chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Temperature Excursion issue; The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A and o32H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature Excursion issue) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 21-Mar-2022, expired on 16-Apr-2022 and was administered on 18-Apr-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 his first vaccination (unknown brand) on 9-Jan-2021 in his left arm , lot number 025L20A, expiration date was not available. no adverse events or side effects were reported, it was also reported that patient received his first vaccination (unknown brand) on 6-Feb-2021 in his left arm , lot number 016M20A, expiration date was not available. no adverse events or side effects were reported.  No concomitant medications were reported  It was reported that the nurse did not noticed the expiration date of the Moderna Covid-19 vaccine The vial was initially stored in the refrigerator on 21-Mar-2022.  No treatments were reported
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: low grade fever (98.8°F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever (98.8°F)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever (98.8°F)). At the time of the report, PYREXIA (low grade fever (98.8°F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.8 (High) 98.8 degree F.         No concomitant medications were reported. Patient received their second booster shot and was experiencing a low grade fever. Treatment information was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Tremor
Clinical narrative: Got real hot after 2nd booster dose; Shaking like crazy after 2nd booster dose; Had chills after 2nd booster dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Got real hot after 2nd booster dose), TREMOR (Shaking like crazy after 2nd booster dose) and CHILLS (Had chills after 2nd booster dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 052F21A, 039B21A and 039B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to vaccine (Tetanus) and Blood pressure abnormal. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LISINOPRIL and AMLODIPINE for Blood pressure abnormal.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2022 at 8:30 AM, the patient experienced FEELING HOT (Got real hot after 2nd booster dose), TREMOR (Shaking like crazy after 2nd booster dose) and CHILLS (Had chills after 2nd booster dose). At the time of the report, FEELING HOT (Got real hot after 2nd booster dose), TREMOR (Shaking like crazy after 2nd booster dose) and CHILLS (Had chills after 2nd booster dose) outcome was unknown.            It was reported that patient not had Covid test nor diagnosed with Covid.  Patient did not received treatment for the events.   This case was linked to MOD-2022-543463, MOD-2022-543447, MOD-2022-543464, MOD-2022-543463 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 01-Apr-2022 and stored in refrigerator on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were initially stored in the refrigerator on 13 Apr 2022 around 8pm. The vial did not undergo any temperature excursions. Patient received 1st booster dose.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 01 Apr 2022 and stored in refrigerator on 13 Apr 2022 around 8 PM; Received expired booster dose beyond MFG expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and stored in refrigerator on 13 Apr 2022 around 8 PM) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and stored in refrigerator on 13 Apr 2022 around 8 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired booster dose beyond MFG expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 01 Apr 2022 and stored in refrigerator on 13 Apr 2022 around 8 PM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient received expired 1st booster dose. Vial was initially stored in the refrigerator on 13 April 2022 around 8PM and the vial did not undergo any temperature excursions.   No treatment details were reported.   This case was linked to MOD-2022-543469 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: felt tired a day after receiving the Moderna Covid-19 vaccine.; painful injection site.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired a day after receiving the Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (painful injection site.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced FATIGUE (felt tired a day after receiving the Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (painful injection site.). At the time of the report, FATIGUE (felt tired a day after receiving the Moderna Covid-19 vaccine.) and VACCINATION SITE PAIN (painful injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. The patient received his first vaccine in his left arm shoulder deltoid muscle. No treatment information was provided by the reporter.   This case was linked to MOD-2022-543480, MOD-2022-543477 (Patient Link).
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered some vaccine that were expired a week ago. It was kept in the fridge.; Patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge.) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported.  The vaccines expired a week before administering it. The vial did not undergo any temperature excursions. The vials were stored in the refrigerator on 28-Feb-2022. The was administered with second booster dose.  No treatment were reported.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022; A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A 1st booster dose of expired Moderna Covid-19 vaccine was administered to a patient today.) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12-Apr-2022 and administered on 19-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that number of doses/vials were 1 dose and vial was not undergone any temperature excursions.  The treatment information was unknown.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022; Patients were administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.  On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 28-Feb-2022 and administered on 18-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vials did not go with any temperature excursions.  No treatment medication was reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: The patient was tired the next day; Patient had a sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient had a sore injection site arm) and FATIGUE (The patient was tired the next day) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A, 026L20A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient had a sore injection site arm). On 03-Feb-2021, the patient experienced FATIGUE (The patient was tired the next day). In February 2022, FATIGUE (The patient was tired the next day) had resolved. At the time of the report, VACCINATION SITE PAIN (Patient had a sore injection site arm) outcome was unknown.            No concomitant medication was reported. The event tiredness lasted for 10 to 12 hours as reported. No treatment medication details were reported.   This case was linked to MOD-2022-543480, MOD-2022-543473 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered some vaccine that were expired a week ago. It was kept in the fridge.; patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A.) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) 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 seven patients were administered an expired vaccine. Vials were stored in the refrigerator on 28-Feb-2022 and were all administered on 18-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to MOD-2022-543471-KC, MOD-2022-543474-CH, MOD-2022-543476-LH, MOD-2022-543479-DF, MOD-2022-543481-RK, (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients were administered an "expired" vaccine; Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (Vials were stored in the refrigerator on 28Feb2022 and were all administered on 18April2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that the vaccines expired a week ago. The vial did not undergo any temperature excursions. Vials were stored in the refrigerator on 28-Feb-2022.  Treatment medications were not reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tired the next day; Pain in injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in injection site arm) and FATIGUE (tired the next day) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 031L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Pain in injection site arm). On 21-Oct-2021, the patient experienced FATIGUE (tired the next day). At the time of the report, VACCINATION SITE PAIN (Pain in injection site arm) and FATIGUE (tired the next day) outcome was unknown.            No concomitant medication reported.  The patient received his third vaccine in his left arm shoulder deltoid muscle.  No treatment medication reported.   This case was linked to MOD-2022-543473, MOD-2022-543477 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered some vaccine that were expired a week ago. It was kept in the fridge.; patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept 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 information was reported.  It was reported that the vaccines expired a week ago. The vial did not undergo any temperature excursions. Vials were stored in the refrigerator on 28-Feb-2022   This case was linked to MOD-2022-543471 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered some vaccine that were expired a week ago. It was kept in the fridge; Patients were administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine) and PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered an expired vaccine) and PRODUCT STORAGE ERROR (Administered some vaccine that were expired a week ago. It was kept in the fridge) 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 on 28-Feb-2022. No concomitant medication was reported.    No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: father also received expired Moderna Covid-19 booster doses; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (father also received expired Moderna Covid-19 booster doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (father also received expired Moderna Covid-19 booster doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (father also received expired Moderna Covid-19 booster doses) outcome was unknown.            No concomitant medications were reported.  No treatment medication reported.   This case was linked to MOD-2022-544178 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine for her first Moderna Covid-19 booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her first Moderna Covid-19 booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007D21A, 044A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her first Moderna Covid-19 booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine for her first Moderna Covid-19 booster dose) outcome was unknown.            No concomitants were reported. Expiration date was 22 NOV 2021. The patient reported no adverse reactions or side effects to her first and second vaccine. No Treatments were reported.   This case was linked to MOD-2022-544178, MOD-2022-543577 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2022: Follow-up received updated No New Information.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Immunisation reaction, Lymphadenopathy, Pyrexia
Clinical narrative: Extreme reactions to every shot; Was really sick; High fever; Had lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Extreme reactions to every shot), ILLNESS (Was really sick), PYREXIA (High fever) and LYMPHADENOPATHY (Had lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Extreme reactions to every shot), ILLNESS (Was really sick), PYREXIA (High fever) and LYMPHADENOPATHY (Had lymph nodes). At the time of the report, VACCINATION COMPLICATION (Extreme reactions to every shot), ILLNESS (Was really sick), PYREXIA (High fever) and LYMPHADENOPATHY (Had lymph nodes) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-543645 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: tiredness; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (tiredness), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was reported that patient received first booster dose.   This case was linked to MOD-2022-543630, MOD-2022-543615, MOD-2022-543563 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient is allergic to Demerol), Blood pressure high (20 years ago No recent change in status such as improvement or worsening) and Cholesterol (20 years ago No recent change in status such as improvement or worsening). Concomitant products included LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, VENLAFAXINE for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced FATIGUE (Fatigue). On 16-Jan-2021, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Height of the patient 6' It was reported that patient never had COVID + test or diagnosis,no other vaccines given within 1 month prior to Moderna COVID-19 vaccine and patient doesn't experienced any similar event in the past. No treatment information were reported by the reporter.   This case was linked to MOD-2022-543739 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sluggishness
Clinical narrative: felt a little more sluggish after the booster, more than the other two doses,; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001C21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,). At the time of the report, SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,) had resolved Patient  also stated that he felt a little more sluggish after the booster, more than the other two doses, and that it indicates that he had a lot of antibodies.  Concomitant medications were not reported. Treatment medications were not reported.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sluggishness, Vaccination site erythema, Vaccination site reaction
Clinical narrative: felt a little more sluggish after the booster, more than the other two doses,; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 001C21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,). At the time of the report, SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,) had resolved Patient  also stated that he felt a little more sluggish after the booster, more than the other two doses, and that it indicates that he had a lot of antibodies.  Concomitant medications were not reported. Treatment medications were not reported.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sluggishness
Clinical narrative: felt a little more sluggish after the booster, more than the other two doses,; arm reaction after first and second dose,; a little  red spot where the needle was injected.; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,), VACCINATION SITE REACTION (arm reaction after first and second dose,) and VACCINATION SITE ERYTHEMA (a little  red spot where the needle was injected.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,), VACCINATION SITE REACTION (arm reaction after first and second dose,) and VACCINATION SITE ERYTHEMA (a little  red spot where the needle was injected.). At the time of the report, SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,), VACCINATION SITE REACTION (arm reaction after first and second dose,) and VACCINATION SITE ERYTHEMA (a little  red spot where the needle was injected.) had resolved.            No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.  Patient stated that he felt a little more sluggish after the booster, more than the other two doses, and that it indicates that he had a lot of antibodies. Also he had an arm reaction after first and second dose, and a little red spot where the needle was injected.   This case was linked to MOD-2022-543683 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sluggishness, Vaccination site erythema, Vaccination site reaction
Clinical narrative: felt a little more sluggish after the booster, more than the other two doses,; arm reaction after first and second dose,; a little  red spot where the needle was injected.; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,), VACCINATION SITE REACTION (arm reaction after first and second dose,) and VACCINATION SITE ERYTHEMA (a little  red spot where the needle was injected.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,), VACCINATION SITE REACTION (arm reaction after first and second dose,) and VACCINATION SITE ERYTHEMA (a little  red spot where the needle was injected.). At the time of the report, SLUGGISHNESS (felt a little more sluggish after the booster, more than the other two doses,), VACCINATION SITE REACTION (arm reaction after first and second dose,) and VACCINATION SITE ERYTHEMA (a little  red spot where the needle was injected.) had resolved.            No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.  Patient stated that he felt a little more sluggish after the booster, more than the other two doses, and that it indicates that he had a lot of antibodies. Also he had an arm reaction after first and second dose, and a little red spot where the needle was injected.   This case was linked to MOD-2022-543683 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lymphadenopathy, Pyrexia
Clinical narrative: really sick; had lymph nodes; high fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), LYMPHADENOPATHY (had lymph nodes) and PYREXIA (high fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick), LYMPHADENOPATHY (had lymph nodes) and PYREXIA (high fever). At the time of the report, ILLNESS (really sick), LYMPHADENOPATHY (had lymph nodes) and PYREXIA (high fever) outcome was unknown.            No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-543645 (Patient Link).   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Painful arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 026L21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (20 years ago . No recent changes in status such as improvement or worsening.), Cholesterol (20 years ago . No recent changes in status such as improvement or worsening.) and Drug allergy (Allergic to Demerol). Concomitant products included LISINOPRIL for Blood pressure high, ATORVASTATIN for Cholesterol, VENLAFAXINE for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm). At the time of the report, PAIN IN EXTREMITY (Painful arm) outcome was unknown.            Height of the patient was 6 feet.  The patient never had COVID  test or diagnosis or no other vaccines given within 1 month prior to Moderna COVID-19 vaccine and patient doesn't experienced any similar event in the past. The patient experienced a painful arm, but did not remember whether was left or right arm. No treatment information were reported by the reporter.   This case was linked to MOD-2022-543751, MOD-2022-543640 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Sluggishness, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Felt a little more sluggish after the booster, more than the other two doses; An arm reaction after first and second dose; A little red spot where the needle was injected; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt a little more sluggish after the booster, more than the other two doses), VACCINATION SITE REACTION (An arm reaction after first and second dose) and VACCINATION SITE ERYTHEMA (A little red spot where the needle was injected) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Patient never had COVID test or diagnosis. Patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced SLUGGISHNESS (Felt a little more sluggish after the booster, more than the other two doses), VACCINATION SITE REACTION (An arm reaction after first and second dose) and VACCINATION SITE ERYTHEMA (A little red spot where the needle was injected). At the time of the report, SLUGGISHNESS (Felt a little more sluggish after the booster, more than the other two doses), VACCINATION SITE REACTION (An arm reaction after first and second dose) and VACCINATION SITE ERYTHEMA (A little red spot where the needle was injected) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  Patient felt a little more sluggish after the booster, more than the other two doses, and that it indicates that the patient had a lot of antibodies. Patient also had an arm reaction after first and second dose and a little red spot where the needle was injected.   This case was linked to MOD-2022-543683, MOD-2022-543927 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 030B21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-543924, MOD-2022-543811 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication of the patient was not reported.  The patient had COVID-19 with fever, burning in throat and exhaustion feeling. COMPANY COMMENT: This is an Spontaneous case concerning a unknown -years-old male patient with no clinical history who experienced the unexpected  event  of COVID-19 (COVID-19) unknown days after 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided.  The patient took unknown antiviral pills for 5 days as corrective treatment.   This case was linked to MOD-2022-543892 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is an Spontaneous case concerning a unknown -years-old male patient with no clinical history who experienced the unexpected  event  of COVID-19 (COVID-19) unknown days after 3rd  dose of  mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided.