chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: UNK
Symptoms: Aggression, Anxiety
Clinical narrative: Child was very anxious/combative, kicking, fighting. Grandmother, his aunt, and 2 nurses Attempted to give Kinrix vaccine IM to R deltoid, pt jerked his arm away pulling the syringe out of his arm and bending the needle and scratching his arm in the process. Scratched area was cleaned with an alcohol pad and a band aid was applied. Grandmother was instructed to schedule an appt with his PCP for his immunizations. Grandmother states she has concerns about his behavior-states he is out of control and combative most of the day. She states she has plans to have him evaluated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had received the COVID-19 original 2 dose series from Pfizer. The arm where vaccinated from the first dose became swollen and red and she was experiencing flu-like symptoms. These symptoms are not abnormal for her, but she still experiences the same residual pain infrequently like she had recently received a vaccine what she hadn't. The pain has no pattern and does not seem to be triggered by anything. It is described as a sore muscle right at the injection site. It typically does not last longer than a day and can resolve on its own. Ice or heat is used for swelling, but patient denies use of treatment for pain. The patient has also received additional COVID-19 boosters in the same arm since the original series. She does not report worsening or changing of the pain after boosters.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Additional dose/administration error
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Erythema, Joint swelling, Skin warm
Clinical narrative: Pt developed redness, warmth and swelling of L knee.  Parents administered tyelnol and Sx resolved withing 1.5 hrs.  Woke next am and was normal.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: gave a patient a Hep B vaccine that was meant for a child, not an adult
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Flu shot was administered into upper shoulder (very high) and hurt immediately.  I figured it would be sore for a few days but now I have instances of severe pain and limited ROM in my right arm (I am right-handed).  The pain can come when I stretch, throw something out, reach for my garage door opener.  I can range in severity with the most painful, dropping me to my knees and making me feel nauseous.  I grab my should the pain slowly starts to subside while I try to breathe.  I have an appointment with my primary on May 16, 2025
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered at inappropriate site
Clinical narrative: Flu shot was administered into upper shoulder (very high) and hurt immediately.  I figured it would be sore for a few days but now I have instances of severe pain and limited ROM in my right arm (I am right-handed).  The pain can come when I stretch, throw something out, reach for my garage door opener.  I can range in severity with the most painful, dropping me to my knees and making me feel nauseous.  I grab my should the pain slowly starts to subside while I try to breathe.  I have an appointment with my primary on May 16, 2025
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Pentacel vaccine was given unintentionally. No reaction noted after vaccine administration.
Age: 58.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Decreased appetite, Dizziness, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT REPORTS FEVER, SWELLING/PAIN IN LEFT ARM, FATIGUE, LACK OF APPETITE, LIGHT HEADEDNESS.
Age: 58.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Pyrexia
Clinical narrative: PATIENT REPORTS FEVER, SWELLING/PAIN IN LEFT ARM, FATIGUE, LACK OF APPETITE, LIGHT HEADEDNESS.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Rash, Urticaria
Clinical narrative: Patient was given HPV (Gardasil 9) on 04/29/25. Patient noticed the start of hives on 04/30/25. Started taking OTC Cetrizine to help alleviate the rash. On 05/03/25 patient and his mother went to ER due to the hives. Patient was given Prednisone 20 mg BID x 5 days. Seen by PCP on 05/06/25 and hives are still present on B/L arms, legs, and on patients face.
Age: 0.17
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: not due for vaccine
Age: 54.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Patient had itching all over her body/mostly on the arm and a red rash around the site of injection.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: The patient complained of a sore arm that has not fully healed since administration of the vaccine. The patient says that the arm is tender to move and believes that he has SIRVA. The patient was instructed to use an NSAID along with icing to relieve pain.
Age: 52.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site pain, Neck pain, Pain
Clinical narrative: Patient reported on 5/5/25 pain that did not go away at the injection site of vaccines received in the right arm, radiating up the shoulder and the neck starting 4/26/25.  Patient's MD determined that it may be SIRVA (Shoulder Injury after Vaccine Administration) and prescribed a muscle relaxer and told patient to apply ice as directed. Patient was told by MD to call pharmacy to tell us to report the adverse event to VAERS.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Patient developed a red, circular rash around the injection site (approx. 3 inches in diameter) within 24 hours of the vaccine.  The rash had completely cleared by 5/6/25 when the patient reported the reaction to the pharmacy.
Age: 1.5
Sex: F
Vaccine: DTAP, DTAPIPVHIB, HEPA, PNC20, VARCEL
Symptoms: Wrong product administered
Clinical narrative: The patient received a dose of Pentacel instead of receiving the single antigen of Hib. Also, the patient received a single antigen dose of DTap. No signs or symptoms noted in patient.
Age: 35.0
Sex: F
Vaccine: PNC20
Symptoms: Feeling abnormal, Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: Injection site was itchy, red, and warm to the touch. Also stated she had a fever and was feeling "out of it".
Age: 1.58
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received a dose of Kinrix at too early of an age.  She did not show any adverse symptoms or side effects after receiving the vaccine.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Patient complained of pain in her left arm that was not going away. she went to see her doctor who diagnosed her with bursitis.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Vomiting
Clinical narrative: vomiting, extreme weakness, would not eat or drink.   About noon on 3/ 26/25 so terribly weak that he fell to the floor.  I had to call the paramedics to get him up and into a chair.  By 6:30 pm he was able to walk by himself.  This was very much like his condition when entering the hospital 11/8/22 with Covid pneumonia
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Arthralgia, Myalgia, Rash
Clinical narrative: extreme arm soreness at injection site, muscle aches, rash on chest and back. Treated with Medrol 4mg
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: varicella given too soon
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Constipation, Diarrhoea, Dizziness
Clinical narrative: dizziness, chills, muscle cramps and stiffness, very tired, sore left arm moving up to shoulder and down to rib cage, increased blood pressure, constipation followed by diarrhea.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Muscle spasms, Musculoskeletal chest pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: dizziness, chills, muscle cramps and stiffness, very tired, sore left arm moving up to shoulder and down to rib cage, increased blood pressure, constipation followed by diarrhea.
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: CSF protein increased, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia
Clinical narrative: progressive muscle weakness, paresthesias of neck back, legs, arms, hands
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: varicella given too soon
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: the second morning after the shot (shot Friday afternoon, adverse event Sunday morning) woke to cellulitis infection 2 inches below injection site
Age: 2.0
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: MMRV (proquad) and Varicella vaccines were both given on 5/2/25. Tried to call pt's parent x2, messages left, no return call as of now.
Age: 0.58
Sex: F
Vaccine: RV1
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse reaction.  I gave the vaccine as the first dose and the infant was older than 15 weeks but younger than 8 months.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Left arm itchy, then hives, took benadryl, Care Now clinic gave Prednisone, fever treated with Tylenol
Age: 0.83
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Depressed level of consciousness, Head lag abnormal, Hypotonia, Lethargy, Visual tracking test abnormal
Clinical narrative: 10 month old patient was checked in at 11:17 AM for WCC. Patient was roomed at 11:54 AM. Initial set of vitals: height 67.31cm, 5.812 kg, head circumference 38.61 cm, 98.9 temp, HR 140, RR32. Dr. assessed the patient and reported the patient as hypotonic, with some head control, alert, could look directly at provider but could not track. Patient could move arms and was interactive. Patient was lying supine but not able to roll at all. Mother reported to provider that patient cannot crawl, cannot sit up. Patient was behind on immunizations, only having a history Hep B at birth. Provider ordered Vaxelis and Prevnar. Administered vaccines. Provider reports patient appeared to be sleeping before to be sleeping before she gave the gave the IM injections. When provider gave shots, patient did not fuss in pain, but slightly opened her eyes. Provider did not notice any immediate adverse reaction and left the patient's room. Mother asked to have Dr. come back in the room because the baby's baseline changed. Dr. entered the room and noticed a change in alertness. She directed staff to call 911. Call was made at 1:38PM. Squad arrived at 1:46PM patient's O2 sat was 93%, HR 137, patient looked lethargic and was limp. Patient was given high dose oxygen with peds mask. EMS took patient at 1:58PM to hospital.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Amnesia, Arthralgia, Cardiac disorder, General physical health deterioration, Laboratory test
Clinical narrative: Patient received her first Shingles vaccine prior to 2019 (Facility, Dr.). Then, patient took the first Shingrix shot on October 8, 2019. Patient had an adverse reaction to the first Shingrix vaccine (racing heart, high blood pressure). After the second Shingrix dose on August 25, 2023, Patient was diagnosed with Polymyalgia Rheumatica (PMR). She has experienced severe shoulder and hip pain. She spent two weeks in the hospital. She has taken Prednisone ever since the diagnosis. She is now trying to taper off of the Prednisone. She now has memory loss, heart and kidney problems and her health as significantly declined.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Polymyalgia rheumatica, Renal disorder
Clinical narrative: Patient received her first Shingles vaccine prior to 2019 (Facility, Dr.). Then, patient took the first Shingrix shot on October 8, 2019. Patient had an adverse reaction to the first Shingrix vaccine (racing heart, high blood pressure). After the second Shingrix dose on August 25, 2023, Patient was diagnosed with Polymyalgia Rheumatica (PMR). She has experienced severe shoulder and hip pain. She spent two weeks in the hospital. She has taken Prednisone ever since the diagnosis. She is now trying to taper off of the Prednisone. She now has memory loss, heart and kidney problems and her health as significantly declined.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient reports she woke up today "feeling terrible." Patient reports  body ached all over, nausea,  redness at the site, swelling at the injection site, and soreness at the injection site.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient reports she woke up today "feeling terrible." Patient reports  body ached all over, nausea,  redness at the site, swelling at the injection site, and soreness at the injection site.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Pallor, Presyncope
Clinical narrative: PT become pale, dizzy, nausea, vasovagal
Age: 34.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth left upper arm site.  Left arm site itching. No treatment, started 5/5/25 before midnight.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: IIIrd nerve paralysis, Laboratory test
Clinical narrative: Third nerve palsy, left eye.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dyskinesia, Dysphemia, Eye movement disorder, Involuntary vocalisation
Clinical narrative: Patient with Tourette's like symptoms since receiving vaccine, increasing in severity. Abnormal neck and eye movements, speech outbursts, stuttering.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: pt was given a Proquad and varicella at the same visit
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Resident became non-responsive and died within 72 hours.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Deafness neurosensory, Hypoacusis, Magnetic resonance imaging
Clinical narrative: Sudden sensorineural hearing loss of the left ear. Woke up on December 13, 2023 around 6am with diminished hearing in the left ear. By the afternoon, there was virtually no hearing in the ear. Despite oral steroid treatments, steroid injections, and hyperbaric chamber therapy, hearing was never regained.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Eye swelling, Injection site rash, Rash
Clinical narrative: Pt in clinic 5/2/25,noted swelling in eyes, more on left one, rash noted on left arm at injection site, on left back of shoulder, both knuckles, more on left, small spot on forehead, marked sites except face with sharpie. Explained  to parent to keep an eye and if it got outside the mark to go to ER. Explained to administer OTC Benadryl  and apply Caladryl. Gave parent name, address, and phone # to facility. Followed up with parent on 5/5/2025. Parent stated did administer OTC meds and everything cleared.
Age: 51.0
Sex: M
Vaccine: FLU3, HEP, TDAP
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Chronic pain of both upper extremities and impaired range of motion of both shoulders .  On 3/18/25 patient reported trying naproxen and diclofenac topical gel.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Malaise, Tremor
Clinical narrative: Body shaking and feeling very sick
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; HCP reports female patient received her second dose of GARDASIL 9 early. HCP states second dose administered on 2/5/2025 and was due on 2/21/2025. No adverse effects reported. No other information provided. No additional AE. No PQC.; This spontaneous report was received from a Nurse and refers to a 33-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 05-FEB -2025, the patient was early vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #Y012508, expiration date: 01-JAN-2027), dose number 2, Single Dose, administered by Unknown route for Prophylaxis. The second dose was due on 21-FEB-2025 (Inappropriate schedule of product administration). No adverse effects were reported.
Vaccine: HEP, HEP, HEP, HPV9, HPV9, MMR, MMR, MMR, RV5, RV5, RV5
Symptoms: Product storage error
Clinical narrative: Medical assistant reporting an unknown number of administrations of RECOMBIVAX HB, MMR II, GARDASIL 9 and ROTATEQ following a temperature excursion.  No symptoms reported and no additional details provided.  This agent is adding RECOMBIVAX HB and GAR; no AE; This spontaneous report was received from a medical assistant and refers to unknown number of unspecified patients. The patients' concurrent conditions, medical history and concomitant therapies were not provided.  On unknown dates, the patients were vaccinated with the following incorrectly stored vaccines: rotavirus vaccine (ROTATEQ) administered orally, lot # 2003174, expiration date 14-SEP-2025; lot # 2032351, expiration date 06-OCT-2025; lot # 2032354, expiration date 12-NOV-2025 (dose, anatomical location were not provided), Human Papillomavirus 9-valent Vaccine (GARDASIL 9) lot # y010466, expiration date 29-OCT-2026; lot # y012865, expiration date 10-OCT-2026 (dose, route of administration, anatomical location were not provided), measles (+) mumps (+) rubella vaccine (MMR II) lot # x019103, expiration date 16-JUL-2025, lot # y009782, expiration date 23-MAY-2026; lot # y007623, expiration date 11-APR-2026  (dose, route of administration, anatomical location were not provided), hepatitis B vaccine (RECOMBIVAX HB) lot # x027728, expiration date 16-OCT-2026; lot # y007989, expiration date 06-DEC-2026; lot # y009551, expiration date 08-DEC-2026 (dose, route of administration, anatomical location were not provided). The suspect vaccines were stored at the temperature of 0.6 degrees Celsius for 5 hours and at 11.1 degrees Celsius for 35 minutes (Product storage error). No adverse events were reported.  This is an invalid report due to lack of the patients' identifiers.; Reporter's Comments:
Sex: M
Vaccine: VARCEL
Symptoms: Device connection issue, No adverse event, Underdose
Clinical narrative: No adverse event; PFS leaked between the Luer Lock/Hub and the needle while administering VARIVAX; resulting in the patient not receiving the full dose of VARIVAX; This spontaneous report was received from a Nurse and refers to a 1-year-old male patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 09-Apr-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) at 0.5 mL (lot #y011017 was verified to be a valid number, expiration date: 18-Jun-2026) diluted with sterile diluent prefilled syringe (PFS) at 0.5 mL (lot #1973320 was verified to be a valid number, expiration date: 20-Nov-2026) (strength, scheme, vaccination site and route of administration were not reported); during the administration sterile diluent PFS leaked between the luer lock/hub and the needle (syringe issue), resulting in the patient not receiving the full dose of VARIVAX (incorrect dose administered). VARIVAX was wasted as a result of the leakage. The nurse confirmed there was no damage to the PFS or to the luer lock/hub when the needle was attached, and no breakage was observed. No photos were available and the product is not available for retrieval, as it has already been discarded into the sharps container. No additional adverse event was reported.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse effects reported. No other information provided. No additional AE.; HCP reports 66 year old female received pediatric dose of PROQUAD instead standard dose of MMR II.; This spontaneous report was received from a medical assistant and refers to a 66-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-APR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y015992; which has been verified to be valid for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, expiration date reported as 32-MAR-2026 but upon internal validation establish as 23-Mar-2026 administered for prophylaxis (strength, exact quantity volume, dose number, route and anatomical site of administration were not provided) with the sterile diluent (BAXTER STERILE DILUENT) (lot # and expiration date were not reported) instead of standard dose of  Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) with the sterile diluent (BAXTER STERILE DILUENT) (Wrong product administered). No adverse effects reported. No other information provided (No adverse event).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Syncope
Clinical narrative: Merck employee with MVCC called to report an adverse event for GARDASIL-9. A pharmacy technician reported that when she was 12 years old, she received the 1st dose of GARDASIL-9 and fainted on the floor. She also reports that she almost fainted with; Almost faint with second and third dose; This spontaneous report was received from a currently 21-year-old female pharmacy technician, reporting on herself.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), (indication, expiration date, and lot # were not reported).  The patient reported that when she was 12 years old, and received the 1st dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) she fainted on the floor (syncope). She also reported that she almost fainted (presyncope) with the 2nd and 3rd doses of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), at unspecified age. No additional AE reported. No PQC reported.  At the reporting time, the outcome of the events was unknown.   The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was determined as not applicable.   The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9), was unknown.    Upon internal review, the event of syncope was determined to be medically significant.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a patient who was administered expired VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 30-MAR-2025, the patient was vaccinated with expired Hepatitis A Vaccine, Inactivated (VAQTA), (invalid lot #X006072, expiration date: 01-Oct-2024) 1 mL (1ml/dose), as prophylaxis (expired product administered).  No symptoms reported. No additional adverse event (AE) was reported
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation, Laboratory test normal, Pain
Clinical narrative: Burning sensation in back; Back pain (with radiation); This serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On 23-AUG-2024, the patient received the 2nd dose of Shingrix (intramuscular). On 23-AUG-2024, less than a day after receiving Shingrix, the patient experienced burning sensation (Verbatim: Burning sensation in back) (serious criteria hospitalization) and back pain (with radiation) (Verbatim: Back pain (with radiation)) (serious criteria hospitalization). The outcome of the burning sensation and back pain (with radiation) were not resolved.   It was unknown if the reporter considered the burning sensation and back pain (with radiation) to be related to Shingrix.     The company considered the burning sensation and back pain (with radiation) to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The reporter was the patient who received her 2nd dose of Shingrix 23 AUG 2024 and had issues of back pain and burning sensation in her back mostly on the left side per the dosage. These symptoms were ongoing, and the reporter had been seen in the hospital a few times and had no positive test drawn at this time.; Sender's Comments: Burning sensation and Back pain are unlisted events which are considered unrelated to GSK vaccine Shingrix.
Vaccine: RVX
Symptoms: Transient ischaemic attack
Clinical narrative: ministroke; This serious case was reported by a consumer via interactive digital media and described the occurrence of ministroke in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced ministroke (Verbatim: ministroke) (serious criteria GSK medically significant). The outcome of the ministroke was not reported.   It was unknown if the reporter considered the ministroke to be related to RSV vaccine.     It was unknown if the company considered the ministroke to be related to RSV vaccine.   Additional Information: GSK receipt date: 01-MAY-2025 This case was reported by a patient via interactive digital media.  Patient stated that he/she also had a mini stroke after the vaccine and patient's daughter had a heart attack. Patient also indicated they won't get another one. This case is 1 of 2 cases reported by same reporter.; Sender's Comments: Transient ischaemic attack is an unlisted event which is considered unrelated to GSK RSV vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles (pre-existing)). Previously administered products included Shingrix (received first dose of Shingrix in 2024).   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 received 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 30-APR-2025 The reporter was the patient's husband.  The patient received her first Shingrix dose about one year ago, in 2024.  She has not yet received her second dose due to insurance. Till the time of reporting the patient did not receive the second dose of Shingrix which led to incomplete course of vaccination.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Right knee Swollen; knee was very sore; This non-serious case was reported by a physician via call center representative and described the occurrence of swelling of knees in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-APR-2025, the patient received Shingrix (left arm). On 30-APR-2025, less than a day after receiving Shingrix, the patient experienced swelling of knees (Verbatim: Right knee Swollen) and knee pain (Verbatim: knee was very sore). The outcome of the swelling of knees was not resolved and the outcome of the knee pain was not reported.   It was unknown if the reporter considered the swelling of knees and knee pain to be related to Shingrix.     It was unknown if the company considered the swelling of knees and knee pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 The physician reported that he received a left arm shot of the medication Shingrix and by this morning, once the patient went to the swimming pool to exercise he noticed his right knee was swollen and very sore compared to the day before.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Back pain
Clinical narrative: abdominal discomfort; sore back; This non-serious case was reported by a consumer via sales rep and described the occurrence of abdominal discomfort in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-APR-2025, the patient received the 2nd dose of Shingrix (unknown arm). On 30-APR-2025, 1 days after receiving Shingrix, the patient experienced abdominal discomfort (Verbatim: abdominal discomfort) and sore back (Verbatim: sore back). The outcome of the abdominal discomfort and sore back were resolving.   It was unknown if the reporter considered the abdominal discomfort and sore back to be related to Shingrix.     It was unknown if the company considered the abdominal discomfort and sore back to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-APR-2025 The patient received subsequent dose of Shingrix. The patient experienced abdominal discomfort and sore back.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: rash; Hives; This non-serious case was reported by a consumer and described the occurrence of rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included acne rosacea. Concomitant products included doxycycline.   On 29-APR-2025, the patient received Shingrix. On 01-MAY-2025, 2 days after receiving Shingrix, the patient experienced rash (Verbatim: rash) and hives (Verbatim: Hives). The outcome of the rash and hives were not resolved.   It was unknown if the reporter considered the rash and hives to be related to Shingrix.     It was unknown if the company considered the rash and hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAY-2025 The patient self reported this case for himself.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the 2nd dose of twinrix after 6 months instead of after 1 month; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of drug dose administration interval too long in a 54-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose (Left arm) on 03-MAY-2024 with batch number: 429jj and expiry date: 01-APR-2026).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received the 2nd dose of twinrix after 6 months instead of after 1 month). The outcome of the drug dose administration interval too long 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: 02-MAY-2025 The pharmacist reported that the patient received the 2nd dose of Twinrix after 6 months instead of after 1 month. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; recently had a small shingles outbreak on my lower back; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Zostavax) for prophylaxis.   On an unknown date, the patient received Shingrix and Zostavax. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: recently had a small shingles outbreak on my lower back). 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 29-APR-2025 The reporter reported that he/she fully vaccinated against shingles (Zostavax and Shingrix), and recently had a small shingles outbreak on his/her lower back. The reporter had a questioned should he/she consider getting the Shingrix vaccine and booster again. The chat bot user mentioned that they noticed that patient mentioned more than one of our products. The patient reported that he/she only recived 1 product. The chat bot user reported that Shingrix was administered as a 2-dose series. The FDA-approved schedule did not include a booster dose of Shingrix or a repeat of the series. The chat bot user reported that they could not give medical advice. It was unknown if the reporter considered the vaccination failure and shingles to be related to Zostavax. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st Shingrix dose 2.5 years; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2.5 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: Patient received 1st Shingrix dose 2.5 years). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 29-APR-2025 The patient self-reported this case. The patient received 1st Shingrix dose 2.5 years ago and had not received the 2nd vaccine.  The reporter asked does patient need to start series all over. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; people that took 2 shots and still got; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patients received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: people that took 2 shots and still got). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 28-APR-2025 This case was reported by a consumer via interactive digital media. The reporter stated that they knew people (patients) that took 2 shots and still got them This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine(Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Nausea
Clinical narrative: nausea; dizziness; headache; joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (patient had a very mild case of Shingles that was caught early), joint pain, nausea and dizziness. Concomitant products included VARICELLA ZOSTER VACCINE.   In APR-2025, the patient received the 2nd dose of Shingles vaccine. On 25-APR-2025, less than a week after receiving Shingles vaccine, the patient experienced nausea (Verbatim: nausea), dizziness (Verbatim: dizziness), headache (Verbatim: headache) and joint pain (Verbatim: joint pain). The outcome of the nausea, dizziness, headache and joint pain were not resolved.   It was unknown if the reporter considered the nausea, dizziness, headache and joint pain to be related to Shingles vaccine.     It was unknown if the company considered the nausea, dizziness, headache and joint pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had a very mild case of Shingles that had been caught early.  The pain had been horrible, not just from the blisters, but it had made his/her joints ache, caused horrible headaches, nausea, and dizziness. It had taken him/her 8 weeks to fully recover.  Then he/she had waited another 2 weeks to get his/her 1st vaccine shot.  He waited about 2 months between the 1st vaccine and the 2nd Shingles vaccine shot.  He/she had his/her 2nd Shingles Vaccine shot 4 days ago.  The first two days, he/she had not felt all that bad after his/her 2nd vaccine shot, but yesterday and today, he/she had experienced nausea, dizziness, headache, and joint pain.  Nothing had been as bad as actually having Shingles, but he/she had been so glad to have had his/her 2nd vaccine and had prayed he/she would not get Shingles again.  Unfortunately, that had happened to some people.  He/she had highly recommended getting the Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Now I still broke out; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (I got shingles at the age of 26 years old). Concurrent medical conditions included nerve damage. Concomitant products included aciclovir sodium (Acyclovir) and gabapentin.   On an unknown date, the patient received Shingles vaccine. In APR-2025, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Now I still broke out). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to 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 : 29-APR-2025 This case was reported by a patient via interactive digital media. He/she got shingles at the age of 26 years old. He/she now 60. The pain was no joke.  He/she took Gabapentin for the nerve damage. Which helped.  He/she took Acyclovir 400 miligrams daily to keep it suppressed.  His/her doctor a few years ago told him/her to get the shot that it would help so he/she would not had to take meds. Now he/she still broke out. So took the meds everyday.  He/she just broke out about a week ago. It had been a few years since he/she did. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pustular
Clinical narrative: itchy; pus filled bumps on face and neck; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   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 pruritus (Verbatim: itchy) and pustule (Verbatim: pus filled bumps on face and neck). The outcome of the pruritus and pustule were resolved.   It was unknown if the reporter considered the pruritus and pustule to be related to Shingles vaccine.     It was unknown if the company considered the pruritus and pustule to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-APR-2025 The patient had first ever shingles vaccine and got itchy, pus filled bumps on face and neck that lasted for more than a month. The patient was on immune compromised, 65 year female actively in treatment for Rheumatoid arthritis.
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: COVID-19, Extra dose administered, Herpes zoster, Immunodeficiency, Neuralgia
Clinical narrative: Suspected vaccination failure; immune system was compromised; I got shingles; had covid; nothing helps the nerve pain; had 3 shingles 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), immunocompromised (Verbatim: immune system was compromised) (serious criteria GSK medically significant), shingles (Verbatim: I got shingles), covid-19 (Verbatim: had covid), post herpetic neuralgia (Verbatim: nothing helps the nerve pain) and extra dose administered (Verbatim: had 3 shingles vaccine). The outcome of the vaccination failure, immunocompromised, covid-19 and post herpetic neuralgia were not reported and the outcome of the shingles was resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure, immunocompromised, shingles, covid-19 and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and immunocompromised to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles, covid-19 and post herpetic neuralgia to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 29-APR-2025 This case was reported by a patient via interactive digital media. The patient had 3 shingles vaccines.  The patient reported to had Covid and then got shingles.  The doctor stated that his/her immune system was compromised.  The pain was extremely painful and nothing helped the nerve pain.  The patient stated hopefully he/she would not get them again.  The patient had them in the same place as the woman above. The patient received 3 doses of Shingles vaccine, 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 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Immunodeficiency  is an unlisted event which is considered unrelated to GSK Shingles vaccine.