chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: U
Vaccine: DTAPIPVHIB, MMR, UNK, VARCEL
Symptoms: Extra dose administered, No adverse event, Product preparation error
Clinical narrative: No other AE; Medical assistant calling to report an adverse event.  Caller reporting the facility inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT.  The patient received both vaccines on the; Medical assistant calling to report an adverse event.  Caller reporting the facility inadvertently reconstituted both the MMR II and VARIVAX Vaccines with the VAXELIS Vaccine instead of the STERILE DILUENT.  The patient received both vaccines on the; VAXELIS Vaccine/also administered the PENTACEL Vaccine; This spontaneous report was received from a medical assistant referred to a 15 month old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.       On 27-JAN-2025, the facility inadvertently reconstituted both the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin(rHA) (M-M-R II) (lot # Y007615, expiration date 11-APR-2026; strength, dose, route were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) (lot # Y011020, expiration date 18-JUN-2026; strength, dose, route were not reported) vaccines with the diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid(VAXELIS) (lot # U7921AA, expiration date 31-OCT-2026; strength, dose, route were not reported) instead of the STERILE DILUENT (strength, dose, route, lot #, expiration date were not reported) (product preparation error). The patient received both vaccines on the same day (wrong product administered). This patient was also administered the diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(PENTACEL) (lot # UK167AA, expiration date 31-OCT-2025; strength, dose, route were not reported)on the same day (accidental overdose). No adverse event was reported.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Influenza like illness, Rash
Clinical narrative: Sick like flu; Developed shingle like rash on my torso; This non-serious case was reported by a consumer and described the occurrence of influenza like illness in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza like illness (Verbatim: Sick like flu) and vesicular rash (Verbatim: Developed shingle like rash on my torso). The outcome of the influenza like illness was unknown and the outcome of the vesicular rash was not resolved.   It was unknown if the reporter considered the influenza like illness and vesicular rash to be related to Shingrix.     It was unknown if the company considered the influenza like illness and vesicular rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JAN-2025 The symptoms were not treated. The reporter did not consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dermatitis atopic
Clinical narrative: flare up of symptoms since taking shingrix vaccine; fl are up of sy mptoms over the past month; This non-serious case was reported by a physician via other manufacturer and described the occurrence of atopic dermatitis in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab (Dupixent) solution for injection for atopic dermatitis.   On an unknown date, the patient received Shingrix. On 27-APR-2020, the patient started Dupixent (subcutaneous). On 02-OCT-2024, an unknown time after receiving Shingrix, the patient experienced atopic dermatitis (Verbatim: flare up of symptoms over the past month). On an unknown date, the patient experienced atopic dermatitis (Verbatim: flare up of symptoms since taking shingrix vaccine). The action taken with Dupixent was unknown. The outcome of the atopic dermatitis and atopic dermatitis were unknown.   It was unknown if the reporter considered the atopic dermatitis and atopic dermatitis to be related to Shingrix.     It was unknown if the company considered the atopic dermatitis and atopic dermatitis to be related to Shingrix.   Additional Information: GSK receipt date: 03-JAN-2025 Patient had flare up of symptoms since taking Shingrix vaccine and flare up of symptoms over the past month while she was treated with Dupilumab.  The patient's past medical history, concomitant, Vaccination and fam ily history were not provided.  On 27-Apr-2020, the patient started taking Dupilumab solution for injection (strength: 300mg/2mL). at a dose of 300 mg QO W subcutaneously for other atopic dermatitis.  It was reported that a flare up of symptoms over the past month. Patient reported they usually get a flare up when she travels nights because of sheets or she catches something. Patient stated Dupilumab is working well for them.  Corrective treatment were not reported for both events. Reported outcome were unknown for both events.
Age: 6.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 7 year old girl had taken DT vaccine at age 6; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   On an unknown date, the patient received dTpa vaccine. On an unknown date, an unknown time after receiving dTpa vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: A 7 year old girl had taken DT vaccine at age 6). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that the 7 year old patient had taken DT vaccine at age 6 which led to inappropriate age at vaccine administration. The reporter asked was it allowed for this patient to take a boost Dtap Boostrix 6 months after her last dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; gave me the worst case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: gave me the worst case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that a patient received Shingles vaccine and it gave patient the worst case of shingles three separate physician had ever seen. Odds was patient would not get it at without the vaccination.  Patient added take chances without it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.   Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still had a mild case of shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles once before there was a vaccine).   On an unknown date, the patient received Shingrix. In DEC-2024, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had a mild case of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that no vaccine was foolproof.  The patient had the vaccine and had a mild case of shingles last month.  The patient also had shingles before there was a vaccine.  This time it was mild, less painful and healed so much quicker. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: FLU3
Symptoms: Product confusion, Wrong product administered
Clinical narrative: band colors on prefilled syringes of Flulaval and Boostrix are similar (Green) and the labels are hard to read, it played a role in administration error; received the Flulaval vaccine inadvertently instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In DEC-2024, the patient received FluLaval 2024-2025 season. On an unknown date, the patient did not receive Boostrix. In DEC-2024, an unknown time after receiving FluLaval 2024-2025 season and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: received the Flulaval vaccine inadvertently instead of Boostrix). On an unknown date, the patient experienced product label confusion (Verbatim: band colors on prefilled syringes of Flulaval and Boostrix are similar (Green) and the labels are hard to read, it played a role in administration error). The outcome of the wrong vaccine administered and product label confusion 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: 03-JAN-2025 The nurse reported that about one week ago (from the date of reporting), an adult patient received the Flulaval vaccine inadvertently instead of Boostrix, which led to wrong vaccine administered. The reporter stated since the band colors on the prefilled syringes of Flulaval and Boostrix were similar (Green), and the labels were hard to read, it played a role in the administration error, which led to product label confusion. The reporter did not have the lot number from the Flulaval vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: bumps; red around the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, 1 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: red around the injection site). On 05-JAN-2025, the patient experienced mass (Verbatim: bumps). The outcome of the injection site erythema and mass were not resolved.   It was unknown if the reporter considered the injection site erythema and mass to be related to Shingrix.     It was unknown if the company considered the injection site erythema and mass to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that a patient received the first dose of Shingrix on Friday afternoon, 3rd January 2025. Also stated her arm was red around the injection site around 12 PM on Saturday, 4th January 2025. She reported her arm started to bother her a lot in the evening on Saturday. Also stated that by 1 AM Sunday, 5th January 2025 the redness had spread a lot and she had a couple of bumps that were very dark red and flesh colored under the bumps. The patient stated she had never had a reaction like this from any other vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: itching on his trunk; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 16-JUL-2024).   On 20-NOV-2024, the patient received the 2nd dose of Shingrix. In NOV-2024, 5 days after receiving Shingrix, the patient experienced pruritus (Verbatim: itching on his trunk). The patient was treated with prednisone. The outcome of the pruritus was not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.     It was unknown if the company considered the pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JAN-2025 Around 5 days after his second dose, he experienced itching on his trunk.  He took prednisone for 5 days and after finishing the medication, the itching has come back.  The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got her 1st dose in 2021 and her 2nd dose in 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose of Shingrix in 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: patient got her 1st dose in 2021 and her 2nd dose in 2024). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter was a 66-year-old female patient. The patient reported on 6th January 2025, that she received both doses of Shingrix at a local pharmacy. The patient did not recall in which arm she received the vaccines and the Lot number and Expiry date were unknown. The patient reported that she got her 1st dose in 2021 and her 2nd dose in 2024 which led to lengthening of vaccinations schedule. (Drug dose administration interval too long).
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not receive Twinrix dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (patient got a dose of Twinrix a year ago).   On an unknown date, the patient did not receive Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not receive Twinrix dose yet). The outcome of the incomplete course of vaccination 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: 14-JAN-2025 The pharmacist reported that the patient got a dose of Twinrix a year ago. The reporter asked question the patient needs to start over the series. Till the time of reporting, the patient did not receive dose of Twinrix, which led to  incomplete course of vaccination.
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. Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events. No treatment information was provided.  This case contains information for the 28th of 32 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 28; 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 27 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 18 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 18; 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 8 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 8; 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 9 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 9; 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 10 out of 32.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).   Reporter did not allow further contact; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:Patient 10; 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 11 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:; 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 19 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. 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 19; 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 medications were reported. It was unknown if the patient experienced any additional symptoms/events No treatment medications were reported.  This case contains information for patient 20 out of 32 patients involved.  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).; 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 medications were reported. It was unknown if the patient experienced any additional symptoms/events No treatment medications were reported.  This case contains information for patient 21 out of 32 patients involved.  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).; 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) (batch no. UNKNOWN) 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.  No treatment information was reported.  This case contains information for patient 22 out of 32.   This case was linked to US-MODERNATX, INC.-MOD-2025-781803 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-781803:master case (patient 22); Reported Cause(s) of Death: Unexplained death
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Influenza
Clinical narrative: anaphylaxia - closing up to the throat/coughs occasionally; flu; This spontaneous case was reported by a patient and describes the occurrence of ANAPHYLACTIC REACTION (anaphylaxia - closing up to the throat/coughs occasionally) in a 71-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac arrhythmia NOS. Concurrent medical conditions included Iodine allergy. Concomitant products included Oseltamivir phosphate for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 26-Jan-2025, the patient experienced INFLUENZA (flu). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (anaphylaxia - closing up to the throat/coughs occasionally) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (anaphylaxia - closing up to the throat/coughs occasionally) outcome was unknown and INFLUENZA (flu) had not resolved.            The patient had no vaccines in the last 4 weeks. Her previous doses included Moderna COVID-19 vaccine Spikevax - all of them except for 2024-2025 formula.  It was reported that, she had the flu and had never taken Tamiflu in her life. Her doctor assigned it to her but the pharmacist asked her if she had any anaphylaxia - closing up to the throat. Patient stated that She had it with Moderna shot and she had to like to take an allergy medication before she even take the shot. Patient stated the anaphylaxis in the Tamiflu, it was due to the iodine in it. Patient was just wondering did the Moderna shot had anything iodine, then she would know she would have to eliminate the Tamiflu.  Patient reiterated that every time she got the Moderna COVID-19 vaccine she experienced like her throat was closing out. The patient did not experience any additional symptoms/events.  No treatment information was provided.; Reporter's Comments: Due to lack of biological plausibility, the event influenza was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: Preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe; The initial case was missing the following minimum criteria: Product complaint only. Upon receipt of follow-up information on 22Jan2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: KC7884, Expiration Date: 30Sep2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), outcome "unknown", described as "Preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe".  Additional information: They are preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe, they have already mixed the product and they are looking for the replacement. When paraphrased the concern: Reporter (Pharmacist) stated, they wanted to know if that was possible because the tip where the needle was supposed to go, it was like it broke off like that never happened before. Sample availability was unknown.  Causality for "preparing the vaccine, and the tip of the vaccine, it broke off and they cannot attach the needle to the syringe" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood catecholamines, Normetanephrine urine increased, Palpitations, SARS-CoV-2 test
Clinical narrative: Palpitations; she believed it was normetanephrine that was elevated; This is a spontaneous report received from a Physician.  An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 as dose 1, single at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hashimotos hypothyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amlodipine, notes: She had preexisting hypertension and was on treatment with amlodipine; Synthroid, start date: 1990, notes: She has hypothyroid Hashimoto's hypothryoiditis and at that date she was on 50mcg of Synthroid and has taken since the late 1990s; Baby aspirin, start date: 2015, notes: she also takes baby aspirin which she has taken since 2015; Atorvastatin, start date: 2015, notes: Was on atorvastatin 20mg back then and still is on that but had to discontinue it to take the Paxlovid and has been on the atorvastatin for a number of years since 2015. The following information was reported: PALPITATIONS (non-serious), outcome "recovered"; NORMETANEPHRINE URINE INCREASED (non-serious), outcome "unknown", described as "she believed it was normetanephrine that was elevated". The event "palpitations" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations.  Additional information: After the vaccine, the patient developed palpitations that intensified, and she knew the palpitations were a possible consequence and the hypertension was a possible consequence and she was not too concerned and then it just got worse and worse. The palpitations finally resolved once she saw a specialist in hypertension and she had the values of her normetanephrine and metanephrine and those are considered stressor levels so she believed it was her normetanephrine that was elevated and does know it affects the angiotensin system and so the intervention was to stop the amlodipine and she could not get in touch with her HCP for a number of weeks and endured the palpitations and the cardiologist did a week long monitor and there was no abnormality on the monitor.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500020513 same patient/vaccine, diff events;
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  An 81-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 19Sep2024 as dose 1, single at the age of 80 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Hashimotos hypothyroiditis" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; BABY ASPIRIN, start date: 2015; AMLODIPINE taken for hypertension, start date: 2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 21Jan2025, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jan2025) Positive. The clinical course was reported as follows: The patient got the vaccine on 19Sep2024 and was not totally shocked when she got COVID but thought the vaccine was protective but she was 80 and took PAXLOVID and her husband also got COVID so they both had it. She had Hashimoto's hypothyroidisms and at that date she was on 50 mcg of Synthroid and had taken since the late 1990s. Therapeutic measures were taken as a result of covid-19, vaccination failure.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for event vaccination failure. This case will be reassessed upon receipt of additional information.