chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Groin pain
Clinical narrative: Pain in groin for one full week; Left testicle swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 17:00 (Lot number: F51614) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GROIN PAIN (non-serious) with onset 15Jan2022 05:15, outcome "unknown", described as "Pain in groin for one full week"; TESTICULAR SWELLING (non-serious) with onset 15Jan2022 05:15, outcome "unknown", described as "Left testicle swollen.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of groin pain, testicular swelling.  Additional information: Patient did not have covid prior to vaccination. Patient tested covid post vaccination. Patient did not have known allergies. Patient did not take other vaccine in four weeks. Patient did not take other medication in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Groin pain, SARS-CoV-2 test, Testicular swelling
Clinical narrative: Pain in groin for one full week; Left testicle swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Jan2022 17:00 (Lot number: F51614) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GROIN PAIN (non-serious) with onset 15Jan2022 05:15, outcome "unknown", described as "Pain in groin for one full week"; TESTICULAR SWELLING (non-serious) with onset 15Jan2022 05:15, outcome "unknown", described as "Left testicle swollen.". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of groin pain, testicular swelling.  Additional information: Patient did not have covid prior to vaccination. Patient tested covid post vaccination. Patient did not have known allergies. Patient did not take other vaccine in four weeks. Patient did not take other medication in two weeks.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram coronary normal, Chest pain, Electrocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: Heart attack; Heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 (Lot number: 32030BD) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Thyroid. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EN6207), administration date: 17Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, LOT: EWO153), administration date: 08Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Heart attack"; CARDITIS (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Heart inflammation". The patient was hospitalized for myocardial infarction, carditis (start date: 06Feb2022). The events "heart attack" and "heart inflammation" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myocardial infarction, carditis. Reported that had a heart attack last week and my doctor said that it was due to me having a reaction to the COVID 19 vaccine because I had heart inflammation and he told me that I need to call and tell you guys this was what was going on. I went to the hospital. I had a heart attack and they gave me pills now. Prior vaccination before four weeks was none reported.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carditis, Myocardial infarction
Clinical narrative: Heart attack; Heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Nov2021 (Lot number: 32030BD) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Thyroid" (unspecified if ongoing), notes: Thyroid. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, LOT: EN6207), administration date: 17Mar2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose: 2, LOT: EWO153), administration date: 08Apr2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Heart attack"; CARDITIS (hospitalization, medically significant) with onset Feb2022, outcome "unknown", described as "Heart inflammation". The patient was hospitalized for myocardial infarction, carditis (start date: 06Feb2022). The events "heart attack" and "heart inflammation" were evaluated at the physician office visit. Therapeutic measures were taken as a result of myocardial infarction, carditis. Reported that had a heart attack last week and my doctor said that it was due to me having a reaction to the COVID 19 vaccine because I had heart inflammation and he told me that I need to call and tell you guys this was what was going on. I went to the hospital. I had a heart attack and they gave me pills now. Prior vaccination before four weeks was none reported.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022; Patient received expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2022, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022) 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 the vials were set to expire on 12-Feb-2022 and based on the stickers they were putting. On 13-Jan-2022, Vaccines placed in refrigerator.  There was no product complaint associated. No treatment medications were reported.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022; Patient received expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Feb-2022, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine placed in refrigerator was on 13-Jan-2022 and dose administered to patient was on 17-Feb-2022) 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 the vials were set to expire on 12-Feb-2022 and based on the stickers they were putting. On 13-Jan-2022, Vaccines placed in refrigerator.  There was no product complaint associated. No treatment medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. On 13-Jan-2022, the vial was initially stored in the refrigerator.  It was reported that as per the healthcare provider, the vials were set to expire on 12-Feb-2022 based on the stickers put on them. The healthcare provider was not sure and did not have the exact expiration date of the vial itself. The healthcare provider asked if they are going to revaccinate the patient or not.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.  It was reported that the vial was placed in refrigerator on 13-Jan-2022.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  It was reported that the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was12-Feb-2022.  No treatment medication was reported by the reporter.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose admistered to patient on 17-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter.  It was reported that the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was12-Feb-2022.  No treatment medication was reported by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter  No Treatment Information were provided by the Reporter
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received expired dose of the Moderna COVID-19 vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Feb 17, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2022, patient administered expired product (received expired dose of the Moderna COVID-19 vaccine). At the time of the report, administered expired product (received expired dose of the Moderna COVID-19 vaccine) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, the vaccines were placed in the refrigerator on Jan 13, 2022. The vials expired on Feb 12, 2022 (based on the stickers/labels). HCP was not sure and did not have the exact expiration date of the vial itself.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patients who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  As per HCP the vials were set to expire on 12Feb2022 based on the stickers they were putting. The HCP was not sure and did not had the exact expiration date of the vial itself.  No treatment medications were reported.   This case was linked to MOD-2022-491348 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/22 and dose admistered to patient on 2/17/22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  As per HCP the vials were set to expire on 12Feb2022 based on the stickers they were putting. The HCP was not sure and did not had the exact expiration date of the vial itself.  No treatment medications were reported.   This case was linked to MOD-2022-491348 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine) 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 13 Jan 2022 vaccines placed in refrigerator.  No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) 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 the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was 12-Feb-2022.  No treatment medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 13-Jan-2022 and dose administered to patient on 17-Feb-2022) 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 the vaccines were placed in refrigerator on 13-Jan-2022. Expiration date placed on vial was 12-Feb-2022.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On 13-Jan-2022, the vial was initially stored in the refrigerator.  It was reported that as per the healthcare provider, the vials were set to expire on 12-Feb-2022 based on the stickers put on them. The healthcare provider was not sure and did not have the exact expiration date of the vial itself. The healthcare provider asked if they are going to revaccinate the patient or not.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Product storage error; patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. On 13-Jan-2022 vial was initially stored in the refrigerator. Vial expired on 12-Feb-2022 and administered to patients on 17-Feb-2022. Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. On 13-Jan-2022 vial was initially stored in the refrigerator. Vial expired on 12-Feb-2022 and administered to patients on 17-Feb-2022. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in refrigerator on 13-Jan-2022 vaccines.   No treatment medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported. Vaccines placed in refrigerator 13 Jan 2022 Expiration date placed on vials 12 feb 2022 Doses administered to patient 17 feb 2022
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported. Vaccines placed in refrigerator 13 Jan 2022 Expiration date placed on vials 12 feb 2022 Doses administered to patient 17 feb 2022
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Vaccines were placed in refrigerator On 13-Jan-2022.  The treatment information was unknown.   This case was linked to MOD-2022-491752 (Patient Link).
Age: 11.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Eleven year old patient given Pfizer (Purple, 12+)
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration
Clinical narrative: Have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; Discoloration throughout my body; Spotting happened immediately; Have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; Discoloration throughout my body; Spotting happened immediately; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 15:00 (Lot number: EW0178) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "Have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; Discoloration throughout my body; Spotting happened immediately". The event "have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; discoloration throughout my body; spotting happened immediately" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin discolouration, condition aggravated.  Additional information: Consumer got the first shot and had been getting discoloration spotting like darkening of color, throughout skin, throughout body and its worsening. Consumer went to dermatologist because the spotting happened immediately, had been taking Triamcinolone Acetonide ointment USP 0.1%. Treatment: Consumer stated, Only the ointment, that's it. The patient did not receive any other vaccines within four weeks prior to the vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Skin discolouration
Clinical narrative: Have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; Discoloration throughout my body; Spotting happened immediately; Have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; Discoloration throughout my body; Spotting happened immediately; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30May2021 15:00 (Lot number: EW0178) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SKIN DISCOLOURATION (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 2021, outcome "not recovered" and all described as "Have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; Discoloration throughout my body; Spotting happened immediately". The event "have been getting discoloration spotting like darkening of color, throughout my skin, throughout my body and its worsening; discoloration throughout my body; spotting happened immediately" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin discolouration, condition aggravated.  Additional information: Consumer got the first shot and had been getting discoloration spotting like darkening of color, throughout skin, throughout body and its worsening. Consumer went to dermatologist because the spotting happened immediately, had been taking Triamcinolone Acetonide ointment USP 0.1%. Treatment: Consumer stated, Only the ointment, that's it. The patient did not receive any other vaccines within four weeks prior to the vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dyspnoea, Fatigue
Clinical narrative: Extreme joint pain. Lower back pain. Fatigue in January 2022 and current.  Intermittent Shortness of breath noticed around January 2022.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Dyspnoea, Fatigue, Headache, Laboratory test
Clinical narrative: High Temperature for up to 4 days ,severe fatigue and body aches as well as getting out of breath and headaches which have continued since the the day of the vaccine
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, X-ray
Clinical narrative: High Temperature for up to 4 days ,severe fatigue and body aches as well as getting out of breath and headaches which have continued since the the day of the vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose normal, Dizziness, Tremor
Clinical narrative: Patient received COVID-19 vaccine. In the observation area, patient reported feeling weak and dizzy.  Patient continued in observation while staff got a stretcher; patient reported that her left side started to shake. A RRT was called and patient was transferred to the ED.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Bipolar disorder
Clinical narrative: Started showing signs of Bipolar Disorder.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Chest discomfort, Dyspnoea, Pain in extremity
Clinical narrative: Patient received vaccine at15:29. At 16:00 patient reported arm pain and stated that her chest felt tight and that she was not able to fully inhale and exhale. BP was taken at 15:30 BP 175/108 -- >  16:00  BP 177/110 -- > 16:05 BP 184/109; fingerstick at 16:10 was 103. A RRT was called and patient was transferred to the ED.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rashes and hives all over the body except for below the knees that come and go throughout the day.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Left underarm swelling the size of a baseball, I sent a message to my doctor.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Differential white blood cell count, Dysphagia, Eye swelling
Clinical narrative: Severe and widespread itching in every inch of my body, initially on my head/scalp and my pelvis and then expanded all over. Duration a good amount of time, maybe 10-15 minutes and then it went away. Same event the day after.  The third day I woke up with a more severe itching mixed to a strong and painful stomach pain, very similar to an acid reflux/heartburn type of pain, where I could barely swallow my saliva. I spent a mostly sleepless night fighting against this chest pain/burning feeling. The third day I needed to go to the Urgent Care. The itching kept migrating all over my body and showing severely, mostly in the morning after my awakening and in the evening before sleeping. At times I would wake up with red and swollen eyes, herpes on my lips and tonsillitis. Stomach pain very painful for a week before improving slightly with medications.