chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test positive, Vision blurred, White blood cell count increased
Clinical narrative: Patient presented on 12/27/2021 with right facial droop and right sided weakness. He also reports numbness in his lips with blurry vision. He had further complaints of chest pain and shortness of breath.  Patient was admitted for closer monitoring. Infectious work up completed when patient was noted to be febrile 101.8F. IV ABX initiated vancomycin and Zosyn, and patient tested positive for COVID-19. During this hospitalization he was also noted to have afib. Neurology was consulted who recommended repeat MRI however could not be completed due to patient's underlying respiratory status  Went into AFib RVR on 01/08 and was started on amiodarone drip, amiodarone drip was subsequently stopped due to bradycardia   January 13, WBC is 23 which is improved from 27. He is on HFNC 50L 70%. BP is elevated; restarted hydralazine and minoxidil. He continues on meropenem.  January 15, patient has requested discontinuation of HD and oxygen support and requests comfort measures only.   Patient was pronounced expired at 16:25.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: After I got the vaccine, my period has been starting 5 to 7 days early every month.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine 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.   Reporter does not had any information about the patient height. Patients had no allergies.  Patients were not taking any concomitant medications.  Moderna Covid-19 booster dose was administered to 4 patients in that deltoid muscle. Patients did not received any other vaccine within 1 month prior to Moderna and at the time of the vaccination and did not had any acute or chronic illnesses. The reporter could not provide any information about the First and the Second dose of the vaccine but they were Moderna. The patients did not received a third dose of the Moderna Covid-19 vaccine and they were not experienced any symptoms yet.  Vial was initially stored in the refrigerator on 18 Jan 2022. Vial did not undergo any temperature excursions.  No treatment medications were provided. Patients did not tested positive for Covid-19.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Reporter details were updated
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna Covid-19 vaccine administered after 30-day Use By Date; Moderna Covid-19 vaccine administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine 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.   The patient was not taking any concomitant medication.  It had been stated that administered to four patients in their deltoid muscle. It had been stated that paitent were not allergies and also did not tested positive for Covid-19. Paitent did not received any other vaccine within one month prior to Moderna and at the time of the vaccination and also did not had any acute or chronic illnesses. . Also did not provide any information about the First and the Second dose of the vaccine. The patient did not receive a third dose of the Moderna Covid-19 vaccine and they did not experienced any symptoms.  Date the vial was initially stored in the refrigerator was 18-Jan-2022.  No Treatment medication reported   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Reporter contact information was updated.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date; Moderna Covid-19 vaccine administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of the Moderna Covid-19 vaccine administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine 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. The reporter did not have any information about the patients height, had no allergies and was not tested positive for Covid-19. The patients did not receive any other vaccine within 1 month prior to Moderna's and, at the time of the vaccination. The patients did not have any acute or chronic illnesses. The caller could not provide any information about the first and the second dose of the vaccine, but only recalled that they were Moderna's. The patients did not receive a third dose of the Moderna Covid-19 vaccine and they are not experiencing any symptoms yet. Number of doses or vials was 4 doses 1 vial. On 18-Jan-2022, the vial was initially stored in the refrigerator.  The vial was not underwent any temperature excursions. No concomitant and treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Follow up document contains reporter contact details was updated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: Patient may have received a booster dose from the vial of expired beyond use date of 02/25/2022; Pharmacy cannot determine if nurse drewthe dose from vial with beyond use date 25-Feb-2022 or moderna vial #lot#070H21A beyond use date of 02-Mar-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient may have received a booster dose from the vial of expired beyond use date of 02/25/2022) and PRODUCT ADMINISTRATION ERROR (Pharmacy cannot determine if nurse drewthe dose from vial with beyond use date 25-Feb-2022 or moderna vial #lot#070H21A beyond use date of 02-Mar-2022) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     The patient's past medical history included Deviated nasal septum. Concurrent medical conditions included Hyperlipidemia, Pulmonary granuloma, HIV infection, Early satiety and Anxiety. Concomitant products included TRAZODONE, BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) and PROPRANOLOL HYDROCHLORIDE (PROPRANOL) for an unknown indication.    On 26-Feb-2022 at 8:51 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2022 at 8:51 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient may have received a booster dose from the vial of expired beyond use date of 02/25/2022) and PRODUCT ADMINISTRATION ERROR (Pharmacy cannot determine if nurse drewthe dose from vial with beyond use date 25-Feb-2022 or moderna vial #lot#070H21A beyond use date of 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient may have received a booster dose from the vial of expired beyond use date of 02/25/2022) and PRODUCT ADMINISTRATION ERROR (Pharmacy cannot determine if nurse drewthe dose from vial with beyond use date 25-Feb-2022 or moderna vial #lot#070H21A beyond use date of 02-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunosuppressed patient received the booster instead of third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunosuppressed patient received the booster instead of third dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included METHOTREXATE, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), FOLIC ACID, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunosuppressed patient received the booster instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunosuppressed patient received the booster instead of third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had no acute and chronic illnesses at the time of vaccination. It was reported that the pharmacist wanted to know how to give the third dose of the Moderna COVID-19 vaccine to patient that received the booster of 0.25. There was no product complaint associated. No treatment medications were reported. It was reported that the patient never had COVID positive test or diagnosis.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Arm hurt; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), CHILLS (Chills) and PYREXIA (Fever) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.    On 31-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurt), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm hurt), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided by the reporter. No treatment information was reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired; On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 9:58 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Jan-2022 at 9:58 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna vaccine was pulled from the freezer on 16-Dec-2021. BUD date was 15-Jan-2022 which was printed in red and taped to the top of the boxes. On 26-Jan-2022, the staff brought it to attention that it was still in the fridge and was expired. It was also reported that 5 doses had been given at that point. On 27-Jan-2022, remaining county sites were checked. All other clinics had been found to have same error of not noticing the BUD date. It was reported that the patient mother/guardian were notified of the error and were also notified that a repeat vaccination was not required. Patient denied any adverse effects. No concomitant medications were reported.  No treatment medications were reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022; 5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022; Patient had 0.5 ml booster dose instead of 0.25ml; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022), ACCIDENTAL OVERDOSE (Patient had 0.5 ml booster dose instead of 0.25ml) and PRODUCT STORAGE ERROR (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 9:59 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Jan-2022 at 9:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) and ACCIDENTAL OVERDOSE (Patient had 0.5 ml booster dose instead of 0.25ml). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022), ACCIDENTAL OVERDOSE (Patient had 0.5 ml booster dose instead of 0.25ml) and PRODUCT STORAGE ERROR (5 doses of the Moderna Covid-19 Vaccine were given past the beyond use date of 15Jan2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna vaccine pulled from freezer on 12/16/2021. date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired and given 5 doses to the patients.  No concomitant products were reported. No treatment drugs were reported
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022; Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 5:34 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Jan-2022 at 5:34 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-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.  No treatment medications were reported.  Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes.  On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point.  Patient notified of error and that a repeat vaccine was not required.  Patient denied any adverse effects.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired 5 doses had been given; Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022 at 3:19 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In January 2022, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-2022). On 16-Jan-2022 at 3:19 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 and and administered on 16-Jan-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.  On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point. BUD date reported as 15 Jan 2022.  On 31-Jan-2022, Moderna responded revaccination was not required.  Patient denied any adverse effects.  No treatment medications were reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge; Expired 5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022 at 3:20 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Jan-2022 at 3:20 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, it was noted that the vaccine was still in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Moderna vaccine was pulled from the freezer on 16-Dec-2021. The beyond use date was 15-Jan-2022 printed in red and taped to the top of the boxes. On 26-Jan-2022, it was noted that the vaccine was still in the fridge and expired 5 doses had been given at that point. On 31-Jan-2022, Moderna responded that revaccination not required.  Later, the patient was notified of error and repeat vaccine was not required. Patient denies any adverse event.  No treatment medications were reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.; Expired dose had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose had been given) and PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2022 at 9:53 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2022 at 9:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose had been given) and PRODUCT STORAGE ERROR (On 16-Dec-2021, moderna vaccine was pulled from freezer. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 16-Dec-2021, moderna vaccine was pulled from freezer. Beyond use date was reported as 15-Jan-2022, which was printed in red and taped to the top of boxes. On 26-Jan-2022, staff brought it to attention that it was still in the freezer and expired. Total 5 doses had been given at that point. On 27-Jan-2022, remaining sites were checked. All other clinics found to have same error of not noticing the beyond use date. The date was then added to daily covid usage and wastage report. On 31-Jan-2022, moderna responded as revaccination was not required.  The patient was notified about medication error and she denied of any adverse events.  No treatment medication were provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: expired 5 doses had been given; The staff brought to the attention that it is still in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired 5 doses had been given) and PRODUCT STORAGE ERROR (The staff brought to the attention that it is still in the fridge) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022 at 3:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jan-2022 at 3:52 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired 5 doses had been given) and PRODUCT STORAGE ERROR (The staff brought to the attention that it is still in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired 5 doses had been given) and PRODUCT STORAGE ERROR (The staff brought to the attention that it is still in the fridge) 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. Moderna vaccine pulled from freezer on 16-Dec-2021. BUD date of 15-Jan-2022 printed in red and taped to the top of the boxes.  On 26-Jan-2022, staff brought it to attention that it was still in the fridge and expired 5 doses had been given at that point.  Patient notified of error and that a repeat vaccine was not required.  Patient denied any adverse effects.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling, Expired product administered, Lymphadenitis, Product storage error
Clinical narrative: Swollen lymphnodes and breast tissue on same side as vaccine; Swollen lymphnodes and breast tissue on same side as vaccine; BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge; Expired-5 doses had been given; This spontaneous case was reported by a nurse and describes the occurrence of BREAST SWELLING (Swollen lymphnodes and breast tissue on same side as vaccine), LYMPHADENITIS (Swollen lymphnodes and breast tissue on same side as vaccine), EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2022 at 4:07 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2022 at 4:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given). On an unknown date, the patient experienced BREAST SWELLING (Swollen lymphnodes and breast tissue on same side as vaccine), LYMPHADENITIS (Swollen lymphnodes and breast tissue on same side as vaccine) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge). At the time of the report, BREAST SWELLING (Swollen lymphnodes and breast tissue on same side as vaccine), LYMPHADENITIS (Swollen lymphnodes and breast tissue on same side as vaccine), EXPIRED PRODUCT ADMINISTERED (Expired-5 doses had been given) and PRODUCT STORAGE ERROR (BUD date was 15-Jan-2022, on 26-Jan-2022 Staff brought it to attention that it was still in fridge) 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 Moderna vaccine was pulled from freezer on 16-Dec-2021, BUD Date of 15-Jan-2022 was printed on top of boxes. On 26-Jan-2022 staff brought it to attention that it was still in fridge. On 31-Jan-2022 Moderna responded that revaccination was not required. It was also reported that Patient reported adverse effects. Per society of breast imaging COVID Vaccine can cause abnormal mammograms up to 6 weeks.   No Treatment was reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point; Expired 5 doses of Moderna Covid-19 Vaccine had been given; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 5 doses of Moderna Covid-19 Vaccine had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2022 at 3:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jan-2022 at 3:28 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 5 doses of Moderna Covid-19 Vaccine had been given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 5 doses of Moderna Covid-19 Vaccine had been given) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 16-Dec-2021 and on 26-Jan-2022, staff brought it to attention that the vaccine was still in the fridge and expired 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Moderna vaccine was pulled from the freezer on 16 Dec 2021. The beyond use date was 15 Jan 2022 printed in red and taped to the top of the boxes. On 26-Jan-2022, it was noted that the vaccine was still in the fridge and expired 5 doses had been given at that point.   On 31-Jan-2022, Moderna responded that revaccination not required.  The patient were notified of the error and that a repeat vaccination was not required. Patient denied any adverse effects.  No treatment medications were reported.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003K21-2A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, LISINOPRIL and PHENTERMINE for an unknown indication.    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a Moderna booster dose from a vial that has been open more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that first and second dose details were unknown. It was reported that patient did not have other vaccines. Symptoms and COVID-19 positive details were unknown. No treatment information details were reported.
Age: 68.0
Sex: F
Vaccine: COVID19, PPV
Symptoms: Fatigue, Limb discomfort, Poor quality product administered, Product storage error, Vaccination site pain
Clinical narrative: one vial who was been administered after 30 days on fridge; Arm Discomfort; Fatigued; Very sore arm at the injection site; Patient received vaccine 4 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (Arm Discomfort), FATIGUE (Fatigued), VACCINATION SITE PAIN (Very sore arm at the injection site), POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date) and PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022J21A) for COVID-19 vaccination.    Co-suspect product included non-company product PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) for an unknown indication.    Concurrent medical conditions included Blood pressure abnormal and Penicillin allergy. Concomitant products included AMLODIPINE for Blood pressure abnormal.   On 10-Feb-2022, the patient received first dose of PNEUMOCOCCAL VACCINE POLYSACCH 23V (PNEUMOVAX 23) (Intramuscular) 1 dosage form. On 10-Feb-2022 at 12:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date). On 11-Feb-2022, the patient experienced LIMB DISCOMFORT (Arm Discomfort), FATIGUE (Fatigued) and VACCINATION SITE PAIN (Very sore arm at the injection site). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge). On 11-Feb-2022, FATIGUE (Fatigued) had resolved. On 12-Feb-2022, LIMB DISCOMFORT (Arm Discomfort) and VACCINATION SITE PAIN (Very sore arm at the injection site) had resolved. At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date) and PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered FATIGUE (Fatigued) and VACCINATION SITE PAIN (Very sore arm at the injection site) to be related. No further causality assessments were provided for LIMB DISCOMFORT (Arm Discomfort), POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine 4 days after use by date) and PRODUCT STORAGE ERROR (one vial who was been administered after 30 days on fridge).    Treatment information was not provided by the reporter.   This case was linked to MOD-2022-500102 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reaction to moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergic to IVP DYE), Fish allergy and Shellfish allergy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to moderna). At the time of the report, VACCINATION COMPLICATION (Reaction to moderna) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna COVID-19 Vaccine 3 days earlier than the allowed grace period) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A and 070H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna COVID-19 Vaccine 3 days earlier than the allowed grace period). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the second dose of Moderna COVID-19 Vaccine 3 days earlier than the allowed grace period) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; Very sore arm at the injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (Very sore arm at the injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Hypertension. Concomitant products included AMLODIPINE for Hypertension.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (Very sore arm at the injection site). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (Very sore arm at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2022-500058 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge; HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge) and PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 10-Feb-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge) and PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  Patient received vaccine four days after use by date and stated that patient experienced no adverse side effects from vaccine.  HCP stated that they received a box of vials on 7 Jan 2022. There was one vial which was used after 30 days being in the fridge (30 days were on 6 Feb 2022) and they administered Moderna COVID-19 vaccine to five patients. The vaccines were administered in the pharmacy. On 10 Feb 2022 the patients received the vaccine one hours after first puncture. HCP stated that there was no temperature excursion during the administration of that vial (the vials were in the fridge).  No treatment information was provided.   This case was linked to MOD-2022-480636.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date; Patient received vaccine 3 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 3 days after use by date) and PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 4:06 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Feb-2022 at 4:06 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 3 days after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine 3 days after use by date) and PRODUCT STORAGE ERROR (HCP administered to 5 patients vaccines after 30 days the vaccines were on the fridge / Patient received vaccine 3 days after use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided.  There was one vial which was been administered after 30 days on fridge (30th day was on 06-Feb-2022). The patient received 1 booster and 1 primary dose. On 09-Feb-2022 the patient received the vaccine almost 3 hours after the first puncture. HCP stated that there was no temperature excursion during the administration of that vial ( the vials were in the fridge). It was reported that the patient experienced no adverse events.  No Treatment Medications were provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Codeine), Drug allergy (Allergic to Phenergan), Allergy to chemicals (Allergic to Contrast dye) and Peanut allergy. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, CLOPIDOGREL, CARVEDILOL, ASPIRIN [ACETYLSALICYLIC ACID], TAMOXIFEN, TRAMADOL and PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient experienced a sore arm after the first dose.  The patient claimed that the patient never got Covid19 even though their granddaughter got covid19 after having the Pfizer vaccine.  It was also reported that the patient was allergic to codeine, Phenergan, contrast dye, peanuts, and others and denied past medical history. The patient was taking Clopidogrel, carvedilol 6.25, allergy medicine Benadryl, aspirin 81 mg, tamoxifen at the time of the vaccinations and was also on tramadol and arthritis strength Tylenol but couldn't remember if these were started after the vaccination.  No treatment information was provided.   This case was linked to MOD-2022-500353 (Patient Link).