chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received HAV (Havrix 720) (batch number LY35X, expiry date 16th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 23rd February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Feb-2023 The licensed practical nurse called to inquire for any information available. The licensed practical nurse reported that they inadvertently administered an expired Havrix pediatric dose to a patient today on the day of reporting.  The healthcare professionals confirmed expired dose was administered in their facility.  The reporter consented to follow up. Additional supportive information: The licensed practical nurse inadvertently administered patient an expired dose of Havrix 720, which led to expired vaccine used.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Vaccine was administer five days after the 30 day storage limit; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 046H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit).    No concomitant product was reported.  Patient received dose 1 of 0.5 ml on 09-Jan-2021 (Lot: 012L20A, intramuscularly, in right deltoid), dose 2 of 0.5 ml on 06-Feb-2021 (Lot: 031L20A, intramuscularly, in right deltoid), dose 3 of 0.25 ml on 02-Nov-2021 (Lot: 011F21A, intramuscularly, in left deltoid), dose 4 of 0.25 ml on 08-Jul-2021 (Lot: 014B22A, intramuscularly, in right deltoid).  It was unknown whether the patient had allergies to medications, food and other products. It was unknown whether the patient was tested positive for COVID-19. It was unknown whether the patient had acute illness at the time of vaccination.   No treatment information was reported.  This case contains information for the first of two patients who received booster dose on 06-Feb-2023 described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-708810, US-MODERNATX, INC.-MOD-2023-712471 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2023: Vaccination start date, event onset date and narrative added. On 17-Feb-2023: Follow-up received included updated reporter details, patient demographics, suspect vaccine batch number and I-narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708810:Master case_08Feb2023 (one dose) US-MODERNATX, INC.-MOD-2023-712471:Case 1 of 2 patient,06Feb2023
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Sinus disorder
Clinical narrative: sinus issues; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SINUS DISORDER (sinus issues) and FATIGUE (fatigue) in a 66-year-old female patient 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 SINUS DISORDER (sinus issues) and FATIGUE (fatigue). At the time of the report, SINUS DISORDER (sinus issues) and FATIGUE (fatigue) had resolved.            Concomitant medications were not reported.  Patient experienced fatigue for about 2 days and then mild fatigue for the three days. Treatment medications were not reported.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Disability
Clinical narrative: Has been almost disabled for a year after receiving your booster; This spontaneous case was reported by a patient and describes the occurrence of DISABILITY (Has been almost disabled for a year after receiving your booster) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 DISABILITY (Has been almost disabled for a year after receiving your booster) (seriousness criteria disability and medically significant). At the time of the report, DISABILITY (Has been almost disabled for a year after receiving your booster) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 23 year old patient of unknown gender, with no reported medical history, who experienced the unexpected serious (disability, medically significant) event of Disability, unknown time after receiving the booster dose with mRNA-1273 vaccine. It was reported that the patient had been almost disabled for a year after receiving the booster dose. No information on detailed clinical course and details pertaining to previous doses was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Nervous system disorder, Palpitations
Clinical narrative: Palpitations; Neurological side effects; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpitations) and NERVOUS SYSTEM DISORDER (Neurological side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations) and NERVOUS SYSTEM DISORDER (Neurological side effects). At the time of the report, PALPITATIONS (Palpitations) and NERVOUS SYSTEM DISORDER (Neurological side effects) had not resolved.            No relevant concomitant medications were reported.   At the time of report, the patient had palpitations and neurological side effects until today.  No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Extra dose administered, SARS-CoV-2 test
Clinical narrative: Consumer accidentally received 2 Bivalent Boosters/received the first Bivalent booster on October 2022 and the second one on 15Feb2023; He also tested positive for Covid 19 infection on 15Dec2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (He also tested positive for Covid 19 infection on 15Dec2022) and EXTRA DOSE ADMINISTERED (Consumer accidentally received 2 Bivalent Boosters/received the first Bivalent booster on October 2022 and the second one on 15Feb2023) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 041H22A and 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.   In October 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Feb-2023, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2022, the patient experienced COVID-19 (He also tested positive for Covid 19 infection on 15Dec2022). On 15-Feb-2023, the patient experienced EXTRA DOSE ADMINISTERED (Consumer accidentally received 2 Bivalent Boosters/received the first Bivalent booster on October 2022 and the second one on 15Feb2023). At the time of the report, COVID-19 (He also tested positive for Covid 19 infection on 15Dec2022) and EXTRA DOSE ADMINISTERED (Consumer accidentally received 2 Bivalent Boosters/received the first Bivalent booster on October 2022 and the second one on 15Feb2023) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2022, SARS-CoV-2 test: Positive.     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 were reported.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  On 11-Feb-2021, patient received the 1st dose of Moderna COVID-19 vaccine, Lot Number: 001B21A. On 08-Apr-2021, patient received the 2nd dose of Moderna COVID-19 vaccine, Lot Number: 030B21A. On 09-Nov-2021, the patient received the 1st Booster Dose of Moderna COVID-19 vaccine, Lot Number: 014F21A. On 02-Apr-2022, the patient received the 2nd Booster Dose of Moderna COVID-19 vaccine, Lot Number: 002M21A.  No treatment medications were reported.   This case was linked to MOD-2023-712465 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was administer five days after the 30 day storage limit; No adverse event; Vaccine was administer five days after the 30 day storage limit; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit), PRODUCT STORAGE ERROR (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (No adverse event) in an adult 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 06-Feb-2023, 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 06-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administer five days after the 30 day storage limit) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit), PRODUCT STORAGE ERROR (Vaccine was administer five days after the 30 day storage limit) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administer five days after the 30 day storage limit) and PRODUCT STORAGE ERROR (Vaccine was administer five days after the 30 day storage limit).    This case contains information for the 2nd patient out of 2 adult patients as described by the reporter.  Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710499, US-MODERNATX, INC.-MOD-2023-708810 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710499:Case 1 of 2 patient, 06Feb2023 US-MODERNATX, INC.-MOD-2023-708810:Master case
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Inflammation
Clinical narrative: immediately developed inflammation in his whole body; Immediately developed inflammation in his whole body but knee is worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INFLAMMATION (immediately developed inflammation in his whole body) and ARTHRITIS (Immediately developed inflammation in his whole body but knee is worse) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 INFLAMMATION (immediately developed inflammation in his whole body) and ARTHRITIS (Immediately developed inflammation in his whole body but knee is worse). At the time of the report, INFLAMMATION (immediately developed inflammation in his whole body) and ARTHRITIS (Immediately developed inflammation in his whole body but knee is worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the patient had good health.  The patient's daughter stated that, her father listened to medical experts and took the Moderna vaccines and immediately developed inflammation in his whole body, but knee was worse. He had been battling this for a year and a half. The reporter didn't know when he received doses. She stated, when it first came out and people were directed to the health Department and sites to have them done. That was when he had his first vaccine and she think it was a few months later he got one booster.  No treatment medications were reported.  Company comment: This spontaneous case report concerns a male patient of an unspecified age with no previous medical history and underlying conditions, who developed non serious unexpected events of Arthritis (AESI) and Inflammation. Reportedly, after the patient had received mRNA-1273 vaccine (dose of the vaccine was not specified), he immediately developed inflammation in his whole body but it was stated that inflammation in the knee was the worst and the patient was having symptoms for a year and a half. At the time of this report, the events were still ongoing and no additional details regarding clinical course of the events were disclosed. No further details were available for medical assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-712478 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: patient received the vaccine and died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (patient received the vaccine and died) 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 immunisation.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            Concomitant medications were not reported.  Treatment information was not provided by the reporter.    Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case reported by a consumer, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and fatal event of death, which occurred on an unknown date after an unspecified dose of mRNA-1273 vaccine. The cause of death was not reported. It is unknown if an autopsy was performed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Unknown cause of death.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Somnolence
Clinical narrative: Malaise; sleepy; tired; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Malaise), SOMNOLENCE (sleepy) and FATIGUE (tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (Malaise), SOMNOLENCE (sleepy) and FATIGUE (tired). On 27-Feb-2021, MALAISE (Malaise), SOMNOLENCE (sleepy) and FATIGUE (tired) had resolved.            Concomitant product use was not provided by the reporter.   After receiving vaccination, the patient felt sleepy/tired. The patient fully recovered without medical intervention the following day 27-Feb-2021. The patient was not bothered by the incident and months later received a Moderna booster.  Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; 1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 030B21A, 014F21A and 002M21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 11-Feb-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021).    No concomitant medication details was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication details was reported.   This case was linked to MOD-2023-712462 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No Adverse Event; Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021) and NO ADVERSE EVENT (No Adverse Event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EW0182, EW0172, FL3198 and 054A22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high, COPD, Heart failure and Coronary artery disease.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021). 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 received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021).    It is unknown if patient was under any concomitant or regular medications No treatment information was provided.   This case was linked to MOD-2023-712562 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Event; Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021) and NO ADVERSE EVENT (No Adverse Event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. EW0182, EW0172, FL3198 and 054A22A) for COVID-19 prophylaxis.     It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Blood pressure high, COPD, Heart failure and Coronary artery disease.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021). 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 received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 1st dose on 27-Apr-2021 and second dose on 18-May-2021).    It is unknown if patient was under any concomitant or regular medications No treatment information was provided.   This case was linked to MOD-2023-712562 (Patient Link).   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No Adverse Event; HCP stated a patient who previously received a COVID-19 Bivalent booster from Pfizer on 21Oct2022 accidentally received another bivalent booster from Moderna on 20Feb2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (HCP stated a patient who previously received a COVID-19 Bivalent booster from Pfizer on 21Oct2022 accidentally received another bivalent booster from Moderna on 20Feb2023.) and NO ADVERSE EVENT (No Adverse Event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7138B) for COVID-19 prophylaxis.     The patient's past medical history included Heart failure. Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (COVID-19 Bivalent booster Lot: GH9702) on 21-Oct-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Blood pressure high, COPD and Coronary artery disease.    On 20-Feb-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (HCP stated a patient who previously received a COVID-19 Bivalent booster from Pfizer on 21Oct2022 accidentally received another bivalent booster from Moderna on 20Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (HCP stated a patient who previously received a COVID-19 Bivalent booster from Pfizer on 21Oct2022 accidentally received another bivalent booster from Moderna on 20Feb2023.) 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 EXTRA DOSE ADMINISTERED (HCP stated a patient who previously received a COVID-19 Bivalent booster from Pfizer on 21Oct2022 accidentally received another bivalent booster from Moderna on 20Feb2023.).    It was unknown if patient was under any concomitant or regular medications. Patient had received 1st dose on 27-Apr-2021 lot: EW0172, 2nd dose on 18-May-2021 lot: EW0182, 1st booster on 21-Jan-2022 lot: FL3198, 2nd booster on 20-Jul-2022. lot: 054A22A.  HCP stated a patient who previously received a COVID-19 Bivalent booster from Pfizer on 21-Oct-2022 accidentally received another bivalent booster from Moderna on 20-Feb-2023. No treatment information was reported.   This case was linked to MOD-2023-712578 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; she gave the wrong vaccine to two patients today 22Feb2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu shot on 22Feb2023 (Dose 1) on 22-Feb-2023; for COVID-19 prophylaxis: Spikevax (Dose 2). Past adverse reactions to the above products included No adverse event with Spikevax and flu shot on 22Feb2023.    On 22-Feb-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023) 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 WRONG PRODUCT ADMINISTERED (she gave the wrong vaccine to two patients today 22Feb2023).    No concomitant medications were reported.  It was reported that the medical assistant gave the wrong vaccine to two patients on 22-Feb-2023, they were supposed to get the adult bivalent vaccine but accidentally administered with 6-11 year old Monovalent vaccine.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712429 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712429:2nd patient case
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose 2) and PFIZER BIONTECH COVID-19 VACCINE (Dose 1). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Feb-2023, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.) 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 WRONG PRODUCT ADMINISTERED (The medical assistant reports that she gave the wrong vaccine to two patients today 22Feb2023.).    No concomitant medications were reported. It was reported that they were supposed to get the adult bivalent, but she accidentally gave them the 6-11 year old monovalent vaccine.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-712443 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712443:2nd patient case
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (Dose 1,monovalent,lot# 042L20A) on 29-Jan-2021, Moderna COVID-19 Vaccine (Dose 2,monovalent,lot # 010M20A) on 26-Feb-2021, Moderna COVID-19 Vaccine (Dose 3,monovalent,lot # 037A22B) on 14-Jun-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dos4,DAVESOMERAN,First bivalent booster andlot #061F22A) on 15-Nov-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 20-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster) 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 EXTRA DOSE ADMINISTERED (Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster).    Concomitant medication was not provided.   Patient received in total 3 doses of the monovalent vaccine and received 2 doses of bivalent booster.  Treatment information was not provided.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Pyrexia, Scan, Tremor
Clinical narrative: Intense tremors; Tingling tongue; 11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Intense tremors), PARAESTHESIA ORAL (Tingling tongue), PARAESTHESIA (11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced TREMOR (Intense tremors), PARAESTHESIA ORAL (Tingling tongue), PARAESTHESIA (11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek) and PYREXIA (Fever). At the time of the report, TREMOR (Intense tremors), PARAESTHESIA ORAL (Tingling tongue), PARAESTHESIA (11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Scan: Scans negative for stroke. On 14-Nov-2021, Scan: Scans negative for stroke.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. On 09-Nov-2021 the patient developed fever and intense tremors which lasted for 6 hours. Again on 13-Nov-2021 developed tingling to right side of face and went to ER and stayed overnight. Ever since had been tingling sensation that varies to right side of face which involves eye, ear, tongue, right side of nose, cheek. Intensity varies which may involved one spot or several. The patient did not experienced any additional symptoms/events.  No treatment medication information was reported.
Age: 64.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vaccine was stored in the fridge on 14Jan2023 and administered on 18Feb2023; no adverse event; Booster Bivalent dose administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date), PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14Jan2023 and administered on 18Feb2023) and NO ADVERSE EVENT (no adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 23-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 18-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 18-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14Jan2023 and administered on 18Feb2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date), PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14Jan2023 and administered on 18Feb2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Booster Bivalent dose administered after expiration date) and PRODUCT STORAGE ERROR (The vaccine was stored in the fridge on 14Jan2023 and administered on 18Feb2023).    Concomitant medications details were not reported by the reporter. Patient did not report any side effects after receiving this dose. Treatment details was not reported by the reporter.
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired dose of Moderna Covid-19 vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient) and NO ADVERSE EVENT (No adverse event) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Feb-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose of Moderna Covid-19 vaccine administered to patient) 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 (Expired dose of Moderna Covid-19 vaccine administered to patient).    Concomitant medication was not provided.   Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Lung disorder
Clinical narrative: Caller is going in for a lung transplant later on this year; This spontaneous case was reported by a patient and describes the occurrence of LUNG DISORDER (Caller is going in for a lung transplant later on this year) 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)) (batch no. 013h22a) for COVID-19 prophylaxis.     Patient never had COVID.     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 LUNG DISORDER (Caller is going in for a lung transplant later on this year). At the time of the report, LUNG DISORDER (Caller is going in for a lung transplant later on this year) 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 were provided. The patient was going in for a lung transplant later on this year. Not related to vaccine. No treatment medication was provided.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Vaccination site induration
Clinical narrative: She had redness all the way down to elbow for a week; indurated area in injection site.; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (She had redness all the way down to elbow for a week) and VACCINATION SITE INDURATION (indurated area in injection site.) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062S22A) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st Booster,lot# 09312A) on 15-Jul-2022, Moderna COVID-19 Vaccine (2nd Primary series, 09312A), Moderna COVID-19 Vaccine (1st Primary series and  002A21A). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    In February 2023, 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. In February 2023, the patient experienced ERYTHEMA (She had redness all the way down to elbow for a week) and VACCINATION SITE INDURATION (indurated area in injection site.). In February 2023, ERYTHEMA (She had redness all the way down to elbow for a week) had resolved. At the time of the report, VACCINATION SITE INDURATION (indurated area in injection site.) 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 provided. Patient received Moderna Covid 19 Bivalent 2 weeks ago. No treatment medications was provided.   This case was linked to MOD-2023-712635 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (expired Moderna Covid-19 vaccine on February 22, 2023 lot number 015B22A expiration date February 12, 2023).    No concomitant medications were reported. No treatment medications were reported.