chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration of Engerix-B after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 3-month-old male patient who received HBV (Engerix B Junior) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 03-JAN-2025, the patient received Engerix B Junior. On 03-JAN-2025, an unknown time after receiving Engerix B Junior, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B after the expiration 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: 03-JAN-2025 Certified medical assistant called to report the maladministration of an expired dose of an Engerix-B 10 micrograms dose to a patient just a few days after the expiration date, which led to an expired vaccine used. The reporter needs an advice on what to do with the patient.  The vaccine administration facility was the same as primary reporter.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Fatigue; Headache; not feeling too good; Extreme dizziness; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5J959, expiry date 25-OCT-2025) for prophylaxis.   On 27-DEC-2024, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: Fatigue), headache (Verbatim: Headache), feeling bad (Verbatim: not feeling too good) and dizziness (Verbatim: Extreme dizziness). The outcome of the fatigue, headache, feeling bad and dizziness were not resolved.   It was unknown if the reporter considered the fatigue, headache, feeling bad and dizziness to be related to Arexvy.     It was unknown if the company considered the fatigue, headache, feeling bad and dizziness to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-JAN-2025 Pharmacist reported that he/she had a patient here who received the Arexvy vaccine a week ago from today, last Friday.  They did experienced some side effects like fatigue, headache and not feeling too good, extremely dizzy and they were still experienced those side effects on the day of reporting.  Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received the 1st dose of Shingrix. In DEC-2024, 2 months after receiving Shingrix, the patient experienced tinnitus (Verbatim: tinnitus). The outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.     It was unknown if the company considered the tinnitus to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2025 Patient DOB (date of birth) and initials were not available. The patient developed tinnitus 2 months after receiving the Shingrix.
Age: 43.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix); she is 43 and I gave her a Dtap Polio; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old female patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 13-JAN-2025, the patient received Kinrix. On an unknown date, the patient did not receive Boostrix. On 13-JAN-2025, an unknown time after receiving Kinrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: gave her a Dtap Polio (Kinrix) instead of a Tdap (Boostrix)) and inappropriate age at vaccine administration (Verbatim: she is 43 and I gave her a Dtap Polio). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 15-JAN-2025 The nurse gave a Dtap Polio (Kinrix) instead of a Tdap (Boostrix) to adult patient, she was 43 which led to wrong vaccine administered and inappropriate age at vaccine administration. The nurse was told to call GlaxoSmithKline and get your recommendations on revaccination. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalization due to COVID/she is getting over COVID; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (hospitalization due to COVID/she is getting over COVID) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy to chemicals (Allergy to polysorbate).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (hospitalization due to COVID/she is getting over COVID) (seriousness criterion hospitalization). At the time of the report, COVID-19 (hospitalization due to COVID/she is getting over COVID) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use), the reporter did not provide any causality assessments.   The patient's age was reported to be over 65 years. No concomitant medications were reported.  The reporter stated that the patient had specifically asked for Moderna as she was getting over COVID. The reporter stated that she ended up in hospital. The reporter believed the patient previously received a dose of Moderna since the patient had specifically asked for Moderna. The patient had an allergy to polysorbate and could not receive several vaccines.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Laboratory test, Pneumonia, Pulmonary thrombosis, Type 2 diabetes mellitus
Clinical narrative: Deep vein thrombosis; Blood clot in lungs; pneumonia; Type 2 Diabetic, borderline Type 1; This is a spontaneous report received from a Consumer or other non HCP.  A 66-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (hospitalization), outcome "unknown", described as "Blood clot in lungs"; DEEP VEIN THROMBOSIS (hospitalization, medically significant), outcome "unknown"; PNEUMONIA (medically significant), outcome "unknown"; TYPE 2 DIABETES MELLITUS (medically significant), outcome "not recovered", described as "Type 2 Diabetic, borderline Type 1". The patient was hospitalized for pulmonary thrombosis (hospitalization duration: 11 day(s)). The patient underwent the following laboratory tests and procedures: lab: Unknown results. Therapeutic measures were taken as a result of pulmonary thrombosis, deep vein thrombosis. Clinical course: Patient who received the latest Comirnaty vaccine. He is having side effects that he was calling to report and wanted to speak to someone about that.  After transfer clarified it's been a while since had the vaccine, but saw a published list of side effects and have couple those wanted to discuss. Clarified side effects she experienced as having deep vein thrombosis and had blood clots in lungs. Deep Vein Thrombosis, he explained he is on blood thinners to keep it from happening. Blood Clot in Lungs, confirmed he thinks itis gone. They pumped him with anticoagulants while in the hospital. He was in the hospital for 11 days due to this. He also added, now he is a Type 2 Diabetic, borderline Type 1 and he was not a diabetic before. He is on a lot of medication. Outcome is unable to provide, stated he is still holding on. He has to watch what he eats and take medication. Treatment: He clarified later the blood thinner as, Eliquis- 2.5mg twice a day, tablet, by mouth. He also clarified, the diabetic medication as Jardiance, dosage unknown and, Rybelsus dosage unknown. He confirmed this was the only Pfizer Comirnaty Vaccine he received. He added that he had pneumonia several times after receiving the vaccine. This occurred months after experiencing deep vein thrombosis and blood clot in lungs. However, does not know the dates to provide. He was hospitalized for a week(as reported). He had labs done during this time, but no further details provided. Prior Vaccinations (within 4 weeks): None.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anti-thyroid antibody, Blood thyroid stimulating hormone, Dry eye, Ear pain, Endocrine ophthalmopathy
Clinical narrative: graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 hours; eye pain; ear pain; dry eye; EYE PRESSURE; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 2, single (Lot number: EW0169) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing); "throwing up" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for blood pressure, reaction(s): "asthma attack"; Metoprolol for blood pressure, reaction(s): "phlegm"; Metoprolol for blood pressure, reaction(s): "spasms"; Metoprolol for blood pressure, reaction(s): "vasomotor reaction". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0158), administration date: 31Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "had pain in her arms", "she also felt sick like had the flu for about 24 hours". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "graves"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "thyroid eye disease"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain in her arms"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she also felt sick like had the flu for about 24 hours"; EYE PAIN (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown"; DRY EYE (non-serious), outcome "unknown"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "EYE PRESSURE"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.9; Blood thyroid stimulating hormone: (02Nov2021) 1.72; SARS-CoV-2 test: (06Jan2022) Positive; Thyroid function test: (unspecified date) graves disease and thyroid eye disease; Thyroxine: (02Nov2021) 1.0. Therapeutic measures were taken as a result of graves' disease (methimazole).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Graves' disease, Inappropriate schedule of product administration, Influenza like illness, Ocular discomfort
Clinical narrative: graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 hours; eye pain; ear pain; dry eye; EYE PRESSURE; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 2, single (Lot number: EW0169) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing); "throwing up" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for blood pressure, reaction(s): "asthma attack"; Metoprolol for blood pressure, reaction(s): "phlegm"; Metoprolol for blood pressure, reaction(s): "spasms"; Metoprolol for blood pressure, reaction(s): "vasomotor reaction". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0158), administration date: 31Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "had pain in her arms", "she also felt sick like had the flu for about 24 hours". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "graves"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "thyroid eye disease"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain in her arms"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she also felt sick like had the flu for about 24 hours"; EYE PAIN (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown"; DRY EYE (non-serious), outcome "unknown"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "EYE PRESSURE"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.9; Blood thyroid stimulating hormone: (02Nov2021) 1.72; SARS-CoV-2 test: (06Jan2022) Positive; Thyroid function test: (unspecified date) graves disease and thyroid eye disease; Thyroxine: (02Nov2021) 1.0. Therapeutic measures were taken as a result of graves' disease (methimazole).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, Thyroid function test, Thyroxine
Clinical narrative: graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 hours; eye pain; ear pain; dry eye; EYE PRESSURE; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 2, single (Lot number: EW0169) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing); "throwing up" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for blood pressure, reaction(s): "asthma attack"; Metoprolol for blood pressure, reaction(s): "phlegm"; Metoprolol for blood pressure, reaction(s): "spasms"; Metoprolol for blood pressure, reaction(s): "vasomotor reaction". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0158), administration date: 31Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "had pain in her arms", "she also felt sick like had the flu for about 24 hours". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "graves"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "thyroid eye disease"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain in her arms"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she also felt sick like had the flu for about 24 hours"; EYE PAIN (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown"; DRY EYE (non-serious), outcome "unknown"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "EYE PRESSURE"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.9; Blood thyroid stimulating hormone: (02Nov2021) 1.72; SARS-CoV-2 test: (06Jan2022) Positive; Thyroid function test: (unspecified date) graves disease and thyroid eye disease; Thyroxine: (02Nov2021) 1.0. Therapeutic measures were taken as a result of graves' disease (methimazole).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: graves; thyroid eye disease; had pain in her arms; she also felt sick like had the flu for about 24 hours; eye pain; ear pain; dry eye; EYE PRESSURE; the first was done on 31Jul2021/the second dose was on 13Aug2021; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 13Aug2021 as dose 2, single (Lot number: EW0169) at the age of 39 years for covid-19 immunisation. The patient's relevant medical history included: "asthma attacks", start date: 2019 (unspecified if ongoing); "throwing up" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for blood pressure, reaction(s): "asthma attack"; Metoprolol for blood pressure, reaction(s): "phlegm"; Metoprolol for blood pressure, reaction(s): "spasms"; Metoprolol for blood pressure, reaction(s): "vasomotor reaction". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EW0158), administration date: 31Jul2021, when the patient was 39-year-old, for Covid-19 immunization, reaction(s): "had pain in her arms", "she also felt sick like had the flu for about 24 hours". The following information was reported: GRAVES' DISEASE (medically significant), outcome "unknown", described as "graves"; ENDOCRINE OPHTHALMOPATHY (medically significant), outcome "unknown", described as "thyroid eye disease"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had pain in her arms"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "she also felt sick like had the flu for about 24 hours"; EYE PAIN (non-serious), outcome "unknown"; EAR PAIN (non-serious), outcome "unknown"; DRY EYE (non-serious), outcome "unknown"; OCULAR DISCOMFORT (non-serious), outcome "unknown", described as "EYE PRESSURE"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "the first was done on 31Jul2021/the second dose was on 13Aug2021". The patient underwent the following laboratory tests and procedures: Anti-thyroid antibody: (02Nov2021) 98.9; Blood thyroid stimulating hormone: (02Nov2021) 1.72; SARS-CoV-2 test: (06Jan2022) Positive; Thyroid function test: (unspecified date) graves disease and thyroid eye disease; Thyroxine: (02Nov2021) 1.0. Therapeutic measures were taken as a result of graves' disease (methimazole).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020504 same patient, different event, different dose of vaccine;
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Brain fog, Dizziness, Investigation
Clinical narrative: extreme dizziness; can't get out of bed; My head is almost never clear; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An 84-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (hospitalization), outcome "not recovered", described as "extreme dizziness"; BEDRIDDEN (non-serious), outcome "not recovered", described as "can't get out of bed"; BRAIN FOG (non-serious), outcome "unknown", described as "My head is almost never clear". The patient underwent the following laboratory tests and procedures: Test: all good. Clinical details: patient was 84 years old. Patient has been having extreme dizziness and was in the hospital. Tests were all good. His/her head was almost never clear. Sometimes he/she can't get out of bed. Patient had the Pfizer shot at the beginning of COVID. Patient asked if this could be from the vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose in 2021).   On 01-NOV-2024, the patient received the 2nd dose of Shingrix. On 01-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix - Late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 10-JAN-2025 Pharmacist mentioned that a patient received the first dose of Shingrix in 2021 and second dose was given on 01-NOV-2024.  The pharmacist asked if the patient should receive a third dose. The reporter did not share information about Shingrix doses such as lot number and expiration date. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 12 out of 32 patients.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 12; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.  This case contains information for patient 13 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.  This case contains information for patient 23 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 14 out of 32 patients.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 14; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.   This case contains information for patient 2 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 2; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.  This case contains information for patient 29 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 29; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.  This case contains information for patient 15 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 1 (Master case); Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided. This case is reported for patient 30 out of 32 patients.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 30; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.   This case contains information for patient 31 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 31; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided          No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.  This case contains information for patient 3 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 3; Reported Cause(s) of Death: Death unexplained
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller said that 32 people of her family were killed because of the vaccine including her niece's baby; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Caller said that 32 people of her family were killed because of the vaccine including her niece's baby) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.  This case contains information for patient 32 out of 32.  Company comment: This case involves a patient of unknown age and gender, with no reported medical history, who experienced the event death (reported as "32 people of her family were killed because of the vaccine"), which occurred on an unknown date, after receiving an unspecified dose of the COVID-19 vaccine (SPIKEVAX COVID-19 VACCINE NOS). The event latency could not be accurately assessed, as the exact dates of vaccination and death were not reported. The exact cause of death was not reported, and it is unknown if an autopsy was performed or not. No further clinical details were provided, such as patient's demographics, medical history, current conditions, concomitant medications, diagnostic/laboratory tests, circumstances surrounding the event, event details, cause, and date of death. The benefit-risk relationship of product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 32; Reported Cause(s) of Death: Death unexplained