chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022; patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K2-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Batch no. EL3302, dose: 0.3 ml  Route: Intramuscular Body site: Left deltoid) on 25-Jan-2021, Pfizer (Dose 2, Batch no. EL9264, dose: 0.3 ml  Route: Intramuscular Body site: Left deltoid) on 22-Feb-2021, Pfizer (Dose 3, Batch no. FF8841 and dose: 0.3 ml  Route: Intramuscular Body site: Left deltoid) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Taken out of freezer on 20-Apr-2022/Vaccine administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was taken out of freezer on 20-Apr-2022 and out of freezer expiration date was 20-May-2022.  The vial did not undergo any temperature excursion.  No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30 days use by date or after manufacturer date of expiry; The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after 30 days use by date or after manufacturer date of expiry) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K2-2A, 013M20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30 days use by date or after manufacturer date of expiry). At the time of the report, PRODUCT STORAGE ERROR (Dose administered after 30 days use by date or after manufacturer date of expiry) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Moderna vaccine lot 033K2-2A manufacturer expiration date was reported as 20-May-2022 and was taken out of freezer on 20-Apr-2022. There were 13 booster doses in 1 vial. The vial was initially stored in the refrigerator on 20-Apr-2022. Out of freezer expiration date was reported as 20-May-2022. The vial did not undergo any temperature excursions.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-575471 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-575471:Master case
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 017E21A, 013M20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  On 24-May-2022, the patient was given expired (4 days expired) Moderna vaccine lot 033K21-2A (manufacturer expiration date 20-May-2022) Intramuscular 0.25mL as a fourth dose. Moderna vaccine lot 033K21-2A with manufacturer expiration date 20-May-2022 was taken out of freezer on 20-Apr-2022. Out of freezer expiration date was 20-May-2022.  The vial was initially stored in the refrigerator on 20-Apr-2022. The vial did not undergo any temperature excursion.  No treatment medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K212A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose number-1, dose and unit-0.3 milliliter, Batch number (EN6207), Route of administration- Intramuscular, Anatomical location-Right deltoid) on 22-Mar-2021, Pfizer (Dose number-2, dose and unit-0.3 milliliter, Batch number (EW0151), Route of administration- Intramuscular, Anatomical location-Left deltoid) on 12-Apr-2021, Pfizer (Dose number-3, dose and unit-0.3 milliliter, Batch number (FF2593), Route of administration- Intramuscular and Anatomical location-Left deltoid) on 30-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine on 24-May-2022) and PRODUCT STORAGE ERROR (Vaccine was taken out from freezer and stored initially in refrigerator on 20-Apr-2022, expired on 20-May-2022 and administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  On 24-May-2022, the patient was given expired (4 days expired) Moderna vaccine lot 033K21-2A (manufacturer expiration date 20-May-2022) Intramuscular 0.25mL as a fourth dose. Vial was taken out of freezer and was initially stored in the refrigerator on 20-Apr-2022. Out of freezer expiration date was 20-May-2022. The vial did not undergo any temperature excursion.  No treatment medications were provided.   This case was linked to MOD-2022-575471 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Gait inability
Clinical narrative: Patient could not walk; Bedridden; This spontaneous case was reported by a patient and describes the occurrence of GAIT INABILITY (Patient could not walk) and BEDRIDDEN (Bedridden) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 025C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced GAIT INABILITY (Patient could not walk) and BEDRIDDEN (Bedridden). At the time of the report, GAIT INABILITY (Patient could not walk) and BEDRIDDEN (Bedridden) outcome was unknown.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bradykinesia, Feeling abnormal, Pain in extremity
Clinical narrative: 24 hours after the 2nd booster, walking real slowly home from the pharmacy; didn't feel right, felt cloudy,It was like he hit a brick wall; arm was hurting; fever at night at approximately 2:30AM; shoulder was hurting; This spontaneous case was reported by a patient and describes the occurrence of BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy), FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall), PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy) and FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall). 16-Jun-2022, the patient experienced PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting). At the time of the report, BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy), FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall), PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2022, Body temperature: 100.6 100.6 F, 99.9 99.9 F and 99.5 99.5 F.         No concomitant medications were reported. No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 24 hours after the 2nd booster, walking real slowly home from the pharmacy; didn't feel right, felt cloudy,It was like he hit a brick wall; arm was hurting; fever at night at approximately 2:30AM; shoulder was hurting; This spontaneous case was reported by a patient and describes the occurrence of BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy), FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall), PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2022, the patient experienced BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy) and FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall). 16-Jun-2022, the patient experienced PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting). At the time of the report, BRADYKINESIA (24 hours after the 2nd booster, walking real slowly home from the pharmacy), FEELING ABNORMAL (didn't feel right, felt cloudy,It was like he hit a brick wall), PAIN IN EXTREMITY (arm was hurting), PYREXIA (fever at night at approximately 2:30AM) and ARTHRALGIA (shoulder was hurting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jun-2022, Body temperature: 100.6 100.6 F, 99.9 99.9 F and 99.5 99.5 F.         No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: could not look at the sun/eyes in the sunlight hurt; This spontaneous case was reported by a patient and describes the occurrence of PHOTOPHOBIA (could not look at the sun/eyes in the sunlight hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PHOTOPHOBIA (could not look at the sun/eyes in the sunlight hurt). At the time of the report, PHOTOPHOBIA (could not look at the sun/eyes in the sunlight hurt) outcome was unknown.     No concomitant medications were reported.  The reporter stated that she received her fourth dose of the Moderna Covid-19 Vaccine on Monday. During Tuesday and Wednesday she reported she could not look at the sun. Her eyes in the sunlight hurt, even with sunglasses. She never had this type of reaction before. She stated she was going to see her eye doctor.  No treatment medications were reported.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Cough, Depression, Fatigue
Clinical narrative: Cough; Adverse drug reaction; Fatigue extreme; Depression; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depression), COUGH (Cough), ADVERSE DRUG REACTION (Adverse drug reaction) and FATIGUE (Fatigue extreme) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic plaque psoriasis).   On 16-May-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 UNK. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced DEPRESSION (Depression), ADVERSE DRUG REACTION (Adverse drug reaction) and FATIGUE (Fatigue extreme). On an unknown date, the patient experienced COUGH (Cough). At the time of the report, DEPRESSION (Depression), COUGH (Cough) and FATIGUE (Fatigue extreme) outcome was unknown and ADVERSE DRUG REACTION (Adverse drug reaction) had not resolved.            No concomitant medications were reported.  On an unknown date, the patient experienced cough. in May 2022, the patient experienced adverse effect of skyrizi, severe fatigue and depression. Moderna covid-19 vaccine was also considered suspect.   The patient had been experiencing severe fatigue and depression in the May 2022 after her initial dose of skyrizi on 16 May 2022. she had cough.   The reporter causality for the event (s) of adverse effect of skyrizi, severe fatigue, depression and cough was not provided.   It was unknown if patient was enrolled in any Covid-19 vaccine trial.  No treatment medications were reported.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Influenza, SARS-CoV-2 test
Clinical narrative: COVID VACCINE BOOSTER GAVE FLU SYMPTOMS; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (COVID VACCINE BOOSTER GAVE FLU SYMPTOMS) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products COVID-19 VACCINE for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (Moderate to severe adult Crohn's disease.).   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form., fourth dose of COVID-19 VACCINE (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, CF. On an unknown date, the patient experienced INFLUENZA (COVID VACCINE BOOSTER GAVE FLU SYMPTOMS). At the time of the report, INFLUENZA (COVID VACCINE BOOSTER GAVE FLU SYMPTOMS) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient received Modena COVID-19 vaccine booster dose and COVID-19 vaccine 2nd booster dose. It was reported that the reporters causality for the event of COVID vaccine booster gave flu symptoms with Humira was not provided and with COVID-19 Vaccine was possible. No treatment information was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022; It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (It looks like there has been a couple of doses given this week. It should have been discarded on 10June2022 and a second booster dose was given 15June2022.) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 10-May-2022 should have been discarded by 10-Jun-2022 and was administered on 15-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received a second booster dose. Concomitant drugs were not reported.  It was reported that the vial was moved from freezer to fridge on 10-May-2022 and should have been discarded on 10-Jun-2022 and was administered 2 doses to patient on  13-Jun-2022 and 15-Jun-2022. The vial did not undergo any temperature excursion. It was also reported that patients have not called to report any side effects.   This case was linked to MOD-2022-590656 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration 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 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was placed in the refrigerator on 24APR2022 and had a 30 day beyond use date of 23APR2022/Focusing on the Use by date administered vaccine past the Manufacturers expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that lot number 068H21A which expired on 02-APR-2022 was placed in the refrigerator on 24-Mar-2022 and had a 30 day beyond use date of 23-Apr-2022. Focusing on the Use by date the vaccine was administered past the Manufacturers expiration date to the patient.  The patient received the booster dose.  It was also reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2022: Significant Live follow-up was received with patient information and suspect drug information.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial  was stored at room temperature of 69 for 23 hours.; vaccine administered to 2 patients more than 12 hours post puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered to 2 patients more than 12 hours post puncture.) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049L21A, 067F21A, 016M20A and 029K20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (sulfa), Drug allergy (Prednisone), Oil allergy (castor oil), GERD and Hypertension. Concomitant products included TOPIRAMATE, METOPROLOL TARTRATE (LOPRESSOR) and AMITRIPTYLINE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Jun-2022 at 1:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 17-Jun-2022 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered to 2 patients more than 12 hours post puncture.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered to 2 patients more than 12 hours post puncture.) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date the vial was initially stored in the refrigerator was 15-Jun-2022. It was first punctured on 16-Jun-2022 at 2:00 PM. Then it was stored at room temperature around 69 F post puncture. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range was 23 hours.  The patient had not tested positive or diagnosed with COVID-19. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as no. The event did not cause the patient to seek medical care. The patient did not experience a similar event in the past.  No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st booster shot on 26Apr2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster shot on 26Apr2021) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster shot on 26Apr2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st booster shot on 26Apr2021) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-590863 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial  was stored at room temperature of 69 for 23 hours.; Vaccine administered to 2 patients more than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049L21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic disease, Hypertension and Cardiomegaly. Concomitant products included METOPROLOL TARTRATE (LOPRESSOR) and AMLODIPINE for an unknown indication.    On 17-Jun-2022 at 1:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 17-Jun-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 2 patients more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial  was stored at room temperature of 69 for 23 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 15Jun2022 . Date(s) and time(S) vial was first punctured :16Jun2022 at 2:00 PM. The vial was  stored  at room temperature around 69 F post puncture . The vial did not undergo any temperature excursion. No treatment medication was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: not feeling well; her husband experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and CHILLS (her husband experienced chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013L20H) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza (given within 1 month prior to Moderna COVID-19 vaccine). Past adverse reactions to the above products included No adverse event with Influenza. Concurrent medical conditions included Hypertension, Alcoholism, Kidney failure, Allergy to animal (Cats) and Stomach function disorder. Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE for Stomach function disorder.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced MALAISE (not feeling well) and CHILLS (her husband experienced chills). On 23-Jan-2021, MALAISE (not feeling well) and CHILLS (her husband experienced chills) had resolved.            Patient did not seek any medical care and experienced a similar event in the past. No treatment medications were reported.   This case was linked to MOD-2022-591122, MOD-2022-591120 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial of Moderna with a BUD of 6/16/22 based on removal from freezer on 5/17/22, vial was given at approximately 8:30 am; 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 (vial of Moderna with a BUD of 6/16/22 based on removal from freezer on 5/17/22, vial was given at approximately 8:30 am) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-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 (vial of Moderna with a BUD of 6/16/22 based on removal from freezer on 5/17/22, vial was given at approximately 8:30 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date) and PRODUCT STORAGE ERROR (vial of Moderna with a BUD of 6/16/22 based on removal from freezer on 5/17/22, vial was given at approximately 8:30 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that Moderna vial had a before use date of 16-Jun-2022 based on removal from freezer on 17-May-2022.  A booster dose from that vial was given at approximately 8:30 am. No treatment drug was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine was administered to a patient as a booster dose past the published expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to a patient as a booster dose past the published expiry date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to a patient as a booster dose past the published expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered to a patient as a booster dose past the published expiry date) 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 adverse events were reported.   This case was linked to MOD-2022-590722, MOD-2021-307110 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) 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 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter has not yet contacted patients for follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after manufacturer date of expiry; Received expired first booster dose after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J COVID-19 Vaccine (First Dose) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 Vaccine.    On 17-Jun-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) 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 information was reported.  On 17-Jun-2022, patient received expired first booster dose of Moderna COVID-19 vaccine. Vial was removed from freezer at 10AM on 17-Jun-2022. 1 dose / 1 dose administered after manufacturer date of expiry. The vial did not undergo any temperature excursions. Patient was on way back to the vaccination site to be re-vaccinated. Re-vaccination was kept on hold, until Tier 2 team reaches out for regarding the urgent case.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered Moderna vaccine booster doses after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna vaccine booster doses after the published expiration date) in a 77-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 03-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna vaccine booster doses after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna vaccine booster doses after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.   No treatment drug information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individuals were administered Moderna vaccine booster doses after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individuals were administered Moderna vaccine booster doses after the published expiration date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individuals were administered Moderna vaccine booster doses after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individuals were administered Moderna vaccine booster doses after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Side effect) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effect). At the time of the report, IMMUNISATION REACTION (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient received booster dose.  Treatment details was not reported by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Individual were administered Moderna vaccine booster dose after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Individual were administered Moderna vaccine booster dose after the published expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  Reporter has not yet contacted patients for follow up.