chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Non-consummation, Poisoning, Stool analysis abnormal, Urine analysis
Clinical narrative: My body is slowly being destroyed by the poison; Currently, I have developed endometrial cells even though I had a hysterectomy; I have not been sexually active; My urine came back with blood in it; My Cologuard just came back abnormal; my mammogram came back abnormal for the first time ever; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: EP6955) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hysterectomy" (unspecified if ongoing); "HPA", start date: 2000 (unspecified if ongoing); "leep procedure" (unspecified if ongoing); "c-section" (unspecified if ongoing); "appendectomy" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing). Concomitant medication(s) included: XANAX. Vaccination history included: pfizer COVID-19 vaccine-purple (DOSE 1, SINGLE, Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left), administration date: 16Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: ENDOMETRIAL DISORDER (non-serious) with onset Jan2023, outcome "unknown", described as "Currently, I have developed endometrial cells even though I had a hysterectomy"; NON-CONSUMMATION (non-serious) with onset Jan2023, outcome "unknown", described as "I have not been sexually active"; STOOL ANALYSIS ABNORMAL (non-serious) with onset Jan2023, outcome "unknown", described as "My Cologuard just came back abnormal"; POISONING (medically significant) with onset Jan2023, outcome "unknown", described as "My body is slowly being destroyed by the poison"; BLOOD URINE (non-serious) with onset Jan2023, outcome "unknown", described as "My urine came back with blood in it"; MAMMOGRAM ABNORMAL (non-serious) with onset Jan2023, outcome "unknown", described as "my mammogram came back abnormal for the first time ever". The events "my body is slowly being destroyed by the poison", "currently, i have developed endometrial cells even though i had a hysterectomy", "i have not been sexually active", "my urine came back with blood in it", "my cologuard just came back abnormal" and "my mammogram came back abnormal for the first time ever" required physician office visit. The patient underwent the following laboratory tests and procedures: Cologuard: abnormal, notes: My Cologuard just came back abnormal and my mammogram came back abnormal for the first time ever. Every time I go for something it is abnormal; Mammogram: abnormal; Urine analysis: with blood in it. It was unknown if therapeutic measures were taken as a result of poisoning, endometrial disorder, non-consummation, blood urine, stool analysis abnormal, mammogram abnormal. Clinical course: No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Jun2024 to 21Jun2024. Additional information: No known allergies. The patient had history of High cholesterol, but stopped atorvastatin while on Paxlovid.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 56-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 05Jan2024 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Patient had no known allergies.Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: COVID-19 (medically significant) with onset Jun2024, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Jun2024, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid form 11Jun2024 to 16Jun2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: pfizer / biontech (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 15Feb2023, when the patient was 68-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 14Sep2022, when the patient was 68-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 2, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 17Nov2021, when the patient was 67-year-old, for COVID-19 Immunization; pfizer / biontech (DOSE 1, SINGLE, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 67-year-old, for COVID-19 Immunization. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Furuncle, SARS-CoV-2 test, Skin exfoliation, Urticaria, Vaccination site discolouration
Clinical narrative: Large burn on left arm; Area swelled, turned deep red; Area swelled, turned deep red; began to peel a week later; leaving a discolored scar/looked like a skin boil and welt; leaving a discolored scar/looked like a skin boil and welt; skin boil and welt; skin boil and welt; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jun2024 as dose 1, single (Lot number: LC4370) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ongoing Autoimmune issues" (ongoing); "chronic inflammation" (ongoing); "Allergy" (unspecified if ongoing), notes: Gluten, nightshades, tomatoes; "antibiotics" (unspecified if ongoing), notes: most antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 03Jun2024, outcome "not recovered" and all described as "Area swelled, turned deep red"; VACCINATION SITE PAIN (non-serious) with onset 03Jun2024, outcome "not recovered", described as "Large burn on left arm"; SKIN EXFOLIATION (non-serious) with onset Jun2024, outcome "not recovered", described as "began to peel a week later"; VACCINATION SITE SCAR (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset Jun2024, outcome "not recovered" and all described as "leaving a discolored scar/looked like a skin boil and welt"; FURUNCLE (non-serious), URTICARIA (non-serious) all with onset Jun2024, outcome "not recovered" and all described as "skin boil and welt". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site scar, Vaccination site swelling
Clinical narrative: Large burn on left arm; Area swelled, turned deep red; Area swelled, turned deep red; began to peel a week later; leaving a discolored scar/looked like a skin boil and welt; leaving a discolored scar/looked like a skin boil and welt; skin boil and welt; skin boil and welt; This is a spontaneous report received from a Consumer or other non HCP.  A 27-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Jun2024 as dose 1, single (Lot number: LC4370) at the age of 27 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ongoing Autoimmune issues" (ongoing); "chronic inflammation" (ongoing); "Allergy" (unspecified if ongoing), notes: Gluten, nightshades, tomatoes; "antibiotics" (unspecified if ongoing), notes: most antibiotics. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 03Jun2024, outcome "not recovered" and all described as "Area swelled, turned deep red"; VACCINATION SITE PAIN (non-serious) with onset 03Jun2024, outcome "not recovered", described as "Large burn on left arm"; SKIN EXFOLIATION (non-serious) with onset Jun2024, outcome "not recovered", described as "began to peel a week later"; VACCINATION SITE SCAR (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset Jun2024, outcome "not recovered" and all described as "leaving a discolored scar/looked like a skin boil and welt"; FURUNCLE (non-serious), URTICARIA (non-serious) all with onset Jun2024, outcome "not recovered" and all described as "skin boil and welt". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid treatment start date 09Jun2024, stop date 14Jun2024.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 55-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 17:30 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Auto-immune arthritis" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "Bipolar" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: 01Jun2022, stop date: 08Jun2024; METHYLFOLATE, start date: 01Oct2023; LEUCOVORIN CALCIUM, start date: 01Jun2022, stop date: 09Jun2024. Past drug history included: Latuda, reaction(s): "Known allergies: latuda". Vaccination history included: BNT162b2 (Vaccine administration time: 02:30 PM , Vaccine lot number: EN6208 , Vaccine dose number: 1 , Vaccine location: Left arm), administration date: 26Mar2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Vaccine administration time: 12:00 PM , Vaccine lot number: EWO164 , Vaccine dose number: 2 , Vaccine location: Right arm), administration date: 22Apr2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2 (Vaccine administration time: 04:30 PM , Vaccine lot number: 320308D , Vaccine dose number: 3 , Vaccine location: Left arm), administration date: 29Oct2021, when the patient was 52-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Vaccine administration date: 23Sep2022 , Vaccine administration time: 06:00 PM , Vaccine dose number: 4 , Vaccine location: Left arm), administration date: 23Sep2022, when the patient was 53-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive COVID-19 home test; Positive COVID-19 home test; This is a spontaneous report received from a consumer.  A 69-year-old female patient (not pregnant) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Dec2023 as dose 1, single (Lot number: HG6396) at the age of 69 years for COVID-19 immunisation. The patient's relevant medical history included: "Oral lichen planus" (unspecified if ongoing); "Vaginal lichen sclerosis" (unspecified if ongoing); "Post-menopausal" (unspecified if ongoing), notes: For 10 plus years; "Mod gingivitis" (unspecified if ongoing). Concomitant medication(s) included: CLOBETASOL, start date: Oct2023; ESTRADIOL, start date: Jul2022; VITAMIN D3, start date: Jan2018; XYZAL, start date: Jan2023. The patient also took other concomitant therapy which included Women's 50+ Multivitamins (unspecified) from Jan2018. Past drug history included: Demerol, reaction(s): "Allergies". Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EN6199), administration date: 07Mar2021, when the patient was 66-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: ER8732), administration date: 28Mar2021, when the patient was 66-year-old, for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER); Lot Number: O51F21A), administration date: 05Nov2021, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER); Lot Number: FP7135), administration date: 25Jun2022, when the patient was 67-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER); Lot Number: GJ6739), administration date: 08Nov2022, when the patient was 68-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 13Jun2024 at 07:45, outcome "recovered with sequelae" (16Jun2024 at 16:30) and all described as "Positive COVID-19 home test". The patient had first positive COVID-19 home test on 13Jun2024 at 7:45 AM. The patient completed full course of nirmatrelvir/ ritonavir (PAXLOVID) as treatment for the events from 13Jun2024 to 18Jun2024. The patient had negative COVID-19 home tests on 16Jun2024 (4:30 PM) and 18Jun2024 (7:45 AM).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 49-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 as dose 1, (toppac); single (Lot number: HG4633) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Non-ischemic cardiomyopathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE, Vaccine lot number=AS7140C, Vaccine location=Left arm), administration date: 16Sep2022, when the patient was 47-year-old, for COVID-19 Immunization; moderna (DOSE 3 (BOOSTER), SINGLE, Vaccine lot number=033F12A, Vaccine location=Left arm), administration date: 30Oct2021, when the patient was 46-year-old, for COVID-19 Immunization; moderna (DOSE 2, SINGLE, Vaccine lot number=022M2OA), administration date: 21Feb2021, when the patient was 45-year-old, for COVID-19 Immunization; moderna (DOSE 1, SINGLE, Vaccine lot number=043L20A, Vaccine location=Left arm), administration date: 22Jan2021, when the patient was 45-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jun2024, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jun2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid as treatment for COVID-19 on 12Jun2024 until 17Jun2024. The patient had no known allergies.  No follow-up attempts are possible.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 57-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Dec2023 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "Meniere's" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2 (BOOSTER), SINGLE, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  An 82-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 08Mar2024 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure and high cholesterol controlled with low doses of medications; "high cholesterol controlled with low doses of medications" (unspecified if ongoing), notes: High blood pressure and high cholesterol controlled with low doses of medications. Concomitant medication(s) included: ROSUVASTATIN, stop date: 10Jun2024. 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; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE; Manufacturer Unknown), for Covid-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] will be requested and submitted if and when received.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2024, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient had no known allergies and medical history. COVID symptoms returned after completing Paxlovid course, and 3 days after testing negative.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 37-year-old female patient received BNT162b2 (BNT162B2), on 26Jul2021 as dose 1, single (Batch/Lot number: unknown), in right arm and on 08Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Preexisting Leukodystrophy" (unspecified if ongoing); "migraine headaches with auras" (unspecified if ongoing); "iron deficiency" (unspecified if ongoing); "anemia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jan2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jan2022) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400198622 same reporter/patient/drug, different AE/dose;US-PFIZER INC-202400199732 same reporter/patient/drug, different AE/dose;
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still has had shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still has had shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  The company considered the vaccination failure to be related to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2024 This case was reported by a patients sister via interactive digital media. The reporters sister had both shots the first one and the 2nd dose of Shingles and still had shingles twice. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case been linked with cases US2024AMR075571 and US2024AMR078002, reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments: Vaccination failure is a is a listed event which is considered related to GSK vaccine Shingles vaccine (2 doses). US-GLAXOSMITHKLINE-US2024AMR075571:same reporter US-GSK-US2024AMR078002:same reporter, Husband case
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received the second 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 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 08th June 2023, batch B4999, expiry date 5th August 2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-JUN-2024 The pharmacist called to report a patient received Shingrix first and had not received the second dose yet, which led to incomplete course of vaccination. The Vaccine Administration Facility was the same as Primary Reporter Consented to follow up.
Age: 0.5
Sex: M
Vaccine: COVID19, DTPPVHBHPB, PNC20, RV5
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: When reconsituting the Pfizer-BioNTech Covid-19 (2023-24) vaccine the staff member used 0.1 mL of diluent instead of 1.1 mL after misinterpeting the instructions.  The child was give the typical 0.3 mL dose leading to an inadvertent administgragtion of a higher than the recommended dose of 3 mcg.   As of six hours after the administration the mother reports that the child has had no adverse events and is acting his normal happy self.  He did take two naps which mom reports is typical for him.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Headache, Magnetic resonance imaging normal, X-ray normal
Clinical narrative: Patient received the vaccine last evening and this morning woke with a headache and low back pain.  The parent informed me today that the same thing happened 1 year ago when the patient received dose #1; she woke with a headache and low back pain.  The headache resolved rather quickly, but the back pain persisted for months (she still periodically has it, but it is not severe).  Per parent, the patient was reportedly seen by an orthopedist (I did not receive these records) and had a workup that consisted of normal X-rays and a normal MRI.  Back pain persisted and has waxed and waned, but this morning she woke up with the same symptoms as after dose #1.
Age: 28.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Head injury, Headache, Loss of consciousness
Clinical narrative: Pt passed out shortly after given both shots.  He hit his head and complained of a minor headache.  No other symptoms were reported.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came in on 6/24/24 explaing she had redness,swelling, itchiness, and pain on the injectin site for 10 days after the immunization.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident expired on 6/22/2024
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle atrophy
Clinical narrative: PATIENT REPORTED TODAY, 6-25-24, THAT SHE HAS ATROPHY OF HER LEFT DELTOID MUSCLE. THE PATIENT BELIEVES THE MODERNA VACCINES MAY HAVE CAUSED THE ATROPHY. SHE HAS RECEIVED A TOTAL OF 7 DOSES IN THE LEFT ARM (4 MONOVALENT AND 3 BIVALENT). THE ATROPHY HAS BEEN A SLOW PROCESS AND WAS NOTICED A FEW MONTHS AGO. THE PATIENT DOES NOT REPORT ANY OTHER ADVERSE EVENTS AT THIS TIME.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: none reported
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt received first dose of Twinrix on 6/22/24. Pt presented to pharmacy on 6/25/24 with erythema, pruritus, and swelling at the injection site on her right deltoid. Pt said the redness, swelling, and itchiness developed about a day after receiving the vaccine. I told her I would call her doctor to discuss the reaction and she said no, she would call if it got worse. She was going to take OTC benadryl for the itchiness and apply an ice pack for the swelling/redness.
Age: 26.0
Sex: M
Vaccine: COVID19, HEP, IPV, MMRV, TDAP, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Proquad was given instead of MMR
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra dose of shingrix (third shot with each being >2 months apart from the one before). This does not follow the CDC vaccination guidelines which state a patient >=65 years old should only receive 2 doses >=2 months apart. The patient did not have any side effects and was notified of the error. It is believed this was a misunderstanding that could have stemmed from the patient having 2 different profiles.
Age: 1.42
Sex: F
Vaccine: PNC20
Symptoms: Decreased appetite, Injection site erythema, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: redness 3inches in all directions of the injection site creating a red bumpy/splotchy patch about 6inches across. Entire thigh is swollen, warm to touch   Decreased appetite. Very fussy. Treatment of bentonite clay paste. Outcome unknown. Treatment still in progress.
Age: 13.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site macule
Clinical narrative: Prevnar given Monday with redness (2.5 cm macular lesion) on deltoid 1 - 24-48 minutes after
Sex: F
Vaccine: DTPPVHBHPB, PNC15, DTPPVHBHPB, PNC15
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure. Patient went to ED that night. Did well thereafter without sequelae; This non-serious spontaneous safety report, with reference number 2760062-1 (VAERS ID# 2760062-1), was received by a partner on 12-JUN-2024 and forwarded on the same day.   The reporter did not provide a causality assessment between Vaxelis and the reported event "Febrile seizure. Patient went to ED that night. Did well thereafter without sequelae."   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RVX
Symptoms: Body temperature increased, Haematochezia, Mucous stools
Clinical narrative: On 4/25/24 the blood in stool started.; He started having mucus in his stool shortly after vaccines; Patient had a temp of 101F the night of vaccines.; This non-serious spontaneous safety report, with the case reference number: 2763446-1 was retrieved from partner from VAERS on 13-JUN-2024 and forwarded to agency on 14-JUN-2024.  The reporter did not provide a causality assessment between Vaxelis and the reported events "patient had a temp of 101F the night of vaccines.  He started having mucus in his stool shortly after vaccines and on 4/15/24 the blood in stool started".  No further information is expected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: HBP reports that 3 day old infant received full dose of ROTATEQ.  No product confusion, human error. Per HBP no adverse effects reported.  No other information provided. No additional AE. No PQC.; no dverse event; This spontaneous report was received from an office manager concerning to a 3-day-old patient of unspecified gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 14-JUN-2024, the patient was vaccinated with a single full dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot#X028882 (expiration date: 04-JUL-2025), administered orally for prophylaxis (strength was not provided), due to a human error and not a product confusion (Inappropriate age at vaccine administration). However, no adverse events were reported.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: received Hiberix diluent alone from 2 different locations; received Hiberix diluent alone from 2 different locations; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old patient who received Hib (Hiberix) (batch number KF25B, expiry date 30-SEP-2025) for prophylaxis.   On 16-APR-2024, the patient received Hiberix. On 16-APR-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: received Hiberix diluent alone from 2 different locations) and inappropriate dose of vaccine administered (Verbatim: received Hiberix diluent alone from 2 different locations). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAY-2024 The nurse stated that the patient received Hiberix diluent alone from 2 different locations, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 7 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024061908:Same reporter / different patient, master case US-GSK-US2024AMR063489:Same reporter / different patient US-GSK-US2024AMR063485:Same reporter / different patient US-GSK-US2024AMR063487:Same reporter / different patient US-GSK-US2024AMR063479:Same reporter / different patient US-GSK-US2024AMR063488:Same reporter / different patient US-GSK-US2024AMR063486:Same reporter / different patient
Sex: U
Vaccine: RSV
Symptoms: Asthenia, COVID-19, Cough, Lethargy, Malaise
Clinical narrative: No/low energy; Cough; stuffy nose; lethergy; COVID-19; Sick; Sore throat; Low grade fever/fever; sore arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of pain in extremity (received on 2nd October 2023). Concurrent medical conditions included asthma.   On 02-MAR-2024, the patient received Arexvy. On 02-MAR-2024, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm). On 22-MAR-2024, the patient experienced covid-19 (Verbatim: COVID-19), sickness (Verbatim: Sick), sore throat (Verbatim: Sore throat) and fever (Verbatim: Low grade fever/fever). On 31-MAR-2024, the patient experienced nasal stuffiness (Verbatim: stuffy nose) and lethargy (Verbatim: lethergy). On an unknown date, the patient experienced loss of energy (Verbatim: No/low energy) and cough (Verbatim: Cough). The patient was treated with NIRMATRELVIR;RITONAVIR (PAXLOVID) and NIRMATRELVIR;RITONAVIR (PAXLOVID). On 04-APR-2024, the outcome of the sickness and fever were resolved (duration 13 days). The outcome of the covid-19 was resolved and the outcome of the pain in arm, sore throat, nasal stuffiness and loss of energy were not reported and the outcome of the lethargy and cough were not resolved.   It was unknown if the reporter considered the covid-19, pain in arm, sickness, sore throat, fever, nasal stuffiness, lethargy, loss of energy and cough to be related to Arexvy.     It was unknown if the company considered the covid-19, pain in arm, sickness, sore throat, fever, nasal stuffiness, lethargy, loss of energy and cough to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAY-2024 The reporter reported that a patient received Arexvy vaccine and experienced sore arm, and no other side effect. On 6th March 2024, the patient got another shot of updated version as the patient was old and had mild asthma.  The patient was planning a trip involving airplane travel so wanted to be sure up to date, sore arm was only side effect of vaccine.  After returning from trip, on 22nd March 2024 suddenly became sick with a sore throat, low 02 sats and fever.   Used a home test which was positive for COVID after contacted doctor's office and asked for Paxlovid. They called it in and patient began taking it that evening, within 2 days, feeling better.  On 27th March 2024 took the last dose in the and feeling well and no fever.  On 31st March 2024 feeling sick again, fever, stuffy nose, low 02, lethargic. It felt like day 1st all over again and this time could not get Paxlovid to knock it back.  Felt sick and had low grade fever until about 4th April, no/low energy.  On 4th April and 6th April 2024 still testing positive and not feeling 100%.  On 4th April , 9th April 2024 and 13th April 2024 testing negative, but still dealing with cough and lethargy.
Sex: U
Vaccine: RSV
Symptoms: Nasal congestion, Oropharyngeal pain, Oxygen saturation decreased, Pain in extremity, Pyrexia
Clinical narrative: No/low energy; Cough; stuffy nose; lethergy; COVID-19; Sick; Sore throat; Low grade fever/fever; sore arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of pain in extremity (received on 2nd October 2023). Concurrent medical conditions included asthma.   On 02-MAR-2024, the patient received Arexvy. On 02-MAR-2024, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm). On 22-MAR-2024, the patient experienced covid-19 (Verbatim: COVID-19), sickness (Verbatim: Sick), sore throat (Verbatim: Sore throat) and fever (Verbatim: Low grade fever/fever). On 31-MAR-2024, the patient experienced nasal stuffiness (Verbatim: stuffy nose) and lethargy (Verbatim: lethergy). On an unknown date, the patient experienced loss of energy (Verbatim: No/low energy) and cough (Verbatim: Cough). The patient was treated with NIRMATRELVIR;RITONAVIR (PAXLOVID) and NIRMATRELVIR;RITONAVIR (PAXLOVID). On 04-APR-2024, the outcome of the sickness and fever were resolved (duration 13 days). The outcome of the covid-19 was resolved and the outcome of the pain in arm, sore throat, nasal stuffiness and loss of energy were not reported and the outcome of the lethargy and cough were not resolved.   It was unknown if the reporter considered the covid-19, pain in arm, sickness, sore throat, fever, nasal stuffiness, lethargy, loss of energy and cough to be related to Arexvy.     It was unknown if the company considered the covid-19, pain in arm, sickness, sore throat, fever, nasal stuffiness, lethargy, loss of energy and cough to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAY-2024 The reporter reported that a patient received Arexvy vaccine and experienced sore arm, and no other side effect. On 6th March 2024, the patient got another shot of updated version as the patient was old and had mild asthma.  The patient was planning a trip involving airplane travel so wanted to be sure up to date, sore arm was only side effect of vaccine.  After returning from trip, on 22nd March 2024 suddenly became sick with a sore throat, low 02 sats and fever.   Used a home test which was positive for COVID after contacted doctor's office and asked for Paxlovid. They called it in and patient began taking it that evening, within 2 days, feeling better.  On 27th March 2024 took the last dose in the and feeling well and no fever.  On 31st March 2024 feeling sick again, fever, stuffy nose, low 02, lethargic. It felt like day 1st all over again and this time could not get Paxlovid to knock it back.  Felt sick and had low grade fever until about 4th April, no/low energy.  On 4th April and 6th April 2024 still testing positive and not feeling 100%.  On 4th April , 9th April 2024 and 13th April 2024 testing negative, but still dealing with cough and lethargy.
Sex: U
Vaccine: RSV
Symptoms: SARS-CoV-2 test positive
Clinical narrative: No/low energy; Cough; stuffy nose; lethergy; COVID-19; Sick; Sore throat; Low grade fever/fever; sore arm; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of covid-19 in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included COVID-19 vaccine with an associated reaction of pain in extremity (received on 2nd October 2023). Concurrent medical conditions included asthma.   On 02-MAR-2024, the patient received Arexvy. On 02-MAR-2024, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm). On 22-MAR-2024, the patient experienced covid-19 (Verbatim: COVID-19), sickness (Verbatim: Sick), sore throat (Verbatim: Sore throat) and fever (Verbatim: Low grade fever/fever). On 31-MAR-2024, the patient experienced nasal stuffiness (Verbatim: stuffy nose) and lethargy (Verbatim: lethergy). On an unknown date, the patient experienced loss of energy (Verbatim: No/low energy) and cough (Verbatim: Cough). The patient was treated with NIRMATRELVIR;RITONAVIR (PAXLOVID) and NIRMATRELVIR;RITONAVIR (PAXLOVID). On 04-APR-2024, the outcome of the sickness and fever were resolved (duration 13 days). The outcome of the covid-19 was resolved and the outcome of the pain in arm, sore throat, nasal stuffiness and loss of energy were not reported and the outcome of the lethargy and cough were not resolved.   It was unknown if the reporter considered the covid-19, pain in arm, sickness, sore throat, fever, nasal stuffiness, lethargy, loss of energy and cough to be related to Arexvy.     It was unknown if the company considered the covid-19, pain in arm, sickness, sore throat, fever, nasal stuffiness, lethargy, loss of energy and cough to be related to Arexvy.   Additional Information: GSK receipt date: 22-MAY-2024 The reporter reported that a patient received Arexvy vaccine and experienced sore arm, and no other side effect. On 6th March 2024, the patient got another shot of updated version as the patient was old and had mild asthma.  The patient was planning a trip involving airplane travel so wanted to be sure up to date, sore arm was only side effect of vaccine.  After returning from trip, on 22nd March 2024 suddenly became sick with a sore throat, low 02 sats and fever.   Used a home test which was positive for COVID after contacted doctor's office and asked for Paxlovid. They called it in and patient began taking it that evening, within 2 days, feeling better.  On 27th March 2024 took the last dose in the and feeling well and no fever.  On 31st March 2024 feeling sick again, fever, stuffy nose, low 02, lethargic. It felt like day 1st all over again and this time could not get Paxlovid to knock it back.  Felt sick and had low grade fever until about 4th April, no/low energy.  On 4th April and 6th April 2024 still testing positive and not feeling 100%.  On 4th April , 9th April 2024 and 13th April 2024 testing negative, but still dealing with cough and lethargy.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Insomnia, Lymph node pain, Odynophagia, Oropharyngeal pain
Clinical narrative: fever; tender lymph node; trouble sleeping; pain swallowing,; minimal coughing; sore throat; This non-serious case was reported by a physician via call center representative and described the occurrence of sore throat in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15-JUN-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, 24 hrs after receiving Shingrix, the patient experienced sore throat (Verbatim: sore throat), fever (Verbatim: fever), lymph node tenderness (Verbatim: tender lymph node), difficulty sleeping (Verbatim: trouble sleeping), swallowing painful (Verbatim: pain swallowing,) and cough (Verbatim: minimal coughing). The patient was treated with ibuprofen. In JUN-2024, the outcome of the fever was resolved. The outcome of the sore throat, difficulty sleeping, swallowing painful and cough were not resolved and the outcome of the lymph node tenderness was unknown.   It was unknown if the reporter considered the sore throat, fever, lymph node tenderness, difficulty sleeping, swallowing painful and cough to be related to Shingrix.     It was unknown if the company considered the sore throat, fever, lymph node tenderness, difficulty sleeping, swallowing painful and cough to be related to Shingrix.   Additional Information: GSK receipt date: 18-JUN-2024 Physician reported a patient the patient received vaccine and at 48 hours had severe sore throat and now at 72 hours the throat, she was having trouble sleeping, really a lot of pain swallowing, minimal coughing and no fever, had fever in the first 24 hours.  There was little to suggest any infectious etiology so the clear symptoms were related to inflammation.  So really one tender lymph node but the throat looks otherwise fine.  At 24 hours she developed a severe throat and it was just been progressing, fevers were gone by 48 hours, had no more fevers and otherwise felt ok, but the sore throat was just severe.  Tried ibuprofen, tried lozenges but nothing seems to help. Consented to follow up.