chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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. In FEB-2025, 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: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 6 weeks).   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 unrelated 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: 14-JUL-2025 This case was reported by a patient via interactive digital media. The patient had the 2 step vaccine a few years ago and diagnosed with shingles in February lasting about 6 weeks at least. Had nothing for comparison. Distressed to learn people have had it several times. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and regarding laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have shingles now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles now). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JUL-2025 This case was reported by a patient via interactive digital media. The patient had shingles now but thankfully not a bad case.  The patient had the vaccine a few years ago. The patient also mentioned his/her had them when was young and was heartbreaking watching her in so much pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: maladministration of an expired dose of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   On 26-JUN-2025, the patient received Boostrix. On 26-JUN-2025, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: maladministration of an expired dose of Boostrix). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JUL-2025 Pharmacist reported the maladministration of an expired dose of Boostrix. Patient received expired dose of Boostrix, which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis.   On 10-JUL-2025, the patient received Havrix. On 10-JUL-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-JUL-2025 The nurse practitioner called to inform that a medical assistant used a dose of Havrix and that it was expired and administered to a patient. According to reporter, dose had expired on 15th February 2025 and was administered on 10th July 2025 which led to expired vaccine used. The reporter mentioned that the expired dose was administered to two twins. The vaccine administration facility was the same as primary reporter.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: two doses administered to the same patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number G22GH, expiry date 01-JUL-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 23-AUG-2023 with batch number: 9B2Y4 and expiry date: 20-JAN-2024).   On 06-SEP-2024, the patient received the 2nd dose of Arexvy. On 06-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: two doses administered to the same patient). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 16-JUL-2025 The pharmacist called to ask for information about the administration of two doses of Arexvy to the same patient which led to extra dose administered. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.
Age: 18.0
Vaccine: COVID19
Symptoms: Eating disorder, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Eating disorder; Vaccine was administered after excursion on 17-Dec-2024; Liquid vaccine was exposed to temperatures greater than 46 degree Fahrenheit with a maximum temperature of 47.91 degree Fahrenheit and was out of range for 16 minutes; This spontaneous case was reported by a nurse and describes the occurrence of EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) in an 18-year-old patient of an unknown gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. B0005) for COVID-19 prophylaxis.     Concurrent medical conditions included Dermatitis since 17-Nov-2021, Scoliosis (Mild scoliosis) since 22-Oct-2018 and ADHD, combined type since 09-Jan-2018. Concomitant products included Ethinylestradiol, Ferrous fumarate, Norethisterone acetate (Loestrin 24 fe) from 05-Jul-2022 to an unknown date for Contraception, Influenza vaccine inact split 3v (Flulaval) and Meningococcal vaccine B (MenB) for an unknown indication.    On 17-Dec-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 17-Dec-2024, the patient experienced EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024). At the time of the report, EATING DISORDER (Eating disorder) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter considered EATING DISORDER (Eating disorder) to be not related. No further causality assessment was provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered after excursion on 17-Dec-2024).    HCP reported multiple excursions in their refrigerator over a period ranging from 03-Dec-2024 to 11-Jun-2025.  The exact highest temperature and total combined excursion time were reported as 47.91 degrees Fahrenheit and 33 minutes.  On 13-Dec-2024, the highest temperature was reported as 47.91 degrees Fahrenheit, and minutes out of range were reported as 16.  No Moderna pediatric vaccine was stored in their refrigerator after 04-Feb-2025.  No adverse reactions noted by patient with respect to vaccinations of 17-Dec-2024.  No treatment medication was reported.  This case contains information for the 5th patient out of 9 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2025-787640 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2025: Follow up contains significant information. Reporter's details, patient details (initials, age, height, weight, race, medical history), suspect product details were added, co suspects were added, event was added and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-787640:Patient 1 (Master case)
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia
Clinical narrative: currently her husband is sick with Covid after he was hospitalized for pneumonia; currently her husband is sick with Covid after he was hospitalized for pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (currently her husband is sick with Covid after he was hospitalized for pneumonia) in an 86-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (currently her husband is sick with Covid after he was hospitalized for pneumonia) (seriousness criteria hospitalization and medically significant) and COVID-19 (currently her husband is sick with Covid after he was hospitalized for pneumonia). At the time of the report, PNEUMONIA (currently her husband is sick with Covid after he was hospitalized for pneumonia) and COVID-19 (currently her husband is sick with Covid after he was hospitalized for pneumonia) had not resolved.            No concomitant medications were reported. It was reported that, currently the patient was sick with Covid after he was hospitalized for pneumonia. His last vaccination with Covid vaccine was 2-3 months ago. It was unknown if the patient experienced any additional symptoms/events No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-023706 (E2B Linked Report). This case was linked to MOD-2021-022223 (Patient Link).; Reporter's Comments: Company comment: Event pneumonia was assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-023706:Wife case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: worse symptoms during his covid infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (worse symptoms during his covid infection) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 205F23-A) for COVID-19 prophylaxis.     The patient's past medical history included CPAP (sleep apnea and uses CPAP). Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 VACCINE (Batch Lot No: 04A2A, Dose 1) on 05-Mar-2021, Moderna COVID-19 VACCINE (Batch Lot No: 007B21A, Dose 2) on 04-Apr-2021, Moderna COVID-19 VACCINE (Batch Lot No: 051F21A, Dose 3) on 03-Nov-2021, Spikevax (Batch Lot No: 016B22A, Dose 4) on 05-Jul-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Batch Lot No: 059F22A, Dose 5) on 26-Oct-2022, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (Batch Lot No: A87170B and Dose 6) on 09-Jun-2023. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 VACCINE, Moderna COVID-19 VACCINE, Moderna COVID-19 VACCINE, Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) and Spikevax. Concurrent medical conditions included Sleep apnea (sleep apnea and uses CPAP).   On 29-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (worse symptoms during his covid infection). At the time of the report, COVID-19 (worse symptoms during his covid infection) outcome was unknown.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that her husband, had also taken 9 doses of Covid vaccines and experienced worse symptoms during his covid infection around the same time that she had hers.  It was reported that the patient administered SPIKEVAX 2023-2024 (Dose 8) on 29-Apr-2024, SPIKEVAX 2023-2024 (Dose 9, Booster) on 30-Jun-2024 and SPIKEVAX 2024-2025 PFS (Dose 10) on 30-Jun-2025.  It was unknown if the patient experienced any additional symptoms or events.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-788129 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-788129:Master Case (Wife)
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got Covid and ended up in the hospital; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jul-2025 and was forwarded to Moderna on 18-Jul-2025.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got Covid and ended up in the hospital) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Asthma, Breast cancer (on cancer therapy) and Autoimmune disorder.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I got Covid and ended up in the hospital) (seriousness criterion hospitalization). At the time of the report, COVID-19 (I got Covid and ended up in the hospital) outcome was unknown.          Patient was disabled and lost the insurance and no income. Patient having asthma and on cancer therapy for breast cancer and autoimmune disease. Patient had all the Covid injections and was due in August for booster. Patient got Covid and ended up in the hospital twice. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Pain in extremity, Rash, Rash erythematous
Clinical narrative: Red rash on left arm and slight pain in same area; Red rash on left arm and slight pain in same area; Red rash on left arm and slight pain in same area; This is a spontaneous report received from a Consumer or other non HCP.  A 52-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 10Jul2025 at 15:30 as dose 1, single (Batch/Lot number: unknown) at the age of 52 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE RASH (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 16Jul2025 at 06:00, outcome "not recovered" and all described as "Red rash on left arm and slight pain in same area". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site rash, vaccination site pain.  Additional Information: Patient have allergy to unspecified drug. The patient did not receive any other vaccines on the same date as the vaccines for which you are reporting. The patient did not receive any other vaccines within 4 weeks prior to the vaccines for which you are reporting. The patient did not take any other medications within 2 weeks of the event starting  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lymphadenopathy
Clinical narrative: The patient's lymph node enlarged and was biopsied; This is a spontaneous report received from an Other HCP from a sales representative.  A 19-year-old female patient (unknown if pregnant) 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: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "The patient's lymph node enlarged and was biopsied". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of lymphadenopathy. Additional information: Treatment received for the adverse event reported as biopsy.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node enlargement; This is a spontaneous report received from a healthcare professional from a sales representative.  An adult female patient (unknown if pregnant) 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 and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Lymph node enlargement". It was unknown if therapeutic measures were taken as a result of lymphadenopathy.  Additional Information: It was unknown if the patient was taking any other medication within 2 weeks of the event starting. It was unknown if the patient received any other vaccines within 4 weeks prior or on the same date as the suspect vaccine.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Jul2025, outcome "unknown". After taking the second COVID vaccine (Cominarty) two weeks ago later patient was diagnosed with Bell's Palsy.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Infantile vomiting, Pyrexia
Clinical narrative: experienced a vomiting following immunization with Comirnaty; experienced a 103F fever following immunization with Comirnaty; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): AE-020050 (BioNTech).  A 9-month-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 2025, outcome "unknown", described as "experienced a 103F fever following immunization with Comirnaty"; INFANTILE VOMITING (non-serious) with onset 2025, outcome "unknown", described as "experienced a vomiting following immunization with Comirnaty". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A friend reported that his 9-month-old son recently experienced a 103F fever and vomiting following immunization with Comirnaty.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a Physician.  A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 53.0
Sex: F
Vaccine: PNC21
Symptoms: Pain, Syncope
Clinical narrative: PATIENT'S REPRESENTATIVE STATES THAT PATIENT FAINTED AND LOTS OF PAIN. PATIENT WENT TO ER FOR THE PAIN
Age: 11.0
Sex: F
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was mistakenly given Meningococcal B instead of Meningococcal Conjugate vaccine.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Arthralgia, Dysphagia, Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Patient stated the morning after she received the 2 vaccines, she felt stiffness and pain radiated from both of her shoulders up to her neck. She could not move her neck and she also had trouble swallowing her food. The pain and stiffness lasted until 7/4/2025. She still has a very minor residual sensation in her throat sometimes.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Oropharyngeal discomfort, Pain
Clinical narrative: Patient stated the morning after she received the 2 vaccines, she felt stiffness and pain radiated from both of her shoulders up to her neck. She could not move her neck and she also had trouble swallowing her food. The pain and stiffness lasted until 7/4/2025. She still has a very minor residual sensation in her throat sometimes.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Depression, Electric shock sensation, Impaired work ability, Magnetic resonance imaging head
Clinical narrative: Post vaccine sensory neuritis in the my hands and feet that started on Sept 18,2024. 10 days after I got the flu vaccine. It progressed to my feet. It was very painful, zaps of pain in my hands and feet and interrupted my sleep and work life.  I am gabapentin and Cymbalta for pain.  I saw a neurologist on Dec 18, 2024 who put me on the gabapentin. My primary put me on Cymbalta for pain and depressed as i got very depressed from the hellish pain as a result of the flu vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Magnetic resonance imaging neck, Pain in extremity, Peripheral sensory neuropathy, Reflex test, Sleep disorder
Clinical narrative: Post vaccine sensory neuritis in the my hands and feet that started on Sept 18,2024. 10 days after I got the flu vaccine. It progressed to my feet. It was very painful, zaps of pain in my hands and feet and interrupted my sleep and work life.  I am gabapentin and Cymbalta for pain.  I saw a neurologist on Dec 18, 2024 who put me on the gabapentin. My primary put me on Cymbalta for pain and depressed as i got very depressed from the hellish pain as a result of the flu vaccine.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Injection site pain, Injection site swelling
Clinical narrative: (L) Deltoid swelling & pain Headache Treatment: antibiotic, sling, Ibuprofen, Benadryl Follow up: 2-3 days
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Blood pressure abnormal, Chills
Clinical narrative: The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, inflammations, worstening headaches, fevers off & on, skin rashes (red) swelling & soreness, muscle & joint pain, & terrible fatigue! Loss of taste & small since getting Covid 3x. Had dizziness & diarrhea, & worstening of Blood Pressure & high pulse. Worstening of cognitive memory & executive functioning tasks.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Diarrhoea, Dizziness, Executive dysfunction, Fatigue
Clinical narrative: The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, inflammations, worstening headaches, fevers off & on, skin rashes (red) swelling & soreness, muscle & joint pain, & terrible fatigue! Loss of taste & small since getting Covid 3x. Had dizziness & diarrhea, & worstening of Blood Pressure & high pulse. Worstening of cognitive memory & executive functioning tasks.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Inflammation, Influenza, Laboratory test
Clinical narrative: The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, inflammations, worstening headaches, fevers off & on, skin rashes (red) swelling & soreness, muscle & joint pain, & terrible fatigue! Loss of taste & small since getting Covid 3x. Had dizziness & diarrhea, & worstening of Blood Pressure & high pulse. Worstening of cognitive memory & executive functioning tasks.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Myalgia, Pain, Pyrexia, Rash erythematous
Clinical narrative: The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, inflammations, worstening headaches, fevers off & on, skin rashes (red) swelling & soreness, muscle & joint pain, & terrible fatigue! Loss of taste & small since getting Covid 3x. Had dizziness & diarrhea, & worstening of Blood Pressure & high pulse. Worstening of cognitive memory & executive functioning tasks.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Upper respiratory tract infection
Clinical narrative: The most noticeable one was on & off chills & flu symptoms, upper respiratory infections, inflammations, worstening headaches, fevers off & on, skin rashes (red) swelling & soreness, muscle & joint pain, & terrible fatigue! Loss of taste & small since getting Covid 3x. Had dizziness & diarrhea, & worstening of Blood Pressure & high pulse. Worstening of cognitive memory & executive functioning tasks.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got it; This serious case was reported by a nurse via interactive digital media and described the occurrence of vaccination failure in a 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 got it). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated 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: 14-JUN-2025 This case was reported by a patient via interactive digital media. The patient had been vaccinated twice and still got it/broke out with it.  The vaccine may have reduced the severity, it was not 100 percent effective.  Also, the patient did not trust any vaccines anymore.  As a nurse, the patient used to. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (doses 1 and 2).
Age: 0.42
Sex: M
Vaccine: DTPPVHBHPB, HPV9, RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 month old male infant given a dose of Gardisil 9, this is an early dose. No current event besides being given an immunization several years before it was due. No signs/symptoms. pt to be observed by family and brought to clinic if any issues.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first dose of Shingrix in 2023. When can the patient receive the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: received her first dose of Shingrix in 2023. When can the patient receive the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 15-JUL-2025 The pharmacist reported that the patient got her first dose of Shingrix in 2023 and asked when can the patient receive the second dose Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd 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 female patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd dose yet). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 09-JUL-2025 A patient received the first dose of Shingrix in 2020 and has not yet received the second dose, which led to incomplete course of vaccination. The reporter did not wish to provide the date of birth of the patient.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the initial Shingrix vaccine more than 2 years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received more than 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: had the initial Shingrix vaccine more than 2 years ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt date: 09-JUL-2025 The patient had the initial Shingrix vaccine. The reporter asked he/she might safely and effectively get the second dose now or should start again with the first dose and take the second as directed 3 to 4 months later. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: sharp pain near injection site; Hot at injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: sharp pain near injection site) and injection site warmth (Verbatim: Hot at injection site). The outcome of the injection site pain and injection site warmth were not reported.   It was unknown if the reporter considered the injection site pain and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site warmth to be related to Shingrix.   Additional Information: GSK Receipt date: 12-JUL-2025 The patient had hot and sharp pain near injection site.
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: How to reduce headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: How to reduce headache). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Shingrix.     It was unknown if the company considered the headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2025 This case was reported by a patient via interactive digital media. The reporter asked that how to reduce headache.
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Skin burning sensation, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shingles shots in 2020/a month ago I got shingles on my thigh; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUN-2025, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shingles shots in 2020/a month ago I got shingles on my thigh). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUL-2025 This case was reported by a patient via interactive digital media. The patient got the shingles shots in 2020 and a month ago, got shingles on thigh. The patient's whole thigh was broken out, burned really bad, still have botches and now it itches. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: RVX
Symptoms: Illness, Productive cough, Respiratory syncytial virus infection, Sputum discoloured, Vaccination failure
Clinical narrative: Suspected vaccination failure; still contracted RSV; coughing up green phlegm; Sickness; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sickness). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: still contracted RSV) and phlegm discolored (Verbatim: coughing up green phlegm). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved (duration 1 month) and the outcome of the phlegm discolored was not resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection, sickness and phlegm discolored to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection, sickness and phlegm discolored to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 12-JUL-2025 This case was reported by a consumer via interactive digital media. The patient was vaccinated too but still contracted RSV.  The patient was sick for a month and that was 2 months ago and he/she was still coughing up green phlegm.  This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine.
Age: 1.5
Sex: F
Vaccine: PNC20, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a dose to Tdap instead of Dtap for her 4th dose.  There has be no reaction at this point that has been made aware of.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Brain fog, Cardiac disorder, Malaise, SARS-CoV-2 antibody test positive
Clinical narrative: Heart problems Tremere's inside brain fog Anxiety sick all the time
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Heart problems Tremere's inside brain fog Anxiety sick all the time
Age: 46.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine Error - When the provider first told me about the vaccine the pt has increase primordiality, she is 4 years out the recommended age group.
Age: 16.0
Sex: M
Vaccine: HEP, MENB, MNQ
Symptoms: Arthralgia, Injected limb mobility decreased, Joint noise, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: Right Shoulder Pain - Persistent right shoulder discomfort began with a few hours after an injection in the right deltoid during the last visit. - Limited mobility prompted an urgent care visit on 7/10 - He describes a sensation of the shoulder blade caving in when both arms are raised and notes a size difference between shoulders. - Pain occurs when sleeping on the right side and crossing the right arm over the body, accompanied by a crunching sound.  He is unable to fully adduct and flex to start a golf swing - Pain and reduced flexion, extension, abduction and adduction - No swelling, redness, or rash. - No strenuous activities since onset. - Pain subsided after 3 days, leading to cancellation of follow-up from facility, but continued limited ROM prompted a visit with PCP on 7/21/25 - Using lidocaine patch, ice, ibuprofen, and Tylenol as recommended, providing some relief. - on Exam- limited right shoulder ROM with pain over the posterolateral deltoid in the groove c/w rotator cuff tendonitis
Age: 16.0
Sex: M
Vaccine: HEP, MENB, MNQ
Symptoms: Pain, Rotator cuff syndrome, Sleep disorder
Clinical narrative: Right Shoulder Pain - Persistent right shoulder discomfort began with a few hours after an injection in the right deltoid during the last visit. - Limited mobility prompted an urgent care visit on 7/10 - He describes a sensation of the shoulder blade caving in when both arms are raised and notes a size difference between shoulders. - Pain occurs when sleeping on the right side and crossing the right arm over the body, accompanied by a crunching sound.  He is unable to fully adduct and flex to start a golf swing - Pain and reduced flexion, extension, abduction and adduction - No swelling, redness, or rash. - No strenuous activities since onset. - Pain subsided after 3 days, leading to cancellation of follow-up from facility, but continued limited ROM prompted a visit with PCP on 7/21/25 - Using lidocaine patch, ice, ibuprofen, and Tylenol as recommended, providing some relief. - on Exam- limited right shoulder ROM with pain over the posterolateral deltoid in the groove c/w rotator cuff tendonitis
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: B-cell lymphoma, Lymph node palpable
Clinical narrative: Felt lymph nodes in neck, now has b cell lymphoma
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: shingrex shot on 06-11-2025 right arm, extreme pain right arm never went away
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Laboratory test abnormal, Rheumatoid factor positive, Swelling
Clinical narrative: Extreme joint pain, fatigue, swelling. Tests have now been positive for Rheumatoid Arthritis, Lupus, and Sjogren's.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: 31 yo G4P3, EDD 5/30/2025,  unknown birth weight
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient came in for second Men B shot in series. Patient had previously been given Bexero for first dose of Men B. Trumenba given for second dose by mistake. Dose 2 marked as invalid.
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Administration error, patient had previously received dose of Prevnar 20 on 3/19/25. Initial dose was not on state registry.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain, Injection site paraesthesia, Paraesthesia
Clinical narrative: Patient received a HPV #2 vaccine in office on 5/27/25. Administered in the left deltoid muscle. Mom called our office on 7/10/25 due to a lump that developed under the tissue at the injection site along with a tingling sensation in patient's arm. The lump was sensitive to touch and when palpated, patient would feel a tingling sensation down his arm to his hand. Otherwise, no pain or trouble moving his arm or hand. Upon collecting history, mom states that the lump developed immediately post vaccination on the same day. Mom also confirms that patient experienced mild arm soreness for 1-2 weeks post vaccination. Patient iced the deltoid muscle which improved the arm soreness but did not improve the lump at the injection site or tingling sensation. During the phone discussion with mom, it was recommended for patient to try a warm compress for 10-15min with massage. Instructed to do this twice daily for the next several days. Mother was instructed to make a follow up appointment that following Monday 7/14/25 if there was no improvement. Attempted to follow up with parent on 7/14/25 but unsuccessful; voicemail was left at 11:42am. Successfully able to follow up with mom on 7/18/25. Mom states that patient is doing much better. Explains that the warm compress and massage greatly improved the lump that was at the injection site and the tingling sensation has fully resolved.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Injection site rash, Rash, Rash erythematous
Clinical narrative: Episode started Thursday, 07/17/2025. The affected locations include the neck, chest, left arm, left lower leg, and right lower leg. The rash is characterized by redness. Mother was told to monitor the baby and a call was made on 7/22/2025 at 11:50AM to follow up on the patient, dad answered and stated that the child no longer has a rash.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: Episode started Thursday, 07/17/2025. The affected locations include the neck, chest, left arm, left lower leg, and right lower leg. The rash is characterized by redness. Mother was told to monitor the baby and a call was made on 7/22/2025 at 11:50AM to follow up on the patient, dad answered and stated that the child no longer has a rash.
Age: 1.0
Sex: F
Vaccine: PNC21
Symptoms: Crying, Immediate post-injection reaction, Pyrexia
Clinical narrative: Patient crying immediately after vaccine given and parent then noted that hives developed several minutes after given vaccine. Hives noted to forehead and one to upper back.  Provider called to room several minutes later and examined patient. Normal vitals and hives self resolved within 15 minutes without any additional spread or other symptoms.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Hypotension, Laboratory test, Musculoskeletal stiffness, Posture abnormal
Clinical narrative: Pt's wife stated stiffening up with head cocking to the side and ultimately dropping, sweating, low blood pressure and being unresponsive for up to 5 minutes while at the breakfast table the morning following vaccine.  Pt was responsive by time ambulance arrived and was coming around.  Was taken to Medical Center.  They ran tests, including a brain scan, and concluded he had syncope.  Pt's wife believed it was a seizure.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Scan brain, Syncope, Unresponsive to stimuli
Clinical narrative: Pt's wife stated stiffening up with head cocking to the side and ultimately dropping, sweating, low blood pressure and being unresponsive for up to 5 minutes while at the breakfast table the morning following vaccine.  Pt was responsive by time ambulance arrived and was coming around.  Was taken to Medical Center.  They ran tests, including a brain scan, and concluded he had syncope.  Pt's wife believed it was a seizure.