chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: Low grade fever; felt a little ick; This non-serious case was reported by a consumer via sales rep and described the occurrence of low grade fever in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine polysacch 23v (Pneumovax) for prophylaxis.   On 08-MAR-2025, the patient received the 1st dose of Shingrix and Pneumovax. On 08-MAR-2025, 24 hrs after receiving Shingrix, the patient experienced low grade fever (Verbatim: Low grade fever) and feeling abnormal (Verbatim: felt a little ick). On 08-MAR-2025, the outcome of the low grade fever and feeling abnormal were resolved.   The reporter considered the low grade fever and feeling abnormal to be related to Shingrix.     The company considered the low grade fever and feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2025 This report was submitted via the online direct entry reporting system.  Reporter shared that 24 hours after receiving Shingrix and Pneumovax he had a low grade fever and felt a little ick for 2 to 3 hours. The reporter considered the low grade fever and feeling abnormal to be related to Pneumovax.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y) for prophylaxis.   Concurrent medical conditions included diabetes. Concomitant products included metformin.   On 13-MAR-2025, the patient received Shingrix. On 17-MAR-2025, 4 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-MAR-2025 The reporter reported that the patient had received Shingrix vaccine and experienced shingles. The symptoms were treated.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; Engerix B pediatric dose was administered to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis.   On 17-MAR-2025, the patient received Engerix B pediatric. On 17-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Engerix B pediatric dose was administered to an adult). The outcome of the underdose and adult use of a child product 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: 25-MAR-2025 The healthcare professional was the reporter. The reporter reported that on 17th march 2025 Engerix B pediatric dose was administered to a adult patient which led to underdose and adult use of a child product.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: Fever; Cold; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cerebral palsy (Cerebral palsy consumer was wheelchair bound). Concomitant products included COVID-19 vaccine and Influenza vaccine (Flu vaccine VII).   On 24-MAR-2025, the patient received Shingrix (left arm). In MAR-2025, less than a week after receiving Shingrix, the patient experienced fever (Verbatim: Fever) and cold (Verbatim: Cold). The outcome of the fever and cold were unknown.   It was unknown if the reporter considered the fever and cold to be related to Shingrix.     It was unknown if the company considered the fever and cold to be related to Shingrix.   Additional Information: GSK receipt date: 25-MAR-2025 Reporter stated that patient received her first dose of Shingrix 24th March, 2025 in her left arm. Reporter stated consumer had a fever of 99.4 degrees Fahrenheit and was cold. The consumer had a diagnosis of cerebral palsy and is wheelchair bound (unknown date of diagnosis.) The consumer had 3 vaccines administered last week on unknown date and had a fever of 101.4 degrees Fahrenheit that resolved within a few days. Patient had COVID, flu and another vaccine (unknown name) administered at the same time last week.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; she was diagnosed with shingles she went to the emergency department and currently experiencing another bout (4th breakout) of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult 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 (intramuscular, left arm) and the 1st dose of Shingrix (intramuscular, right arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: she was diagnosed with shingles she went to the emergency department and currently experiencing another bout (4th breakout) of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2025 The patient self-reported this case. The patient completed the vaccination series of Shingrix vaccine and the first dose was administered some time after turning 50 years old and the second dose was administered 3 months later and since completion of vaccine series she had been diagnosed with shingles four times.   The patient stated at the time of call to GSK she was currently experiencing another bout (4th breakout) of shingles. The shingles appeared on the right side of her bottom with each occurrence and the breakout lasts approximately a week or more.   The patient first time she was diagnosed with shingles she went to the emergency department because she thought she had been bitten by a spider and was diagnosed and released from the emergency department.  The patient had a questions whether the pharmacy administered Shingrix because she did not see the vial(s) the medication came from only a syringe filled with liquid.   The patient provided vaccinating pharmacy information so lot numbers could be obtained. The patient did not had pictures that she could provide of her shingles breakout. 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 52F7M) for prophylaxis.   On 14-DEC-2024, the patient received the 1st dose of Shingrix. On 14-DEC-2024, less than a day after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date : 25-MAR-2025 Patient took 1st dose of Shingrix and experienced shingles.
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: upset stomach; This non-serious case was reported by a other health professional via sales rep and described the occurrence of upset stomach in an specified number of patients 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 upset stomach (Verbatim: upset stomach). The outcome of the upset stomach was unknown.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.     It was unknown if the company considered the upset stomach to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-MAR-2025 Reporter stated that two patients experienced upset stomach after first dose of Shingrix.  Age or gender was not specified.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: I had like flu symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID-19 vaccine (had to get the Covid vaccine).   In SEP-2019, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: I had like flu symptoms). The outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 26-MAR-2025 The patient self-reported this case for herself. She received the 1st dose of Shingrix in September 2019 and had not received the 2nd dose yet. The patient reported for some reason the vaccine was not available at the time. She received the 1st dose at a local pharmacy. The patient reported that after that she had to get the Covid vaccine and forgot all about the 2nd dose of Shingrix. The patient inquired when should she get the 2nd dose. The patient reported that she had like flu symptoms with the 1st dose of Shingrix.  The patient did not provide additional medical history or medications information.
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of injection site reaction in a unspecified number of patients 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 injection site reaction (Verbatim: Injection site reaction). The outcome of the injection site reaction was resolved.   The reporter considered the injection site reaction to be related to Shingrix.     The company considered the injection site reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2025 Pharmacist reported that patients occasionally reported injection site reactions with Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt like crap for a few days; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of feeling abnormal in a 50-year-old male 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 feeling abnormal (Verbatim: Felt like crap for a few days). The outcome of the feeling abnormal was resolved.   The reporter considered the feeling abnormal to be related to Shingrix.     The company considered the feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-MAR-2025 The reporter reported that although patient felt like crap for a few days after the first Shingrix vaccination, he returned for the second vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Rash
Clinical narrative: had tiny pimples all over cheeks; rash on her face; This non-serious case was reported by a consumer via call center representative and described the occurrence of pimples in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included upper respiratory tract infection. Concomitant products included metoprolol and doxycycline.   On 25-MAR-2025, the patient received the 1st dose of Shingrix. In MAR-2025, less than a day after receiving Shingrix, the patient experienced pimples (Verbatim: had tiny pimples all over cheeks) and rash (Verbatim: rash on her face). The outcome of the pimples and rash were resolving.   It was unknown if the reporter considered the pimples and rash to be related to Shingrix.     It was unknown if the company considered the pimples and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-Mar-2025 The reporter was the patient who received her first dose of Shingrix on Monday, 25 March 2025. She states that she developed a rash on her face the same night and it was as she had tiny pimples all over my cheeks. These were on both sides of her face. Symptoms had gotten better after use of an antihistamine recommended by her doctor. She also stated that she finished a dose of doxycycline a couple days ago for an upper respiratory infection developed prior to the dose.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never went back to receive the 2nd 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 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix (Intramuscular) on 05-JAN-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: never went back to receive the 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 27-MAR-2025 The reporter stated that he received his 1st dose of Shingrix and never went back to receive the 2nd dose Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been link with US2025037146, reported by the same reporter.; Sender's Comments:  US-GSK-US2025037146:Same reporter/Different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not received the 2nd 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 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix (Intramuscular) on 05-JAN-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: did not received the 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 27-MAR-2025 The reporter was the spouse of the patient who stated his wife received her 1st dose of Shingrix and never received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case had been link with US2025037142, reported by the same reporter.; Sender's Comments:  US-GSK-US2025037142:Same reporter/Different patient
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: of suspect vaccine subcutaneously instead of intramuscularly; 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number 3E99M, expiry date 31-DEC-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo (subcutaneous, left deltoid) .5 ml. On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: of suspect vaccine subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 The reporter was the healthcare professional calling from a facility to get further guidance from MI. The reporter stated that a minor child received first dose of suspect vaccine subcutaneously instead of intramuscularly in his left lower deltoid which led to intramuscular formulation administered by other route. The reporter did not provide the date that the vaccine was given.
Age: 67.0
Sex: M
Vaccine: COVID19, FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix (left arm). In JAN-2023, the patient received the 1st dose of Shingrix (left arm). On 27-OCT-2024, the patient received Influenza vaccine (left arm). In NOV-2024, the patient received COVID-19 vaccine (right arm). In OCT-2024, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with prednisone acetate (Prednisone). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-MAR-2025 The patient reported he received SHINGRIX dose 1 in Jan 2023 and dose 2 in April 2023 in the left arm. He stated on 27 October 2024, He received the regular flu shot (no name) in left arm. Had Covid shot in right arm in Nov 2024. He states he experienced itchy rash bumps (10 to 20) in a band/line, on front of left shoulder since October 2024. He was diagnosed with shingles and thinks SHINGRIX did not work for him. He stated a week later Nov 2024 he received the COVID shot in right arm. He still had not fully recovered from shingles. He stated he was given medicines like prednisone pills, prednisone shot, a cream for the itch and a gel that had silver in it, he purchased for the rash. Medical disclaimer provided. This case was considered as suspected vaccination failure as details regarding completion of laboratory confirmation regarding shingles were unknown at the time of reporting. It was unknown if the reporter considered the vaccination failure and shingles to be related to Flu vaccine and Covid-19 vaccine.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 & 2).
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Rash
Clinical narrative: rash; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24-AUG-2024, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash (Verbatim: rash) and incomplete course of vaccination (Verbatim: Inappropriate schedule of vaccine administered). The outcome of the rash was not resolved and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK receipt date: 27-APR-2025 Consumer was the reporter, stated that he received his first dose of Shingrix on 24th August 2024 in the left arm. Consumer forgot to get his second dose of Shingrix in the recommended interval of 2 to 6 Months. Consumer stated he will have the second dose administered this week. Consumer stated that he broke out in a rash on the back of one leg and went to urgent care and Shingles was ruled out by the doctor. Consumer stated now the rash has spread to the other leg and was on both front and back of legs. Consumer stated the vaccine was administered at Pharmacy. No further information was provided.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Dyspnoea, Dysstasia, Flatulence
Clinical narrative: Nausea; Vertigo dizziness; Gas in stomach; Fever chills; Unable stand up; Labored breathing; Burning neck; Vision abnormal; This non-serious case was reported by a consumer and described the occurrence of nausea in a 45-year-old female patient who received Herpes zoster (Shingrix) (expiry date MAR-2025) for prophylaxis.   The patient's past medical history included meningitis, encephalitis, seizure, stroke and transient ischemic attack. Concurrent medical conditions included sleep disturbance, diabetes, systemic lupus erythematosus, rheumatoid arthritis and balance difficulty. Concomitant products included zolpidem.   On 27-MAR-2025, the patient received Shingrix. On 27-MAR-2025, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), vertigo (Verbatim: Vertigo dizziness), gas in stomach (Verbatim: Gas in stomach), fever chills (Verbatim: Fever chills), difficulty in standing (Verbatim: Unable stand up), labored breathing (Verbatim: Labored breathing), burning sensation (Verbatim: Burning neck) and abnormal vision (Verbatim: Vision abnormal). The outcome of the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision were not resolved.   It was unknown if the reporter considered the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision to be related to Shingrix.     It was unknown if the company considered the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2025 The patient self reported this case for herself. Patient was a woman with diabetes and some autoimmune conditions that physicians were still investigating, which were connected to lupus and rheumatoid arthritis.  In the past, patient had experienced serious health issues, including meningitis, encephalitis, seizures, and a stroke at the age of six.  More recently, she had a transient ischemic attack (TIA) in 2020 and had been dealing with balance problems. Symptoms of Fever chills were treated.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vertigo, Visual impairment
Clinical narrative: Nausea; Vertigo dizziness; Gas in stomach; Fever chills; Unable stand up; Labored breathing; Burning neck; Vision abnormal; This non-serious case was reported by a consumer and described the occurrence of nausea in a 45-year-old female patient who received Herpes zoster (Shingrix) (expiry date MAR-2025) for prophylaxis.   The patient's past medical history included meningitis, encephalitis, seizure, stroke and transient ischemic attack. Concurrent medical conditions included sleep disturbance, diabetes, systemic lupus erythematosus, rheumatoid arthritis and balance difficulty. Concomitant products included zolpidem.   On 27-MAR-2025, the patient received Shingrix. On 27-MAR-2025, less than a day after receiving Shingrix, the patient experienced nausea (Verbatim: Nausea), vertigo (Verbatim: Vertigo dizziness), gas in stomach (Verbatim: Gas in stomach), fever chills (Verbatim: Fever chills), difficulty in standing (Verbatim: Unable stand up), labored breathing (Verbatim: Labored breathing), burning sensation (Verbatim: Burning neck) and abnormal vision (Verbatim: Vision abnormal). The outcome of the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision were not resolved.   It was unknown if the reporter considered the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision to be related to Shingrix.     It was unknown if the company considered the nausea, vertigo, gas in stomach, fever chills, difficulty in standing, labored breathing, burning sensation and abnormal vision to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-MAR-2025 The patient self reported this case for herself. Patient was a woman with diabetes and some autoimmune conditions that physicians were still investigating, which were connected to lupus and rheumatoid arthritis.  In the past, patient had experienced serious health issues, including meningitis, encephalitis, seizures, and a stroke at the age of six.  More recently, she had a transient ischemic attack (TIA) in 2020 and had been dealing with balance problems. Symptoms of Fever chills were treated.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: his Tennitus has gotten worse; This non-serious case was reported by a consumer via call center representative and described the occurrence of tinnitus aggravated in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included arthritis (Arthritis), anxiety (Anxiety) and tinnitus (on his left ear). Concomitant products included omeprazole (Prilosec), gabapentin and mirtazapine (Remeron).   On 19-MAR-2025, the patient received Arexvy. On 20-MAR-2025, 1 days after receiving Arexvy, the patient experienced tinnitus aggravated (Verbatim: his Tennitus has gotten worse). The outcome of the tinnitus aggravated was not resolved.   It was unknown if the reporter considered the tinnitus aggravated to be related to Arexvy.     It was unknown if the company considered the tinnitus aggravated to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-MAR-2025 The patient has a history of Tinnitus on his left ear. Patient reports that he received Arexvy on 3/19/2025. Since receiving the vaccine, his Tinnitus has gotten worse.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: the patient received a total of 0.94 ml of Shingrix on a single day; received 0.44 ml; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a male 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 .5 ml and the 1st dose of Shingrix .44 ml. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced overdose (Verbatim: the patient received a total of 0.94 ml of Shingrix on a single day) and incomplete dose administered (Verbatim: received 0.44 ml). The outcome of the overdose and incomplete dose administered were not applicable.   Additional Information: GSK Receipt Date: 28-MAR-2025 The pharmacist reported that what was the next steps if a patient only received 0.44 milliliter of the first dose, which led to incomplete dose administered. The product was then identified as Shingrix.  She was driving at the time of the outbound call and therefore did not have the access to the patient's date of birth or other information such as the lot number.  She stated that he did some research on center of disease control website and immunization organization which indicated that the dose should be re administered thus she called the patient back to the pharmacy and administer 0.5 milliliter.  Therefore,  the patient received a total of 0.94 milliliter of Shingrix on a single day, which led to overdose. No further information available.  Pharmacist was aware that safety may follow up with her to collect more details.
Sex: F
Vaccine: MENB
Symptoms: Injection site mass
Clinical narrative: develop a BB like bump on the injection site; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number A274J) for prophylaxis.   On 03-MAR-2025, the patient received the 1st dose of Bexsero (right arm). On 03-MAR-2025, less than a day after receiving Bexsero, the patient experienced injection site swelling (Verbatim: develop a BB like bump on the injection site). The outcome of the injection site swelling was resolving.   The reporter considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the injection site swelling to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-MAR-2025 The mother of patient was a Medical Assistant. The patient had small BB like bump at the injection site and was reported as worsened. It had gone down a little but the bump still was there.
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: the other only received the liquid adjuvant; the other only received the liquid adjuvant; This non-serious case was reported by a nurse via patient support programs and described the occurrence of inappropriate preparation of medication in a adult patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 28-MAR-2025, the patient received the 1st dose of Arexvy. On 28-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: the other only received the liquid adjuvant) and inappropriate dose of vaccine administered (Verbatim: the other only received the liquid adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 28-MAR-2025 The two older adult patients was vaccinated with first dose of Arexvy vaccine, one with mixed components and the other only received the liquid adjuvant. The clinic was unsure which patient received the full dose and which patient received partial dose.  The patients were a married couple.  The Medical Assistant in the clinic administered a correct dose of Arexvy for one patient and the other only received the adjuvant liquid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 78.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: a patient received Priorix intramuscular instead of subcutaneously; Priorix received to patient 78 year old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 78-year-old female patient who received MMR (Priorix) (batch number X3M3D, expiry date 01-APR-2025) for prophylaxis.   On 27-MAR-2025, the patient received Priorix (intramuscular, left arm) .5 ml. On 27-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: a patient received Priorix intramuscular instead of subcutaneously) and inappropriate age at vaccine administration (Verbatim: Priorix received to patient 78 year old). The outcome of the subcutaneous injection formulation administered by other route 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: 31-MAR-2025 On 27 MAR 2025, a patient received Priorix intramuscularly instead of subcutaneously which led to Subcutaneous injection formulation administered by other route. The patient was 78 year old female and received Priorix which led to Inappropriate age at vaccine administration.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient received Priorix by the intramuscular route instead of subcutaneously; Adult patient received priorix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a adult female patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis.   On 29-MAR-2025, the patient received Priorix (intramuscular). On 29-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient received Priorix by the intramuscular route instead of subcutaneously) and inappropriate age at vaccine administration (Verbatim: Adult patient received priorix vaccine). The outcome of the subcutaneous injection formulation administered by other route 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: 31-MAR-2025 The patient self reported this case for herself. An adult female patient received Priorix on 29th March 2025 by the intramuscular route instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route and Inappropriate age at vaccine administration.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; 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 8-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received the 1st dose of Havrix on unknown date) and Havrix (received the 2nd dose of Havrix on unknown date).   On 31-MAR-2025, the patient received the 3rd dose of Havrix. On 31-MAR-2025, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 31-MAR-2025 The Healthcare professional reported that a third Havrix dose was administered on the day of reporting to an 8 year old female patient, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling fingers; This non-serious case was reported by a physician via sales rep and described the occurrence of tingling of extremity in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (right deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: Tingling fingers). The outcome of the tingling of extremity was resolved.   The reporter considered the tingling of extremity to be related to Shingrix.     The company considered the tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-MAR-2025 The patient received a dose of Shingrix and experienced tingling fingers which was not serious.  No other products were received by the patient.
Sex: M
Vaccine: RVX
Symptoms: Arthralgia, Incorrect dose administered
Clinical narrative: Arthralgia; 1ml RSV vaccine was given; This non-serious case was reported by a consumer and described the occurrence of arthralgia in a 69-year-old male patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number PK9C5) for prophylaxis.   Concurrent medical conditions included diabetes and colitis. Concomitant products included azathioprine (Imuran), metformin hydrochloride (Medformin), atorvastatin calcium (Lipitor), balsalazide, mirabegron and esomeprazole.   On 16-NOV-2024, the patient received RSV vaccine 1 ml. On 16-NOV-2024, an unknown time after receiving RSV vaccine, the patient experienced overdose (Verbatim: 1ml RSV vaccine was given). On 20-NOV-2024, the patient experienced arthralgia (Verbatim: Arthralgia). The outcome of the arthralgia was not resolved and the outcome of the overdose was not applicable.   It was unknown if the reporter considered the arthralgia to be related to RSV vaccine.     It was unknown if the company considered the arthralgia to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 01-APR-2025 Consumer reported that he took the RSV vaccine and experienced arthralgia. Patient received 1ml of RSV vaccine which led to overdose.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient had several cases of shingles, then got first vaccine and then got shingles again before second dose; This non-serious case was reported by a consumer via sales rep and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Patient had several cases of shingles).   On 01-JUN-2024, the patient received the 1st dose of Shingles vaccine (left deltoid). On 09-SEP-2024, 100 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Patient had several cases of shingles, then got first vaccine and then got shingles again before second dose). The outcome of the shingles was resolved.   The reporter considered the shingles to be unrelated to Shingles vaccine.   The company considered the shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date : 01-APR-2025 Patient had several cases of shingles, then got first vaccine and then got shingles again before second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain after shot for 6 days; Body aches the first 24 hours; This non-serious case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-MAR-2025, the patient received Shingrix (left deltoid). On 28-MAR-2025, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm pain after shot for 6 days) and general body pain (Verbatim: Body aches the first 24 hours). On 03-APR-2025, the outcome of the pain in arm was resolved (duration 6 days). The outcome of the general body pain was resolved (duration 24 hrs).   The reporter considered the pain in arm and general body pain to be related to Shingrix.     The company considered the pain in arm and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2025 The reporter reported that the patient received a subsequent dose of Shingrix vaccine and experienced sore arm and body aches and had arm pain after shot for 6 days and the body aches for the first 24 hours
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling at injection site; redness at the injections site; pain at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAR-2025, the patient received the 1st dose of Shingrix (left arm). On 17-MAR-2023, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at the injections site) and injection site pain (Verbatim: pain at the injection site). On 17-MAR-2025, the patient experienced injection site swelling (Verbatim: swelling at injection site). On 20-MAR-2023, the outcome of the injection site erythema and injection site pain were resolved (duration 3 days).  On 20-MAR-2025, the outcome of the injection site swelling was resolved (duration 3 days).   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 03-APR-2025 The patient reported that after receiving the 1st dose of Shingrix vaccine he experienced pain, swelling, redness at the injection site for 4 days then was completely recovered. The batch number and expiry date of Shingles vaccine were unknown.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: If I didn't get a second shingrix vaccine (it's been 2 years); This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date, the patient received 1st dose).   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 incomplete course of vaccination (Verbatim: If I didn't get a second shingrix vaccine (it's been 2 years)). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 18-MAR-2025 The reporter asked if the he/she didn't get a second Shingrix vaccine (it's been 2 years) should he/she start over and get two with appropriate time between the two. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Still have horrible nerve damage in my eye forehead, ear, side to center of skull; hard to deal with the heat; Suspected Vaccination failure; got the worse case shingles the right side of my head the whole quarter from my eye all the way back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (several times, usually just a little patch on neck or shoulder), back pain (bit of pain in back) and shoulder pain (bit of pain in back up to shoulder).   On an unknown date, the patient received Shingles vaccine. On 26-NOV-2024, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the worse case shingles the right side of my head the whole quarter from my eye all the way back). On an unknown date, the patient experienced post herpetic neuralgia (Verbatim: Still have horrible nerve damage in my eye forehead, ear, side to center of skull) and skin warm (Verbatim: hard to deal with the heat). The outcome of the vaccination failure, shingles and skin warm were not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and skin warm to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, post herpetic neuralgia and skin warm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAR-2025 This case was reported by a patient via interactive digital media. The patient had shingles several times, usually just a little patch on neck or shoulder and the patient could always felt them coming on with a bit of pain in his/her back up to shoulder.  Then the patient got the vaccine a couple years ago and got the worse case of shingles and that had been a nightmare and the right side of head the whole quarter from eye all the way back.  The patient still had horrible nerve damage in his/her eye, forehead, ear, side to center of skull and felt like a little guy in there with a pick axe trying to get out.  It was very hard to deal with the heat and the pain and had been 4 months and still in pain.  Nothing helped and stated he/she wouldn't wish this on anyone. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about  the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 3 years since i got the first, can i go ahead now and get the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose of Shingrix 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 3 years since i got the first, can i go ahead now and get the second shot). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 19-MAR-2025 The reporter reported that it had been 3 years since got the first, could he/she go ahead now and get the second shot or do need to start over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.