chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Lymphoma, Lung disorder (missing lower 2 lobes of left lung) and Sulfonamide allergy (sulfa). Concomitant products included GABAPENTIN from 01-Dec-2018 to 21-Apr-2023 for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-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 (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-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 (Dose 2 on 12-APR-2021 and Dose 3 on 20-AUG-2021).    Patient received Moderna Dose 4 on 8-Jul-2022 Batch/Lot No: Unknown and Location of injection: Arm Left. Patient received Moderna Dose 5 on 8-Sep-2022 at 07:30 PM Batch/Lot No: Unknown and Location of injection: Arm Left. Patient received Paxlovid for treatment of COVID-19 from 6-Apr-2023 to 10-Apr-2023. Patient had Recurrence of COVID-19 on 16-Apr-2023 09:30. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: he felt sleepy afterwards; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (he felt sleepy afterwards) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (he felt sleepy afterwards). At the time of the report, SOMNOLENCE (he felt sleepy afterwards) outcome was unknown.            No concomitant medications were reported. The patient received all 3 vaccines from Moderna, and he did great on those vaccines except he felt sleepy afterwards. No treatment medications were reported.   This case was linked to MOD-2023-720962 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Somnolence
Clinical narrative: received all 3 vaccines from Moderna, and he did great on those vaccines except he felt sleepy; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (received all 3 vaccines from Moderna, and he did great on those vaccines except he felt sleepy) in a male 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 third 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 SOMNOLENCE (received all 3 vaccines from Moderna, and he did great on those vaccines except he felt sleepy). At the time of the report, SOMNOLENCE (received all 3 vaccines from Moderna, and he did great on those vaccines except he felt sleepy) 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 reported. No treatment medications were reported.   This case was linked to MOD-2023-720960 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Encephalitis, Encephalopathy, Positron emission tomogram
Clinical narrative: Encephalitis; encephalopathy; This spontaneous case was reported by a patient and describes the occurrence of ENCEPHALITIS (Encephalitis) and ENCEPHALOPATHY (encephalopathy) in a male 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.     Concurrent medical conditions included Measles, Rheumatoid arthritis and Parkinson's disease. Concomitant products included ABATACEPT for Rheumatoid arthritis.    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 ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant) and ENCEPHALOPATHY (encephalopathy) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) and ENCEPHALOPATHY (encephalopathy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Positron emission tomogram: Positive.         It was reported that patient had encephalitis and encephalopathy from the Moderna Vaccine.  Treatment medication was not reported. Company Comment: This is a spontaneous case concerning a male patient of an unknown age with a history of Measles, Rheumatoid arthritis and Parkinson's disease, who experienced the serious (due to medically significant) unexpected, events of encephalitis (AESI) and encephalopathy, which occurred on an unknown date and with unknown latency after a dose of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine. It was reported that patient had encephalitis and encephalopathy from the Moderna Vaccine. No further information was disclosed. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/BA.5) vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose from a vial with a BUD 23-Apr-2023 to adult patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient) 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)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose from a vial with a BUD 23-Apr-2023 to adult patient) 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 (Dose from a vial with a BUD 23-Apr-2023 to adult patient).    No concomitant medications were reported.     No treatment medications were reported.  This case contains information for the 2nd of 2adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721017 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721017:Patient 1
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 20-MAR-2023; No adverse event; Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender 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.     No Medical History information was reported.    On 21-Apr-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 21-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023) 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 expired on 19-Apr-2023 and was used for vaccinations on 21-Apr-2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-MAR-2023).    Concomitant medication was not provided.  Reporter reported that the vial was individual vial and size was 2.5 ml. The vial did not undergo any temperature excursion. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-721044 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721044:1st patient case (Master case)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023) 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)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Apr-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 14-Apr-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 (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023) 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 (patient has received the Moderna Bivalent vaccine that was past it's 30 day use by date of April 13, 2023).    Concomitant product information was not provided by the reporter.   Patient didn't had any information about previous COVID-19 vaccination doses and it was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient received the vaccine on 14-Apr-2023.  Treatment medication was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023; No adverse event; Administered expired Moderna Vaccines to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 22-Apr-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 22-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccines to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023) 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 (Administered expired Moderna Vaccines to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 13-Mar-2023 and was administered on 22-Apr-2023).    No concomitant medications were provided.  Pharmacist was calling to find out about the stability of expired Moderna vaccines as it was administered to several patients after 30-day use by date.  Dose administered after 30-day use by date or after manufacturer date of expiry.  The individual vial size was 2.5 ml.   The vial was initially stored in the refrigerator on 13-Mar-2023.  The vial did not undergo any temperature excursions.  No treatment medication was provided.  This case contains information for the 11th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Follow-up received included patient age, gender, initial, date of administration added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023) 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 dose of the monovalent Moderna COVID19 vaccine/Date of administration April 21 2023).    No concomitant medications was reported. No treatment medications was reported.  HCP wanted dosing information on patients 6 Months of Age and Older Not Previously Vaccinated with a COVID-19 Vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-721291 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721291:Master case
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever around 102; Chills; Body aches; The worst headache of my life; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life) in a 63-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 PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life). At the time of the report, PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: Fever around 102.     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.   Concomitant medication use information was not provided by reporter.  Patient had fever around 102, chills, body aches, and the worst headache of life. Patient had the same symptoms after every vaccine and every booster. Patient had 2 vaccines and 2 boosters. It was always started the night that had the vaccine.  It was unknown if the patient experienced any additional symptoms/events.  Treatment Medication use information was not provided by reporter.   This case was linked to MOD-2023-721304 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Fever around 102; Chills; Body aches; The worst headache of my life; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life). At the time of the report, PYREXIA (Fever around 102), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (The worst headache of my life) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: around 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient had 2 vaccines and 2 boosters. She had the same symptoms with every vaccine and every booster and it always started the night that she had the vaccine. Treatment information was not reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Imaging procedure, Lumbar puncture
Clinical narrative: Cerebral edema/ Cerebral Ischemia; This literature-non-study case was reported in a literature article and describes the occurrence of BRAIN OEDEMA (Cerebral edema/ Cerebral Ischemia) in a 30-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRAIN OEDEMA (Cerebral edema/ Cerebral Ischemia) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Cerebral edema. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Imaging procedure: Initially showed scattered cortical thrombosis. On an unknown date, Lumbar puncture: Elevated opening pressure.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered BRAIN OEDEMA (Cerebral edema/ Cerebral Ischemia) to be related.    No concomitant and treatment medications were reported.  24 hours after receiving first dose of the Moderna COVID-19 vaccine, the patient developed severe headache. Three weeks later patient was admitted with subacute headache and confusion. An external ventricular drain was placed, but patient continued to have elevated intracranial pressure.  Ultimately, patient required a hemicraniectomy, but intractable cerebral edema resulted in patient death.  Pathology was consistent with thrombosis and associated inflammatory response. Though correlational, her medical team surmised that the mRNA vaccine may have contributed to this presentation.  Company Comment: This is a literature non-study case concerning a 30-year-old female patient with no reported medical history, who experienced the serious (fatal, hospitalization and medically significant) unexpected event brain edema. The event occurred 24 hours after receiving the first dose of mRNA-1273 vaccine. 24 hours after receiving first dose of the Moderna COVID-19 vaccine, the patient developed severe headache. Three weeks later patient was admitted with subacute headache and confusion. An external ventricular drain was placed, but patient continued to have elevated intracranial pressure. Ultimately, patient required a hemicraniectomy, but intractable cerebral edema resulted in patient death. Pathology was consistent with thrombosis and associated inflammatory response. The reported cause of death was Cerebral edema. It is unknown if an autopsy was performed.  Relevant diagnostic tests included Imaging tests that initially showed scattered cortical thrombosis, and Lumbar puncture resulted in elevated opening pressure. No concomitant and treatment medications were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Cerebral edema
Sex: M
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: she has seen similar cases being talked about online where people have experienced the same issues as her husband.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (she has seen similar cases being talked about online where people have experienced the same issues as her husband.) in an adult male 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 IMMUNISATION REACTION (she has seen similar cases being talked about online where people have experienced the same issues as her husband.). At the time of the report, IMMUNISATION REACTION (she has seen similar cases being talked about online where people have experienced the same issues as her husband.) 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. No treatment medications was provided.
Age: 20.0
Sex: F
Vaccine: COVID19-2, TTOX
Symptoms: Vaccination site pain
Clinical narrative: The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 0661122A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TETANUS VACCINE for an unknown indication.    No Medical History information was reported.   On 21-Apr-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. On an unknown date, the patient received dose of TETANUS VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine). At the time of the report, VACCINATION SITE PAIN (The patient reports some arm pain, but nothing extreme. She feels it in her right arm, where she got the COVID vaccine) 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 medication was reported. No treatment information was reported.   This case was linked to MOD-2023-720811 (Patient Link).
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Localised infection, Pain
Clinical narrative: infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black; Pain; This spontaneous case was reported by a patient and describes the occurrence of LOCALISED INFECTION (infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 044A21A and 022M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (4 heart attacks.). Concurrent medical conditions included Allergic reaction to bee sting and Coronary heart disease.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOCALISED INFECTION (infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black) (seriousness criterion disability) and PAIN (Pain). The patient was treated with Surgery (Toe amputation) for Localised infection. At the time of the report, LOCALISED INFECTION (infection in the left foot/left foot 2 of his toes has been remove due to the infection/toe is infected and turning black) and PAIN (Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient stated that patient had 3 doses (Which included two booster). Patient had an infection in the left foot. In the left foot 2 of patient's toes had remove due to the infection (the right toe and the one next to it) in 01-Nov-2022 or 04-Nov-2022. Patient was a disabled "Private". Treatment information was not provided.  Company Comment:  This is a spontaneous case concerning a 56-year-old, male patient with current condition of Coronary heart disease and medical history of four heart attacks, who experienced the unexpected serious (disability) event of toe infection. The event is reported in relationship with the administration of mRNA-1273 vaccines. Latency could not be assessed due to lack of information. It is reported that patient required amputation of two toes and one more toe is also infected and in turning black. Mentioned medical history could be a risk factor and confounder for the event, however very limited information was provided. Further information was requested. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.) 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)) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-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 31-Mar-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration 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 (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The manufacture date was 24-Mar-2023. The unknown vial was initially stored in the refrigerator 07-Mar-2023 and did not underwent any temperature excursions. All three vials remained in the correct refrigerated storage until administration with no temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720850, US-MODERNATX, INC.-MOD-2023-720851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720850: US-MODERNATX, INC.-MOD-2023-720851:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.; No Adverse Event; Given expired vaccine. 9APR2023 was expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.), WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.) and NO ADVERSE EVENT (No Adverse Event) in an 81-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: Moderna COVID-19 Vaccine on 08-Mar-2021, Moderna COVID-19 Vaccine on 05-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE on 03-Jan-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE.    On 24-Apr-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.). On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given expired vaccine. 9APR2023 was expiration date.), WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.) 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 (Given expired vaccine. 9APR2023 was expiration date.) and WRONG PRODUCT ADMINISTERED (Also given a 6y-11y presentation when the dose should have been for 12 above /dose administered today was a monovalent product and not a bivalent vaccine.).    No concomitant medications were reported. It was reported that patient received 2nd booster dose and no symptoms were reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2023: Live follow up received: suspect product coding and additional event verbatim was updated
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly, Inappropriate schedule of product administration
Clinical narrative: Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).; 2021 Heart enlargement but no symptoms.; This spontaneous case was reported by a patient and describes the occurrence of CARDIOMEGALY (2021 Heart enlargement but no symptoms.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).). In 2021, the patient experienced CARDIOMEGALY (2021 Heart enlargement but no symptoms.). At the time of the report, CARDIOMEGALY (2021 Heart enlargement but no symptoms.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Shot #1: First Primary monovalent dose on 10 FEB2021 (Lot# & Exp. Date: unknown). Shot #2: 2nd Primary monovalent dose on 19MAR2021 (Lot# & Exp. Date: unknown).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment medications was provided.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Off label use, Wrong product administered
Clinical narrative: No adverse event; Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.; off label use; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.), OFF LABEL USE (off label use) and NO ADVERSE EVENT (No adverse event) in a 40-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.) and OFF LABEL USE (off label use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.), OFF LABEL USE (off label use) 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 WRONG PRODUCT ADMINISTERED (Patient was given the incorrect dosage of a Moderna bivalent.This was their second dose following a previous dose of the Moderna Monovalent product/. Was given a dose from the presentation with the dark pink cap at a dosage of 0.25mL.) and OFF LABEL USE (off label use).    Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received Moderna Monovalent vaccine as first dose.  No concomitant medications was reported.  No symptoms was reported.  No treatment medications was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Hallucination, Headache, Hyperhidrosis
Clinical narrative: Hallucinating; Sweats; Could not get out of bed for 4-5 days after each shot; Headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident (Damage to upper and lower back, and both knees. Knee replaced in 1999.) in 1991 and Knee replacement in 1999. Concomitant products included PARACETAMOL (TYLENOL), MORPHINE and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinating) (seriousness criterion medically significant), HYPERHIDROSIS (Sweats), BEDRIDDEN (Could not get out of bed for 4-5 days after each shot), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, HALLUCINATION (Hallucinating), HYPERHIDROSIS (Sweats), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown and BEDRIDDEN (Could not get out of bed for 4-5 days after each shot) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided. Company Comment: This is a spontaneous case concerning a 53-year-old male patient with a history of use of morphine as concomitant medication due to damage to upper and lower back and both knees after accident, who experienced the serious (due to medically significant) unexpected, event of Hallucination, which occurred on an unknown date after the first and second dose of mRNA-1273 vaccine, together with other non-serious events, as pyrexia between others. It was reported that after the monovalent vaccines he had fever, sweats, hallucinating, headache, fatigue. Could not get out of bed for 4-5 days after each shot. Medical history of concomitant medication with morphine, and patient having pyrexia after dose could be a confounding factor for the event Hallucination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-721103 (Patient Link).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Hallucinating; Sweats; Could not get out of bed for 4-5 days after each shot; Headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinating) in a 53-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Accident (Damage to upper and lower back, and both knees. Knee replaced in 1999.) in 1991 and Knee replacement in 1999. Concomitant products included PARACETAMOL (TYLENOL), MORPHINE and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Hallucinating) (seriousness criterion medically significant), HYPERHIDROSIS (Sweats), BEDRIDDEN (Could not get out of bed for 4-5 days after each shot), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, HALLUCINATION (Hallucinating), HYPERHIDROSIS (Sweats), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown and BEDRIDDEN (Could not get out of bed for 4-5 days after each shot) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided. Company Comment: This is a spontaneous case concerning a 53-year-old male patient with a history of use of morphine as concomitant medication due to damage to upper and lower back and both knees after accident, who experienced the serious (due to medically significant) unexpected, event of Hallucination, which occurred on an unknown date after the first and second dose of mRNA-1273 vaccine, together with other non-serious events, as pyrexia between others. It was reported that after the monovalent vaccines he had fever, sweats, hallucinating, headache, fatigue. Could not get out of bed for 4-5 days after each shot. Medical history of concomitant medication with morphine, and patient having pyrexia after dose could be a confounding factor for the event Hallucination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-721103 (Patient Link).