyroiditis.    On 19-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body). On an unknown date, the patient experienced PRURITUS (Across upper torso a little itchy) and RASH (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; LORATADINE (CLARITINE) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Across upper torso a little itchy), URTICARIA (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) and RASH (rash and hives on ankles, feet, toes, mainly middle lower extremities, stomach, occasionally on arm/travels throughout body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Histamine level: more active/increased (High) more active/increased.         No concomitant medications were reported. Patient's date of birth mentioned.   The patient had allergy to poison ivy. She did not have seasonal allergies and had not added any new foods to diet. Moderna 2nd booster dose Lot number was reported as 027L21A or Z1A. The patient suspected hives and rash were due to vaccine in combination with having hashimotos. She experienced hives and rash had been going for weeks and saw doctor. The rash and hives happened through the day, histamines were more active at night.  Treatment with Benadryl, Claritin, prednisone made that worse.  The patient had not experienced a similar event in the past.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: had a red spot at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (had a red spot at the site of the injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Dementia and Cirrhosis of liver.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (had a red spot at the site of the injection). At the time of the report, VACCINATION SITE ERYTHEMA (had a red spot at the site of the injection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided. The patient had Cirrhosis of the liver and dementia before receiving her first primary dose of the Moderna Covid-19 vaccine. No treatment information was provided.   This case was linked to MOD-2022-576601 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: The vial undergo temperature excursions; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     no Allergies were reported.  Previously administered products included for Product used for unknown indication: pfizer (As primary series). Past adverse reactions to the above products included No adverse reaction with pfizer.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine It was reported that dosages received in January with the same lot number, 045L21A. They were put in the freezer and from 23-Feb-2022 until the 12-May-2022 they administer them to 13 patients, all booster dosages, after they expired. Maximum and minimum temperatures reached were 44.6 degree F and 38.8 degree F. Excursion duration were reported as 3 months. Vials were moved from freezer to refrigerator on 20-JAn-2022. The vial undergo any temperature excursions. Number of vials/doses impacted: 660 doses, and they have now 520.  No treatment medication reported.   This case was linked to MOD-2022-572778 (Patient Link).
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: The vial was moved from freezer to refrigerator and expired on 20-Jan-2022; Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F; Patient received an expired vaccine for a booster dose on 01-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose on 01-Mar-2022), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator and expired on 20-Jan-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Moderna Vaccine (First dose with lot number 014B21A) on 02-May-2021 and MODERNA COVID-19 VACCINE (Second dose with lot number 037C21A) on 30-May-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna Vaccine. Concurrent medical conditions included Allergy to venom (Bee venom) and Sulfonamide allergy (Sulfa antibiotics).    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose on 01-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator and expired on 20-Jan-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose on 01-Mar-2022), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator and expired on 20-Jan-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The date the vial was initially stored in the refrigerator on 20-Jan-2022.  The vial undergo any temperature excursions: yes  Storage condition at the time of the excursion: refrigerated storage  Maximum or minimum temperatures reached, as applicable : Maximum 44.6°F minimum 38.8°F  Excursion duration: 3 months  No treatment medication was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Pain in hand; Swelling; stiffness in hand; Fatigue; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in hand), SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness in hand), FATIGUE (Fatigue) and CONDITION AGGRAVATED (Condition aggravated) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Rheumatoid arthritis: HUMIRA (HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB).). Past adverse reactions to the above products included No adverse event with HUMIRA.   On 12-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2022, 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 PAIN IN EXTREMITY (Pain in hand), SWELLING (Swelling), MUSCULOSKELETAL STIFFNESS (stiffness in hand), FATIGUE (Fatigue) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, PAIN IN EXTREMITY (Pain in hand), MUSCULOSKELETAL STIFFNESS (stiffness in hand) and FATIGUE (Fatigue) had not resolved and SWELLING (Swelling) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.            No Concomitant medication reported. Event Onset date reported year 2022. The patient experienced swells up real bad after the Covid Booster. It was unknown if patient was enrolled in covid vaccine trial. No Treatment medication reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Patient received second booster dose on May 2022.  They stated that they were calling back to provide more information to receive an assessment on invalid dose administration to 16 patients. They were busy when they had called earlier and could not provide any information to the agent at that time. The 16 patients were administered a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date period. Treatment medications were not reported.
Age: 51.0
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 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 4:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 4:24 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 51.72 for dose administered on 14-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 35 degrees Fahrenheit from 10:00 AM to 11:00 AM, on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM and 14-Feb-2021 with temperature 32,35 degrees Fahrenheit from 09:00 AM to 03:00 PM. 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 and 12-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 Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past 30 day beyond use date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In May 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past 30 day beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The patient had received 2nd booster. No treatment medication was provided.
Age: 30.0
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 a 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 30-year-old male 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 9:20 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021, 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 30.23.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM, temperature was 32, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent 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.  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: 27.0
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 27-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 27-Feb-2021 at 9:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 9:43 AM, the patient experienced 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). 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.   Concomitant products were not provided.  The age of patient was provided as 27.62.  Batch number 014M20A underwent temperature excursion on 27-Feb-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 199, 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.  On 27-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 34-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, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-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. 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 34.01 Years.   Concomitant products were not provided.   On 03-Apr-2021, Excursion time was 09:00 AM, temperature was 34,   total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.   On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
Age: 53.0
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 53-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 9:11 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:11 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, 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 reported as 53.08.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, 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 Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 52.0
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 52-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 4:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:25 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.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.99 on 15-Apr-2021.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021 (Batch number: 044B21A ).  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: 30.0
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 30-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 30-Mar-2021 at 9:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:09 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 30-Mar-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 173, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 30-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021 (Batch number: 019B21A). 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: 30.0
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 30-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 9:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 9:15 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.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.02.  Concomitant products were not provided.  On 15-Apr-2021, at excursion time 9 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, 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 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4PM: 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 Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Age: 18.0
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 an 18-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 at 12:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 12:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 18.68.  Concomitant product use was not provided by the reporter.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit from 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: didn't feel good,felt crappy; laid around and fatigue; second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel good,felt crappy), FATIGUE (laid around and fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 939905) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A). On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue). At the time of the report, FEELING ABNORMAL (didn't feel good,felt crappy), FATIGUE (laid around and fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A) outcome was unknown.            No treatment drugs were reported   This case was linked to MOD-2022-577184, MOD-2022-577205, MOD-2022-577206 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Sluggishness
Clinical narrative: Two weeks after my vaccine, my legs started feeling really tired and sluggish. It got progressively worse as time went by. Now, 1 year later, it's gotten so bad that I can barely walk. I saw my Neurologist on 5/23/2022 and am getting referrals for some testing that's going to start on 06/13/2022. I'm getting a Brain MRI, Myasthenia Gravis, NCS test, and getting testing for Guillain-Barre Syndrome. And then I'm getting a referral to start Physical Therapy.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Neuropathy peripheral, Pain, Scan
Clinical narrative: Neuropathy in hips, back, and legs