chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Client had a foreign IZ record; I missed HPV immunization entry during the allotted time for this appt. I believed the entries on the record were correct; then I looked to the foreign record and then I realized that the client had already two doses. Client was notified at that moment and verbalized understanding.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Transient cellulitis (flesh swollen, painful, hot to touch, flesh hardened and inflexible) across and surrounding all three injection sites and expanded out an additional 1.5" in all directions (upward and downward from the row of injection sites, and out laterally in both directions from the outside injection sites). Cellulitis developed in the space of a few hours, and remained painful for more than 10 days. Hardened area started moving downward from the row of injection sites (as if pulled downward through the tissues by gravity) after the third day, and gradually decreased in size (area at and under the skin slowly shrinking) until finally regaining normal tissue texture/flexibility, normal tissue color/temperature, and no longer causing discomfort by the 12th or 13th day.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pain in extremity, Pyrexia
Clinical narrative: On 5/16/2025, the patient reports symptom of fever of 100.6 degrees Fahrenheit at 0200, which resolved when they woke up for work at 0900. The patient reports symptoms of arm soreness and body aches. The patient also reports shortness of breath, which they described as "taking a breath that felt different than normal". The patient reports that the shortness of breath immediately resolved after the episode and that no other episodes occurred. On 5/17/2025, the patient reports that symptoms of arm soreness and body aches resolved without requiring medical intervention. The patient reports not taking any medications or seeking medical attention for symptoms. On 05/19/2025, the patient reports no other symptoms.
Age: 31.0
Sex: M
Vaccine: TD
Symptoms: Extra dose administered, No adverse event
Clinical narrative: THIS PATIENT HAD NO ADVERSE SYMPTOMS. ADMINISTERED  COVID-19 VACCINE INTERVAL ONE WEEK APART 2ND DOSE. THIS IS NOT RECOMMENDED DOSE.
Age: 30.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Nausea, Syncope
Clinical narrative: nausea, brief vasovagal syncope. Pt has experienced similar symptoms with blood draws/immunizations. Pt also noted to be in a fasting stage. Pt given water and food, recovered from symptoms very quickly
Age: 24.0
Sex: M
Vaccine: JEV1, UNK
Symptoms: Chest X-ray normal, Chills, Electrocardiogram normal, Laboratory test normal, Musculoskeletal chest pain
Clinical narrative: Developed left side lower chest wall pain on 22MAY that woke him up. Received southern hemisphere flu and JE-VC vaccines on 19MAY and had reported fever, chills and body aches since. Went to ER and had labs, EKG and chest Xray which were unremarkable. He was given Toradol injection and Lidocaine patch.
Age: 24.0
Sex: M
Vaccine: JEV1, UNK
Symptoms: Pain, Pyrexia
Clinical narrative: Developed left side lower chest wall pain on 22MAY that woke him up. Received southern hemisphere flu and JE-VC vaccines on 19MAY and had reported fever, chills and body aches since. Went to ER and had labs, EKG and chest Xray which were unremarkable. He was given Toradol injection and Lidocaine patch.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blister, Nausea, Rash, Vomiting
Clinical narrative: 5/18/25 developed nausea and vomiting, in late evening. 5/19/25 woke up with rash(blister-like) on arm and spread to face. Was evaluated by provider on 5/19/25 and diagnosed with varicella. Mom reported that she had a shingles outbreak in April.
Age: 1.42
Sex: F
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given Tdap vaccine instead of DTaP vaccine. No none symptoms, and expected to recover. Health department stated valid dose.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Throat irritation
Clinical narrative: Patient returned to pharmacy counter after sitting in his car for about 40 minutes. He stated his throat felt funny and scratchy. He said it occurred immediately after vaccination which was why he stayed and sat in his car. When it wasn't improving he came in.  He was sat down and given a benadryl 25mg tablet. He stated he had received previous doses  of covid vaccine at Pharmacy, so we called and they showed he had previously received both Pfizer (9/24) and Moderna (11/23). He never had any previous reaction. He laid down on the floor for about 1 hour. He asked for cool rag for his neck and water to drink. Pharmacists checked pulse which was ~60bpm and o2 sat was 96. He never experienced any difficulty breathing or swallowing. He did not think he needed EMS called. There was no visible reaction at the injection site. After about 2 hours in total, patient stated he felt fine to leave. Patient was contacted back today and stated he was fine and had no further side effects. He had been sent home with an additional benadryl that he stated he did not have to take.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: THIS PATIENT HAD NO ADVERSE REACTIONS WHEN WE CHECKED, BUT THIS REPORT IS ADMIISTERED 2ND DOSE INTERVAL ONLY ONE WEEK APART. THIS IS NOT RECOMMENDED DOSE. WE CHECKED THIS PATIENT IN SYSTEM, HE GAVE DIFFERENT NAME, NOT IN THE SYSTEM.
Age: 30.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, No adverse event, Wrong product administered
Clinical narrative: Patient received the meningococcal B vaccine instead of hepatitis B. When the RN got a hold of the patient the next morning, she stated that she had no side effects from it and felt well. Her PCP felt that she was low risk for any complications with breastfeeding, so she advised for her to continue breastfeeding. Patient was notified of this and that she received the wrong vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Swollen, red, tight, and hot deltoid at site of injection
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: ERYTHEMA AND SWELLING AT SITE OF THE VACCINES, MOM THINK SUPPER PART OF ARM WHERE THE DTAP/IPV WAS INJECTED
Age: 70.0
Sex: F
Vaccine: PNC21
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: Well the next day my feet and ankle were swollen and i was wearing sandals and they got tight on me and that lasted about 2 days. They have started to go down.  I did look up adverse events and saw that it was something that could happen.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted approximately 5-10 minutes after having received vaccine.  Regained consciousness after around 30 seconds and remained on floor while emergency staff monitored vitals.  Patient was cleared to leave with no additional harm observed about 10-15 minutes later and was feeling much better.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Hypoaesthesia, Paraesthesia
Clinical narrative: Toes numb, followed 5 months later by feet and hands tingling (pins and needles feeling).
Age: 87.0
Sex: F
Vaccine: PNC20
Symptoms: Joint swelling
Clinical narrative: pt arm now swollen to elbow. recommended pt go to pcp or urgent care. she was unsure if she was going to bc "she dont like going to the doctor". she said she would see if son would take her today. at time of this report i am unsure if she actually went yet
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: It was discovered that patient is 2 months old and this combo vaccine is only licensed for patients 4-6 years of age. There have been no adverse events reported at this time. Provider has been informed
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; HCP calling to report T/E. PROQUAD was inadvertently administered on 4/23/2025. No other information was known or provided.  T/E case# 02794150, Request case# 02794185.   No additional AE reported.  No PQC reported .    ?    Names of vaccines invol; This spontaneous report was received from a nurse and refers to a(n) patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 23-Apr-2025, the patient was inadvertently vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008789, expiration date: 30-Oct-2025), diluted in sterile diluent (MERCK STERILE DILUENT), (expiration date, and lot # were not reported), for Prophylaxis. The vaccine had a temperature excursion o 72 F for a timeframe of 216 hours, There were no previous temperature excursions. No adverse event was reported.
Vaccine: PNC21
Symptoms: Product administered to patient of inappropriate age, Product label on wrong product
Clinical narrative: They thought Capvaxive was the same as Prevnar 20 so they gave the Capvaxive; Caller reported that they have copies of internal emails that they sent to the providers and they have been labeling another Merck product, Capvaxive, was being labeled as Prevnar 21.; They administered the product PCV-21/capvaxive to a baby.; This spontaneous report was received from a reporter and refers to a baby patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, route of administration, vaccination site, lot # and expiration date were not reported) administered for prophylaxis. It was reported that the providers were labeling PCV-15 and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as PCV-21/Capvaxive) as pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) (reported as Prevnar), and now there has been an administration error (product label on wrong product). The product of PCV-21/capvaxive was administered to a baby and the PCV-21/Capvaxive was not indicated for use in babies (product administered to patient of inappropriate age). They thought Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was the same as pneumococcal vaccine conj 20v (CRM197) (PREVNAR 20) so they gave the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (wrong product administered). The office thought it was Prevnar with an extra serotype, but that was not what happened. There could be more mistakes because of the misrepresentation of other 2 products. It was concerning.
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a patient. The caller did not have any other additional information to add to further clarify the details, including patient demographics or the dates of a; No adverse event; This spontaneous report was received from a/an Pharmacist and refers to a(n) 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 an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Z003766, expiration date: 30-Jan-2027) administered by Unknown route. The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prophylaxis.  On an unknown date, the patient experienced A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a patient. The caller did not have any other additional information to add to further clarify the details, including patient demographics or the dates of a. On an unknown date, the patient experienced No adverse event.   At the reporting time, the outcome of A pharmacist called and reported that an improperly stored dose of VARIVAX was administered to a patient. The caller did not have any other additional information to add to further clarify the details, including patient demographics or the dates of a and No adverse event was unknown.   The action taken with Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable.   The case ws determined to be non-valid due to lack of patient's identifiers.
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called to report that an expired dose of MMRII was inadvertently administered to one patient on 04/28/2025. Caller confirmed the product has no history of temperature excursion. Permission given to contact HCP. No additional information provided.; This spontaneous report was received from Nurse Practitioner 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 28-Apr-2025, the patient was inadvertently vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X011431, expiration date: 19-Apr-2025), dose number 1, administered by Unknown route (strength, dose, frequency, vaccination scheme, and anatomical location were not reported) as Prophylaxis. No adverse event occurred. Caller confirmed the product has no history of temperature excursion.
Vaccine: HBHEPB
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; patient was administered PEDVAXHIB during a temperature excursion.; This spontaneous report was received from an office manager and refers to a(n) patient of unknown age and gender.   The patient's medical history, conditions and concomitant therapies were not reported.   On 22-Apr-2025, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), (lot #Y005248, expiration date: 17-Sep-2026) (1 dose), for prophylaxis, during a temperature excursion. The temperature was 0 degrees Celsius for a time frame of 1 hour. There were no previous temperature excursion. No additional Adverse Event was reported.
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported; ROTATEQ involved in a temperature excursion was administered to 1 patient; This spontaneous report was received from a Medical Assistant 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 an unknown date, the patient was vaccinated with an improperly stored 1 dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), (strength, dose, formulation, route and site of administration not provided), lot # 4009341 was established as invalid upon internal validation, expiration date was reported as 24-NOV-2025, administered for prophylaxis (product storage error). The patient had no symptoms, no additional adverse event (AE) (no adverse event).  On an unknown date, the suspect vaccine was involved in a temperature excursion of 32.0 degrees Fahrenheit (F) for 1 hour and 30 minutes. No previous excursions reported. Lot # is being requested and will be submitted if received.
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No  additional AE; HCP calling to report expired administration of VAQTA on 05/22/2025; This spontaneous report was received from a medical assistance  referring to a patient, age and gender was not reported.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 22-MAY-2025, the patient was vaccinated with an expiration dose of  Hepatitis A Vaccine, Inactivated Suspension for injection (VAQTA), for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y006122, with expiration date on 17-MAY-2025). (Expired product administered). There was not adverse event reported. (No adverse event).
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Pruritus
Clinical narrative: patient had itching all over; Pain injection site; swollen at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (episode of Shingrix sometime around February and March of 2025), rash and scab. Concurrent medical conditions included disability.   On 15-MAY-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 ml. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain injection site) and injection site swelling (Verbatim: swollen at the injection site). On an unknown date, the patient experienced generalized pruritus (Verbatim: patient had itching all over). The outcome of the injection site pain and injection site swelling were unknown and the outcome of the generalized pruritus was not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and generalized pruritus to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site swelling and generalized pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter was the patient. The patient reported on 15th May 2025, that he received the 1st dose of Shingrix vaccine at the beginning of May 2025 at a local pharmacy. The patient reported the vaccine was administered in the right arm. The patient reported that for the first 3 days he had pain at the injection site, and it was swollen. The patient reported that he had a previous episode of Shingrix sometime around February and March of 2025. The patient reported that he got the vaccine after his rash and scabbing was gone. The patient reported that after receiving the vaccine the patient had itching on the back, arm, chin, neck, head. The patient had itching all over. The patient reported that it had not improved. The patient described it was like welts or swelling spots. The reporter stated it was still happening and had not improved. The reporter reported that the patient did not see any rash, it was just itching. No additional information was reported. The patient declined to provide demographics and disconnected from the call abruptly. The agent was unable to obtain any additional information.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: sore arm (area were vaccine was administered); Dizziness; Headache; Blurry vision; Sweating; Fatigue extreme; Tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 18-MAY-2025, the patient received Boostrix (left arm). In MAY-2025, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: sore arm (area were vaccine was administered)). On 18-MAY-2025, the patient experienced dizziness (Verbatim: Dizziness), headache (Verbatim: Headache), blurred vision (Verbatim: Blurry vision), sweating (Verbatim: Sweating), fatigue (Verbatim: Fatigue extreme) and tinnitus (Verbatim: Tinnitus). In MAY-2025, the outcome of the injection site pain was resolved.  On 18-MAY-2025, the outcome of the dizziness, headache, blurred vision, sweating, fatigue and tinnitus were resolved.   It was unknown if the reporter considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix.     It was unknown if the company considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix.   Additional Information: GSK receipt date: 19-MAY-2025 Patient's mother stated that bout 10 seconds after the patient was administered the vaccine, patient began to feel following symptoms (dizziness, bad headache, blurry vision, profuse sweating, extreme tinnitus, extreme fatigue). Patient was given some water to drink, and in about 5 to 10 minutes later, symptoms stopped. Patient had a sore arm (area were vaccine was administered) later that night. Symptoms did not recur and patient had fully recovered.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Tinnitus, Vision blurred
Clinical narrative: sore arm (area were vaccine was administered); Dizziness; Headache; Blurry vision; Sweating; Fatigue extreme; Tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis.   On 18-MAY-2025, the patient received Boostrix (left arm). In MAY-2025, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: sore arm (area were vaccine was administered)). On 18-MAY-2025, the patient experienced dizziness (Verbatim: Dizziness), headache (Verbatim: Headache), blurred vision (Verbatim: Blurry vision), sweating (Verbatim: Sweating), fatigue (Verbatim: Fatigue extreme) and tinnitus (Verbatim: Tinnitus). In MAY-2025, the outcome of the injection site pain was resolved.  On 18-MAY-2025, the outcome of the dizziness, headache, blurred vision, sweating, fatigue and tinnitus were resolved.   It was unknown if the reporter considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix.     It was unknown if the company considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix.   Additional Information: GSK receipt date: 19-MAY-2025 Patient's mother stated that bout 10 seconds after the patient was administered the vaccine, patient began to feel following symptoms (dizziness, bad headache, blurry vision, profuse sweating, extreme tinnitus, extreme fatigue). Patient was given some water to drink, and in about 5 to 10 minutes later, symptoms stopped. Patient had a sore arm (area were vaccine was administered) later that night. Symptoms did not recur and patient had fully recovered.
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergy/allergic reaction from the 1st one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergy/allergic reaction from the 1st one). The outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     It was unknown if the company considered the allergic reaction to be related to Shingrix.   Additional Information: GSK receipt date: 15-MAY-2025 The case was reported by the patient via interactive digital media. No doctor said that he/she did not need it because he/she had a allergy, allergic reaction from the 1st one.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had two shingles episodes since the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (got shingles outbreaks several times a year as a stress response) and stress.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shingles episodes since the vaccine). The outcome of the vaccination failure and shingles were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. The company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she got shingles outbreaks several times a year as a stress response.  He/she got the two-part Shingrix vaccine a year ago in 2024 (from the date of reporting). It made no difference.  He/she had two shingles episodes since the vaccine, and they had not been any milder. 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  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shinglesfrom a friend who had ybr shingles shot; 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: got shinglesfrom a friend who had ybr shingles shot). 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.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a consumer via interactive digital media. Consumer reported that got shingles from a friend who had ybr shingles shot. 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.
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: skin peeling on hands and feet; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin peeling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2025, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin peeling (Verbatim: skin peeling on hands and feet). The outcome of the skin peeling was not resolved.   It was unknown if the reporter considered the skin peeling to be related to Shingles vaccine.     It was unknown if the company considered the skin peeling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the 1st vaccination in April and had a severe allergic reaction, skin peeling on hands and feet and still peeling on the day of reporting. The patient was not sure if want the second one.
Vaccine: VARZOS, VARZOS
Symptoms: Eye pain, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; now have shingles; terrible pain in my eye; 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 an unknown date, 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), shingles (Verbatim: now have shingles) and eye pain (Verbatim: terrible pain in my eye). The outcome of the vaccination failure was not reported and the outcome of the shingles and eye pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and eye pain 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 and eye pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine and booster dose of shingles about 5 years ago and at the time of reporting the patient had shingles. It's on the left side of face and head.  The patient has terrible pain in eye. Going to get pressure checked in eye in just a few minutes. It was very painful. This case was considered as suspected vaccination failure as details regarding 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 , time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles  (1st dose)and  Shingles (2nd dose) .
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got both shots and have had shingles twice since then; 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.   The patient's past medical history included shingles.   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: I got both shots and have had shingles twice since then). 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: 17-MAY-2025 This case was reported by a patient via interactive digital media. The patient got both shots and have had shingles twice since then, worse than before he/she got the shots. The patient asked to do some research and stated, wish he/she had. 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 (h/o shingles, insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have it now in my eye area; 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.   The patient's past medical history included shingles.   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 ophthalmic herpes zoster (Verbatim: I have it now in my eye area) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster was not resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAY-2025 The case was received from the patient via interactive digital media. The reporter have it now in his/her  eye area.  This was 3rd time and he/she got the vaccine after 1st time. This case was considered as suspected vaccination failure as details regarding completion of primary 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Ophtalmic Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Malaise, Neuralgia, Pain
Clinical narrative: Suspected vaccination failure; I have them right now; nerve pain on all day; felt under the weather all last week; 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 MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt under the weather all last week). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have them right now) and post herpetic neuralgia (Verbatim: nerve pain on all day). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia was resolved and the outcome of the feeling abnormal was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and feeling abnormal 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, post herpetic neuralgia and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she had them right at the time of reporting.  The reporter had the shots last fall thank goodness.  The reporter felt under the weather all last week.  Experience the nerve pain on all day Saturday and erupted Saturday night.  The eruptions were minor for me but the pain, fatigue and fever were still very uncomfortable.  The reporter was  on anti-virals.  The reporter thanked goodness for the vaccine.  The reporter was sure he/she would have been very sick without it. This case was considered as suspected vaccination failure as details regarding completion of primary 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: Pyrexia, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have them right now; nerve pain on all day; felt under the weather all last week; 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 MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt under the weather all last week). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have them right now) and post herpetic neuralgia (Verbatim: nerve pain on all day). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the post herpetic neuralgia was resolved and the outcome of the feeling abnormal was resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and feeling abnormal 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, post herpetic neuralgia and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAY-2025 The case was received from the patient via interactive digital media. The reporter reported that he/she had them right at the time of reporting.  The reporter had the shots last fall thank goodness.  The reporter felt under the weather all last week.  Experience the nerve pain on all day Saturday and erupted Saturday night.  The eruptions were minor for me but the pain, fatigue and fever were still very uncomfortable.  The reporter was  on anti-virals.  The reporter thanked goodness for the vaccine.  The reporter was sure he/she would have been very sick without it. This case was considered as suspected vaccination failure as details regarding completion of primary 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: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; i had t 3 times; 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 had t 3 times). 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-MAY-2025 This case was reported by a patient via interactive digital media. The patient had it 3 times different, in the body, burning sensation, the vaccine did not work on patient. 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.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles a few weeks ago; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles a few weeks ago). 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 Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2025 This case was reported by a patient via interactive digital media The patient just got shingles a few weeks ago (from the date of reporting) in 2025. After having the two-part shot eight years ago. The patient's physician said that if he/she had not had the shot it would have been way worse. The Shingrix shot was 90 percent, but the patient guesses that he/she got from the 10 percent. This case was considered as suspected vaccination failure as details regarding 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 laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Doses 1 and Dose 2).
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; develop a small case of shingles; This serious case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (developed a small area of shingles over the years). Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: develop a small case of shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2025 Patient had been vaccinated with both doses of Shingrix and he was a 74 year old man with diabetes.  Patient developed a small area of shingles over the years before and after vaccination.  Even though he got vaccinated he still continues to develop a small case of shingles sometimes. 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   primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).