chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19, FLU3, HEPA
Symptoms: Eyelid rash, Pyrexia, Rash, Rash pruritic, Swelling of eyelid
Clinical narrative: Pt states that that night she started with a slight rash on her hairline as well as a fever. The fever lasted 3 days and the rash continued to spread so it is now all over her face. On day 4 her eyelids were a bit puffy - esp the L one. Applied  1% hydrocortisone cream. On day 4, rash spread to her cheeks and forehead and eyelids this AM. Rash is slightly itchy. Denies any tongue swelling/SOB. On Day 4 had congestion today and felt slightly dizzy. Took Tylenol for fever. No new foods or anything new to her face - just the 2 creams that she's been using for a while now - benzoyl peroxide and differin cream. No history of any vaccine reactions or food allergies. No rash on other parts of body. Suggested adding loratadine and continue using hydrocortisone. By day 7 rash and itching improved and loratadine and hydrocortisone was discontinued. On day 10, rash had returned but without swelling. By day 14 symptoms resolved.  Past Medical History: Unremarkable
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Electrocardiogram ambulatory abnormal, Headache, Injection site pain
Clinical narrative: I had severe chills, muscle soreness of injection site, muscle aches and headache 10 hours after injection. The next morning I had the same symptoms but with post vaccination tachycardia (114-123 BPM). My normal resting heart rate is 68 BPM. My smart Watch kept alerting me of an increased heart rate at rest. After receiving the alerts I checked it manually and was getting the same while checking my radial pulse. I was a firefighter/EMT and currently work in the medical field. My blood pressure was also elevated 145/97
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Tachycardia
Clinical narrative: I had severe chills, muscle soreness of injection site, muscle aches and headache 10 hours after injection. The next morning I had the same symptoms but with post vaccination tachycardia (114-123 BPM). My normal resting heart rate is 68 BPM. My smart Watch kept alerting me of an increased heart rate at rest. After receiving the alerts I checked it manually and was getting the same while checking my radial pulse. I was a firefighter/EMT and currently work in the medical field. My blood pressure was also elevated 145/97
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Costochondritis, Electrocardiogram abnormal, Heart rate irregular, Hypoaesthesia
Clinical narrative: 03 September 2021 I was in the emergency room. I was hooked up to an EKG, I had an irregular heartbeat and I had lost sense of touch in my hands (they were purple). I had costochondritis, and I was on a 6-month profile.  I also was awarded a 30% disability  They described it as: severely dilated left atrial cavity with trace tricuspid regurgitation of unknown etiology. I am now wearing a device for two weeks to see if I still have an irregular heartbeat from the vaccine.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Left atrial dilatation, Skin discolouration, Tricuspid valve incompetence
Clinical narrative: 03 September 2021 I was in the emergency room. I was hooked up to an EKG, I had an irregular heartbeat and I had lost sense of touch in my hands (they were purple). I had costochondritis, and I was on a 6-month profile.  I also was awarded a 30% disability  They described it as: severely dilated left atrial cavity with trace tricuspid regurgitation of unknown etiology. I am now wearing a device for two weeks to see if I still have an irregular heartbeat from the vaccine.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia, Urticaria
Clinical narrative: Patient developed hives on face only, a fever of 100, muscle pain and exhaustion this morning after vaccination yesterday. No anaphylaxis suspected. Benadryl given as treatment of hives.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Exfoliative rash, Fatigue, Neuralgia, Pain
Clinical narrative: starting Friday morning felt achy and tired, starting friday night shooting nerve pain, starting saturday morning, scaly rash on face with swelling and redness -- all symptoms continuing today 2/9/25
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: starting Friday morning felt achy and tired, starting friday night shooting nerve pain, starting saturday morning, scaly rash on face with swelling and redness -- all symptoms continuing today 2/9/25
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Patient woke up from his nap with a rash/hives on his face and neck which was at noon and noticed the rash go away over time. Then when he woke up from his second nap around 4:30pm it came back again. We noticed the trend that wherever his skin was getting warm the rash would appear. Then at night patient had his bath and the hives appeared for a third time on his legs. This solidified our assumption that heat was causing the rash/hives which has never happened to patient before. After 48 hours after receiving the Hep A we didn t continue to see the adverse events return.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was recommended by her nurse practitioner to get a dose of the RSV vaccine. She presented to the pharmacy asking for the vaccination and it was provided; however she had already received the same vaccine a year earlier on 1/30/24. This is a second dose given outside of guidelines. No adverse side effects reported.
Age: 57.0
Sex: F
Vaccine: FLU3, TDAP, VARZOS
Symptoms: Abdominal distension, Erythema, Injection site pain, Injection site warmth, Skin lesion
Clinical narrative: on 2/9/25 patient came to walk in care at clinic reporting swelling and pain in left arm where she got her shingrix and flu vaccinations. Provider examined the patient and documented 9x8cm erythematous lesion on left deltoid, musculoskeletal pain, warm to the touch. For treatment, patient was given 30mg/ml of Ketorolac Tromethamine solution, 1 mL, given one time, prescribed famotidine tablet 20mg tablets, take 1 tablet at bedtime as needed and fexofenadine HCl 180mg tablets, swallow whole with water orally once a day. Patient left the clinic.
Age: 91.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis around the injection site and down the arm
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Fatigue, Postural orthostatic tachycardia syndrome, Syncope
Clinical narrative: Fainted, started having long term auto immune disorders. Suffered from chronic fatigue and POTS. Was treated for several years as if auto immune. Changes to diet. Was prescribed medication to help with fainting.
Age: 77.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The pt complained about pain in both arms, she mentioned can barley lift her arms,. The pain started couple hours after the vaccine was administered and got worse. Pt did not take any ibuprofen or tylenol to relieve the pain. She also denied any redness or swelling
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECIEVED ONE BOOSTRIX IN 2024 AND ANOTHER IN 2025 NOT IN ACCORDANCE WITH ACIP GUIDELINES
Age: 85.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PATIENT RECEIVED 1 BOOSTRIX IN 2024 AND ANOTHER IN 2025 NOT IN ACCORDANCE WITH ACIP GUIDELINES
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of Prevnar 20 when only one dose is recommended. Patient not currently experiencing any side effects
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Alanine aminotransferase increased, Ammonia decreased, Amnesia, Angiogram normal
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Bilirubin urine, Blood alcohol normal, Blood culture negative, Blood glucose normal
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium normal, Blood potassium decreased, Blood thyroid stimulating hormone decreased, Blood urea decreased, Blood urea increased
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea nitrogen/creatinine ratio increased, Blood urine absent, Brain oedema, C-reactive protein increased, CSF culture negative
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: CSF glucose normal, CSF oligoclonal band absent, CSF protein increased, CSF red blood cell count positive, CSF test normal
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: CSF white blood cell count negative, Chest X-ray normal, Computerised tomogram head normal, Diplopia, Drug screen positive
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram abnormal, Epstein-Barr virus test negative, Full blood count, Fungal test negative, Glucose urine absent
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Gram stain, JC polyomavirus test negative, Magnetic resonance imaging head abnormal, Mean cell volume decreased, Mental status changes
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Mycobacterium test negative, Nitrite urine absent, Posterior reversible encephalopathy syndrome, Procalcitonin normal
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Protein urine absent, Prothrombin time prolonged, Red blood cell count normal, Red blood cell sedimentation rate decreased, SARS-CoV-2 test negative
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Specific gravity urine normal, Treponema test negative, Troponin I normal, Urine ketone body absent, Urobilinogen urine
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, West Nile virus test negative, White blood cells urine negative, X-ray dental normal, pH urine normal
Clinical narrative: Behavioral changes began 08/26/201,  Altered mentation began 08/28/2021, Cerebral edema, blurry/ double vision, memory loss began 08/30/2021
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Food allergy, Immunisation reaction, Injection site rash
Clinical narrative: I became infected with the Alpha Gal Syndrome (Meat Allergy). I became allergic to Beef, Pork, bovine, and porcine gelatin.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Pruritus
Clinical narrative: Itchy palms and soles of feet for 4 years
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Brain fog, Fatigue, Gastrointestinal microorganism overgrowth, Impaired work ability
Clinical narrative: Within a day or so of getting the vaccine I became chronically fatigued, had severe brain fog, all over body pain like a fever from the flu, had insomnia, nausea and struggled to eat foods without pain.  The symptoms worsened after vaccine #2.  I went to part time work in April of 2021 and had to quick working due to the illness in June of 2021.  I was later diagnosed with SIBO and Mast Cell Activation Syndrome.   I was later diagnosed with dysautnomia and POTS after years of disabling symptoms.  Although it took years to reach these diagnosis they all began after the vaccine.  After obtaining the COVID virus in August of 2024, I had a flare of symptoms again and Long COVID was confirmed by clinic.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Insomnia, Mast cell activation syndrome, Nausea, Pain
Clinical narrative: Within a day or so of getting the vaccine I became chronically fatigued, had severe brain fog, all over body pain like a fever from the flu, had insomnia, nausea and struggled to eat foods without pain.  The symptoms worsened after vaccine #2.  I went to part time work in April of 2021 and had to quick working due to the illness in June of 2021.  I was later diagnosed with SIBO and Mast Cell Activation Syndrome.   I was later diagnosed with dysautnomia and POTS after years of disabling symptoms.  Although it took years to reach these diagnosis they all began after the vaccine.  After obtaining the COVID virus in August of 2024, I had a flare of symptoms again and Long COVID was confirmed by clinic.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome
Clinical narrative: Within a day or so of getting the vaccine I became chronically fatigued, had severe brain fog, all over body pain like a fever from the flu, had insomnia, nausea and struggled to eat foods without pain.  The symptoms worsened after vaccine #2.  I went to part time work in April of 2021 and had to quick working due to the illness in June of 2021.  I was later diagnosed with SIBO and Mast Cell Activation Syndrome.   I was later diagnosed with dysautnomia and POTS after years of disabling symptoms.  Although it took years to reach these diagnosis they all began after the vaccine.  After obtaining the COVID virus in August of 2024, I had a flare of symptoms again and Long COVID was confirmed by clinic.
Sex: F
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: Eczema Rash; This non-serious case was reported by a consumer and described the occurrence of eczematous rash in a 51-year-old female patient who received Herpes zoster (Shingles vaccine) (batch number 5RK5T, expiry date 16-APR-2026) for prophylaxis.   On 04-MAR-2024, the patient received the 1st dose of Shingles vaccine. On 02-APR-2024, 29 days after receiving Shingles vaccine, the patient experienced eczematous rash (Verbatim: Eczema Rash). The outcome of the eczematous rash was not resolved.   It was unknown if the reporter considered the eczematous rash to be related to Shingles vaccine.     It was unknown if the company considered the eczematous rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-JAN-2025 Patient was the reporter. Concomitant medication included multiple daily medications for multiple purpose. The symptoms were treated.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Vaccine incorrect diluent used; Vaccine incorrect diluent used; This non-serious case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution 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 wrong solution used in drug reconstitution (Verbatim: Vaccine incorrect diluent used) and inappropriate dose of vaccine administered (Verbatim: Vaccine incorrect diluent used). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-JAN-2025 The nurse reported that the patient received Shingrix vaccine with incorrect diluent used, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case is linked with US2023AMR151817, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR151817:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: sick; This non-serious case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: sick). The outcome of the sickness was resolved (duration 1 month).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter reported that a patient had the first shot of Shingrix a few years ago when dealing with immune issues and experienced severely sick for a month after the vaccine.  The reporter said that it was one of the vaccines that is a live virus make sure immune system can handle it.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: back pain; This non-serious case was reported by a physician via sales rep and described the occurrence of back pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included Age: more than 50 years.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced back pain (Verbatim: back pain). The outcome of the back pain was not reported.   It was unknown if the reporter considered the back pain to be related to Shingrix.     It was unknown if the company considered the back pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-FEB-2025 A patient received the second dose of Shingrix and experienced back pain which messed up his back.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered a dose of Kinrix which was expired on 27th Oct, 2024; 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 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 14-JAN-2025, the patient received Kinrix. On 14-JAN-2025, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Kinrix which was expired on 27th Oct, 2024). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-JAN-2025 Other HCP reported that administered a dose of Kinrix to a 5 year old male patient on 14th Jan, 2025 which had an expiration date of 27th Oct, 2024, which led to expired product used. The vaccines were quarantined in the back of the fridge but apparently the staff member did not notice the sign. At the time of reporting, a repeat dose has not been administered.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult male 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 pain in arm (Verbatim: arm soreness). The outcome of the pain in arm was unknown.   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: 16-JAN-2025 Patient reported arm soreness after receiving Shingrix.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 34 months old female patient received an adult dose of Havrix; A 34 months old female patient received an adult dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 34-month-old female patient who received HAV (Havrix adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: A 34 months old female patient received an adult dose of Havrix) and overdose (Verbatim: A 34 months old female patient received an adult dose of Havrix). The outcome of the adult product administered to child and overdose were unknown.   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: 16-JAN-2025 A registered nurse called to report that they administered an adult dose of Havrix to a 34 months old female patient, which led to adult product administered to child and overdose. And enquiring whether this dose count as valid.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Did not receive 2nd 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose on 16-FEB-2023).   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: Did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-JAN-2025 Other HCP reported that a 71 years old female patient received a dose of Shingrix and now the patient wanted to get the second dose, which led to incomplete course of vaccination. Reporter asked the patient needs to repeat the series or not. This case is linked with  US2020058338 reported by same reporter.; Sender's Comments:  US-GSK-US2020058338:same reporter
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received a Menveo that was expired by few months; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA982A, expiry date 31-OCT-2024) for prophylaxis.   On 20-JAN-2025, the patient received Menveo. On 20-JAN-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: received a Menveo that was expired by few months). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-JAN-2025 Physician reported that a child yesterday that received a Menveo that was expired by few months, which led to expired vaccine used.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product preparation issue
Clinical narrative: patient was administered 2 vials of adjuvant and no powder (Antigen); patient was administered 2 vials of adjuvant and no powder (Antigen); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number D5AP5, expiry date 31-AUG-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered 2 vials of adjuvant and no powder (Antigen)) and inappropriate dose of vaccine administered (Verbatim: patient was administered 2 vials of adjuvant and no powder (Antigen)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-JAN-2025 The pharmacist reported that the patient was administered 2 vials of adjuvant and no powder (Antigen) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  There had been no complaints of any effects.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: skin rash all over his body and itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a elderly male patient who received Herpes zoster (Shingrix) (batch number 5A4H7, expiry date 31-OCT-2026) for prophylaxis.   On 01-NOV-2024, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced itchy rash (Verbatim: skin rash all over his body and itching). The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JAN-2025 The patient received Shingrix and within a couple of days of receiving the second dose, he had a skin rash all over his body and itching. The patient reported that he continued to have the rash and itching today (date of reporting), but not as severe.
Age: 22.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA989A, expiry date 30-NOV-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 21-JAN-2025 Other HCP reported that they administered an expired dose of Menveo (2 vial), the powder portion expired on 30th Nov, 2024, which led to expired product used. Reporter asked that they have to revaccinate the patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number BP74J, expiry date 15-NOV-2026) for prophylaxis.   Previously administered products included Shingrix (1st dose on 24th Dec, 2019), Shingrix (2nd dose on 27th Feb, 2020) and Zostavax.   On 18-JAN-2025, the patient received the 3rd dose of Shingrix. On 18-JAN-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 22-JAN-2025 Other HCP reported that a patient got a 3rd dose of Shingrix. According to reporter on 24th Dec, 2019, the patient received the 1st dose of Shingrix. Then, on 27th Feb, 2020 the patient received the 2nd dose of Shingrix. After that, on 18th Jan, 2025 the patient received the 3rd dose of Shingrix, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd dose of shingrix; This non-serious case was reported by a pharmacist 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 (patient got 1st Zoster, Shingrix vaccine, on Oct 2020).   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: did not receive 2nd dose of shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-JAN-2025 Physician reported that a patient got his 1st Zoster, Shingrix vaccine, on Oct 2020, this was almost 4 and a half years later. Reporter asked was he ok to get another one or does he needs to start the series all over again. Till the time of reporting patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Incomplete course of vaccination
Clinical narrative: got off schedule with their 2nd dose due to COVID; This non-serious case was reported by a physician via call center representative and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patients received their first dose during COVID on an unknown date).   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 social problem (Verbatim: got off schedule with their 2nd dose due to COVID). The outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 31-JAN-2025 Reporter stated that 3 patients got their 1st Shingrix dose during COVID and got off schedule with their 2nd dose due to that, she then stated it was 1 or 2 patients.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On 08-JAN-2025, the patient received Havrix. On 08-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 03-FEB-2025 Nurse reported a patient was administered an expired dose of Havrix, which led expired vaccine used. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration
Clinical narrative: Kinrix SC instead of IM; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5G23D, expiry date 21-AUG-2026) for prophylaxis.   On 03-FEB-2025, the patient received Kinrix (subcutaneous). On 03-FEB-2025, an unknown time after receiving Kinrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Kinrix SC instead of IM). The outcome of the intramuscular formulation administered by other route was unknown.   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: 03-FEB-2025 Registered nurse reported that a male patient received by error Kinrix subcutaneously instead of Intramuscular which led intramuscular formulation administered by other route. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: Maladministration of Hiberix Diluent portion alone; administered the syringe diluent only; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of Hiberix Diluent portion alone) and inappropriate dose of vaccine administered (Verbatim: administered the syringe diluent only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-FEB-2025 The reporter had a staff person that administered the syringe diluent only, that was saline, which led inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter asking was there any waiting period or should they just bring them back in for proper administration. The reporter could not find any guidance online specifically, but obvious sense of logic would say that it's not valid and no waiting period needed.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration 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 17-year-old male patient who received HBV (Engerix B) (batch number PZT72S, expiry date 15-DEC-2024) for prophylaxis.   On 03-FEB-2025, the patient received Engerix B. On 03-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration after the expiration date). The outcome of the expired vaccine used was unknown.   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: 03-FEB-2025 Registered Nurse called mentioning that they gave an ENGERIX-B dose today, after the vaccine expired on 15th December 2024 which led to expired vaccine use. Registered Nurse wanted advise on this situation. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further detail was obtained in this call.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Product preparation issue
Clinical narrative: hard knot at injection site; Injection site hard knot; swelling at injection site; redness at injection site; mistakenly administered Shingrix adjuvant only; mistakenly administered Shingrix adjuvant only; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site mass in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis.   On 28-JAN-2025, the patient received the 1st dose of Shingrix. On 28-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: mistakenly administered Shingrix adjuvant only) and inappropriate preparation of medication (Verbatim: mistakenly administered Shingrix adjuvant only). On 30-JAN-2025, the patient experienced injection site mass (Verbatim: hard knot at injection site), injection site induration (Verbatim: Injection site hard knot), injection site swelling (Verbatim: swelling at injection site) and injection site erythema (Verbatim: redness at injection site). The outcome of the injection site mass, injection site induration and injection site swelling were not resolved and the outcome of the injection site erythema, inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   It was unknown if the reporter considered the injection site mass, injection site induration, injection site swelling and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site mass, injection site induration, injection site swelling and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-FEB-2025  The pharmacy technician mistakenly administered Shingrix adjuvant only, without reconstitution to the patient, which led inappropriate preparation of medication and inappropriate dose of vaccine administered. The error was discovered two days later.  The patient returned to the pharmacy on 30 January 2025 with injection site redness, swelling, and a hard knot. The vaccine administration facility was the same as primary reporter. Nothing else was reported. The case was linked with case US2019160501, reported by the same reporter.; Sender's Comments:  US-GSK-US2019160501:same reporter
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: A 46 years old female patient received a dose of Havrix after a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old female patient who received HAV (Havrix) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On 02-JAN-2025, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: A 46 years old female patient received a dose of Havrix after a temperature excursion.). The outcome of the incorrect storage of drug was unknown.   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: 04-FEB-2025 The health care professional reported that a patient got vaccinated with Havrix after a temperature excursion, which led to incorrect storage of drug. The health care professional would like to know if the patient needs to be revaccinated.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: ended getting 3rd dose in 2/25; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in March 2024) and Shingrix (received 2nd dose of Shingrix vaccine in May 2024).   In FEB-2025, the patient received the 3rd dose of Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: ended getting 3rd dose in 2/25). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter reported that the patient received three doses of shingrix. Two doses two months apart in march 2024 and May 2024 patient was not sure if they got the second dose. Patient received 3rd dose in February 2025, after dose given after some research turned out patient got 2nd dose and wasn't reported, which led to extra dose administered. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (Patient received first dose in April 2024).   On 04-FEB-2025, the patient received the 2nd dose of Shingles vaccine. On 04-FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-FEB-2025 Patient reported about the shingles vaccine, stated that he had second one, and the pharmacy told him that it was ok, as patient received first one on Apr 2024, but he was not able to get 2nd one until the day before reporting, so it was longer than 6 months. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received 2 doses of Twinrix, one in April and one in May of 2010; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in April 2010) and Twinrix (received 2nd dose in May 2010).   On an unknown date, the patient received the 3rd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: patient received 2 doses of Twinrix, one in April and one in May of 2010). The outcome of the incomplete course of vaccination was unknown.   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: 05-FEB-2025 The pharmacist reported a patient received 2 doses of Twinrix, one in April and one in May of 2010. The pharmacist did not have lot or expiration date of product. The pharmacist stated that he believed it was administered at MD office. Till the time of reporting, the patient did not receive 3rd dose of Twinrix vaccine which led to incomplete course of vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Cutaneous T-cell lymphoma, Rash
Clinical narrative: A skin rash started  on the patient's torso a week after receiving vaccine.   The rash persisted and  never went away.  It is now biopsied and the diagnosis is Mycosis Fungoides a form of  Cutaneous Lymphoma
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Bursitis
Clinical narrative: Bursitis was reported as worsened; This non-serious case was reported by a physician via sales rep and described the occurrence of bursitis in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-NOV-2024, the patient received the 1st dose of Arexvy (left arm). On 27-NOV-2024, less than a day after receiving Arexvy, the patient experienced bursitis (Verbatim: Bursitis was reported as worsened). The outcome of the bursitis was not resolved.   The reporter considered the bursitis to be related to Arexvy.     The company considered the bursitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-FEB-2025 The patient received Arexvy vaccine and experienced bursitis.; Sender's Comments:  US-GSK-US2023145295:same reporter US-GSK-US2023056053:same reporter US-GSK-US2021AMR103016:same reporter US-GSK-US2020AMR210194:same reporter US-GSK-US2020AMR210190:same reporter US-GLAXOSMITHKLINE-US2020AMR089276:same reporter US-GLAXOSMITHKLINE-US2020AMR083961:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered the Shingrix vaccine but only gave the dilute; administered the Shingrix vaccine but only gave the dilute; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication 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 inappropriate preparation of medication (Verbatim: administered the Shingrix vaccine but only gave the dilute) and inappropriate dose of vaccine administered (Verbatim: administered the Shingrix vaccine but only gave the dilute). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JAN-2025  The reporter had a nurse that administered the Shingrix vaccine but only gave the dilute which led to inappropriate preparation on medication and inappropriate dose of vaccine administered. The reporter was trying to find out if any of these lot numbers was the dilute TJ534, 745JK, 946580 and LG5577. The reporter was trying to narrow it down so the patient could receive the complete vaccine just not the dilute.
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Herpes zoster, Malaise, Mobility decreased, Swelling face
Clinical narrative: I had shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles on the side of my face).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: I had shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-JAN-2025 This case was reported by a patient via interactive digital media. The patient had shingles on the side of the face just had the first shot, 2 weeks later the patient woke up side of the face hurt like hell swollen went to the doctor she took one look and she said that the patient had shingles had to be in the room for a month and couldn't get out of bed sick as the patient could be but they can not tell that the patient had it and don't want it anymore but the patient was told that you can get it again.
Age: 1.58
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered
Clinical narrative: 4th dose of FluLaval administered; 3rd dose of FluLaval administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-month-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 4S5YG, expiry date 30-JUN-2025) for prophylaxis.   Co-suspect products included Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   Previously administered products included Flulaval (patient had 1st dose on December 18th, 2023) and Flulaval (patient had 2nd dose on January 20th, 2024).   On 12-DEC-2024, the patient received the 4th dose of FluLaval 2024-2025 season. On 09-SEP-2024, the patient received the 3rd dose of FluLaval 2024-2025 season. On 09-SEP-2024, not applicable after receiving FluLaval 2024-2025 season and an unknown time after receiving FluLaval 2024-2025 season, the patient experienced extra dose administered (Verbatim: 3rd dose of FluLaval administered). On 12-DEC-2024, the patient experienced extra dose administered (Verbatim: 4th dose of FluLaval administered). The outcome of the extra dose administered and extra dose administered were unknown.   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: 13-JAN-2025 The patient received 4 dose of Flulaval which led to extra dose administered.