chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Red blood cell sedimentation rate, Streptococcus test negative, Urine analysis, Urticaria
Clinical narrative: Full body hives/rash starting one day after administered vaccine. Hives lasting on and off for two weeks. Throat swelling about a week after administered vaccine. Macular edema confirmed by optometrist with headaches 2 weeks after administered vaccine.
Age: 68.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: Shingrix arm (left)- Pain in left arm from shoulder to elbow right after vaccination and beginning to feel better 5/25/25.  Also a red rashy patch below and laterally to injection site of shingrix of about 2in by 3in...said it showed up the following day
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse reaction at this time.  Patient was to receive a flu vaccine, but inadvertently received Shingrix.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Catheterisation cardiac abnormal
Clinical narrative: Patient's wife stated that the patient was hospitalized on May 19th and had to go to the cath lab. The cardiologist was unable to complete the procedure as the one artery was so occluded. He told the patient and his wife that he had not seen anything like it and it may be a result of a recent vaccine administration.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Pt stated she had all the symptoms of flu that lasted a few days and also pain and swelling in right arm that continues to this day.  She states the pain is similar to the pain she had when her rotator cuff was torn, lack of motion.
Age: 1.58
Sex: M
Vaccine: MMR
Symptoms: Diarrhoea, Laboratory test, Lethargy, Pyrexia, Vomiting
Clinical narrative: Fever started the night of the vaccination. Fever for a total of 7 days at the time of reporting. Developed vomiting, diarrhea, lethargy. Admitted to the hospital on 5/23/25 for IV fluid. Continued with fevers. Possible incomplete Kawasaki disease.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood glucose decreased, Computerised tomogram normal, Mydriasis, Scan with contrast normal, Vision blurred
Clinical narrative: Blurred vision in left eye, left pupil dilated, low blood sugar
Age: 53.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Abdominal distension, Injection site erythema, Pain, Pyrexia
Clinical narrative: Patient still has swelling, redness, soreness, and slight fever on 05/25/25, five days after the vaccines were given.  The redness and swelling are limited to the upper left arm region above the elbow.  Patient also states the presence of a slight fever.  Patient is taking acetaminophen for the fever and soreness, and cold compresses for the swelling,  and will wait to see the response.
Age: 54.0
Sex: M
Vaccine: HEP, PNC20
Symptoms: Incomplete course of vaccination, Wrong product administered
Clinical narrative: Pharmacist did not review records before administering vaccine to patient despite printing the form(s) out. HEPLISAV-B was administered on 01/07/2025 instead of the TWINRIX that he was originally receiving. This incident was repeated again on 2/11/2025 by pharmacist. As a result, the patient did not complete his original TWINRIX vaccination schedule and had to be scheduled to complete 2 doses of HAVRIX in order to have immunity for both hepatitis A and B.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: PATIENT COMPLAINED ABOUT HAVING CHILLS THE NEXT DAY FOLLOWED BY REDNESS AROUND THE INJECTION SITE WITH ITCHING AND BEING SORE
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Rash
Clinical narrative: facial rash
Age: 40.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site pain, Paraesthesia
Clinical narrative: There was immediate bruising and bleeding at the injection site on the upper left arm. A dark bruise also appeared about an inch and a half down from the injection site on the upper left arm. The bruising lasted for two weeks. The arm was immediately sore at the injection site and continues to be sore nearly two months later. Tingling in the arm, which runs down to my left pinky and ring fingers, started after the injection, and continues today.
Vaccine: HEPA
Symptoms: Product label issue
Clinical narrative: Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefilled syringe is latex-free; Product complaint/ Pictures of this discrepancy-sticker on box, PI, product; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product label confusion in an unspecified number of patients who received HAV (Havrix adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced product label confusion (Verbatim: Havrix-Adult box has a sticker that says contains latex. PI inside this box states that the prefilled syringe is latex-free) and pharmaceutical product complaint (Verbatim: Product complaint/ Pictures of this discrepancy-sticker on box, PI, product). The outcome of the product label confusion and pharmaceutical product complaint 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: 15-MAY-2025 The reporter was the HCP (health care professional). He was a medication safety pharmacist with 300 pharmacies. One of his pharmacists informed him that a box of Havrix-adult had a contains latex sticker on the front. The PI (product information) included inside this box reads: the tip cap and rubber plunger stopper of the prefilled syringe were not made with natural rubber latex. Pictures of this discrepancy (sticker on box, PI, product) would be sent to referencing the case number, which led to product label confusion and pharmaceutical product complaint. Confirmed that all operations were performed appropriately before defect was discovered. The Havrix-Adult box has a sticker that said contains latex. The PI inside this box stated that the prefilled syringe was latex-free. After partial use of the multi pack, the defect discovered. The product was administered. The box or carton and PI components was involved in the complaint Per QA Liaison, no return of suspect product or packaging was requested at this time. The reporter did not know how many doses have been used from the box. The customer 1 was the pharmacy that had the suspect product. For now, their information was here rather than in the HCP section as the reporter's email address needed to be noted for follow-up. Unspecified number of Havrix doses administered. There was a product complaint to report and complaint ID was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Haemorrhage, Pruritus
Clinical narrative: Extreme itching, bleeding; Bleeding; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cardiac stent placement (Heart stent operation in January). Concurrent medical conditions included blood pressure high and blood cholesterol increased. Concomitant products included prasugrel hydrochloride (Effient), morniflumate (Flomax), rosuvastatin, losartan, acetylsalicylic acid (Asprin), pantoprazole sodium (Pantoprazole) and vitamins.   On 12-MAY-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: Extreme itching, bleeding) and hemorrhage (Verbatim: Bleeding). The patient was treated with hydrocortisone acetate;pramocaine hydrochloride (Hydroxine). The outcome of the pruritus and hemorrhage were not resolved.   It was unknown if the reporter considered the pruritus and hemorrhage to be related to Shingrix.     It was unknown if the company considered the pruritus and hemorrhage to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAY-2025 The patient was also on Effient for a heart stent operation in January. Other medications were reported as one a day Vitamin, Flomax, Hydroxine, Rousuvastatin, Losartan, Asprin, Pantoprozole. The patient wanted to know if this was a reaction to Shingrix and how long it would last. If there was any antidotes to cancel the allergic reaction. (Extreme itching, bleeding) Were the symptoms treated was reported as no.
Age: 45.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: The vaccine had expired one month earlier; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HBV (Engerix B adult) (expiry date APR-2025) for prophylaxis.   On 08-MAY-2025, the patient received the 3rd dose of Engerix B adult. On 08-MAY-2025, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: The vaccine had expired one month earlier). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 19-MAY-2025 This report was submitted via the online direct entry reporting system. The reporter was the patient. The patient received his third Engerix-B adult dose and the vaccine had expired one month earlier, which led to expired vaccine used. The vaccinator did not provide him with the lot number and exact expiration date. The formulation was unknown. Doctor's office recommended the expired dose be repeated, but the patient has not yet decided if he would do this. Nothing else was reported. The patient/reporter did not provide lot number to the patient.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: she incorrect reconstituted Shingrix; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional 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: she incorrect reconstituted Shingrix) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 20-MAY-2025 This report was submitted via the online direct entry reporting system. Healthcare professional (HCP) was the reporter. Healthcare professional reported she incorrect reconstituted Shingrix (reconstitution error), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No further information was provided/obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: not sure if she ever went back to receive the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received first dose 2 to 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: not sure if she ever went back to receive the second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 20-MAY-2025 This report was submitted via the online direct entry reporting system. The patient did not have any lot number information to provide. The reporter was a patient that received her first dose of Shingrix 2 to 3 years ago from her pharmacist at her local pharmacy, and was not sure if she ever went back to receive the second dose. The patient reported that she normally received vaccines in her left arm, but this was not confirmed. The patient thought the Shingrix first dose was administered as an IM injection, but this was not confirmed. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: administered expired Arexvy vaccine to 2 patients; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a elderly female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis.   On 21-MAY-2025, the patient received the 1st dose of Arexvy (left arm). On 21-MAY-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: administered expired Arexvy vaccine to 2 patients). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 21-MAY-2025 The reporter reported that the patient who had received expired Arexvy vaccine which led to, expired vaccine used. As it was administered to 2 patients, there were 2 initials by pharmacist as they was husband and wife. This case had been link with US2025AMR064187, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR064187:Male patient
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity
Clinical narrative: Blisters; pain in hands/pain in feet; This non-serious case was reported by a physician via sales rep and described the occurrence of blister in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2025, the patient received the 1st dose of Shingrix. On 07-MAY-2025, 20 days after receiving Shingrix, the patient experienced blister (Verbatim: Blisters) and pain in extremity (Verbatim: pain in hands/pain in feet). The outcome of the blister and pain in extremity were not resolved.   The reporter considered the blister and pain in extremity to be related to Shingrix.     The company considered the blister and pain in extremity to be related to Shingrix.   Additional Information: GSK receipt date: 21-MAY-2025 The physician reported that the patient had received 1st dose of Shingrix vaccine and experienced blisters and pain on hands and feet.  The reporter mentioned that blister and pain on hands and feet was reported as worsened. The expiry date of Shingrix was unknown. This case had been link with US2025063517, reported by the same reporter.; Sender's Comments:  US-GSK-US2025063517:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: recived 1st dose in 2023 and did not go back to receive the second dose of the vaccine series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 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: recived 1st dose in 2023 and did not go back to receive the second dose of the vaccine series). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 22-MAY-2025 The reporter was the patient who received the Shingrix vaccine in 2023 and did not go back to receive the second dose of the vaccine series. The patient did not wanted to give any information after he was told that a safety report would be filed. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; 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 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 25-MAR-2025, the patient received the 3rd dose of Shingrix. On 25-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of Shingrix). The outcome of the extra dose administered was not applicable.   Additional Information: GSK receipt date: 22-MAY-2025 The reporter reported that the patient completed her series of Shingrix (dates not provided). The reporter reported that on 25th March 2025 received a 3rd dose of Shingrix which led to, extra dose administered. No further information was obtained/provided.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received HBV (Engerix B) (batch number 92DJ3) for prophylaxis.   On 22-MAY-2025, the patient received Engerix B (intramuscular) .5 ml. On 22-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired vaccine used). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2025 The medical assistant reported that she gave a dose of Engerix-B on the day of reporting which was expired on 03rd May 2025 which led to expired vaccine used.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I have shingles with the vaccine, got it from a friend who received the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have shingles with the vaccine, got it from a friend who received the vaccine). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingles with the vaccine, got it from a friend who received the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine."
Vaccine: RVX, VARZOS
Symptoms: Somnolence
Clinical narrative: Only side effects were being sleepy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and RSV vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and RSV vaccine, the patient experienced sleepiness (Verbatim: Only side effects were being sleepy). The outcome of the sleepiness was not reported.   It was unknown if the reporter considered the sleepiness to be related to Shingles vaccine and RSV vaccine.     It was unknown if the company considered the sleepiness to be related to Shingles vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 18-MAY-2025 The patient saw doctor for annual exam and was told about a patient that got shingles in her eye and went thru excruciating pain and ended up having her eye removed. The patient took his advice and got the shingles vaccine along with the Rsv vaccine. The only side effects were being sleepy. The second shingles dose was due in 2 to 6 months.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: The patient felt badly; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling abnormal in a 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: The patient felt badly). The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingrix.     It was unknown if the company considered the feeling abnormal to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAY-2025 The patient felt badly after dose 1 of Shingrix. The patient refused to take dose 2 of Shingrix due to the side effects of dose 1.
Sex: M
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: has administered Expired Arexvy vaccine to 2 patients; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of expired vaccine used in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5P4A5, expiry date 27-MAR-2025) for prophylaxis.   On 21-MAY-2025, the patient received the 1st dose of Arexvy (left arm). On 21-MAY-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: has administered Expired Arexvy vaccine to 2 patients). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK receipt date: 21-MAY-2025 The reporter reported that the patient had received expired Arexvy vaccine which led to, expired vaccine used. As it was administered to 2 patients, there were 2 initials by pharmacist as they was husband and wife. This case had been link with US2025063393, reported by the same reporter.; Sender's Comments:  US-GSK-US2025063393:Female patient
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sickness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Had shingles before vaccine).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sickness). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-MAY-2025 This case was reported by a patient via interactive digital media.  Patient reported that he/she was sick after 1st dose. Followed through 2nd but, no reaction. Patient had shingles before vaccine. Patient hoped never to have it again.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: severe pain that lasted for several months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: severe pain that lasted for several months). The outcome of the pain was resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-MAY-2025 This case was reported by a patient via interactive digital media.  The vaccine gave me severe pain that lasted for several months, so patient not getting the second shot.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got a dose of shingrix in december of 2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2022).   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: got a dose of shingrix in december of 2022). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 21-MAY-2025 The reporter reported that they had a patient who received a dose of Shingrix in December 2022 but did not return for the second dose until May 2025. The patient was wondering if they needed to restart the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheits as the lowest reached Boostrix (39LB7 and 2B723), which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. No expiration date given for the vaccines nor date of administration. This is 1 of 35 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061551:same patient,Different suspect US-GSK-US2025061545:same reporter,Different suspect US-GSK-US2025061574:Same reporter,Different patient US-GSK-US2025061573:Same reporter,Different patient US-GSK-US2025061572:Same reporter,Different patient US-GSK-US2025061571:Same reporter,Different patient US-GSK-US2025061570:Same reporter,Different patient US-GSK-US2025061569:Same reporter,Different patient US-GSK-US2025061568:Same reporter,Different patient US-GSK-US2025061567:Same reporter,Different patient US-GSK-US2025061565:Same reporter,Different patient US-GSK-US2025061564:Same reporter,Different patient US-GSK-US2025061563:Same reporter,Different patient US-GSK-US2025061562:Same reporter,Different patient US-GSK-US2025061561:Same reporter,Different patient US-GSK-US2025061560:Same reporter,Different patient US-GSK-US2025061559:Same reporter,Different patient US-GSK-US2025061558:Same reporter,Different patient US-GSK-US2025061557:Same reporter,Different patient US-GSK-US2025061556:Same reporter,Different patient US-GSK-US2025061555:Same reporter,Different patient US-GSK-US2025061554:Same reporter,Different patient US-GSK-US2025061553:Same reporter,Different patient US-GSK-US2025061552:Same reporter,Different patient US-GSK-US2025061550:Same reporter,Different patient US-GSK-US2025061549:Same reporter,Different patient US-GSK-US2025061537:Same reporter,Different patient US-GSK-US2025061536:Same reporter,Different patient US-GSK-US2025061534:Same reporter,Different patient
Age: 0.17
Sex: F
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 2-month-old female patient who received DTPa (Infanrix) for prophylaxis.   Previously administered products included Infanrix (On 03-MAR-2020, the patient received 1st dose) and Kinrix (On 15-JUL-2024, the dose was received with batch number 3RT93 and expiry date 03-APR-2026).   On an unknown date, the patient did not receive the 2nd dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2025 The patient already got kinrix before.  The reporter wanted to catch them up because they were not up to date on their DTAP or their polio. They have only had a dose of the DTAP and those were the only ones they had with the DTAP and same with the Polio, they just have those two doses in her life. The reporter consented to follow up. Health care professional (HCP) called to inquire the safety of administering a Second dose of Kinrix. They've administered a first dose of Kinrix in July 15th, 2024. The Patient only received one dose of DTAP vaccine and one Kinrix and those were the only two doses of DTAP or Polio IPV that the patient received in her life.
Age: 46.0
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after Temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 46-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number cx4hl, expiry date 09-NOV-2026) for prophylaxis.   On 21-MAY-2025, the patient received Boostrix. On 21-MAY-2025, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after Temperature excursion). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-MAY-2025 A nurse called in to request data about the need to revaccinate a patient after a dose of Boostrix was given after a temperature excursion which led to incorrect storage of drug. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient/administration of the vaccine was probable; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient/administration of the vaccine was probable). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2025 The pharmacist reported a Bexsero vaccine was left out of the fridge for 14 hours at room temperature and the pharmacist stated that the vaccine was not administered but he mentioned that the vaccine was at the patient's home so, administration of the vaccine was probable, which led to incorrect storage of drug
Age: 50.0
Sex: M
Vaccine: DTAP
Symptoms: Underdose
Clinical narrative: accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix); patient that is 50 years old, and accidentally they gave it Dtap (Infanrix) to him; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 50-year-old male patient who received DTPa (Infanrix) (batch number TX77L, expiry date 28-SEP-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-MAY-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 21-MAY-2025, an unknown time after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix)) and inappropriate age at vaccine administration (Verbatim: patient that is 50 years old, and accidentally they gave it Dtap (Infanrix) to him). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2025 The physician reported that they had a little issue with one of their patient and a vaccine administration as there have been a mix up, they order Tdap (Boostrix) for a patient that was 50 years old and accidentally they gave it Dtap (Infanrix) to him, instead of Tdap (Boostrix), which led to wrong vaccine administered and inappropriate age at vaccine administration The Vaccine Administration Facility is the same as Primary Reporter
Age: 73.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: early 3rd dose; Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 22-MAY-2025, the patient received the 3rd dose of Twinrix. On 09-APR-2025, the patient received the 2nd dose of Twinrix. On 09-APR-2025, not applicable after receiving Twinrix and an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 22-MAY-2025, the patient experienced drug dose administration interval too short (Verbatim: early 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too long 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: 22-MAY-2025 The reporter called and reported that they gave a Twinrix vaccine outside the normal interval, so they wanna now if did they need to repeat the dose. they gave the 3rd dose to soon. The vaccine administration facility was the same as primary reporter. The healthcare professional reported that the 2nd dose was a late 2nd dose which led to lengthening of vaccination schedule, and the 3rd dose was an early which led to shortening of vaccination schedule.
Age: 0.58
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration of Engerix-B After the Expiration Date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old male patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 21-MAY-2025, the patient received the 1st dose of Engerix B. On 21-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B After the Expiration Date). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2025 The medical assistance reported that a pediatric male patient received on 21th May 2025 an expired Engerix-B first dose which led to expired vaccine administered. The patient already has a combination vaccine with hep B. The vaccine administration facility was the same as primary reporter.
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: incorrect administration of pentacel as only the hib component was reconstituted with sterile water with no reported adverse event; incorrect administration of pentacel as only the hib component was reconstituted with sterile water with no reported adverse event; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who had incorrect administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] as only the hib component was reconstituted with sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had incorrect administration of an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for immunization as only the hib component was reconstituted with sterile water with no reported adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Vaccine: DTAPIPVHIB
Symptoms: Exposure via skin contact, No adverse event
Clinical narrative: PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported adverse event; PENTACEL trickled down their baby's thigh after the needle was pulled back, with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a 4 months old and unknown gender patient who was administered with Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] however some of it trickled down their baby's thigh after the needle was pulled back, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received less than 0.5 mL dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection, (unknown strength  and expiry date) lot number not reported via unknown route in the thigh NOS (not otherwise specified) for immunization however some of it trickled down their baby's thigh after the needle was pulled back, with no reported adverse event.  Information regarding batch number corresponding to the one at time of event occurrence is requested.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5-year-old patient was given ADACEL in error, with no reported adverse event; Initial information received on 22-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old and unknown gender patient who was given Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] in error, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for immunization, in error, with no reported adverse event (product administered to patient of inappropriate age) (latency same day).  Information regarding batch number corresponding to the one at time of event occurrence was requested.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Impaired healing, Scab
Clinical narrative: red spot with scab that never heals;
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Ear infection, Ear operation, Tympanic membrane perforation
Clinical narrative: Double ear infection the right ear drum ruptured and after three surgeries to fix it I have lost most of my hearing in the right ear
Age: 0.5
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; Inbound call from HCP stating that they administered VARIVAX to a patient who was 6 months old at the time/date of administration. The patient is now 8 months old. No further information provided. No symptoms described by HCP. No further patient info; This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a 6-month-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 05-Mar-2025, at the age of 6 months, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) injection, 0.5 ml, lot #y013346, expiration date: 02-Aug-2026 (dose number, route of administration and anatomical location were not provided), for prophylaxis (Product administered to patient of inappropriate age). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot# and expiry date were not reported). At the reporting time, the patient was 8 months old. No further information was provided. No symptoms were described by HCP and no other adverse event was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular
Clinical narrative: itching; still getting chicken pox like spots; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included acrivastine (Benadryl).   On 29-APR-2025, the patient received Shingrix. On 04-MAY-2025, 5 days after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: still getting chicken pox like spots). On an unknown date, the patient experienced pruritus (Verbatim: itching). The outcome of the varicella-like rash was not resolved and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the varicella-like rash and pruritus to be related to Shingrix.     It was unknown if the company considered the varicella-like rash and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2025 The patient self-reported this case for herself. The patient reported that she took the Shingrix vaccine and experienced symptoms such as still getting chicken pox like spots and started taking Benadryl to help with itching but spots were ongoing. The symptoms were not treated. No other products were received by the patient.