chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Urinary tract infection
Clinical narrative: Bad reaction to the moderna covid vaccine; COLITIS; Injection site itching; Injection site hives; Injection site tenderness; Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), URINARY TRACT INFECTION (Urinary tract infection), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site hives) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriatic arthritis and Plaque psoriasis. Concomitant products included COVID-19 VACCINE for COVID-19 vaccination.   On 06-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2022, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). On an unknown date, the patient experienced IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE PAIN (Injection site tenderness). At the time of the report, IMMUNISATION REACTION (Bad reaction to the moderna covid vaccine), COLITIS (COLITIS), URINARY TRACT INFECTION (Urinary tract infection), INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE URTICARIA (Injection site hives) and INJECTION SITE PAIN (Injection site tenderness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 10 out of 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported. The reporter's causality for the events of bad reaction to the Moderna covid vaccine, colitis, injection site reaction/ itchiness/hives/tenderness unknown onset, urinary tract infection with adalimumab solution for injection was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Myalgia
Clinical narrative: Sick as a dog 14 Hours after the 2nd primary shot; Body aches 14 Hours after the 2nd primary shot; Fatigue 14 Hours after the 2nd primary shot; Fever 101.4F 14 Hours after the 2nd primary shot; Chills 14 Hours after the 2nd primary shot; Nausea 14 Hours after the 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot) and CHILLS (Chills 14 Hours after the 2nd primary shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot), CHILLS (Chills 14 Hours after the 2nd primary shot) and NAUSEA (Nausea 14 Hours after the 2nd primary shot). On 20-Mar-2021, ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot), CHILLS (Chills 14 Hours after the 2nd primary shot) and NAUSEA (Nausea 14 Hours after the 2nd primary shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 F.         No concomitant medication was reported.  No treatment information was reported.  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, lot number 023M20A.   This case was linked to MOD-2022-669124, MOD-2022-669098 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Sick as a dog 14 Hours after the 2nd primary shot; Body aches 14 Hours after the 2nd primary shot; Fatigue 14 Hours after the 2nd primary shot; Fever 101.4F 14 Hours after the 2nd primary shot; Chills 14 Hours after the 2nd primary shot; Nausea 14 Hours after the 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot) and CHILLS (Chills 14 Hours after the 2nd primary shot) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot), CHILLS (Chills 14 Hours after the 2nd primary shot) and NAUSEA (Nausea 14 Hours after the 2nd primary shot). On 20-Mar-2021, ILLNESS (Sick as a dog 14 Hours after the 2nd primary shot), MYALGIA (Body aches 14 Hours after the 2nd primary shot), FATIGUE (Fatigue 14 Hours after the 2nd primary shot), PYREXIA (Fever 101.4F 14 Hours after the 2nd primary shot), CHILLS (Chills 14 Hours after the 2nd primary shot) and NAUSEA (Nausea 14 Hours after the 2nd primary shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.4 F.         No concomitant medication was reported.  No treatment information was reported.  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, lot number 023M20A.   This case was linked to MOD-2022-669124, MOD-2022-669098 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Mobility decreased, Myalgia
Clinical narrative: Can't move left arm  and Can't lay on left arm; Pain Left Arm injection site; Fatigue; Fever; Chills; Nausea; Body aches; Headaches; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm), VACCINATION SITE PAIN (Pain Left Arm injection site), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 303807772) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Oct-2022 at 11:30 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm), VACCINATION SITE PAIN (Pain Left Arm injection site), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headaches). On 30-Oct-2022, FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved. At the time of the report, MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm) outcome was unknown and VACCINATION SITE PAIN (Pain Left Arm injection site) had not resolved.      No concomitant information provided It was reported that, patient called the Nurses hotline and she stated to place heat on it. Patient had been treating the left arm with heat. No treatment information provided.   This case was linked to MOD-2022-669096, MOD-2022-669124 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Can't move left arm  and Can't lay on left arm; Pain Left Arm injection site; Fatigue; Fever; Chills; Nausea; Body aches; Headaches; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm), VACCINATION SITE PAIN (Pain Left Arm injection site), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 303807772) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Oct-2022 at 11:30 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm), VACCINATION SITE PAIN (Pain Left Arm injection site), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headaches). On 30-Oct-2022, FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Body aches) and HEADACHE (Headaches) had resolved. At the time of the report, MOBILITY DECREASED (Can't move left arm  and Can't lay on left arm) outcome was unknown and VACCINATION SITE PAIN (Pain Left Arm injection site) had not resolved.      No concomitant information provided It was reported that, patient called the Nurses hotline and she stated to place heat on it. Patient had been treating the left arm with heat. No treatment information provided.   This case was linked to MOD-2022-669096, MOD-2022-669124 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No allergies were reported. Patient never had COVID positive test or diagnosis. It was reported patient had no flu or pneumonia vaccine in 2021.  Concurrent medical conditions included Diabetes and Anxiety. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included unspecified medication for anxiety. Patient had never experienced similar event in the past. No treatment medication were provided.   This case was linked to MOD-2022-669114, MOD-2022-669113 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Hyperglycaemia, Neck pain, Vaccination site induration, Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No allergies were reported. Patient never had COVID positive test or diagnosis. It was reported patient had no flu or pneumonia vaccine in 2021.  Concurrent medical conditions included Diabetes and Anxiety. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included unspecified medication for anxiety. Patient had never experienced similar event in the past. No treatment medication were provided.   This case was linked to MOD-2022-669114, MOD-2022-669113 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Vaccination site induration, Vaccination site pain
Clinical narrative: Soreness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No allergies were reported. Patient never had COVID positive test or diagnosis. It was reported patient had no flu or pneumonia vaccine in 2021.  Concurrent medical conditions included Diabetes and Anxiety. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included unspecified medication for anxiety. Patient had never experienced similar event in the past. No treatment medication were provided.   This case was linked to MOD-2022-669114, MOD-2022-669113 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: lymphnodes in her arm pit on the same side of the injection; Soreness at the injection site; hardness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M20A) for COVID-19 vaccination.     Patient had no history of allergy. Patient not had COVID + test or diagnosis. Patient did not had any flu or pneumonia vaccines in 2021.  Concurrent medical conditions included Anxiety and Diabetes. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site). At the time of the report, LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection) had not resolved and VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site) outcome was unknown.            Concomitant medication also included unspecified medication for anxiety. Patient received vaccination in left side. No treatment medication was reported.   This case was linked to MOD-2022-669109, MOD-2022-669113 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Hyperglycaemia, Neck pain, Vaccination site induration, Vaccination site pain
Clinical narrative: lymphnodes in her arm pit on the same side of the injection; Soreness at the injection site; hardness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M20A) for COVID-19 vaccination.     Patient had no history of allergy. Patient not had COVID + test or diagnosis. Patient did not had any flu or pneumonia vaccines in 2021.  Concurrent medical conditions included Anxiety and Diabetes. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site). At the time of the report, LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection) had not resolved and VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site) outcome was unknown.            Concomitant medication also included unspecified medication for anxiety. Patient received vaccination in left side. No treatment medication was reported.   This case was linked to MOD-2022-669109, MOD-2022-669113 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymph node pain, Vaccination site induration, Vaccination site pain
Clinical narrative: lymphnodes in her arm pit on the same side of the injection; Soreness at the injection site; hardness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 007M20A) for COVID-19 vaccination.     Patient had no history of allergy. Patient not had COVID + test or diagnosis. Patient did not had any flu or pneumonia vaccines in 2021.  Concurrent medical conditions included Anxiety and Diabetes. Concomitant products included GLIPIZIDE and LINAGLIPTIN (TRADJENTA) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection), VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site). At the time of the report, LYMPH NODE PAIN (lymphnodes in her arm pit on the same side of the injection) had not resolved and VACCINATION SITE PAIN (Soreness at the injection site) and VACCINATION SITE INDURATION (hardness at the injection site) outcome was unknown.            Concomitant medication also included unspecified medication for anxiety. Patient received vaccination in left side. No treatment medication was reported.   This case was linked to MOD-2022-669109, MOD-2022-669113 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 3 boosters; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (3 boosters) and NO ADVERSE EVENT (No adverse event) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 037F21A, 022M20A, 019B21A and 022M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Feb-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) (Intramuscular) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Nov-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (3 boosters) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (3 boosters) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (3 boosters).    Concomitant medications were not reported.  On 28-Feb-2021 patient had received 1st dose of vaccine with lot number 022M20A. On 31-Mar-2021 patient had received 2nd dose of vaccine with lot number 019B21A, On 08-Aug-2021 patient had received 3rd dose of vaccine with lot number 022M20A. On 06-Nov-2021 patient had received 4th dose of vaccine with lot number 037F21A. On -14-Jul-2022 patient had received 5th dose of vaccine with lot number 059A22A.  Patient was not  immunocompromised. No treatment information was provided by the reporter
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am; No Adverse event; administered a dose from a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago), PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Nov-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago), PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered a dose from a vial that was punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (The vial was first punctured on 03-Nov-2022 at 10:45 am and administered on 4-Nov-2022 at 9 am).    No concomitant information was reported. The patient age was reported as 2.5 years. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 31-Oct-2022. The vial was first punctured on 03-Nov-2022 at 10:45 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius is equal to 46degree to 77 degree Fahrenheit) was 3 minutes. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Said that she has a terrible head cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Said that she has a terrible head cold) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Said that she has a terrible head cold). At the time of the report, NASOPHARYNGITIS (Said that she has a terrible head cold) had not resolved.            No concomitant medications were reported. It was reported that the patient looked miserable and had terrible head cold that had not gone away despite any treatment.   This case was linked to US-MODERNATX, INC.-MOD-2022-669102, US-MODERNATX, INC.-MOD-2022-668777 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669102:same reporter US-MODERNATX, INC.-MOD-2022-668777:same reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm was swollen and red for 13 days; arm was swollen and red for 13 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (arm was swollen and red for 13 days) and ERYTHEMA (arm was swollen and red for 13 days) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021c21a, 037k20a and 023l20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to topical drugs (rash to oilment) and Allergy to antibiotic (doxycycline). Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen and red for 13 days) and ERYTHEMA (arm was swollen and red for 13 days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Nov-2021, PERIPHERAL SWELLING (arm was swollen and red for 13 days) and ERYTHEMA (arm was swollen and red for 13 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. First dose was received on 05-Dec-2020 or 06-Dec-2020. Following vaccination the same day of vaccination 8 to 12 hours after receiving the booster dose patient experienced the adverse events. Adverse events did not cause patient to seek medical care. It was reported that patient did not experienced a similar event in the past, when she had the polio vaccine or small pox vaccine might be.   This case was linked to MOD-2022-669121, MOD-2022-669123 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pyrexia
Clinical narrative: other things; fever; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (other things) and PYREXIA (fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Allergy to topical drugs (rash to oilment) and Allergy to antibiotic (doxycycline). Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (other things) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (other things) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. First dose was received on 05-Dec-2020 or 06-Dec-2020. Adverse events did not cause patient to seek medical care. It was reported that patient did not experienced a similar event in the past, when she had the polio vaccine or small pox vaccine might be.   This case was linked to MOD-2022-669117, MOD-2022-669123 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No adverse event; Given a little lower on the arm than typical; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Oct-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Given a little lower on the arm than typical).    The concomitant medication was not reported by reporter. The caller was the store manager of the pharmacy. He stated that a patient got her booster, and it was given a little lower on the arm than typical. Patient enquired was that going to cause any issues with the vaccine being less effective. The lot number was not available.  The treatment medication was not reported by reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: arm was more red; This spontaneous case was reported by a pharmacist and describes the occurrence of ERYTHEMA (arm was more red) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023l20a and 037k20a) for COVID-19 vaccination.     Patient did not have any medical history related to mentioned adverse event and did not have any acute and chronic illnesses at the time of vaccination. No other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccination.  Concurrent medical conditions included Penicillin allergy, Allergy to topical drugs (rash to oilment) and Allergy to antibiotic (doxycycline). Concomitant products included LISINOPRIL and VITAMINS NOS for an unknown indication.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ERYTHEMA (arm was more red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In 2021, ERYTHEMA (arm was more red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The adverse event did not cause the patient to seek medical care.  The patient recalled that the patient experienced a similar event when she had received the polio vaccine or small pox vaccine.  The patient received the first dose on 05-Dec-2020 or 06-Dec-2020.   This case was linked to MOD-2022-669117, MOD-2022-669121 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient believes vaccine was administered too close to or near the joint; sore arm; sore shoulder; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient believes vaccine was administered too close to or near the joint) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7165B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (sore shoulder). On 28-Oct-2022, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient believes vaccine was administered too close to or near the joint). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ARTHRALGIA (sore shoulder) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Patient believes vaccine was administered too close to or near the joint) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: lower than authorized dose volume; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (lower than authorized dose volume) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (lower than authorized dose volume) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (lower than authorized dose volume) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (lower than authorized dose volume).    No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a 30-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (We had a patient that received Moderna Covid-19 Vaccine, Bivalent as the 1st dose of the primary series).    No Concomitant medications were provided. No treatment medications were provided.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; Received Moderna Covid 19 Monovalent as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose) and NO ADVERSE EVENT (no adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057A22A, 036CZIA and 016CZIA) for COVID-19 prophylaxis.     Concurrent medical conditions included Bee sting hypersensitivity (Bees allergy) and Allergy to animal dander (Cat hair allergy).   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Moderna Covid 19 Monovalent as a booster dose).    No concomitant medications were reported.  The reporter stated that one of her colleague had accidentally administered Moderna Covid-19 vaccine as a booster dose instead of providing the Moderna Covid-19 Bivalent booster dose.  On 04-Nov-2022, the patient received first booster dose of Moderna COVID-19 Vaccine.  No treatment information was reported.   This case was linked to MOD-2022-669141 (Patient Link).
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Patient recieved first dose on 03-May-2021 and second dose on 01-Jun-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 03-May-2021 and second dose on 01-Jun-2022) and NO ADVERSE EVENT (no adverse event) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 036CZIA and 016CZIA) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to bee sting (Bees) and Allergic to cats (Cat hair).   On 03-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Jun-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 03-May-2021 and second dose on 01-Jun-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 03-May-2021 and second dose on 01-Jun-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient recieved first dose on 03-May-2021 and second dose on 01-Jun-2022).    Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-669138 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Monovalent instead of Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Monovalent instead of Bivalent Booster).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-669163 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669163:MOD-2022-669144(Husband case)
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 21-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine administered to the patient is past it's 30 day beyond use date).    No concomitant medications were reported.  No treatment details were reported.  Product administered was Monovalent vaccine from Individual vial of size 5.5 ml.  The vial was initially stored in the refrigerator on 01-Oct-2022.  Vial did not undergo any temperature excursions.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Received expired Bivalent booster after 30-day Use By Date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Received expired Bivalent booster after 30-day Use By Date).    Concomitant product use was not provided by the reporter.  It was reported that vial was received as liquid with note use by date was 30-Oct-2022.  On 31-Oct-2022, the patient received bivalent booster after 30-day Use By Date.  Vial did not undergone any temperature excursions.  Treatment information was not provided.