chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.  No Medical History information was reported.  On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication of the patient was not reported.  The vial was initially stored in the refrigerator on 04-Nov-2021 and the reporter reported that they thaw the vial on the same day. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-497431 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  Treatment medication was not provided by the reporter  It was reported that date the vial was initially stored in the refrigerator on 04Nov2021 and 01Dec2021 The nurse clarified that the lookup tool said the expiration date was 09Oct2021, so the patient received two expired doses.   This case was linked to MOD-2022-497418 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients received expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired doses) 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 Reporter explained that they thaw the vial on the same day that they had a vaccine clinic. Date the vial was initially stored in the refrigerator: 04-Nov-2021 and 01-Dec-2021. There were 6 total patients (but total 7 doses) who received the expired dose from lot number 047B21A. The vial did not undergo any temperature excursions. Treatment information include not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: injected expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (injected expired Moderna COVID-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Storage condition of the vial was refrigerated storage; maximum or minimum temperatures reached, as applicable (specify temp is in C or F): normal refrigerated temperature range 38 Fahrenheit to 40 Fahrenheit; date vial moved from freezer to refrigerator: 24-Jan-2022; currently the vial was stored in a nursing home and the reporter was not sure if the vial was discarded or the vial was still in the refrigerator. Upon visual inspection no abnormality was noted; Pertinent details: the vial was unpunctured and had no previous excursion.  No adverse event was reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-493214 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, the vial was moved from freezer to refrigerator. It was reported that the vaccine was stored refrigerated at the time of the excursion in normal refrigerated temperature range 38 F to 40 F. The pertinent details for the vial were that they it was unpunctured and had no previous excursion. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each).  No abnormality was reported during visual inspection of vaccine state change. There was no product complaint associated. The vial location was in a nursing home and was not sure if they discarded the vial or still had it in the refrigerator.  No treatment medications were reported.   This case was linked to MOD-2022-493214 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 10 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that storage condition at the time of the excursion was refrigerated storage (temp 38F to 40F). On 24-Jan-2022 vial was moved from freezer to refrigerator. No abnormality was reported in vaccine state change. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each). Vial was unpunctured and no previous excursion was reported.  No treatment medications were reported.   This case was linked to MOD-2022-493214 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 10 patients (Patient 6 out of 10); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 6 out of 10)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 6 out of 10)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 6 out of 10)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was stored in refrigerated condition under 38 to 40 Fahrenheit. On 24-Jan-2022 vial was moved from freezer to refrigerator. No abnormality detected during visual inspection. No temperature excursion or no puncture had been happened.  No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. A nurse injected expired Moderna COVID-19 vaccine to 10 patients on 23-Feb-2022. Vaccine was stored in refrigerator at the time of excursion with a temperature range 38F to 40F. On 24-jan-2022, the vial was moved from freezer to refrigerator. It was reported that Vial location was in a nursing home and reporter was not sure if they discarded the vial or they still had it in the refrigerator.  Total number of vials/doses impacted were 1 vial = 7.5 ml (14 dose each), only 10 doses administered (9 booster and 1 second dose).The vial was not previously punctured nor undergone any excursion. !0 vaccine recipients had been monitored by the nursing staff at the skilled nursing facility. No adverse events reported at all. No treatment medications were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, the vial was moved from freezer to refrigerator. It was reported that the vaccine was stored refrigerated at the time of the excursion in normal refrigerated temperature range 38 F to 40 F. The pertinent details for the vial were that they it was unpunctured and had no previous excursion. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each).  No abnormality was reported during visual inspection of vaccine state change. There was no product complaint associated. The vial location was in a nursing home and was not sure if they discarded the vial or still had it in the refrigerator.  No treatment medications were reported.   This case was linked to MOD-2022-493214 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 9 out of 10). No adverse events reported at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 24-Jan-2022, the vial was moved from freezer to refrigerator. It was reported that the vaccine was stored refrigerated at the time of the excursion in normal refrigerated temperature range 38 F to 40 F. The pertinent details for the vial were that they it was unpunctured and had no previous excursion. Number of vials or doses impacted 1 vial 7.5 ml (14 dose each).  No abnormality was reported during visual inspection of vaccine state change. There was no product complaint associated. The vial location was in a nursing home and was not sure if they discarded the vial or still had it in the refrigerator.  No treatment medications were reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 10 patients (Patient 10 out of 10). No adverse events reported at all) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  A nurse injected expired Moderna COVID-19 vaccine to 10 patients on 23-Feb-2022. Vaccines were stored at normal refrigerated temperature range 38F to 40F. Date the vial was moved from freezer to refrigerator was on 24-Jan-2022. Vial location was in a nursing home and reporter was not sure if they discarded the vial or they still have it in the refrigerator. Visual inspection noting any vaccine state change was no abnormality reported. Total number of vials/doses impacted were 1 vial = 7.5 ml (14 dose each), only 10 doses administered (9 booster and 1 second dose).  No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Product use issue
Clinical narrative: 3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022; immunocompromised patient received a 0.25ml 3rd Dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient received a 0.25ml 3rd Dose) and PRODUCT USE ISSUE (3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058h21a, 042j21a, 007m20a and 025j21-2a) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 11-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient received a 0.25ml 3rd Dose). On 28-Feb-2022, the patient experienced PRODUCT USE ISSUE (3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022). On 11-Nov-2021, ACCIDENTAL UNDERDOSE (immunocompromised patient received a 0.25ml 3rd Dose) outcome was unknown. At the time of the report, PRODUCT USE ISSUE (3rd dose 0.25ml Nov 11 2021 -4th dose 0.25ml Feb 28 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Follow up received on 28-Feb-2022 includes no new information
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Inappropriate schedule of product administration
Clinical narrative: First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A12A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (17 years ago was reported.) in 2004. Concurrent medical conditions included Hypertension. Concomitant products included WARFARIN for Anticoagulant therapy, LOSARTAN for Heart rate abnormal, METOPROLOL for Hypertension, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was on 01 Feb 2021 and second dose was on 12 Mar 2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 4.9 4.9.         No treatment medication was reported.  Initial titer was 4.9 in September which was exponentially lower than anyone the patient knew after having the first two doses.Patient did not got the antibody level he was expecting, was reported.Concerned about the efficacy, was reported.   This case was linked to MOD-2022-477578 (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Dizziness, Dyspnoea, Malaise
Clinical narrative: Weakness; not enough blood supply to my heart; does not feel well especially when walking fast; difficulty of breathing; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CARDIAC DISORDER (not enough blood supply to my heart), MALAISE (does not feel well especially when walking fast), DYSPNOEA (difficulty of breathing) and DIZZINESS (dizziness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (had stents in his heart.) and Stent placement. Concurrent medical conditions included Blood pressure high. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Blood pressure high.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness), CARDIAC DISORDER (not enough blood supply to my heart), MALAISE (does not feel well especially when walking fast), DYSPNOEA (difficulty of breathing) and DIZZINESS (dizziness). At the time of the report, ASTHENIA (Weakness), CARDIAC DISORDER (not enough blood supply to my heart), MALAISE (does not feel well especially when walking fast), DYSPNOEA (difficulty of breathing) and DIZZINESS (dizziness) outcome was unknown.            Other concomitant medication included unspecified medicine for his high blood pressure.  Patient reported that prior to the vaccine (before Jun2021) he had a stress test and had very good results. Patient reported that the 2 vaccines may not be the direct reason for his having instances of angina, developed feelings in my chest like angina. He reported that all these might be due to aging. He talked to his doctor who told him that it is not good enough reason and advised him to go get the booster dose. No further information on myocarditis/pericarditis queries.  No treatment medication was provided by the reporter.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: 8 year old received 0.5ml dose of the Moderna covid19 vaccine; it was expired/ received expired vaccine; received first dose of Pfizer and second dose of Moderna; it was left out of the refrigerator since Friday the 25Feb2022; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old received 0.5ml dose of the Moderna covid19 vaccine), EXPIRED PRODUCT ADMINISTERED (it was expired/ received expired vaccine), PRODUCT STORAGE ERROR (it was left out of the refrigerator since Friday the 25Feb2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose of Pfizer and second dose of Moderna) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (first dose) on 25-Jan-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 28-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Feb-2022, the patient experienced PRODUCT STORAGE ERROR (it was left out of the refrigerator since Friday the 25Feb2022). On 28-Feb-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old received 0.5ml dose of the Moderna covid19 vaccine), EXPIRED PRODUCT ADMINISTERED (it was expired/ received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose of Pfizer and second dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (8 year old received 0.5ml dose of the Moderna covid19 vaccine), EXPIRED PRODUCT ADMINISTERED (it was expired/ received expired vaccine), PRODUCT STORAGE ERROR (it was left out of the refrigerator since Friday the 25Feb2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received first dose of Pfizer and second dose of Moderna) outcome was unknown.            There was no medical history at the time of vaccination. No concomitant medication information was provided.  The patient received 0.5ml vaccine dose of the Moderna covid19 vaccine as his second dose and that it was expired because it was left out of the refrigerator since Friday the 25-Feb-2022. The first dose was of Pfizer which was taken on 28-Feb-2022. Patient's allergies (medications, food and other products) related information was unknown. It was unknown if the patient ever had COVID  test or diagnosis.  The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). It was unknown if the patient experienced a similar event in the past. The patient had no symptoms.  No treatment medication information was provided.   Reporter did not allow further contact
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Expired vaccine used; 0.3ml administered as booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered as booster) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03AC21A, 025L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered as booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered as booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered as booster) to be not related.    No concomitant medication information was provided. No treatment medication were provided.   This case was linked to MOD-2022-486834 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given with no adverse reaction reported) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 011M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (HTN, Improved) since 2014, GERD (GERD, Controlled) and Hyperlipidemia. Concomitant products included AMLODIPINE from 2022 to an unknown date and EZETIMIBE, SIMVASTATIN (VYTORIN) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given with no adverse reaction reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given with no adverse reaction reported) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was H 25 MGCTZ and start date of Amlodipine was on 02-2022. The patient ethnicity were reported as Hispanic or Latino and not Hispanic or Latino and allergy reported as no known drug allergies. Patient did not diagnosed or tested positive with COVID-19. The treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: going to therapy every week "because of what I saw/Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (going to therapy every week "because of what I saw/Possible AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (going to therapy every week "because of what I saw/Possible AE). At the time of the report, ADVERSE EVENT (going to therapy every week "because of what I saw/Possible AE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  It was reported as patient was going to therapy every week. No treatment medication information was given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Follow up received contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Starts to feel okay again, Able to breathe again, shoulder pain went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Starts to feel okay again, Able to breathe again, shoulder pain went away) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Shoulder pain.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Starts to feel okay again, Able to breathe again, shoulder pain went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Starts to feel okay again, Able to breathe again, shoulder pain went away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient reported that four days after receiving the Moderna COVID-19 vaccination he starts to feel okay again, was able to breathe again and shoulder pain went away after he had it from COVID-19 before the shot. No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gait inability
Clinical narrative: Became weak; Couldn't walk well; This spontaneous case was reported by a physician and describes the occurrence of GAIT INABILITY (Couldn't walk well) and ASTHENIA (Became weak) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced GAIT INABILITY (Couldn't walk well). On 29-Dec-2021, the patient experienced ASTHENIA (Became weak). At the time of the report, GAIT INABILITY (Couldn't walk well) and ASTHENIA (Became weak) had not resolved.      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 medication was reported. It was reported that, on the same day, she was not the same person. She couldn't walk well and became weak the next day.  No treatment medication was reported.   This case was linked to MOD-2022-497995 (Patient Link).   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dyskinesia, Hallucination
Clinical narrative: hallucinating; movement was not like that of a young person; She couldn't balance.; This spontaneous case was reported by a physician and describes the occurrence of HALLUCINATION (hallucinating) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2022, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), DYSKINESIA (movement was not like that of a young person) and BALANCE DISORDER (She couldn't balance.). At the time of the report, HALLUCINATION (hallucinating), DYSKINESIA (movement was not like that of a young person) and BALANCE DISORDER (She couldn't balance.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was  provided. It was mentioned that the patient had been seen by doctors and was told to observe. The patient had two doses of vaccines and mentioned that on the same day, patient was not the same person. Patient couldn't walk well, and became weak the next day. It was reported that the patient has still having all the symptoms. No treatment medication information was provided  Company comment: This spontaneous case concerns a 26-year-old female patient with no medical history reported, who experienced the serious (medically significant) unexpected event of Hallucination, and associated events of Dyskinesia and Balance disorder, on the day after receiving the second dose of mRNA- 1273 vaccine. The patient had experienced Gait inability after the first dose of mRNA- 1273 vaccine, which was ongoing at the time of the report, but it is uncertain if the symptom worsened after the second dose. The patient visited a physician, and expectant management was decided. However, no further clinical information was provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2022-497979 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 26-year-old female patient with no medical history reported, who experienced the serious (medically significant) unexpected event of Hallucination, and associated events of Dyskinesia and Balance disorder, on the day after receiving the second dose of mRNA- 1273 vaccine. The patient had experienced Gait inability after the first dose of mRNA- 1273 vaccine, which was ongoing at the time of the report, but it is uncertain if the symptom worsened after the second dose. The patient visited a physician, and expectant management was decided. However, no further clinical information was provided. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Rash pruritic
Clinical narrative: rash that itches like hell all over my body/rash that itches intensely; Nauseated for 10-12 days; got tired just going to the bathroom; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash that itches like hell all over my body/rash that itches intensely), NAUSEA (Nauseated for 10-12 days) and FATIGUE (got tired just going to the bathroom) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tracheostomy. Concurrent medical conditions included Heart failure.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (rash that itches like hell all over my body/rash that itches intensely), NAUSEA (Nauseated for 10-12 days) and FATIGUE (got tired just going to the bathroom). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash that itches like hell all over my body/rash that itches intensely) had not resolved, NAUSEA (Nauseated for 10-12 days) had resolved and FATIGUE (got tired just going to the bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported as patient was very short winded.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness
Clinical narrative: had flu-like symptoms with first two doses /flu-like syndrome; feeling terrible for over a week with each shot; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu-like symptoms with first two doses /flu-like syndrome) and FEELING ABNORMAL (feeling terrible for over a week with each shot) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Ex-smoker (0.5 packs/day) and Ex-tobacco user (Pt quit 18 years ago). Previously administered products included for Product used for unknown indication: Influenza (Flu) Vaccine on 19-Sep-2019. Past adverse reactions to the above products included No adverse event with Influenza (Flu) Vaccine. Family history included CVA (Paternal Grandfather) and Type II diabetes mellitus (Father). Concurrent medical conditions included Hyperlipidemia (Improvement, under control with diet and medication) since 09-Jan-2002, Hypertension (Improvement, under control with diet and medication) since 01-Jan-2015, Anxiety (Improvement, under control with diet and medication) since 09-Jan-2006, GERD (Improvement, under control with diet and medication) since 01-Jan-2002, Post-traumatic stress disorder (Improvement, under control with diet and medication) since 09-Jan-2006, Alcohol use (1 standard drink = 0.6 oz pure alcohol,1-2 glasses every other week) and Marijuana use (3.0 times per week,Helps with anxiety, per pt, and he prefers it to Xanax). Concomitant products included OMEPRAZOLE from 01-Jan-2006 to an unknown date for GERD, ATORVASTATIN from 01-Jan-2015 to an unknown date for Hyperlipidemia, AMLODIPINE from 01-Jan-2015 to an unknown date for Hypertension, SERTRALINE from 06-Jan-2019 to an unknown date for Post-traumatic stress disorder, ALPRAZOLAM from 06-Jan-2019 to an unknown date for Post-traumatic stress disorder and Anxiety.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu-like symptoms with first two doses /flu-like syndrome) and FEELING ABNORMAL (feeling terrible for over a week with each shot). At the time of the report, INFLUENZA LIKE ILLNESS (had flu-like symptoms with first two doses /flu-like syndrome) outcome was unknown and FEELING ABNORMAL (feeling terrible for over a week with each shot) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient received vaccine on right shoulder.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-445640, MOD-2022-498346.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Chromaturia, Dysuria, SARS-CoV-2 test
Clinical narrative: burning sensation when urinating; his urine is black; lower back pains; had chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (burning sensation when urinating), CHROMATURIA (his urine is black), BACK PAIN (lower back pains) and CHILLS (had chills) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in August 2020. Concurrent medical conditions included Penicillin allergy.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced DYSURIA (burning sensation when urinating), CHROMATURIA (his urine is black), BACK PAIN (lower back pains) and CHILLS (had chills). At the time of the report, DYSURIA (burning sensation when urinating), CHROMATURIA (his urine is black) and CHILLS (had chills) had not resolved and BACK PAIN (lower back pains) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, SARS-CoV-2 test: positive (Positive) POSITIVE.         No concomitant were reported. It was reported that patient had no Acute and Chronic illnesses at the time of vaccination.Patient stated that had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that back pain has gotten Better, everything else is the same. No treatment were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatments were reported. It was reported that Expired vaccine given with no adverse reaction
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Expired vaccine used; 0.3ml administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 038B21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Myalgia, Depression and Conjunctivitis. Concurrent medical conditions included Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 12-Mar-2021 to an unknown date and HYDROXYZINE (ATARAX [HYDROXYZINE]) from 12-Mar-2021 to an unknown date for Anxiety.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (0.3ml administered).    The patient received expired vaccine but not experienced any adverse reaction.  No treatment drug details was reported.   This case was linked to MOD-2022-486834 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Overdose
Clinical narrative: Expired vaccine used; 0.3 ml administered as booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3 ml administered as booster) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 047B21A and 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Dyslipidemia (start date of dyslipidemia was in 2022) and Depression since 2020.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3 ml administered as booster). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and OVERDOSE (0.3 ml administered as booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown that, the patient was tested positive for COVID-19 or not. No concomitant and treatment medications were reported. No adverse event was reported and the patient did not seek any medical care.