chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Medical Assistant, 04/17/2025 went to dismissed patient after the 10mins from receiving vaccines, I noticed a small bump on the Left thigh. Alerted Dr. about possible vaccine reaction, and she followed up with the patient. Dr. 04/17/2025 evaluated pt in clinic, noted to have a large lesion to L lateral thigh. Lesion was round, about 5cm in diameter, with redness and swelling. No fluctuance. Pt also had a similar lesion to the inner R thigh that mom states was present since yesterday and thought it was  a spider bite, mom states pt did not have have the lesion to L thigh prior to vaccine administration. Pt reports the lesion hurts, but does not itch. No other systemic symptoms such as hives, face/tongue/lip swelling, wheezing, coughing, SOB, vomiting or diarrhea. Advised mom that this is likely a mild reaction to the vaccine, apply warm compresses at home and monitor. Call MD if any changes such as enlargement of lesion. Go to ER if develops hives, fever, wheezing, cough, face/tongue/lip swelling or any other concerns. Mom expressed understanding and agrees with plan. Will ensure incident report is filed.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; temperature excursion on varivax; This spontaneous report was received from a/an Consumer or other non health professional 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 04-Mar-2025, the patient started therapy with improperly stored (Incorrect product storage) Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE), Solution for injection (lot #Y011712, expiration date: 02-Jul-2026) 0.5 mL administered by Unknown route for prophylaxis together with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported).  Time frame of temperature excursion: 13 hours 15 minutes 0 seconds. Temperature: 14.65 Fahrenheit (F). The patient experienced no additional adverse event. There was no data logger involved.
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; improper storage of product in use; This spontaneous report was received from a physician referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported.   On 03-Mar-2025, the patient was vaccinated with improperly stored vaccine of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE) injection (lot #Y011712, expiration date: 02-Jul-2026), 0.5 mL, diluted with sterile diluent (MERCK STERILE DILUENT) (expiration date, and lot # were not reported) as prophylaxis (improper storage of product in use). The vaccine was exposed to temperature excursion (Temperature: 14.65 F, Time frame: 13 hours 15 minutes 0 seconds) on 29-Jan-2025. No symptomatic events reported (no adverse event). There was no previous temperature excursion.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic adverse events were reported; the vaccines were late right away; one dose of GARDASIL-9 was  administered to a patient; This spontaneous report was received from a nurse and refers to a(n) 13-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 07-Apr-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9) injection, lot #Z002903, expiration date: 15-Dec-2026, 0.5 ml / once, product quantity: 1, administered for prophylaxis (strength and route, anatomical site were not provided). The Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL-9) that had arrived after the "must receive by date" (Product shipment delay). The vaccine was received on 07-Apr-2025 and had a must receive by date of 06-Apr-2025. It was reported that they did not catch that the vaccines were late right away and the vaccines appeared to still be cool (Improper storage of product in use). It was confirmed no symptomatic adverse events were reported in the patient who received the dose (No adverse event). Reporter was returning 19 of the 20 doses she ordered.; Sender's Comments: Priority : 5 , Is case serious : No , MNSC number : 02784533-02784524 , CLIC number : , ESTAR number : , IRMS number : 500UW00000Y0zmKYAR|08042025150020|7379 , Central date : 2025-04-08 , Classification : DMC, Attachment description : NSC Call , Safety case number : , MNSC case number : 02784533 , MNSC interaction number : 02784524 , Integration log UniqueID : 500UW00000Y0zmKYAR|08042025150020|7379 , Service cloud CaseID : 500UW00000Y0zmKYAR
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chest pain, Computerised tomogram normal, Dyspnoea, Imaging procedure
Clinical narrative: Hard time talking; Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest; Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.; Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025; Hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest pain in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2025 15:00, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2025, 1 days after receiving Shingrix, the patient experienced chest pain (Verbatim: Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest), back pain (Verbatim: Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.), difficulty breathing (Verbatim: Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025) and pain (Verbatim: Hurts). On an unknown date, the patient experienced speech disorder (Verbatim: Hard time talking). The outcome of the chest pain, back pain, difficulty breathing, pain and speech disorder were not resolved.   It was unknown if the reporter considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix.     It was unknown if the company considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 The reporter reported that a patient that received the first dose of Shingrix and reports that she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest and lower back and was still experiencing these events.  The patient also reports that she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues.  The patient reports that she is having a hard time talking. The patient went to the emergency room on 9-APR-2025, and they did a Cat Scan, Lung Scan, Lab Work, and Imaging (no further information provided), and did not find anything wrong with the patient.  The patient was sent home the same day (unclear if ante meridiem or post meridiem), with pain medication to take every six hours (unknown product information).
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Painful respiration, Sleep disorder, Speech disorder, Ventilation/perfusion scan
Clinical narrative: Hard time talking; Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest; Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.; Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025; Hurts; This non-serious case was reported by a consumer via call center representative and described the occurrence of chest pain in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-APR-2025 15:00, the patient received the 1st dose of Shingrix (left arm). On 08-APR-2025, 1 days after receiving Shingrix, the patient experienced chest pain (Verbatim: Chest pain/she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest), back pain (Verbatim: Back pain/pain in lower back and is still experiencing these events today, 10-APR-2025.), difficulty breathing (Verbatim: Can not Breathe/she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues today, 10-APR-2025) and pain (Verbatim: Hurts). On an unknown date, the patient experienced speech disorder (Verbatim: Hard time talking). The outcome of the chest pain, back pain, difficulty breathing, pain and speech disorder were not resolved.   It was unknown if the reporter considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix.     It was unknown if the company considered the chest pain, back pain, difficulty breathing, pain and speech disorder to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 The reporter reported that a patient that received the first dose of Shingrix and reports that she woke up during the night Tuesday morning, 8-APR-2025 with pain in her chest and lower back and was still experiencing these events.  The patient also reports that she cannot breathe and it hurts to breathe, which also started 8-APR-2025 and continues.  The patient reports that she is having a hard time talking. The patient went to the emergency room on 9-APR-2025, and they did a Cat Scan, Lung Scan, Lab Work, and Imaging (no further information provided), and did not find anything wrong with the patient.  The patient was sent home the same day (unclear if ante meridiem or post meridiem), with pain medication to take every six hours (unknown product information).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizzy spells; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizzy spells in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 04-APR-2025, the patient received Shingles vaccine (intramuscular, left deltoid) .5 ml. On 04-APR-2025, 4 hrs after receiving Shingles vaccine, the patient experienced dizzy spells (Verbatim: Dizzy spells). The outcome of the dizzy spells was not resolved.   It was unknown if the reporter considered the dizzy spells to be related to Shingles vaccine.     It was unknown if the company considered the dizzy spells to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2025 The reporter was a patient's husband.  The reporter states that the patient started having intermittent episodes of dizziness approximately 4 hours after receiving suspect vaccine. Dizzy spells were ongoing, and patient was seeing her physician at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received his second dose.; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   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: has not received his second dose.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 10-APR-2025 The case was self reported by patient. The patient who received his first dose of Shingrix about 5 years ago and had not received his second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 Reporter is the patient who stated that he experienced a sore arm with first dose of Shingrix, he received his first dose in his left arm. This case is linked with case US2025044420, reported by the same reporter.; Sender's Comments:  US-GSK-US2025044420:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Feeling cold, Pain in extremity, Pruritus
Clinical narrative: sore arm; Feeling cold; Fatigue; hives on both arms; Itching; breathing heavy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included diclofenac sodium (Diclofenac), thyroid, cholesterol and cortisone acetate (Cortisone).   In MAR-2025, the patient received the 1st dose of Shingrix. On 09-APR-2025, less than a month after receiving Shingrix, the patient experienced hives (Verbatim: hives on both arms), pruritus (Verbatim: Itching), labored respiration (Verbatim: breathing heavy) and fatigue (Verbatim: Fatigue). On an unknown date, the patient experienced pain in arm (Verbatim: sore arm) and feeling cold (Verbatim: Feeling cold). The outcome of the hives, pruritus, labored respiration and fatigue were not resolved and the outcome of the pain in arm was resolved and the outcome of the feeling cold was unknown.   It was unknown if the reporter considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix.     It was unknown if the company considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 The reporter is the patient's husband. He stated that the patient received her first dose of Shingrix about 2 or 3 weeks ago. She experienced a sore arm which went away. Yesterday, she developed hives on both her arms. She was also experiencing itching on her back. The reporter applied some cortisone cream to her back last night. The patient was also breathing heavy, has fatigue, and is feeling cold. This case was linked with case US2025044416 from the same reporter.; Sender's Comments:  US-GSK-US2025044416:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: sore arm; Feeling cold; Fatigue; hives on both arms; Itching; breathing heavy; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included diclofenac sodium (Diclofenac), thyroid, cholesterol and cortisone acetate (Cortisone).   In MAR-2025, the patient received the 1st dose of Shingrix. On 09-APR-2025, less than a month after receiving Shingrix, the patient experienced hives (Verbatim: hives on both arms), pruritus (Verbatim: Itching), labored respiration (Verbatim: breathing heavy) and fatigue (Verbatim: Fatigue). On an unknown date, the patient experienced pain in arm (Verbatim: sore arm) and feeling cold (Verbatim: Feeling cold). The outcome of the hives, pruritus, labored respiration and fatigue were not resolved and the outcome of the pain in arm was resolved and the outcome of the feeling cold was unknown.   It was unknown if the reporter considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix.     It was unknown if the company considered the hives, pruritus, labored respiration, pain in arm, fatigue and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 The reporter is the patient's husband. He stated that the patient received her first dose of Shingrix about 2 or 3 weeks ago. She experienced a sore arm which went away. Yesterday, she developed hives on both her arms. She was also experiencing itching on her back. The reporter applied some cortisone cream to her back last night. The patient was also breathing heavy, has fatigue, and is feeling cold. This case was linked with case US2025044416 from the same reporter.; Sender's Comments:  US-GSK-US2025044416:same reporter
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site nodule, Peripheral swelling, Wrong technique in product usage process
Clinical narrative: site developed a knot; administered the vaccine with the air pocket in the prefilled syringe; Arm swelling; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site nodule in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number Dd72h) for prophylaxis.   On 13-MAR-2025, the patient received Bexsero (left arm). On 13-MAR-2025, less than a day after receiving Bexsero, the patient experienced swelling arm (Verbatim: Arm swelling). On an unknown date, the patient experienced injection site nodule (Verbatim: site developed a knot) and wrong technique in product usage process (Verbatim: administered the vaccine with the air pocket in the prefilled syringe). The outcome of the injection site nodule, swelling arm and wrong technique in product usage process were unknown.   It was unknown if the reporter considered the injection site nodule and wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The reporter considered the swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site nodule and wrong technique in product usage process to be related to Bexsero and Bexsero Pre-Filled Syringe Device. The company considered the swelling arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 07-APR-2025 Other HCP reported that they followed updated guidelines and administered the vaccine with the air pocket in the prefilled syringe, which led to wrong technique in product usage process. Reporter stated that right away the site developed a knot.
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: made me feel bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad (Verbatim: made me feel bad). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient via interactive digital media. The patient took first shot of Shingles vaccine and it made him/her feel bad. The patient reported he/she never got around to getting second one.  The patient stated that they say if you get the vaccines and get shingles they would not be as bad.  The patient stated only think they have one vaccine now.
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included varicella zoster vaccine (Patient had first dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza (Verbatim: flu). The outcome of the influenza was not reported.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     It was unknown if the company considered the influenza to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-APR-2025 This case was reported by a patient via interactive digital media. Reporter stated that their second shot was far worse than the first they thought they had the flu.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm is sore but worth the light pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had a light case of shingles at 45 yrs old) and shingles (In July 2024 came down with severe case of Shingles). Previously administered products included Shingles vaccine (old probably 10 years ago got the Shingles vaccination).   On 11-APR-2025, the patient received the 1st dose of Shingles vaccine. On 11-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: My arm is sore but worth the light pain). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date 11-APR-2025 and 13-APR-2025 This case was reported by a patient via interactive digital media. The patient had a light case of shingles at 45 yrs old Probably 10 years ago got the Shingles vaccination.  In July 2024 came down with severe case of Shingles.  The reporter was not aware of new vaccination but believe him/her now.  The patient got the first shot three days ago and arm was sore but worth the light pain.  The reporter also reported he/she would get the second shot in 2 months.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I had a mild case of 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. On an unknown date, 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: I had a mild 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 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: 11-APR-2025 This case was reported by a patient via interactive digital media. The patient reported he/she had two vaccines and physician said he/she had a mild case of shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: they never got their Second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received their First Shingrix dose on April, 2014).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: they never got their Second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date 14-APR-2025 Pharmacist reported that he/she had a couple of questions. So, he/she had a Patient that received their First Shingrix dose in April, 2014 and they never got their Second dose. Pharmacist wants to ask is ok to go ahead and take their second Dose now or not. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case has been had linked with US2025AMR046253,reported by the same reporter; Sender's Comments:  US-GSK-US2025AMR046253:
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles in one arm; 2 doses in Oct; 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.   In OCT-2024, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In OCT-2024, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short (Verbatim: 2 doses in Oct). In FEB-2025, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles in one arm). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the drug dose administration interval too short was not applicable.   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: 13-APR-2025 This case was reported by a patient via interactive digital media.  The patient stated that he/she was vaccinated, 2 doses in October. At the time of reporting patient have had shingles in one arm for 2 months now. The patient stated that it was intense burning, slowly spreading up to underarm. No rash were reported. The patient stated it took a while to diagnose it. All internal and guess mild compared to most because patient did. The patient suggested to get the vaccine, patient had encouraged everybody to get it. The patient received 2nd dose of Shingrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. This case was considered as suspected vaccination failure as laboratory test regarding shingles was 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 vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at the injection site; redness and swelling at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness and swelling at the injection site) and injection site swelling (Verbatim: redness and swelling at the injection site). The outcome of the injection site erythema was not reported and the outcome of the injection site swelling was not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Shingrix.   Additional Information: GSK Receipt Date : 12-APR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine the day before reporting and had redness and swelling at the injection site. The reporter asked if he/she could take Motrin or Benadryl to help with the swelling.; Sender's Comments:  US-GSK-US2025AMR046242:same reporter US-GSK-US2025AMR046252:same reporter US-GSK-US2025AMR046239:same reporter US-GSK-US2025AMR046250:same reporter US-GSK-US2025AMR046237:same reporter
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Hypoacusis, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got shingles in my eye; got shingles in my scalp, face last fall; Hearing has been affected; 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, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: got shingles in my eye) (serious criteria GSK medically significant), facial herpes zoster (Verbatim: got shingles in my scalp, face last fall) and hearing impaired (Verbatim: Hearing has been affected). The outcome of the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and hearing impaired were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, facial herpes zoster and hearing impaired to be related to Shingrix and Shingrix.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the facial herpes zoster and hearing impaired to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient got both Shingrix vaccinations and just got shingles in his/her eye, scalp, face last fall and the hearing had been affected and it had been awful. This case was considered as suspected vaccination failure since the details regarding the time to onset and 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  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix (Dose 1& 2). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1& 2).
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pharmacy shared they vaccinated patients over the age of 55; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate age at vaccine administration (Verbatim: Pharmacy shared they vaccinated patients over the age of 55). The outcome of the inappropriate age at vaccine administration was not applicable.   Additional Information: GSK Receipt Date: 09-APR-2025 Pharmacy shared they vaccinated patients over the age of 55 that have compromised immune system and the claims were denied which led to Inappropriate age at vaccine administration.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm hurt but better  than this; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 14-APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm hurt but better  than this). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt Date: 15-APR-2025 This case was reported by a patient via interactive digital media. The patient said that get the shot.  The patient received Shingles vaccine and before one day of reporting the arm was hurt but better than this.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccines and still got a severe case of them; 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 herpes zoster (Verbatim: I had the vaccines and still got a severe case of them). The outcome of the vaccination failure and herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient received Shingles vaccines and still got a severe case of them.  The pain was unreal. 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 the completion of primary vaccination schedule, time to onset 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."
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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, 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: 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 and shingles to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine year ago in 2024 (from the date of reporting) and when they came out with the advanced Shingrix double injection preventative, her husband and she (patient) both got the shots and guess what not only patient got shingles, the physician said it was the worst case he had ever seen. 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 Shingrix vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingrix vaccine.
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; broke out along the same nerve with red patches with little blisters/ it was shingles; Under stress; 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), shingles (Verbatim: broke out along the same nerve with red patches with little blisters/ it was shingles) and stress (Verbatim: Under stress). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the vaccination failure, shingles and stress were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and stress to be related to Shingles vaccine.     The company considered the vaccination failure, shingles and stress to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-APR-2025 This case was reported by a patient via interactive digital media. The patient stated this had happened with him/her also. The patient had the Shingles vaccine and twice, under. Under stress, the patient broke out along the same nerve with red patches with little blisters. The patient's physician both times said it was shingles. Also gave him/her a prescription for Valtrex. The patient was really surprised that it broke through, but fortunately it was just an annoyance not an agony This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and 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, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster and Stress are unlisted events which are considered unrelated to GSK Shingles vaccine."
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got shingles between the first and second shot; 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: I got shingles between the first and second shot). 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.   Linked case(s) involving the same patient:  US2019AMR229096   Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter got shingles between the first and second shot. It was a very mild case.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; but got Shingles anyway; 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: but got Shingles anyway). 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 : 13-APR-2025 This case was reported by a patient via interactive digital media. He/she had the Shingles shot but got Shingles anyway. 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.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Administration instead of Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 07-APR-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 07-APR-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Administration instead of Boostrix). The outcome of the wrong vaccine administered 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: 08-APR-2025 The patient was received a Dtap (Infanrix) vaccine that was an error, because they should have gotten the Tdap (Boostrix), which led wrong vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose to an adult patient; Pediatric dose to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 06-MAR-2025, the patient received Engerix B pediatric. On 06-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose to an adult patient) and underdose (Verbatim: Pediatric dose to an adult patient). The outcome of the adult use of a child product and underdose 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: 09-APR-2025 A 20-year-old patient was given Engerix B, the birth to 19 year old Engerix-B. The Vaccine Administration Facility is the same as Primary Reporter The healthcare professional confirmed that it was the Engerix-B vaccine, and that the patient received the pediatric dose which led to adult use of a child product and underdose.
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: Inappropriate Storage Error; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16-JAN-2025, the patient received Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Boostrix. On 16-JAN-2025, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Inappropriate Storage Error). The outcome of the incorrect storage of drug 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: 09-APR-2025 The physician reported that he had submitted his continuous thermometer readings for review by the VFC program, and was told had a temperature excursions at 0.91 degree Celcius and the total time out of range is 20 minutes.  Reporter believed it was an error, as 20 min prior the temperature was 4.92 degree Celcius on 16 January 2025 at 11:42 am 20 minutes, the next temperature was taken at 12:02 pm where it registered 0.43 degree Celsius.  There was a patient Involvement, which led to incorrect storage of drug.