chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: A few minutes after vaccination, child had an episode of pallor, passing out/syncope, and per mom: seizing episode. Provider immediately responded, had child lay flat on exam table. HR low (55) - see notes below and diaphoretic and pallor. Monitored for about 15 min, noted BP and HR increased to appropriate levels during that monitoring. Child was less diaphoretic and color returned. Noted had not eaten breakfast. Child was given sucker/lollipop and snack to assist in correcting any drop in blood glucose.   Believed to be a vasovagal response and possible low blood glucose event d/t fasting and stressor of receiving vaccines. Noted child was fearful at the time of vaccination.   VS after event:  1050: 93/55, hr 55 (laying) 1052: 95/61 hr 88 (laying) 1055: 98/59 hr 90 (sitting) 1100: 91/62 hr 96 (standing) no breakfast, nervous
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Urticaria
Clinical narrative: On 6/11/25 @ 8:34pm I received a message from RN regarding patient's shots, she attached a photo of his arm. It appears to be a reaction to the one of the vaccines. She instructed the Mother to give the child Benadryl and to take child to the clinic in the AM or the ER tonight if child began having worse symptoms. I explained I was out of town but would report it to VAERs on 6/16/25 when I returned. I asked for Mother to call me.   The child's right upper arm was erythematous, whelps and what appeared to be blisters were noted . No fever reported.   Child was "acting  fine".
Age: 66.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: This subcutaneous vaccine formulation  was administered as IM.   No abnormal S/S to report. This was administration error only.  Reported to PCP immediately. Follow up Titers put in place to check if patient received immunity from it.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient said his reaction was delayed by about 4 days. He had redness around the injection site with red dots inside the redness (circle of about 3 inches long). Patient  has eczema and other dermatitis.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Injected limb mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: she's been having pain in her arm that radiates to the back of the shoulder to her neck. States she is unable to lift her right arm, if she needs to she is using the left to assist. Symptoms started night she got vaccine
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, PNC20
Symptoms: Expired product administered
Clinical narrative: After vaccinations were administered to the child it was discovered that the Prevnar 20 dose expired in 12/2024. Dose was manually added to Department of Public Health during the visit because the nurse was not able to scan the barcode. After discovery that the Prevnar was expired, the dose was deleted from Department of Public Health. The dose will be repeated at the next clinic visit.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives started 6/5 and come and go, Treated with benadryl and zyrtec 10mg once daily.  No other symptoms
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: patient experienced hives/itching/red bumps on skin at least 6 hours post vaccination administration
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Prior to vaccination, pt was asked if he has ever felt faint or dizzy/fainted after receiving a vaccine, which he denied.  Vaccine was given around 10:50 am while pt was sitting.  Shortly after vaccination (around 30 seconds) pt appeared to look faint.  RN administering vaccine stood next to pt and verbally checked how pt was feeling.  Pt was closing eyes and appearing dizzy.   Pt was given juice and a snack which at this time pt did not have.  Once pt was appearing to come more around, pt stated that he had not eaten much in the last 2 days.  Staff was able to get pt to sit in chair and have snack for about 10 minute s and reporting feeling ok.  Pt then got up from chair stating he was going to get his bag but would come back and finish snack.  RN was then alerted by community health navigators in hallway that pt had passed out.  RN went to pts side to check on him and assisted pt to sofa nearby.  BP check 140/78, pulse 73, O2 100%.  Pt stated that he did not hit head.  Sports Drink and snacks were again given to pt as he had not eaten much recently.  After pt had Sports drink and snack, staff assisted pt to a different room to lie on sofa.  Pt stated he felt okay at this time but agreed to lay down for some time.  After another 10 minutes, pt decided to leave facility, declining any other care.  Pt appeared well to staff at this time.
Age: 20.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient given MMR dose #2 on 6/16/2025. MMR vaccine expired on 6/11/2025.  Vaccine given in the 1000 hour and he returned to class. Patient returned to clinic in the 1400 hour and informed of administration of expired vaccine. He was asymptomatic.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Borrelia test positive, Electromyogram, Genetic testing, Laboratory test abnormal
Clinical narrative: Weakness in left leg, partial foot drop after 2nd dose on 3/18/21.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Motor neurone disease, Muscular weakness, Peroneal nerve palsy
Clinical narrative: Weakness in left leg, partial foot drop after 2nd dose on 3/18/21.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Granulomatous lymphadenitis, Immunohistochemistry, Sarcoidosis, Thymectomy, Thymoma malignant
Clinical narrative: Dose 1:  1/19/2021 Lot#026L20A expires 6/28/21; Dose 2 2/16/2021 Lot#024M20A expires 8/3/2021 both doses in left arm.  Pfizer vaccination 12/20/2021 Lot#FF2587 expired 12/2021 left arm booster.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thymus enlargement
Clinical narrative: Dose 1:  1/19/2021 Lot#026L20A expires 6/28/21; Dose 2 2/16/2021 Lot#024M20A expires 8/3/2021 both doses in left arm.  Pfizer vaccination 12/20/2021 Lot#FF2587 expired 12/2021 left arm booster.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Unevaluable event
Clinical narrative: none at this time
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Fatigue, Migraine
Clinical narrative: cluster migraine, fatigue
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Pain, Pain in extremity
Clinical narrative: pt states that later that night after getting vaccinated her arm was hurting. By the next day everything on her body was  hurting and aching. Especially her legs as they felt like they locked up. Her hands, elbow, and area around her back and chest were aching. She took a couple of ibuprofen and then a BC powder. She contacted her clinic to let them know how bad she was hurting and they told her that these symptoms were part of the vaccine side effects that may last a week or two but it has been longer than that.  She states if she isn't taking something for the pain, that the pain is terrible and she doesn't know what else to do. During the first week she experienced dizziness and headaches that is better now but she continues having body aches and pains and has to have pain meds.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Chest pain, Dizziness, Headache
Clinical narrative: pt states that later that night after getting vaccinated her arm was hurting. By the next day everything on her body was  hurting and aching. Especially her legs as they felt like they locked up. Her hands, elbow, and area around her back and chest were aching. She took a couple of ibuprofen and then a BC powder. She contacted her clinic to let them know how bad she was hurting and they told her that these symptoms were part of the vaccine side effects that may last a week or two but it has been longer than that.  She states if she isn't taking something for the pain, that the pain is terrible and she doesn't know what else to do. During the first week she experienced dizziness and headaches that is better now but she continues having body aches and pains and has to have pain meds.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: pt states that later that night after getting vaccinated her arm was hurting. By the next day everything on her body was  hurting and aching. Especially her legs as they felt like they locked up. Her hands, elbow, and area around her back and chest were aching. She took a couple of ibuprofen and then a BC powder. She contacted her clinic to let them know how bad she was hurting and they told her that these symptoms were part of the vaccine side effects that may last a week or two but it has been longer than that.  She states if she isn't taking something for the pain, that the pain is terrible and she doesn't know what else to do. During the first week she experienced dizziness and headaches that is better now but she continues having body aches and pains and has to have pain meds.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Crying, Decreased appetite, Eye pain, Fatigue, Headache
Clinical narrative: Friday 6/13 woke up c/o bilateral eye pain, headaches, fevers up to 102 headaches fatigue and decreased appetite. Motrin helps the fevers but pain severe in eyes will cry in pain per Mom.
Age: 7.0
Sex: F
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Friday 6/13 woke up c/o bilateral eye pain, headaches, fevers up to 102 headaches fatigue and decreased appetite. Motrin helps the fevers but pain severe in eyes will cry in pain per Mom.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product dose omission issue, Wrong product administered
Clinical narrative: Client was given Quadracel instead of Vaxelis which was the vaccine intended.  Client missed third Hep B vaccine
Age: 17.0
Sex: F
Vaccine: ADEN_4_7, HEP
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Adenovirus pills given with instructions not to touch, bite, crush or chew pill and chase with water. I notice patient chewing and she spat the pills in a cup. She did not swallow pills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Computerised tomogram head normal, Computerised tomogram neck normal, Dysarthria, Electrocardiogram normal
Clinical narrative: Within 14 days of administration I experienced vertigo while seated, and word finding difficulities. Subsequently I experienced intermittent aphasia, dysarthria, tingling on the left side of my head and face, muscle contrations in my neck.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Electroencephalogram normal, Magnetic resonance imaging head normal, Magnetic resonance imaging neck normal, Muscle contractions involuntary, Paraesthesia
Clinical narrative: Within 14 days of administration I experienced vertigo while seated, and word finding difficulities. Subsequently I experienced intermittent aphasia, dysarthria, tingling on the left side of my head and face, muscle contrations in my neck.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vertigo
Clinical narrative: Within 14 days of administration I experienced vertigo while seated, and word finding difficulities. Subsequently I experienced intermittent aphasia, dysarthria, tingling on the left side of my head and face, muscle contrations in my neck.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Contusion, Pain in extremity, Peripheral swelling, Supraventricular tachycardia, Thrombosis
Clinical narrative: Blood clots in legs and arms.  SVTs.  Very painful, swollen and one had bruising.  Some lasting weeks most last a few days.  I take ibuprofen for the pain.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Autism spectrum disorder, Crying, Non-24-hour sleep-wake disorder, Pyrexia
Clinical narrative: Fever, increased crying & deminished sleep cycles for months
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Blister, Blister rupture, Pruritus, Rash erythematous, Scab
Clinical narrative: Around two weeks after the proquad vaccine, patient presented with itchy small, fluid-filled blisters all over his arms and legs. Quickly over the next 48 they spread all over his legs, arms, some of his back and belly. They were not present on his feet, hands, or in his mouth. There was no fever. They appeared to leak a clear fluid initially, and then over the next few days, the red bumps developed scabs. New bumps showed up for several days, with a mix of bumps, blisters, and scabs. We brought him to the doctor a couple days in to rule out any other virus, but chicken pox caused by the vaccine appeared to be the mostly likely scenario.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Varicella post vaccine
Clinical narrative: Around two weeks after the proquad vaccine, patient presented with itchy small, fluid-filled blisters all over his arms and legs. Quickly over the next 48 they spread all over his legs, arms, some of his back and belly. They were not present on his feet, hands, or in his mouth. There was no fever. They appeared to leak a clear fluid initially, and then over the next few days, the red bumps developed scabs. New bumps showed up for several days, with a mix of bumps, blisters, and scabs. We brought him to the doctor a couple days in to rule out any other virus, but chicken pox caused by the vaccine appeared to be the mostly likely scenario.
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Swelling, Ultrasound scan, X-ray
Clinical narrative: left shoulder pain, swelling x  11 days.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: no AE observed
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Fall, Generalised tonic-clonic seizure, Head injury
Clinical narrative: Approximately 1-2 minutes after administration into left deltoid, patient experienced  tonic-clonic seizure activity. He was sitting on the table during administration, fell forward, off the table and hit his head.  Patient was examined by physician post seizure and advised to proceed to ER. Mother declined ambulance transportation. Patient was wheelchaired to his family vehicle, placed in the passenger side, and dad and mom proceeded to take him to the ER for further evaluation and imaging studies.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Sterile diluent was added to the vaccine vial, and the vaccine was administered to the patient. The patient reported a full sensation and no other symptoms.  Per the manufacturer, this dose is considered invalid and will need to be re-administered.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received an extra dose of shingrix. Dose 1- 8/22/2020, Dose 2- 7/5/2021, Dose 3- 4/1/2025. Pt did not experience any adverse effects from this.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Attention deficit hyperactivity disorder, Behaviour disorder, Insomnia, Oppositional defiant disorder, Tic
Clinical narrative: Developed facial tic, followed by vocal tic, developed behavioral issues. Had to be seen by specialist to address ask if the issues. He is now in multiple medications when he was on nothing prior and was a normal healthy kid.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Tourette's disorder
Clinical narrative: Developed facial tic, followed by vocal tic, developed behavioral issues. Had to be seen by specialist to address ask if the issues. He is now in multiple medications when he was on nothing prior and was a normal healthy kid.
Age: 3.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Consumer reports no symptoms or effects since getting the MMR II vaccine; No additional AE; he is 41 years old and that was his first dose of the MMR II, reporting he believes he had a dose of one of the MMRs as a child/ I think I had one dose of one of the MMRs as a child, but that was like 38 years ago" so he had not further information.; This spontaneous report was received from a Consumer or other non health professional and refers to a 41-year-old male patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   In approximately 1987 (reported as around 38 years ago), the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (reported as MMR vaccine) (manufacturer unknown), Injection, dose number 1, (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On 21-May-2025 around 6:00 PM, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, dose number 2, (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. Suspect vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT), Solution for injection (expiration date, and lot # were not reported).   It was reported, that the patient was 41 years old and on 21-MAY-2025 at 6:00 PM that was his first dose of the suspect vaccine (discrepancy), reporting he believed he had a dose of one of the MMR vaccine as a child. He thank he had one dose of one of the MMRs as a child, but that was like 38 years ago, so he had not further information (Inappropriate schedule of product administration). Consumer reported no symptoms or effects since getting the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccine; no additional AE (no adverse event).   Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AE.; Inbound call from HCP calling to report administration of GARDASIL-9 that was expired.  Caller states that the first dose of the series was administered to a 14 year old male on 3-JUN-2025.  Caller reports that the dose administered on 4-JAN-2025.  C; Information has been received from a Medical Assistant and refers to a 14-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Jun-2025, the first dose of the series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (0.5 mL once, lot #W017539, expiration date: 04-Jan-2025; strength and route were not provided) was administered to the patient for prophylaxis (expired vaccine used). It was also reported that the dose administered on 04-Jan-2025. No symptomatic adverse events reported. No additional AE. No additional information at that time.
Sex: F
Vaccine: RVX, RVX
Symptoms: Inappropriate schedule of product administration
Clinical narrative: a 2 month old female patient was inadvertently given a second dose of ROTATEQ very early; No other AE/No PQC.; This spontaneous report was received from a Nurse and refers to a 2-month-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 05-JUN-2025, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), dose number 1, at a dose of 2 mL (route of administration, lot # and expiration date were not reported). then, on an unknown date, conflicting information also reported as 13-JUN-2026, inadvertently given a second dose very early, at a dose of 2 mL (route of administration, lot # and expiration date were not reported) for prophylaxis (Inappropriate schedule of vaccine administered). No other AE/No PQC.
Vaccine: RVX, RVX, RVX, RVX
Symptoms: Extra dose administered, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: suspected vaccination failure; RSV; received 4 vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis, RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis and RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included respiratory syncytial virus infection.   On an unknown date, the patient received the 4th dose of RSV vaccine, the 3rd dose of RSV vaccine, the 2nd dose of RSV vaccine and the 1st dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and extra dose administered (Verbatim: received 4 vaccines). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine, RSV vaccine, RSV vaccine and RSV vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2025 This case was reported by a patient via interactive digital media. Patient received 4 vaccines and became infected again and felt again like they did before had received any vaccinations, which led to extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding RSV infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine (Dose 1, 2, 3 and 4).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Somnolence
Clinical narrative: she felt sleepy; she felt achy; This non-serious case was reported by a consumer via call center representative and described the occurrence of sleepiness in a 76-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included osteoporosis, hypothyroidism and asthma. Previously administered products included influenza vaccine with an associated reaction of pain in extremity (received in left arm in October 2017 and experienced increase in urination) and Prevnar 13 with an associated reaction of pain in extremity (received in left arm in October 2017 and experienced increase in urination).   On 29-MAY-2025, the patient received the 1st dose of Shingles vaccine (left arm). On 29-MAY-2025, less than a day after receiving Shingles vaccine, the patient experienced sleepiness (Verbatim: she felt sleepy) and pain (Verbatim: she felt achy). The outcome of the sleepiness and pain were resolved (duration 2 days).   It was unknown if the reporter considered the sleepiness and pain to be related to Shingles vaccine.     It was unknown if the company considered the sleepiness and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-JUN-2025 The reporter then reports that in October of 2017 She received the flu vaccine with the pneumonia vaccine called Prevnar 13 in the left arm at the same time.  She states the night of the vaccines in 2017 her left arm had pain, and she had a hard time getting out of bed. The reporter states that getting bed was especially difficult due to have to urinate frequently. The reporter believes that the increase in urination was due to the Flu and Pneumonia vaccine.  She states that she received her first Shingles vaccine.  The reporter states that the day of her vaccine she felt sleepy and achy. This lasted 2 days and then resolved.
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Taste disorder
Clinical narrative: Loss of taste; This non-serious case was reported by a consumer and described the occurrence of taste loss in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease, atrial fibrillation and spinal stenosis. Concomitant products included oxycodone hydrochloride (Oxycodone) and metoprolol succinate (Metoprolol).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced taste loss (Verbatim: Loss of taste). The outcome of the taste loss was unknown.   It was unknown if the reporter considered the taste loss to be related to Shingrix.     It was unknown if the company considered the taste loss to be related to Shingrix.   Additional Information: GSK receipt date: 07-JUN-2025 Consumer stated that before loss of taste, both salt & sweet were intensified, way too strong for patient and patient would always been an addict of both most through life. Patient had antibiotics.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on waist and chest; Itch; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension (has hypertension). Concomitant products included amlodipine maleate (Amlodipine).   On 02-JUN-2025, the patient received the 1st dose of Shingrix. On 09-JUN-2025, 7 days after receiving Shingrix, the patient experienced hives (Verbatim: Hives on waist and chest) and pruritus (Verbatim: Itch). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the hives and pruritus were resolved.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.     It was unknown if the company considered the hives and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUN-2025 The reporter was the patient.   The patient received the first dose of Shingrix on Monday, 2 June 2025 from a local pharmacy.  On 9 June 2025, the patient experienced hives and itch on his waist and chest.   The patient took Benadryl and the hives resolved.
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; couple months later came down with it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, several months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: couple months later came down with it). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 06-JUN-2025 This case was reported by a patient via interactive digital media. The patient got the RSV vaccine and a couple months later came down with it (respiratory syncytial virus infection). It was horrible.  The patient thought the symptoms would have lessened since he/she had been vaccinated.  The patient said nope. It took a month to turn the corner to feeling somewhat better.  The patient further said that he/she would rather have covid than that, any day. This case was considered as suspected vaccination failure as details regarding laboratory test confirming respiratory syncytial virus infection 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, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I took Shingrix first shot on date 11/22/2019 and the second shot on date 05/16/2022; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22-NOV-2019).   On 16-MAY-2022, the patient received the 2nd dose of Shingrix. On 16-MAY-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: I took Shingrix first shot on date 11/22/2019 and the second shot on date 05/16/2022). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 06-JUN-2025 This case was reported by a patient via (Shingrix GSK chatbot) interactive digital media. The patient took Shingrix first shot, and the second shot received later than the recommended interval, which led to lengthening of vaccination scheduled.
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Still feeling achy today; 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 (Shingrix) for prophylaxis.   On 04-JUN-2025, the patient received the 1st dose of Shingrix. In JUN-2025, less than a week after receiving Shingrix, the patient experienced pain (Verbatim: Still feeling achy today). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. The patient reported that he/she received a first dose of Shingrix vaccine last Wednesday and was still feeling achy today.  The patient enquired was this normal.
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; nerve pain; 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.   Concurrent medical conditions included immunocompromised (because I was compromised is why I got them).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and nerve pain (Verbatim: nerve pain). The patient was treated with amitriptyline. The outcome of the vaccination failure was not reported and the outcome of the shingles and nerve pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain 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 and nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. Consumer reported that had the shingles, same places as you.  He /she was still deal with the nerve pain from the shingles. It's had been 3 years on Mother's Day. The reporter mentioned his /her doctor said there's no cure for shingle pain and did provide a script.  The reporter mentioned doctor prescribed Amitriptyline 10 mg tab and was mentioned to take 2 Tab in the morning and 2 tabs at night. The reporter mentioned It's not a cure but sure helps. The reporter was also mentioned had gotten the shingle shot 2 months before the shingles appeared and said that because was compromised why got them. The reporter was waiting on getting a liver. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Back pain, Blister, Feeling abnormal, Herpes zoster, Hypoaesthesia
Clinical narrative: Suspected vaccination failure; still got a mild case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got a mild case). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she took the vaccine and still got a mild case. It was awful. The patient had pain in his/her right rib around to stabbing pain in his/her back, numbness and tingling on his/her stomach.  He/she only had about 7-8 blisters. Miserable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Paraesthesia, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got a mild case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got a mild case). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she took the vaccine and still got a mild case. It was awful. The patient had pain in his/her right rib around to stabbing pain in his/her back, numbness and tingling on his/her stomach.  He/she only had about 7-8 blisters. Miserable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: made me very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: made me very sick). 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: 07-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that the vaccine made him/her very sick.
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity
Clinical narrative: arm hurts; red arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurts) and erythema of extremities (Verbatim: red arm). The outcome of the pain in arm and erythema of extremities were not reported.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2025  This case was reported by a patient via interactive digital media. The patient got the vaccine, but arm hurts and was red the second day.
Vaccine: VARZOS
Symptoms: Eye haematoma, Fall, Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles a year later in my left eye; shingles a year later on the left part of my head; had a bad fall; hematoma in left eye; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles a year later in my left eye) (serious criteria GSK medically significant), shingles (Verbatim: shingles a year later on the left part of my head), fall (Verbatim: had a bad fall) and eye hematoma (Verbatim: hematoma in left eye). The outcome of the vaccination failure, ophthalmic herpes zoster, shingles, fall and eye hematoma were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, fall and eye hematoma to be related to Shingles vaccine.     The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles, fall and eye hematoma to be related to Shingles vaccine.   Additional Information: GSK receipt date: 09-JUN-2025 This case was reported by a patient via interactive digital media. Patient had shingles shots and got shingles a year later on the left part of head and in left eye. Physician said patient would have been screaming with pain, if it weren't for the fact that patient had shots. The virus attacks areas where immunity is the lowest, especially on the head. Patient had a bad fall 7 months earlier that resulted in a hematoma over left eye. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain
Clinical narrative: pain at the injection site; light headedness; exhaustion; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-JUN-2025, the patient received the 1st dose of Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: pain at the injection site), light headedness (Verbatim: light headedness) and exhaustion (Verbatim: exhaustion). The outcome of the injection site pain, light headedness and exhaustion were not reported.   It was unknown if the reporter considered the injection site pain, light headedness and exhaustion to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, light headedness and exhaustion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-JUN-2025 This case was reported by a patient via interactive digital media. The patient had the first shot one day prior to the reporting and experienced light headedness, pain at the injection site, exhaustion. The patient would took it over shingles.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect route of product administration
Clinical narrative: administered a dose of Hiberix 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 2-year-old female patient who received Hib (Hiberix) (batch number 9532H, expiry date 16-JUL-2026) for prophylaxis.   On 06-JUN-2025, the patient received Hiberix. On 06-JUN-2025, an unknown time after receiving Hiberix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered a dose of Hiberix subcutaneously instead of intramuscularly). The outcome of the intramuscular formulation administered by other route was not applicable.   Additional Information: GSK Receipt Date: 06-JUN-2025 Nurse called to request information about the possible routes of administration if another nurse administered a dose of Hiberix subcutaneously instead of intramuscularly, which led intramuscular formulation administered by other route.
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024); This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024)). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK receipt date: 06-JUN-2025 Medical assistant reported that Havrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024).  Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes).  No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call.  This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071798:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes).; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) 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: Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024). Highest temperature reached was9.76C and they were above range for 1 hour and 15 minutes in total (5x15 minutes).). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 06-JUN-2025 The medical assistant reported that Boostrix was exposed to 5 excursions in 2024 and 2025 (4 of 5 were in 2024).  Highest temperature reached was 9.76 Celsius and they were above range for 1 hour and 15 minutes in total (5x15 minutes).  No other excursions reported. The majority of all vaccines reported were administered to patients, which led to incorrect storage of drug. Caller transferred from vaccine reimbursement center, the reporter did not have patient, product, other adverse event details available during call.  This is 1 of 8 linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025071804:Same reporter, Different suspect US-GSK-US2025071799:Same reporter, Different suspect US-GSK-US2025071800:Same reporter, Different suspect US-GSK-US2025071801:Same reporter, Different suspect US-GSK-US2025071802:Same reporter, Different suspect US-GSK-US2025071803:Same reporter, Different suspect US-GSK-US2025071805:Same reporter, Different suspect