chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 24 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: 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. US-MODERNATX, INC.-MOD-2025-781803:Patient 24; 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 16 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: 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. US-MODERNATX, INC.-MOD-2025-781803:Patient 16; 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 4 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: 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. US-MODERNATX, INC.-MOD-2025-781803:Patient 4; 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 25 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: 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. 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 5 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: 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. US-MODERNATX, INC.-MOD-2025-781803:Patient 5; 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 17 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: 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. 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 26 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: 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. US-MODERNATX, INC.-MOD-2025-781803:Patient 26; 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 6 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: 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. US-MODERNATX, INC.-MOD-2025-781803:Patient 6; 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 7 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 7; Reported Cause(s) of Death: Death unexplained
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Haematological malignancy
Clinical narrative: She had Covid twice; She also has a blood cancer diagnosis; This serious initial Spontaneous safety report was received by Novavax on 23-Jan-2025 from a Consumer or other non-health professional via Novavax Medical Information (Case No. NOV25-00044).  A 72-year-old Female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) (Intramuscular) (Lot number was not provided in the report) on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date after vaccination the patient experienced She also has a blood cancer diagnosis (PT: Haematological malignancy) (Serious: Other Medically Important Condition) and on an unspecified date after vaccination the patient experienced She had Covid twice (PT: COVID-19).  At the time of reporting, the event outcome of Haematological malignancy was Unknown and COVID-19 was Unknown.; Sender's Comments: This 72-year-old Female experienced Haematological malignancy and COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula).  The event Haematological malignancy was assessed as serious.  The event COVID-19 was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Haematological malignancy and COVID-19 is considered Possible.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Joint range of motion decreased
Clinical narrative: the bone in my left arm is killing me/pain when i lift my arm; the bone in my left arm is killing me/pain when i lift my arm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY); alprazolam (XANAX). The patient's relevant medical history included: "copd" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2; unknown manufacturer), for covid-19 immunization. The following information was reported: BONE PAIN (hospitalization, life threatening), JOINT RANGE OF MOTION DECREASED (hospitalization, life threatening), outcome "unknown" and all described as "the bone in my left arm is killing me/pain when i lift my arm". The event "the bone in my left arm is killing me/pain when i lift my arm" required emergency room visit. The action taken for fluticasone furoate, umeclidinium bromide, vilanterol trifenatate and alprazolam was unknown.  Clinical course: When asked if the adverse reaction required her to go to the emergency room, the patient said, "yes because the bone in my left arm is killing me". Patient can feel pain in her bone and cannot lift up her arm and definitely need more than an x-ray because it would not show in the x-ray. This happens for doing the right thing, getting a booster shot for covid which she received 2 years ago (in 2023). She has pain when she lifts her arm.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Red, itchy arm; Red, itchy arm; This is a spontaneous report received from a Consumer or other non HCP.  A 75-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 21Jan2025 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 14Jan2025 as dose number unknown, single; SECTRAL. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 21Jan2025 at 16:00, outcome "not recovered" and all described as "Red, itchy arm". Therapeutic measures were not taken as a result of erythema, pruritus.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 60.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Rash papular, Rash pruritic
Clinical narrative: large rash, itchy and still spreading and slightly swollen; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 21Jan2025 at 15:48 as dose number unknown, 0.5ml single (Lot number: LJ5283, Expiration Date: 31May2026) at the age of 60 years intramuscular, in left deltoid for immunisation; influenza vaccine inact split 3v (FLULAVAL), on 21Jan2025 as dose number unknown, single (Lot number: 9H5J5, Expiration Date: 30Jun2025) for immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: RASH PRURITIC (non-serious) with onset 26Jan2025, outcome "not recovered", described as "large rash, itchy and still spreading and slightly swollen". Therapeutic measures were taken as a result of rash pruritic.  Additional information: Reporter (Medical assistant) was calling from a doctor's office, because they have a patient who had an adverse reaction to the Prevnar 20. The doctor was asking if there was anything else, she was using hydrocortisone cream (Treatment) and the doctor was recommending Benadryl for the adverse reaction (Treatment). Reporter stated that the patient was having a large rash, itchy and still spreading and slightly swollen. The patient was on several medications, Not on reporting day. Reporter stated, she still experiencing the reaction.
Age: 61.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Arthralgia, Back pain, Gait disturbance, Muscle tightness, Musculoskeletal pain
Clinical narrative: Left Psoas tightness; lower back pain; buttock pain; difficulty walking; hip pain; This is a spontaneous report received from a Nurse.  A 61-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Jan2025 as dose 1, single (Lot number: LJ5283) at the age of 61 years, in right deltoid for immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2025 as dose number unknown, single (Lot number: 8080803), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "Left Psoas tightness"; MUSCULOSKELETAL PAIN (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "buttock pain"; GAIT DISTURBANCE (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "difficulty walking"; ARTHRALGIA (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "hip pain"; BACK PAIN (non-serious) with onset 19Jan2025 at 06:00, outcome "not recovered", described as "lower back pain". Therapeutic measures were taken as a result of muscle tightness, back pain, musculoskeletal pain, gait disturbance, arthralgia.  Additional information: On 18Jan2025 received co-suspect Moderna 2024-2025 covid vaccine. Unknown if patient took any other medications within 2 weeks of the event starting. All symptoms associated with Left Psoas tightness including lower back pain, hip pain, buttock pain, difficulty walking, no prolonged hospitalization due to it. When asked what treatment received for the adverse event? So far, the pain was still existing as of this date.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This is a spontaneous report received from a consumer.  An adult male patient received BNT162b2 Omicron (KP.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Hospitalization" (ongoing). The patient took concomitant medications. The patient received other medications in two weeks. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization; COVID-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. No other vaccine was administered in four weeks or on the same date of the suspect COVID-19 vaccine. The following information was reported: DEATH (death, prolonged hospitalization, disability, life threatening, medically significant), outcome "fatal", described as "Died". Therapeutic measures were taken as a result of death. The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. The patient's child was doing this for the patient as he died from getting the COVID-19 vaccines and boosters. The adverse events resulted in death, prolongation of existing hospitalization (treatment received during existing hospitalization), life-threatening illness (immediate risk of death from the event), and disability or permanent damage. Per patient's child, the patient did not recover from the event.  The information on the batch/lot number for BNT162b2 Omicron (KP.2) will be requested and submitted if and when received.; Reported Cause(s) of Death: Died
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Paraesthesia
Clinical narrative: tingling in the fingers; loss of smell and taste; loss of smell and taste; This is a spontaneous report received from a Consumer or other non HCP.  A 35-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 01May2024, outcome "not recovered" and all described as "loss of smell and taste"; PARAESTHESIA (non-serious) with onset 01May2024, outcome "not recovered", described as "tingling in the fingers". Therapeutic measures were not taken as a result of paraesthesia, anosmia, ageusia. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm swelling (10 mm), hot to the touch, redness, and pain. Started 1 day after injections. Parents have been giving Benadryl every 4-6 hours and Tylenol for pain.
Age: 56.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injected limb mobility decreased, Pain in extremity, Rash macular, Tenderness
Clinical narrative: Patient experienced extreme soreness on right arm and could not move it beyond an acute angle. 4 days later, on Thursday, patient found red splotches further down the upper arm with distinct borders that was tender and painful to touch. Patient can now move arm freely and still experiences mild soreness.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Swelling face
Clinical narrative: swollen jaw
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold
Clinical narrative: A few days after patient received flublok, patient experienced a cold sensation in fingers/face which still lingers somewhat to this day. Patient has seen a few doctors in regards to this but the cause is uncertain and some believe it may possibly have been due to the vaccine.
Age: 0.42
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given extra HEP B Vaccine along with combination vaccination.  NO adverse side effects or s/s of complications were observed in patient by staff.
Age: 29.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Proquad is not supposed to be given to anyone over the age of 12 years old. This patient is 29 years old.
Age: 19.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Proquad is not supposed to be given to anyone over the age of 12 years old. This patient is 19 years old.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: red, itchy hive-like rash on neck, back, and hip. pt stated it began about 1 week after the vaccine was administered. used an OTC "itch cream" on it which did help. rash is still present. Advised patient to consult their prescriber to determine if the vaccine caused the reaction, and if patient should receive the second dose in the series.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: ADMINISTRATION ERROR. DUPLICATE VACCINE. RECEIVED SEPTEMBER 2023
Age: 73.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Head injury, Scan normal, Syncope
Clinical narrative: syncope after getting IMZ, EMS cleared patient to follow up with primary, primary suggested walk-in clinic, walk-in said to go to ER since patient hit her head
Age: 73.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site rash, Injection site warmth, Peripheral swelling
Clinical narrative: Rash below injection site that started the day after injection. Infection and was given Augmentin 875 mg twice daily for 7 days. Swollen arm. Hot around injection site. Couldn't move or lift arm on day after vaccine.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Contusion, Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: The next day ( 01/18/2025)  following the vaccine, patient experienced bruising, swelling, inflamed area, pain.  The next following days  ) 01/18-23/ 2025) patient kept experiencing pain, new sign of itching and redness and on day 5 post vaccines the swelling increased, pain reaching the elbow. Patient went primacy doctor who prescribed oral antibiotic, topical steroid and pain medication.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Swelling
Clinical narrative: The next day ( 01/18/2025)  following the vaccine, patient experienced bruising, swelling, inflamed area, pain.  The next following days  ) 01/18-23/ 2025) patient kept experiencing pain, new sign of itching and redness and on day 5 post vaccines the swelling increased, pain reaching the elbow. Patient went primacy doctor who prescribed oral antibiotic, topical steroid and pain medication.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: N/A; received wrong vaccine for age group
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left thigh redness & swelling from injection site down to above knee.
Age: 50.0
Sex: M
Vaccine: HPV9, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RSV vaccination administered when HPV  was to be administered.
Age: 50.0
Sex: M
Vaccine: HPV9, RSV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: RSV vaccination administered when HPV  was to be administered.
Age: 11.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP called to report a 11-year-old patient was administered PROQUAD, when she was only due for Varicella vaccine. Inquiring about the validity of the Varicella and potential side effects of additional MMR II.  See request cases, 02741163 and 0271190.; This spontaneous report was received from Other Health Professional (Medical Assistant) and refers to an 11-year-old female patient.  The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 22-JAN-2025, the patient was vaccinated with measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, lot #X026597, expiration date: 11-MAY-2025, administered for prophylaxis (strength, dose, route of administration, and anatomical site of injection were not provided). The patient was only due for the varicella vaccine, but the combination vaccine (PROQUAD) was administered instead (wrong product administered). Additionally, the patient was vaccinated with sterile diluent (MERCK STERILE DILUENT) solution for injection/infusion (strength, dose description, lot #, expiry date, route of administration, and indication were not provided).  No additional adverse events were reported (no adverse event). No additional information was available.
Age: 61.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient has not report and medical concerns or symptoms regarding this report; Pharmacist stated that a 61 year old patient was concomitantly administered VARIVAX and MMR II during the same vaccination appointment today; This spontaneous report was received from a pharmacist and refers to a 61-year-old of unknown gender.The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-JAN-2025, during the same vaccination appointment, the patient was concomitantly vaccinated with a both varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter/two dose series and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter /two dose series, administered for prophylaxis (strengths, lot numbers, expiry dates, and routes of administration were not provided) (product administered to patient of inappropriate age ).  It was confirmed the patient has not report and medical concerns or symptoms regarding this report (no adverse event). No additional information provided.  Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Customer calling to report temperature excursion. PROQUAD dose was administered on 1/23/2025.; This spontaneous report was received from an Other Health Professional and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 23-JAN-2025, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, lot #Y010050, expiration date: 25-NOV-2025, administered for prophylaxis (strength, and route of administration were not provided) (product storage error).
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Body aches as worsened; headache was reported as worsened; This non-serious case was reported by a other health professional via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-JAN-2025, the patient received Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Body aches as worsened) and headache (Verbatim: headache was reported as worsened). The outcome of the general body pain and headache were not resolved.   The reporter considered the general body pain and headache to be related to Shingrix.     The company considered the general body pain and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JAN-2025 The patient received Shingrix and had body aches and headache. Body aches and headache was reported as worsened. The patient had subsequent dose of Shingrix.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number G97Y2, expiry date 15-NOV-2026) for prophylaxis.   On 04-JAN-2025, the patient received the 1st dose of Shingrix. On 04-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder) and inappropriate dose of vaccine administered (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone/gave the adjuvant to the Shingrix vaccine and did not mix it with the powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that who received Shingrix adjuvant alone without the powder as a Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The case had been linked to US2025001095, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2025001095:Same reporter/Different aptient