chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I have shingles now. 3rd time and I had the vaccine; 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.   The patient's past medical history included shingles.   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 have shingles now. 3rd time and I had the vaccine). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 07-APR-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she had shingles at the time of reporting third time and patient had the vaccine. This time it was the worst patient ever had, also indicated that it was not fun. On meds and will be getting 2nd vaccine after these are gone. Patient would not wish this on worst enemy.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure, Visual impairment
Clinical narrative: Suspected vaccination failure; shingles on the left side of her face and neck and it affected the vision in her left eye; she got shingles on the left side of her face and neck; 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, several months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles on the left side of her face and neck and it affected the vision in her left eye) (serious criteria GSK medically significant) and facial herpes zoster (Verbatim: she got shingles on the left side of her face and neck). The outcome of the vaccination failure, ophthalmic herpes zoster and facial herpes zoster were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be related to Shingrix and Shingrix.     The company considered the vaccination failure, ophthalmic herpes zoster and facial herpes zoster to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 08-APR-2025 This case was reported by a patient's nephew/niece via interactive digital media. The patient got both doses of the Shingrix shot and a few months after the second shot she got shingles on the left side of her face and neck and it affected the vision in her left eye and the shots did not helped her. This case was considered as suspected vaccination failure since the details regarding the laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Herpes zoster and Ophthalmic herpes zoster are unlisted events which are considered unrelated to GSK vaccine Shingrix."
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm was sore is all I get my 2nd shot in may; 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.   Previously administered products included Varicella zoster vaccine (received 1st dose on an unknown date).   In MAY-2024, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm was sore is all I get my 2nd shot in may). 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: 10-APR-2025 This case was reported by a patient via interactive digital media. The arm of the patient was sore all and get 2nd shot in may.
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: gave me 3 shingle shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: gave me 3 shingle shots). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 13-APR-2025 The patient received 3 Shingles shot, which led to extra dose administered. This case was reported by a patient via interactive digital media.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Maladministration of Menveo One-vial Presentation After the Expiration Date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number PZ75H, expiry date 28-FEB-2025) for prophylaxis.   On 07-APR-2025, the patient received Menveo. On 07-APR-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Maladministration of Menveo One-vial Presentation After the Expiration Date). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 07-APR-2025 The reporter reported that 7th April 2025 a female patient received Menveo one vial presentation expired dose, with lot number PZ75H, expiration date 2/28/2025, which led to expired vaccine used. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Accidentally administered Infanrix to 11 years patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) for prophylaxis.   On 07-APR-2025, the patient received Infanrix. On 07-APR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Accidentally administered Infanrix to 11 years patient). The outcome of the inappropriate age at vaccine administration 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 On 08 Apr 2025, a medical assistant called to inform that there was a vaccine error. According to reporter, on 07 Apr 2025, an 11 year old patient received a dose of Infanrix which led to Inappropriate age at vaccine administration but originally the patient was intended to receive a Tdap dose.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Muscular weakness
Clinical narrative: Fatigue and chills and extreme leg weakness going on 11 days and counting from 2nd Shingrix shot.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Blood glucose normal, Headache, Nausea, Retching, Vomiting
Clinical narrative: 10021038--HYPONATREMIA^ 10047700--VOMITING 10/4/24 1240 patient received COVID and Influenza vaccine within the past two days and notes headache and nausea with some vomiting of bile this morning. Reports he work up nauseated, vomited and then consumed ice cream and yogurt around 0600 this morning. He denies any ongoing vomiting, fever, chills, abdominal pain, tremors. Blood sugar this morning was reported as 155. VS are WNL. 10/5/24 0331 (S) Situation patient reporting severe nausea without emesis (dry heaving) and requesting relief. PRN anti-emetic not effective. (B) Background patient reports side effects from recent covid vaccine received. (A) Assessment Nursing and medical intervention  provided no relief. (R) Recommendations MOD ordered alternative anti-emetic. Nursing staff to monitor for interactions. Patient was hospitalized at Hospital ( 10/5/2024 - 10/8/2024) with hyponatremia (dx per patient Nephrologist on 10/5/2024 9:56 AM at hospital) related to his venlafexine. This was discontinued and patient was placed on Welbutrin. Oct 08, 2024@13:19:59 pharmacist entered allergy into system. Sodium levels were monitored closely upon return to CLC.
Age: 82.0
Sex: M
Vaccine: PNC20
Symptoms: Beta haemolytic streptococcal infection, Chills, Fatigue, Hyponatraemia, Influenza
Clinical narrative: I received pneumonia vaccination Prevnar 20 0.5 ML INJ PFIZ. Symptoms of fever, chill, exhaustion, body ache followed. On 04/03/2025 I was hospitalized (redacted hospital name) with pneumonia, sepsis, secondary bacterial injection, group B strep, and Influenza A. Discharge was 4/10/2025. I am recovering at home treating continuing hyponatremia and lactic acidosis.
Age: 82.0
Sex: M
Vaccine: PNC20
Symptoms: Laboratory test, Lactic acidosis, Pain, Pneumonia, Pyrexia
Clinical narrative: I received pneumonia vaccination Prevnar 20 0.5 ML INJ PFIZ. Symptoms of fever, chill, exhaustion, body ache followed. On 04/03/2025 I was hospitalized (redacted hospital name) with pneumonia, sepsis, secondary bacterial injection, group B strep, and Influenza A. Discharge was 4/10/2025. I am recovering at home treating continuing hyponatremia and lactic acidosis.
Age: 82.0
Sex: M
Vaccine: PNC20
Symptoms: Sepsis
Clinical narrative: I received pneumonia vaccination Prevnar 20 0.5 ML INJ PFIZ. Symptoms of fever, chill, exhaustion, body ache followed. On 04/03/2025 I was hospitalized (redacted hospital name) with pneumonia, sepsis, secondary bacterial injection, group B strep, and Influenza A. Discharge was 4/10/2025. I am recovering at home treating continuing hyponatremia and lactic acidosis.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Deafness bilateral, Ear discomfort, Hypoacusis, SARS-CoV-2 test positive
Clinical narrative: I experienced loss of hearing after getting a two dose regimen of the Moderna shot in January and February, 2021 and subsequently, On February 14, 2022, getting Covid 19, confirmed by an Abbott Labs Diagnostic test. My Audiologist doctor examined my ears after three and a half weeks of the loss of about 75% of my hearing in both of my ears and prescribed a regimen of Nasal rinse once per day and Flonase once per day. After four plus weeks my hearing slowly returned to pre-covid-19 acuity. Since then, my ears "plug up" with a decrease in hearing ability at the drop of a hat or for no obvious reason. It's a constant problem. I never had anything like this condition before the Covid shots and the subsequent Covid-19 infection.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Chills, Erythema, Injection site erythema, Injection site pruritus, Musculoskeletal stiffness
Clinical narrative: Reaction / side effects from Pneumococcal Pneumonia vaccine last 5 days; arm was red and stiff / swollen about 5 inches in diameter and was hot to the touch. Also for these 5 days had itching around this red area on the arm where the vaccine administered. Had chills, but only within the first 48 hours.
Age: 52.0
Sex: F
Vaccine: PNC21
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Reaction / side effects from Pneumococcal Pneumonia vaccine last 5 days; arm was red and stiff / swollen about 5 inches in diameter and was hot to the touch. Also for these 5 days had itching around this red area on the arm where the vaccine administered. Had chills, but only within the first 48 hours.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: Betaseron working very well, no exacerbation for over 4 years. Her last exacerbation was around 2019 when she got a flu shot and she had allergic reaction to it.
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: LPN attempted to administer an RSV (Abrysvo) vaccine to a patient and the reconstitution process of the vaccine kit, the luer locking section of the syringe fell off. LPN tried it a second time with another kit from the same box and lot number and it was defective as well. A third kit was obtained from a different box that had the same lot number and there was no issue with reconstituting the vial with that kit's syringe. The LPN had previous experience in reconstituting the kits. Situation- two RSV vaccine kits noted to be defective as the syringe and adapter had unsecure connection and detached while mixing medication causing the adapter and vial to vail onto dirty surface. LOT# LH4511 EXP: 2025/10. Background-potential risk for infection. Assessment--vaccines deemed defective and were not used. Response- vaccines wasted.
Vaccine: COVID19
Symptoms: Condition aggravated, Mast cell activation syndrome, Mechanical urticaria, Rash, Urticaria
Clinical narrative: I got the moderna COVID booster. And about a week after the booster I developed hives all over my body and dermotagraphia. After several months of dealing with it and not being able to touch my own face without having hives and rashes in the areas touched I went to the allergist assuming I developed an allergy to soap or something to find out I have Mast Cell Activation Syndrome most likely caused as a reaction to the COVID booster. I now have an allergy to my own sweat which the allergist saw at the appointment and diagnosed me with MCAS.
Vaccine: COVID19
Symptoms: Urticaria cholinergic
Clinical narrative: I got the moderna COVID booster. And about a week after the booster I developed hives all over my body and dermotagraphia. After several months of dealing with it and not being able to touch my own face without having hives and rashes in the areas touched I went to the allergist assuming I developed an allergy to soap or something to find out I have Mast Cell Activation Syndrome most likely caused as a reaction to the COVID booster. I now have an allergy to my own sweat which the allergist saw at the appointment and diagnosed me with MCAS.
Age: 1.08
Sex: F
Vaccine: HIBV
Symptoms: Cyanosis
Clinical narrative: Circumoral cyanosis Blue skin - hands and feet developed 1 hour after administration of HiB vaccine. Parent reports this reaction has occurred with administration of vaccines. Since receiving 4 month vaccines
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Peripheral swelling
Clinical narrative: large red hot swollen thigh area came in to dr office to have it check out. Arnica PRN,  MOTRIN prn, Epson salt soaks. 4 cm x 2.5 cm all red around, hard to walk or climb
Age: 3.0
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh large area swollen, red and warm to touch. Mom did Epsom salt bath, area and warm compresses
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional  AE/No PQC.; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. See T/E case #0277601. HBP reported that vaccines were administered to patients. No symptomatic events reported. MD agrees to be correspondence contact for AE case. No additional AE/No PQC; This spontaneous report was received from a 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 21-MAR-2025, the patient was vaccinated with improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y011712 and expiration date: 02-JUL-2026, 0.5 mL for prophylaxis (dose number, route and site of administration were not provided). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion lasted 13 hours 15 minutes 0 seconds in temperature of 14.65F. No previous temperature excursion noted (improper storage of product in use).
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) VARIVAX (y013350   8/2/2026) Temperature: 14.92F Time frame:; This spontaneous report was received from a nurse 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-Mar-2025, the patient was vaccinated with an improperly stored dose of Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #y013350, expiration date: 02-Aug-2026) for prophylaxis (improper storage of product in use). No adverse event was reported.  The vaccine underwent a temperature excursion of 14.92 degrees Fahrenheit for 1 hour and 40 minutes.
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms reported at the time of the call; administration of improperly stored VAQTA to one patient on 2/3/2025; This spontaneous report was received from a medical assistant concerning 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 unspecified date, doses of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe, underwent a temperature excursion at 34.6 degrees Fahrenheit (F) during 1 hour, 0 minutes and 0 seconds, without previous temperature excursions.  On 03-Feb-2025, the patient was vaccinated by a healthcare professional, with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) pre-filled syringe, lot #Y014585, expiration date reported as 12-Nov-2025 but upon internal verification established as 01-Feb-2026, 0.5 mL administered as prophylaxis (dosage regimen, anatomical location and route of administration were not provided) (product storage error.)  There were no symptoms informed at the time of the report (no adverse event.)
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received their first dose at age 15 in 10/2019 but may need the second and third doses now at age 20.; No additional AE nor PQC; Information has been received from Business Partner/CRO on 11-Apr-2025.  This spontaneous report was received from a/an Pharmacist and refers to a(n) 20-year-old patient of unknown 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 Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9).  On an unknown date, the patient experienced A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received their first dose at age 15 in 10/2019 but may need the second and third doses now at age 20.. On an unknown date, the patient experienced No additional AE nor PQC.   At the reporting time, the outcome of A HCP called to inquire about the administration spacing of GARDASIL 9 for a patient who received their first dose at age 15 in 10/2019 but may need the second and third doses now at age 20. and No additional AE nor PQC was unknown.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: potential missed 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 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (was vaccinated with his first dose on 7th March 2019 injected into his right deltoid, Batch Number:gz29l and expiry date :23rd May 2021).   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: potential missed dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 However, current medical records did not show a vaccine was recorded as being administered potential missed dose. Consumer stated he believed it might not had been entered into the system as he was adamant about completing the series.  Consumer also stated the provider was physician with.  Reporter no longer had that insurance or that doctor as now live in, had been unsuccessful in contacting that doctor. Date and lot number was provided correspond to the first dose administered. Consumer was unable to provide the doctors phone number and address at the time of the call but would obtain the information and call back to update. No further information was obtained/provided. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered the adjuvant without having it reconstituted with the vaccine; administered the adjuvant without having it reconstituted with the vaccine; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis.   Concurrent medical conditions included hyperlipidemia. Concomitant products included atorvastatin.   On 15-APR-2025, the patient received the 1st dose of Shingrix (left deltoid). On 15-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered the adjuvant without having it reconstituted with the vaccine) and inappropriate preparation of medication (Verbatim: administered the adjuvant without having it reconstituted with the vaccine). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK Receipt Date: 15-APR-2025 The health care professional reported that a patient administered the adjuvant without having it reconstituted with the vaccine, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. There was no anything would like to share about the primary disease.  The patient was taking it as a preventive measure. There was no anything would like to share about a complicating disease.  Patient was taking it as a preventive measure.
Vaccine: MMR
Symptoms: Malaise
Clinical narrative: the patient became sick; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of sickness in a patient who received MMR (Priorix) for prophylaxis.   In MAR-2025, the patient received Priorix. On 08-APR-2025, less than 2 months after receiving Priorix, the patient experienced sickness (Verbatim: the patient became sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Priorix and Priorix Pre-Filled Syringe Device.     It was unknown if the company considered the sickness to be related to Priorix and Priorix 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 : 08-APR-2025 Nurse reported that one month ago the patient received GlaxoSmithKline (GSK) version of vaccine (Priorix) and on the day of reporting the patient became sick came into the office.  No additional adverse events were reported. No further information was provided.  No product quality complaint (PQC) was provided.
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: head pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Patient had Shingles on head). Previously administered products included varicella zoster vaccine and Shingrix.   On an unknown date, the patient received the 2nd dose of Shingrix. In APR-2025, 7 years after receiving Shingrix, the patient experienced headache (Verbatim: head pain). The outcome of the headache was not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     It was unknown if the company considered the headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-APR-2025 Patient stated that after having Shingles, on head, they received the old shingles vaccine, then had two-part Shingrix Vaccine approximately 7 years ago.  Patient was experiencing head pain for the second day, similar to that of the early days leading up to when they first had Shingles. Also asked if they can take the Shingrix vaccine again.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: was more painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Tetanus vaccine with an associated reaction of pain (received tetanus shot and was painful).   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 pain (Verbatim: was more painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain 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. The shingles shot was more painful than a tetanus shot for him/her.  The patient suggested that took it on a Friday so you have the weekend to recover.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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: Shingles). The outcome of the vaccination failure and shingles were not reported.   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. The company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by the reporter via interactive digital media. The reporter's dad (patient) got shingles from the vaccine, and it was so painful. He was fine before it. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This was 1 of the 2 linked cases reported by the same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. US-GSK-US2025AMR045179:Same reporter/ different  patient
Vaccine: VARZOS
Symptoms: Arthralgia, Diaphragmatic disorder, Ear pain, Neck pain, Pain
Clinical narrative: disabled diaphragm; I suffered severe pain at left ear, neck, shoulder, scalp; I suffered severe pain at left ear; severe pain at upper torso; I suffered severe pain at neck; severe pain at scalp; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diaphragmatic disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diaphragmatic disorder (Verbatim: disabled diaphragm), shoulder pain (Verbatim: I suffered severe pain at left ear, neck, shoulder, scalp), ear pain (Verbatim: I suffered severe pain at left ear), pain (Verbatim: severe pain at upper torso), neck pain (Verbatim: I suffered severe pain at neck) and scalp pain (Verbatim: severe pain at scalp). The outcome of the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain were not reported.   It was unknown if the reporter considered the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain to be related to Shingrix.     It was unknown if the company considered the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter suffered severe pain at left ear, neck, shoulder, scalp, upper torso, disabled diaphragm.
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: disabled diaphragm; I suffered severe pain at left ear, neck, shoulder, scalp; I suffered severe pain at left ear; severe pain at upper torso; I suffered severe pain at neck; severe pain at scalp; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of diaphragmatic disorder in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diaphragmatic disorder (Verbatim: disabled diaphragm), shoulder pain (Verbatim: I suffered severe pain at left ear, neck, shoulder, scalp), ear pain (Verbatim: I suffered severe pain at left ear), pain (Verbatim: severe pain at upper torso), neck pain (Verbatim: I suffered severe pain at neck) and scalp pain (Verbatim: severe pain at scalp). The outcome of the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain were not reported.   It was unknown if the reporter considered the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain to be related to Shingrix.     It was unknown if the company considered the diaphragmatic disorder, shoulder pain, ear pain, pain, neck pain and scalp pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2025 This case was reported by a patient via interactive digital media. The reporter suffered severe pain at left ear, neck, shoulder, scalp, upper torso, disabled diaphragm.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: the vaccine is horrid, sick for 4 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: the vaccine is horrid, sick for 4 days). The outcome of the sickness was resolved (duration 4 days).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccine was horrid. The patient was sick for 4 days. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 3 times after getting the shots; 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: had shingles 3 times after getting the shots). 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: 12-APR-2025 The case was received from the patient via interactive digital media. The reporter reported that the patient (his/her employee's physician) has had the vaccine and had shingles 3 times after getting the shots. 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, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had both doses of the vax and still got a bad 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Had both doses of the vax and still got a bad 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: 12-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that the patient had both doses of the vaccination and still got a bad case of shingles. 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 vaccine Shingles vaccine (dose 1) and Shingles vaccine (dose 2).
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix 7 years ago/missed second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 7 years ago (2018)).   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: first dose of Shingrix 7 years ago/missed second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-APR-2025 The nurse contacted safety team via chat and requested to remain anonymous.  The reporter enquired if the patient received first dose of Shingrix 7 years ago, still they just get the second dose or have to restart the series. Till the time of reporting, the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination. The agent asked if that actually happened with a patient and the reporter answered it in yes.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Diluent only administered; accidentally received only the diluent portion of Hiberix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old male patient who received Hib (Hiberix) for prophylaxis.   On 20-MAR-2025, the patient received the 3rd dose of Hiberix. On 20-MAR-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Diluent only administered) and inappropriate dose of vaccine administered (Verbatim: accidentally received only the diluent portion of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 07-APR-2025 A registered nurse reported that a six-month 25 day old patient accidentally received only the diluent portion of Hiberix as their third dose, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. They stated that they did not have the lot number or expiration date of the vaccine as the full vaccine was not administered and declined to received follow up. They requested to have the case escalated to global and, even though only the diluent portion inquiry was reported, an adverse event detail was added for the possible third dose.  The vaccine administration facility was the same as primary reporter.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 11 year old received Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9KB9G) for prophylaxis.   On 11-MAR-2025, the patient received Infanrix. On 11-MAR-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old received Infanrix). The outcome of the inappropriate age at vaccine administration 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 Other HCP reported that an 11 year old patient was administered Infanrix, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Maladministration of a Kinrix vaccine instead of a Pediarix to a 6 month old patient.; a six month old male patient was administered a Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 26-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Pediarix. On 26-FEB-2025, an unknown time after receiving Kinrix and not applicable after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Maladministration of a Kinrix vaccine instead of a Pediarix to a 6 month old patient.) and inappropriate age at vaccine administration (Verbatim: a six month old male patient was administered a Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2025 The licensed practical nurse called to ask about guidance because a six month old male patient was administered a Kinrix vaccine instead of a Pediarix dose which led to wrong vaccine administered and inappropriate age at vaccine administration. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further detail was provided from the Licensed Practical Nurse end in this call. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to get 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 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to get their second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-APR-2025 The pharmacist explained that a patient got their first dose of Shingrix on 2021, but they forgot to get their second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: an expired dose of Kinrix was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 11-APR-2025, the patient received Kinrix. On 11-APR-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Kinrix was administered). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-APR-2025 The nurse reported that an expired dose of Kinrix was administered, which led to expired vaccine used
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: the right arm "Completely feels like it's falling apart and coming off."; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (the right arm "Completely feels like it's falling apart and coming off.") in an adult male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (the right arm "Completely feels like it's falling apart and coming off."). At the time of the report, LIMB DISCOMFORT (the right arm "Completely feels like it's falling apart and coming off.") had not resolved.            No concomitant medications were reported.  It was reported that, the patient had 2 more shots in the right arm. Till the reporting date, the right arm completely felt like it was falling apart and coming off.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-784670 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit). At the time of the report, PAIN IN EXTREMITY (One shot of Moderna in [the] left arm about 4 or 5 years ago/ left arm still hurts a little bit) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was reported that patient had received one shot of Moderna in the left arm about 4 or 5 years ago. Then had two more shots in right arm. To this day, the left arm was still hurting a little bit.  Reporter causality was not reported. It was unknown if the patient experienced any additional symptoms or events.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2025-784675 (Patient Link).   Reporter did not allow further contact