chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a duplicate vaccine. Patient received original pcv20 vaccine on 03/11/2023, and duplicate vaccination on 03/24/2025. Patient reports no adverse effects from duplicate vaccine.
Age: 61.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Pain in extremity, Toothache
Clinical narrative: Patient received Shingrix and Capvaxive in the left deltoid on the same day.  Had shoulder, then elbow, then finger pain that lasted approximately 10 days before completely resolving.  Experienced joint pain and muscle aches making it difficult to move fingers.  No redness or itching reported at injection sites.  Also started to experience teeth pain about a week later and was unsure if it was related to vaccine.  Received follow up care and was prescribed antibiotic and steroid 1/16/25. RPH requests clarification about CDC recommendation that Shingrix can be administered concomitantly with other vaccines at "different anatomical sites" --does this mean that 2 vaccines on the same day must go in different arms altogether if receiving Shingrix, or is the same arm but injection sites 1 inch apart okay?
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: RECEIVED A DUPLICATE/REDUDANT RSV VACCINE (FIRST VACCINE 11/17/2023)
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: the BUD was beyond 60s out of the freezer. no reported issues with patient.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: RECEIVED A DUPLICATE/REDUDANT FLU SHOT IN THE SAME FLU SEASON 2018-2019 (FIRST FLU QUAD PF 8/21/2018)
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: BUD on vaccine out of the freezer was beyond 60 days. no reported issues from parents.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: the vaccine was BUD of 60 days. no reported patient issues.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac discomfort
Clinical narrative: PATIENT HAD TO CALL 911 AT HOME 2 HOURS AFTER GETTING THE VACCINE AS HE FELT HE WAS HAVING A HEART ATTACK. HE WAS RUSHED TO THE HOSPITAL AND AS OF TODAY, 3/25/25, PER WIFE, HE WILL UNDERGO HEART SURGERY. OUTCOME NOT YET KNOWN.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Pt received shingles vaccine #1 and #2 and both times she developed severe vomiting that lasted 8 hours
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: RSV (ABRYSVO) indicated for adults over 60 yrs of age and pregnant women 32-36 weeks was administered to 2 month old. No treatment required- informed patient's mother baby monitored.
Age: 70.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: 10-weeks now since vaccination. Upper left arm continues to be in great pain from certain movements. Also, range of motion is limited, compared to prior to vaccination. Arm pain never stopped after initial injection. Results: sleep losss, pain, & physical limitations with left arm. Rotator cuff injury has been ruled out. Tried Urgent Care 1st.  I have since been seen & x-rayed by Orthopaedic M.D., visited with my Primary Dr. (Internist). I have been instructed to take Advil & prescribed 650mg Tylenol, but neither offers much relief. I am currently prescribed & participating in Physical Therapy and have completed 4-sessions to date. I will continue PT, and I will be following up in 1-week with the Orthopaedic provider, Dr.  He may, or may not, reccomend a Cortisone shot.  After 10-weeks, I continue to be in signifigant pain and have limitations on the movement of my left arm.  I am otherwise, active and healthy for my age.  I was diagnosed with prostate cancer in October 2019, and had successful surgery to remove the prostate gland in February 2021. I have been cancer-free since then.  I have never had an adverse reaction to a vaccine before this.  I am very concerned that these adverse symptons from my RSV vaccine may be permanent or chronic.
Age: 70.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder, X-ray limb
Clinical narrative: 10-weeks now since vaccination. Upper left arm continues to be in great pain from certain movements. Also, range of motion is limited, compared to prior to vaccination. Arm pain never stopped after initial injection. Results: sleep losss, pain, & physical limitations with left arm. Rotator cuff injury has been ruled out. Tried Urgent Care 1st.  I have since been seen & x-rayed by Orthopaedic M.D., visited with my Primary Dr. (Internist). I have been instructed to take Advil & prescribed 650mg Tylenol, but neither offers much relief. I am currently prescribed & participating in Physical Therapy and have completed 4-sessions to date. I will continue PT, and I will be following up in 1-week with the Orthopaedic provider, Dr.  He may, or may not, reccomend a Cortisone shot.  After 10-weeks, I continue to be in signifigant pain and have limitations on the movement of my left arm.  I am otherwise, active and healthy for my age.  I was diagnosed with prostate cancer in October 2019, and had successful surgery to remove the prostate gland in February 2021. I have been cancer-free since then.  I have never had an adverse reaction to a vaccine before this.  I am very concerned that these adverse symptons from my RSV vaccine may be permanent or chronic.
Sex: F
Vaccine: PPV
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: Medical Assistant was cut by a PNEUMOVAX 23 pfs; Is the syringe broken into 2 or more pieces? YES---THE OTHER PIECE IS MISSING; Was the product administered or exposed to patient's bodily fluids (i.e. biohazardous)? YES; Medical Assistant was cut by a PNEUMOVAX 23 pfs; This spontaneous report was received from a medical assistant and refers to herself, a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 04-Mar-2025, the patient was cut by a glass of a broken finger flange of a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (lot #X027348, expiration date: 24-Jan-2026) 0.5 mL (Skin laceration) syringe (Injury associated with device). The syringe was broken into 2 or more pieces (Syringe issue). The injury occurred after removing the syringe from the tray, while trying to attach the needle to the syringe. The syringe tray was intact and undamaged on receipt. The product was exposed to patient's bodily fluids (Accidental exposure to product). The vaccine was not administered. A the time of reporting, the outcome of the event was unknown.  The causal relationship between the events and Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was related.
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: Caller states a 27 year old patient missed their second dose. The first dose was administered on 11/07/2024 and they have not received their second dose as of yet.; No other AE; This spontaneous report was received from a pharmacist and refers to a 27-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 07-NOV-2024, the patient was vaccinated with the first dose of human papillomavirus 9-valent vaccine, recombinant suspension for injection (GARDASIL 9) administered as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) It was reported that the patient did not received he second dose of the previous mention vaccine as of yet (Inappropriate schedule of product administration). No other adverse event (No adverse event).
Age: 0.5
Sex: M
Vaccine: DTAP, DTAPHEPBIP, FLU3, FLU3, FLU4, HEPA, HEPA, HIBV, PNC13, RV5
Symptoms: Autopsy, Death, Inappropriate schedule of product administration
Clinical narrative: This 2 year old boy passed away while napping; Dose 2 administered on 29Dec2022 and dose 3 on 02Mar2023 (after 9 weeks); This is a spontaneous report received from a Consumer or other non HCP.  A 2-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 02Mar2023 as dose 3, single (Lot number: FX6077) at the age of 6 months for immunisation; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), on 02Mar2023 as dose number unknown, single) for immunisation; influenza vaccine inact split 3v (FLULAVAL), on 02Mar2023 as dose number unknown, single) for immunisation; influenza vaccine inact split 3v (FLUARIX), on 02Mar2023 as dose number unknown, single) for immunisation; fluconazole (FLUZONE [FLUCONAZOLE]), on 02Mar2023 as dose number unknown, single) for immunisation; hib vaccine conj (ompc) (PEDVAXHIB), on 02Mar2023 as dose number unknown, single) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX), on 02Mar2023 as dose number unknown, single) for immunisation; hepatitis a vaccine inact (VAQTA), on 02Mar2023 as dose number unknown, single) for immunisation; hepatitis a vaccine inact (HAVRIX), on 02Mar2023 as dose number unknown, single) for immunisation; rotavirus vaccine live reassort oral 5v (ROTATEQ), on 02Mar2023 as dose number unknown, single (Lot number: FX6077) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: prevnar 13 (Dose 1, single, Lot Number: FN5555), administration date: 03Nov2022, when the patient was 2-month-old, for Immunization; prevnar 13 (Dose 2, single, Lot Number: FN5555), administration date: 29Dec2022, when the patient was 4-month-old, for Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Mar2023, outcome "unknown", described as "Dose 2 administered on 29Dec2022 and dose 3 on 02Mar2023 (after 9 weeks)"; DEATH (death, medically significant) with onset 09Mar2025, outcome "fatal", described as "This 2 year old boy passed away while napping". The patient date of death was 09Mar2025. The reported cause of death was unknown.  Clinical course: Dose 1, 2 and dose 3 received on Doctor's office/urgent care. No other vaccine in four weeks. Unknown if other medications in two weeks. This 2 year old boy passed away while napping with no previous conditions and an autopsy was pending. Autopsy performed, autopsy remarks as pending. No known allergies. No treatment received for event-as reported.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Peg 3350, reaction(s): "Allergy: PEG 3350", notes: PEG, 3350 or something; Miralax, reaction(s): "allergy to Miralax". Vaccination history included: Comirnaty (2024-2025 formula) (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "they noticed symptoms/have an allergy to ingredient in COVID-19 vaccine".  Additional information: The patient received 3 doses. The patient had an allergy to ingredient in COVID-19 vaccine, clarified a PEG 3350 or something allergy, an allergy to MiraLAX (said the ingredient in Miralax was also in the vaccine).   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: heart problems; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "heart problems". Clinical details: the reporter (patient's father) stated his wife, daughter (patient) and he all got the Pfizer mRNA shots. All now have heart problems. Pfizer owes compensation to all of them who have suffered so severely. The patient will undergo an ablation on Thursday, 20Mar2025.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly female 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had the shingles). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date : 20-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that the side effects were not worth it and he/she had the shingles. 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 vaccine Shingrix.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient that accidentally received IM versus subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 67-year-old patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 14-MAR-2025, the patient received Priorix (intramuscular). On 14-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient that accidentally received IM versus subcutaneous). The outcome of the subcutaneous injection formulation administered by other route 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: 14-MAR-2025 Pharmacist reported they changed to the Priorix, the MMR-II, and did not realize that Priorix is preferred to be subcutaneously administration versus IM, which is the other manufacturer.  So, they wanted to see if there was any risk that they need to be aware of, for they have a patient that accidentally received IM versus subcutaneous. The vaccine which is preferred to be subcutaneously administered to the patient intramuscularly, which led to subcutaneous injection formulation administered by other route.
Vaccine: RV5
Symptoms: Infantile vomiting
Clinical narrative: HBP called and placed Medical Assistant on the line who reported an infant who vomited a dose of ROTATEQ about 5 minutes after administration. No patient demographics were known at the time of call. No additional information was known by reporter. No; infant who vomited a dose of ROTATEQ about 5 minutes after  administration; This spontaneous report was received from a Consumer or other non-health professional and refers to a(n) Infant patient of unknown exact age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), administered by oral route (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On an unknown date (about 5 minutes after administration), the patient experienced infantile vomiting. The patient vomited a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) (accidental underdose). At the reporting time, the outcome of infantile vomiting was unknown.   The causal relationship between the event of i infantile vomiting n and Rotavirus Vaccine, Live, Oral, Pentavalent was unknown/not reported/not provided.
Vaccine: PNC15
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; Medical Assistant calling to report inadvertently administering a dose of VAXNEUVANCE to a 1 month and 4-day old child. Caller stated patient has not experienced any symptoms. Permission to contact HCP was granted. No additional information provided.; This spontaneous report was received from a medical assistant concerning a 1 month and 4-day-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-MAR-2025, the patient was inadvertently vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE)  (lot #Y010032, expiration date: 17-FEB-2027) administered for Prophylaxis (Inappropriate age at vaccine administration) (Dose, route and anatomical location were not reported). No adverse event was reported.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptomatic events.; administration of expired GARDASIL-9.; a T/E that had previously occurred; This spontaneous report was received from an other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Aug-2024, the vaccine Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) had temperature excursion of 51F for 1 hours 12 minutes 0 seconds. There was no previous excursion.  On 21-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection (0.5 ml, lot #X014788 has been verified to be a valid lot number, expiration date: 07-Mar-2025; strength was not provided) by intramuscular route for prophylaxis (expired product administered, product storage error). No symptomatic events were reported (no adverse event).
Age: 38.0
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; patient received their first dose of GARDASIL 9 on April 1, 2024, and the second dose on March 24, 2025.; This spontaneous report was received from a Pharmacist and refers to a 39-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 01-Apr-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, dose number 1, 0.5 mL (lot #, expiration date, anatomical location, and route of administration date were not reported) for prophylaxis. On 24-Mar-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection, dose number 2, 0.5 mL (lot #, expiration date, anatomical location, and route of administration date were not reported) for prophylaxis (Inappropriate schedule of product administration). Reporter asked about alternative dosing schedules for the suspect vaccine. No adverse effects were reported; no additional adverse event (AE) (no adverse event).  Additional information is not expected.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; T/E for VARIVAX on 1/29/2025. HBP reported that vaccines were administered to patients; This spontaneous report was received from regarding a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 29-JAN-2025, a temperature excursion (TE) occurred for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), at 14.65 degree Fahrenheit (F) for 13 hours and 15 minutes, with no previous TE. On 28-FEB-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, 0.5 ml, administered as prophylaxis (lot number Y011712 has been verified to be valid for Varicella Virus Vaccine Live [Oka-Merck] [VARIVAX], expiration date 02-Jul-2026) (Product storage error).   No additional adverse event was reported for the patient.  This is one of several reports from the same reporter.
Age: 1.0
Vaccine: MMR, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse reported MMR II was administered after a temperature excursion to unknown amount of patients. HCP is unable to provide patient information or dates of administration at this time.; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.   On 13-JAN-2025, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as prophylaxis (Lot No. X011441 has been verified to be a valid lot number for [measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live], expiration date reported and upon internal validation established as 19-APR-2025 (strength, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product storage error); that was reconstituted with sterile diluent (BAXTER STERILE DILUENT) (Lot N., expiration date, route and anatomical location of administration were not provided), after a temperature excursion of 10.9 degree Celsius (C) during a time frame of 1 hour with 37 minutes. No previous temperature excursion was reported. No additional adverse event (AE) was reported. (no adverse event).; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-03-24 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : X011441 GF , Central date : 2025-03-21 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number :
Age: 1.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Syringe issue
Clinical narrative: she does not know which vaccine of the three administered it was, was leaking out of the syringe onto the table before the patient received the vaccination; her 1 year old son, who is a male patient and a minor infant, received Kinrix yesterday; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete dose administered in a 1-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 31-AUG-2026) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) for prophylaxis.   Concomitant products included Varicella zoster vaccine (Varicella vaccine).   On 11-MAR-2025, the patient received Kinrix (intramuscular, left thigh) .5 ml and MMR vaccine (left thigh). On 11-MAR-2025, an unknown time after receiving Kinrix and MMR vaccine, the patient experienced incomplete dose administered (Verbatim: she does not know which vaccine of the three administered it was, was leaking out of the syringe onto the table before the patient received the vaccination) and inappropriate age at vaccine administration (Verbatim: her 1 year old son, who is a male patient and a minor infant, received Kinrix yesterday). The outcome of the incomplete dose administered and inappropriate age at vaccine administration were 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 12-MAR-2025 The reporter was the mother called to report that her 1-year-old son, who was a patient and a minor infant, received Kinrix yesterday (day before reporting), which led to an inappropriate age at vaccine administration. The reporter had reported this event to VAERS. The patient also received his MMR vaccine and Varicella vaccine (on right thigh) yesterday on 11-MAR-2025. All three vaccines were administered for the patient's routine vaccinations.  The reporter also reported that one of the syringes, and she did not know which vaccine of the three administered it was, was leaking out of the syringe onto the table before the patient received the vaccination, which led to an incomplete dose administered. No other condition was reported. The reporter had reported all that was provided about these adverse events.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure/lack of drug effect; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female 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 vaccination failure (Verbatim: Suspected vaccination failure/lack of drug effect) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with menthol, zinc oxide (Gold Bond Medicated), calamine, cortisone, lidocaine and aesculus hippocastanum seed, butyl aminobenzoate, halibut-liver oil, yeast dried (Preparation H). 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAR-2025 The reporter called, stating that the only medication that had worked for the itching was gold bond medicated powder.  The reporter stated that the following list of medications had not worked for the itching, Calamine lotion, Cortisone 10 cream, Lidocaine cream, or Preparation H.  The reporter stated that the itching and pain the patient had experienced with shingles after having received Shingrix was horrendous and relentless. 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. This case is linked with US2025AMR022743, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025AMR022743:same reporter
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness at the injection site after receiving the first dose of Shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood cholesterol increased. Concomitant products included simvastatin.   On 10-MAR-2025, the patient received the 1st dose of Shingrix. On 15-MAR-2025, 5 days after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injection site after receiving the first dose of Shingrix). The outcome of the injection site erythema was resolving.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site erythema to be related to Shingrix.   Additional Information: GSK receipt date: 19-MAR-2025 Customer reported developing redness at the injection site after receiving the first dose of Shingrix. Vaccine was administered on 10th March 2025, redness developed on 15th March 2025.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot 2nd dose; 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 received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on 15th march 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: forgot 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient self-reported this case for himself/herself. patient had taken Shingrix on 15th March 2024 but had forgotten the second dose and was asking for the best course of action. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Pruritus, Swelling face, Swelling of eyelid
Clinical narrative: Suspected Vaccination failure; Got shingles January 28, right side of face swelled and right eye was almost shut Still hurts and itches; 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. On 28-JAN-2025, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles January 28, right side of face swelled and right eye was almost shut Still hurts and itches). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the two shot vaccine about 2 years ago and got shingles on 28th January and the right side of face swelled and right eye was almost shut and still hurts and itches. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected Vaccination failure; Got shingles January 28, right side of face swelled and right eye was almost shut Still hurts and itches; 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. On 28-JAN-2025, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles January 28, right side of face swelled and right eye was almost shut Still hurts and itches). 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 and shingles to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the two shot vaccine about 2 years ago and got shingles on 28th January and the right side of face swelled and right eye was almost shut and still hurts and itches. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel like crap; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: feel like crap). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the second shot made him/her feel like crap the next day, though he/she did not miss work because of it.  Get the shot, but not the day before something important.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; still got 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: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). 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 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: 19-MAR-2025 This case was reported by a patient via interactive digital media. The reporter was patient. The reporter reported that got the 2 part vaccine and still got shingles, 6 weeks now and counting. The reporter asked who was having fun now. 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 the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Stress, Vaccination failure, Varicella
Clinical narrative: Suspected vaccination failure; I have them right now my sixth time; Chickenpox; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 61-year-old 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), shingles (Verbatim: I have them right now my sixth time) and chickenpox (Verbatim: Chickenpox). The outcome of the vaccination failure and chickenpox were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and chickenpox 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 and chickenpox to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she was 61 year old and had vaccine by a pain doctor bad choice on his/her part. Patient had them right now sixth time and this was the worst ever and they said stress was what bring them out Gabapion was the only thing stop pain been through every opioid there was Chicken pox and if you ever did lsd aka acid stayed in base of spinal cord rest of life could not get a good trip back. 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: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; have had shingles twice; 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: have had shingles twice). 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: 18-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she has had the shot, and have had shingles twice. 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 vaccine  Shingles vaccine.
Vaccine: VARCEL, VARZOS
Symptoms: Herpes zoster, Pain, 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 VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylaxis.   The patient's past medical history included chickenpox (had chickenpox when he/she was little).   On an unknown date, the patient received Shingles vaccine and VARICELLA 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: shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure 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: 19-MAR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had chickenpox when he/she was a child, and in his/her case, it was really bad.  Later, he/she got the vaccine but still ended up with shingles, which were very painful.  It felt like neither the chickenpox vaccine nor the shingles vaccine made much of a difference for him/her. It was unknown if the reporter considered shingles to be related to varicella vaccine. 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.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a female 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 feeling unwell (Verbatim: feel sick). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2025 This case was reported by a patient via interactive digital media. The patient stated that hubby and she got the vaccine. The patient watched her strong mother beg for morphine from shingles pain. The vaccine made patient feel sick, but it was nothing compared to what she saw her mother go through.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: bad case of shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: bad case of shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-MAR-2025 The patient self reported this case for himself/herself. This case was reported by a patient via interactive digital media. Patient had received one, he/she had not known he/she was supposed to get two, and he/she ended up with a bad case of shingles.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter knows someone that got the shingles shot 3 years ago and got shingles 2 weeks later and it still lingers some.