chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. It was reported that 3 doses from different vials were used and no temperature excursions. It was reported that the vial was initially stored in the refrigerator on 11-Jan- 2022 and beyond use date for that was  11-Feb-2022. It was reported that the vial undergo any temperature excursions reported None. No concomitant medication was reported. No treatment medication was reported. This case was linked to MOD-2022-573737 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: possible administration of invalid dose to patients; Never reached an acceptable range and was always warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was always warm by at least 2 degree C) 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. 011F21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was always warm by at least 2 degree C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (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.   Concomitant medication was not provided.  There were 4 days temperature data (between 01-Apr-2022 and 04-Apr-2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 22-Feb-2021 to 26-Apr-2022, there was 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 might had been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: Severe metallic taste in mouth that maximized about 1.5-2hrs; Diarrhea over 2-3 days - soft then liquid; This spontaneous case was reported by a non-health professional and describes the occurrence of DYSGEUSIA (Severe metallic taste in mouth that maximized about 1.5-2hrs) and DIARRHOEA (Diarrhea over 2-3 days - soft then liquid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1 Batch/Lot No: EL8982 Location of injection: Arm Left Vaccine Administration Time: 02:00 PM) on 19-Jan-2021 and Pfizer (Dose Number: 2 Batch/Lot No: EM9810 Location of injection: Arm Left Vaccine Administration Time: 02:00 PM) on 09-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.   On 08-Nov-2021 at 10:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 05-May-2022, the patient experienced DYSGEUSIA (Severe metallic taste in mouth that maximized about 1.5-2hrs) and DIARRHOEA (Diarrhea over 2-3 days - soft then liquid). On 10-May-2022, DYSGEUSIA (Severe metallic taste in mouth that maximized about 1.5-2hrs) and DIARRHOEA (Diarrhea over 2-3 days - soft then liquid) had resolved.            It was reported that patient had no allergy.  No Medical History information was reported.  Concomitant medication reported as Nature made started on 01-Mar-2022 and stop date reported as 20-May-2022.  The stop date was reported as 08-NOV-2021 for Moderna COVID-19 Vaccine.   It was reported that patient taking other medications/products within 2 weeks of starting COVID-19 treatment.   No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; coughing; Low grade tmeperature; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), COUGH (coughing) and PYREXIA (Low grade tmeperature) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Arteriovenous malformations. Concurrent medical conditions included Hypothyroidism. Concomitant products included NIRMATRELVIR, RITONAVIR (PAXLOVID) from 07-May-2022 to 12-May-2022 for COVID-19 treatment, LEVOTHYROXINE from 07-May-2022 to 21-May-2022 for an unknown indication.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced RHINORRHOEA (Runny nose), COUGH (coughing) and PYREXIA (Low grade tmeperature). At the time of the report, RHINORRHOEA (Runny nose), COUGH (coughing) and PYREXIA (Low grade tmeperature) was resolving.            The patient had past drug reaction allergy. The patient took other medications/products within 2 weeks of starting COVID-19 treatment.  The patient previously receives a COVID-19 Vaccine. The patient did not receive any treatment for reported events. Device date was reported as 21-May-2022.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\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 never reached an acceptable range and was always warm by at least 2 degree C\possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C\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: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Possible administration of invalid dose to patients; Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) 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. 025C21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) 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 1-Apr-2022 and  4-Apr-2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C. Between 22-Feb-2021 to 26-Apr-2022 there was 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 was 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. 017C21A) 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 was between 4/1/2022 and 4/4/2022 however it never reached an acceptable range and was always warm by 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 the facility during this time period. Lot numbers include: 017C21A. Some vials may have been moved to a refrigerator at some point. There were no temperature data for that storage unit so the reporter has requested to provide guidance on the viability of the vaccine given the missing temperature data.
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 patient; 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 patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 002C21A) 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 patient). 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 patient) 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 01 Apr 2022 and 04 Apr 2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C.  Between 22 Feb 2021 to 26 Apr 2022 there is no other temperature data available.  Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period. Lot numbers were provided include 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: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; Possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042B21A) 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. In April 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) 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.   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 was no temperature data for that storage unit.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 031B21A) 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 never reached an acceptable range and was always warm by at least 2 degree C). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) 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: Poor quality product administered, Product temperature excursion issue
Clinical narrative: possible administration of invalid dose to patients; Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) 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. 026B21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) 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.  There were 4 days temperature data for the freezer storage unit between 1-APR-2022 and 4-APR-2022, however it never reached an acceptable range and was always warm by at least 2 degrees C.   Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; Possible administration of invalid dose to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016B21A) 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 never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patient) 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 01 Apr 2022 and 04 Apr 2022) for the freezer storage unit, however it never reached an acceptable range and was always warm by at least 2 degree C.  Between 22 Feb 2021 to 26 Apr 2022 there is no other temperature data available.  Total 6640 doses of COVID-19 Moderna Vaccine were received by this facility during this time period. Lot numbers were provided include 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: Poor quality product administered, Product temperature excursion issue
Clinical narrative: possible administration of invalid dose to patient; Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product storage error/temperature excursion/never reached an acceptable range and was always warm by at least 2 degrees C) and POOR QUALITY PRODUCT ADMINISTERED (possible administration of invalid dose to patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  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 was no temperature data for that storage unit.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 029A21A) 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 never reached an acceptable range and was always warm by at least 2 degree C.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) 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 were 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 was 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 might have been moved to a refrigerator at some point. There was no temperature data for that storage unit.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Possible administration of invalid dose to patients; Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) 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. 025A21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) 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.  There were 4 days temperature data for the freezer storage unit between 1-APR-2022 and 4-APR-2022, however it never reached an acceptable range and was always warm by at least 2 degrees C.   Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) 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. 001A21A) 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. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C.) 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 was 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 was no temperature data for that storage unit. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: FINGERS AND TOES WER ON FIRE; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (FINGERS AND TOES WER ON FIRE) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriatic arthritis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (FINGERS AND TOES WER ON FIRE). At the time of the report, BURNING SENSATION (FINGERS AND TOES WER ON FIRE) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant product has been reported.  Patient experienced lack of efficacy with Skyrizi (Risankizumab).  No treatment drug has bene provided.  The reporter causality for events extremities burning sensation of was not provided  and lack of drug effect was reasonable possibility. It was not known if the patient was involve in Covid-19 vaccine clinical trial. Primary reporter's contact for the lot number is not available.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021 at 10:24 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 10:26 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 73.34 and 73.42. Concomitant products were not provided. On 28-Feb-2021, Excursion time was 09 AM, temperature was 27 and Excursion time was 01 PM, temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021 (For Batch: 014M20A). On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45 (Batch: 014M20A). On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021 (Batch: 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 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 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.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Depression, Fatigue, Malaise
Clinical narrative: Depression; Not feeling best; Chest pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depression), MALAISE (Not feeling best), CHEST PAIN (Chest pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced DEPRESSION (Depression), MALAISE (Not feeling best), CHEST PAIN (Chest pain) and FATIGUE (Fatigue). At the time of the report, DEPRESSION (Depression) and FATIGUE (Fatigue) had not resolved, MALAISE (Not feeling best) outcome was unknown and CHEST PAIN (Chest pain) had resolved.            Concomitant medication list was not provided. Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Bad, bitter taste in mouth. Diarrhea.) and DIARRHOEA (Bad, bitter taste in mouth. Diarrhea.) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051f21A, 024C21A and 024C21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Drug allergy (None that  patient aware of). Concomitant products included VENLAFAXINE HCL from 22-Jan-2022 to an unknown date for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022, the patient experienced DYSGEUSIA (Bad, bitter taste in mouth. Diarrhea.). On 21-May-2022, the patient experienced DIARRHOEA (Bad, bitter taste in mouth. Diarrhea.). At the time of the report, DYSGEUSIA (Bad, bitter taste in mouth. Diarrhea.) and DIARRHOEA (Bad, bitter taste in mouth. Diarrhea.) outcome was unknown.            Pfizer has permission to contact patient about this report Pfizer also has permission to contact patient's healthcare provider about this report Patient post COVID vaccination medication was not tracked. the patient previously received a COVID-19 Vaccine Bad, bitter taste in mouth. Diarrhea. Device Date : 22May2022 . The treatment history was not provided.
Age: 85.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: reoccurrence of positive covid test; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (reoccurrence of positive covid test) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Sjogren's and Drug allergy. Concomitant products included PREDNISONE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced COVID-19 (reoccurrence of positive covid test). At the time of the report, COVID-19 (reoccurrence of positive covid test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.Concomitant product included Hydroxcflorine.  Company comment: This spontaneous case concerns a 86-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving first dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 7-May-2022 to 12-may-2022.She was tested positive 7 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 86-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving first dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 7-May-2022 to 12-may-2022.She was tested positive 7 days after the treatment with Paxlovid. SARS-CoV-2 test positive on 19-may-2022. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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 80-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 12:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:21 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. The age of patient was provided as 80.33 years for batch number 014M20A. The age of patient was provided as 80.41 years for batch number 019B21A. Concomitant products were not provided. On 28-Feb-2021, at excursion time 09 AM, temperature was 27 and excursion time 01 PM, temperature was 26, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vials were moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, at excursion time 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vials were moved to clinic on 27-Mar-2021. 15 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 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 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.