chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: PNC20
Symptoms: Sinusitis, Transient ischaemic attack, Visual field defect, Visual field tests normal
Clinical narrative: acute onset left facial and left upper extremity numbness, peripheral vision loss associated with dizziness and gait imbalance. Per patient above symptoms started around 630 AM. admitted on 05/12/2025 with PMH of HTN, hypothyroidism, asthma, arthritis who presented for acute left facial and arm numbness, vision loss, and dizziness with last known well time at 2230 on 5/11/2025. Neurological examination revealed decreased sensation over left V1-V3 distribution, monocular left eye double vision with left lateral gaze, and NIHSS of 1 for mild-to-moderate sensory loss. CT/CTA head and neck were negative for acute findings with no large vessel occlusion, and MRI Brain and Orbit with and without contrast on 5/12/2025 showed no evidence of acute stroke. The patient was not a thrombolysis candidate as last known well time was beyond 4.5 hours, and was started on ASA 81 mg daily. By 5/13/2025, all neurological symptoms had completely resolved, and TIA was determined to be the most likely diagnosis with secondary stroke prevention measures recommended, including initiation of Crestor 20 mg daily to target LDL <70 mg/dL Patient deferred this for now, advised to discuss with his PCP. Blood pressure was managed with home medications (amlodipine 10 mg daily and lisinopril 40 mg daily) plus PRN IV labetalol/hydralazine with a goal SBP <140 mmHg. The patient's other medical conditions included hypothyroidism (on levothyroxine 125 mcg daily), gout (on allopurinol 450 mg daily), respiratory conditions (asthma, COPD, OSA requiring CPAP), and GERD with esophageal stricture (on pantoprazole 40 mg daily). Incidental findings included sinusitis on MRI, mildly elevated liver enzymes (AST 42 U/L, ALT 38 U/L), and elevated sedimentation rate (13 mm/hr), with a transthoracic echocardiogram with no PFO , no thrombus, no shunts
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient received additional dose of vaccine.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient presented for 4 month well child visit, immunization record was reviewed and deficiency of age appropriate vaccines were detected, ordered placed for completion, and Kinrix vaccine was administered instead pediarix vaccine, no adverse events or reactions noted after vaccination upon chart review, issue was realized, spoke to health department, vaccine is safe and valid, no further action recommended, patient's family was contacted with no answer, will reach out to the family again for the incident.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unevaluable event
Clinical narrative: monitor
Age: 54.0
Sex: F
Vaccine: VARCEL
Symptoms: Audiogram abnormal, Deafness unilateral, Magnetic resonance imaging head normal
Clinical narrative: Loss of hearing on the right side.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Rash erythematous
Clinical narrative: Three days after receiving vaccination employee developed pink rash on both arms and legs.
Age: 63.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Eyelid rash, Pruritus, Rash pruritic, Throat irritation
Clinical narrative: My armpit on the left side started itching, later I had a few itchy bumps that came up on the left side  then my left eye started to itch and I rubbed it and it swelled a bit, which then caused a little  itching in throat so I took a Zyrtec and 5mg of Benadryl which took care of it.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, UNK, DTPPVHBHPB, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Our son was scheduled to receive Hep B, Polio, and Hib vaccines and received 2 of each, plus DTAP.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, UNK, DTPPVHBHPB, IPV, MMRV
Symptoms: Extra dose administered
Clinical narrative: Child was given vaxelis (DTAP, hepatitis B,polio and Haemophilus influenzae type b (Hib) instead of just DTAP. So child ended up getting extra dose of hep B, and IPV.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Infant irritability, Musculoskeletal stiffness, Pyrexia, Rhinorrhoea, Seizure
Clinical narrative: 15mo here with observed seizure like activity at home Dad reports he was holding patient and patient laid back in his arms and "went stiff" for 15-20 seconds Stiffness remitted without recurrence Patient was initially sleepy but is now awake and fussing Mom reports patient has had fever and fussing for the past 48 hours or so Patient received Daptacel and Varivax 6 days ago Mom reports patient has had a runny nose and is presently teething He had a fever 7d ago, but only that night and was afebrile for 4-5 days in the interim Patient has had some intermittent emesis per dad. No noted diarrhea.  There has not been any noted cough, throat pain, difficulty breathing, rash, swelling, other noted symptoms or concerns.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Somnolence, Teething
Clinical narrative: 15mo here with observed seizure like activity at home Dad reports he was holding patient and patient laid back in his arms and "went stiff" for 15-20 seconds Stiffness remitted without recurrence Patient was initially sleepy but is now awake and fussing Mom reports patient has had fever and fussing for the past 48 hours or so Patient received Daptacel and Varivax 6 days ago Mom reports patient has had a runny nose and is presently teething He had a fever 7d ago, but only that night and was afebrile for 4-5 days in the interim Patient has had some intermittent emesis per dad. No noted diarrhea.  There has not been any noted cough, throat pain, difficulty breathing, rash, swelling, other noted symptoms or concerns.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Diarrhoea, Lip swelling, Malaise, Oral mucosal eruption
Clinical narrative: pt received the covid vaccine in our office  on 5/12 at 4:24, mom called at 8:30 the next morning to report pt felt "crummy" & developed a rash on his face/mouth. called a bit later to say his lips swelled to twice their size, pt sent to ED, treated with epi & sent home. returened to our office the next day for a follow up, urticaria, later that day developed diarrhea & started vomiting, went to ED again where he was admitted
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vomiting, White blood cell count increased
Clinical narrative: pt received the covid vaccine in our office  on 5/12 at 4:24, mom called at 8:30 the next morning to report pt felt "crummy" & developed a rash on his face/mouth. called a bit later to say his lips swelled to twice their size, pt sent to ED, treated with epi & sent home. returened to our office the next day for a follow up, urticaria, later that day developed diarrhea & started vomiting, went to ED again where he was admitted
Age: 28.0
Sex: F
Vaccine: CHIK
Symptoms: Abdominal pain, Adrenocortical insufficiency acute, Asthenia, Blood glucose decreased, Diarrhoea
Clinical narrative: Severe weakness, fatigue, abdominal pain, vomiting, diarrhea, low blood pressure, low blood sugar, fever, and rapid heart rate over several hours after vaccine, seen at ER, diagnosed with adrenal crisis, improved with hydrocortisone
Age: 28.0
Sex: F
Vaccine: CHIK
Symptoms: Fatigue, Heart rate increased, Hypotension, Pyrexia, Vomiting
Clinical narrative: Severe weakness, fatigue, abdominal pain, vomiting, diarrhea, low blood pressure, low blood sugar, fever, and rapid heart rate over several hours after vaccine, seen at ER, diagnosed with adrenal crisis, improved with hydrocortisone
Age: 1.08
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given Menveo instead of MMR. The Menveo in stock was the one vial preparation which is not indicated for children under 10 years. This vaccine was also given incorrectly given outside of the schedule. Mother was contacted and informed of the situation, local health department was also contacted for recommendation's and mom was advised off these as well. to date, we are not aware of any adverse reactions to the vaccine given.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Client given MMR II on 5-15-25 and 5-20-25. No treatment.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired upon administration
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was expired upon administration
Age: 1.25
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: On  05/19/2025 patient presented to clinic for vaccination. Patient was to receive MMR & Varicella. Patient was given Varivax and Proquad was mistakenly grabbed and administered rather than MMR II. No side effects have been reported by parent. Vaccines were administered at 09:37AM 05/19/2025. Discovered 1:00PM 05/19/2025. Provider notified. Manufacturer Merck & Co contacted and reported that adverse event according to product warning label likelihood is increased with the double dose of Varicella Vaccination. Parent notified of increased risk for fever, injection  site reaction, rash. Advised on s/s to watch for.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Concussion, Contusion, Eye swelling, Fatigue
Clinical narrative: Adverse histamine reactions, eyes swell up, rashes, abnormal bleeding/bruising, swollen lips, swollen face leaving severe bruising, arm swelled in a rash the nigh of the shot, brain fog, concussion, eyesight changes, headaches-severe,  extreme exhaustion,  hives , sun allergy when I have never been allergic to the sun before, I have many pictures all dated and time stamped starting since the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Headache, Histamine intolerance, Hormone analysis, Lip swelling
Clinical narrative: Adverse histamine reactions, eyes swell up, rashes, abnormal bleeding/bruising, swollen lips, swollen face leaving severe bruising, arm swelled in a rash the nigh of the shot, brain fog, concussion, eyesight changes, headaches-severe,  extreme exhaustion,  hives , sun allergy when I have never been allergic to the sun before, I have many pictures all dated and time stamped starting since the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Photosensitivity reaction, Rash, Swelling face, Urticaria
Clinical narrative: Adverse histamine reactions, eyes swell up, rashes, abnormal bleeding/bruising, swollen lips, swollen face leaving severe bruising, arm swelled in a rash the nigh of the shot, brain fog, concussion, eyesight changes, headaches-severe,  extreme exhaustion,  hives , sun allergy when I have never been allergic to the sun before, I have many pictures all dated and time stamped starting since the vaccination.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Adverse histamine reactions, eyes swell up, rashes, abnormal bleeding/bruising, swollen lips, swollen face leaving severe bruising, arm swelled in a rash the nigh of the shot, brain fog, concussion, eyesight changes, headaches-severe,  extreme exhaustion,  hives , sun allergy when I have never been allergic to the sun before, I have many pictures all dated and time stamped starting since the vaccination.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Disseminated varicella, Skin lesion, Varicella virus test positive, Varicella zoster viraemia
Clinical narrative: Disseminated varicella - multiple cutaneous lesions and varicella viremia. Confirmed to be vaccine strain via PCR.
Age: 34.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: There have been not side effects reported. It was determined after the vaccine was given that this was an extra dose.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash started on belly , chest and some on face.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt was given DTaP instead of TDaP, no side effects reported at this time
Age: 59.0
Sex: F
Vaccine: CHIK
Symptoms: Arthritis reactive, Laboratory test, Oedema peripheral, Phlebitis, Ultrasound Doppler
Clinical narrative: generalized bilateral phlebitis, ankle edema, reactive arthritis of hands
Age: 66.0
Sex: F
Vaccine: COVID19, HEP, MMR
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: Patient was admitted to hospital and diagnosed with Systemic inflammatory response syndrome (sirs). The exact date and time of event were not communicated to us nor was the length and duration of treatment
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Cough, Hypoaesthesia oral, Muscle twitching, Rash macular, Throat clearing
Clinical narrative: The employee c/o coughing, trying to clear throat, numb lips, itching face and Left arm became splotchy. Employee was treated i the ED with steroids' and antibiotics.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse reactions reported.
Age: 3.0
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792544. HCP reported that only VARIVAX was administered to one patient. PROQUAD was not administered to anyone. No symptomatic events reported. HCP agrees to be correspond; This spontaneous report was received from a/an Nurse and refers to a(n) 3-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015100, expiration date: 06-Sep-2026) 0.5 mL administered by Unknown route. On 15-Apr-2025, the patient started therapy with sterile diluent (MERCK STERILE DILUENT), 0.5 mL administered by Unknown route (indication, expiration date, and lot # were not reported). The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), for the treatment of Prophylaxis.  On 15-Apr-2025, the patient experienced Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792544. HCP reported that only VARIVAX was administered to one patient. PROQUAD was not administered to anyone. No symptomatic events reported. HCP agrees to be correspond. On an unknown date, the patient experienced no adverse event.   At the reporting time, the outcome of Inbound call from HCP regarding a T/E for VARIVAX and PROQUAD. See T/E case #02792544. HCP reported that only VARIVAX was administered to one patient. PROQUAD was not administered to anyone. No symptomatic events reported. HCP agrees to be correspond and no adverse event was unknown.   The action taken with Varicella Virus Vaccine Live (Oka-Merck) and sterile diluent was reported as not applicable.
Sex: F
Vaccine: PNC21
Symptoms: Feeling hot, Injection site erythema, Malaise, Pyrexia
Clinical narrative: injected with a CAPVAXIVE injection a few weeks ago, that she had a large red area that took 1 to 2 days to go away; fever; Vaccination site warmth; malaise; This spontaneous report was received from a pharmacist and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 2025 (also report as a few weeks ago), the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), (lot # and expiration date were not reported) for prophylaxis.  On 2025, the patient had a large red area that took 1 to 2 days to go away. It also had fever and was warm, having a lot of warmth and fever. She had also a day or so of general malaise, after the injection. She recovered from the events (also reported as from the injection) on an unspecified date in 2025. No hospitalization or prolonged treatment was needed.  The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE reported.; patient was administered GARDASIL9 during a temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 23-Apr-2025, the patient was vaccinated with an improperly storage dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y012508, expiration date: 01-Jan-2027) for prophylaxis. No additional adverse event was reported.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse does not report any side effects/symptoms.; patient received GARDASIL 9 outside of the recommended dosing schedule/first dose 24OCT2024/second dose 21NOV2024. Patient has returned for dose 3 today but has not yet received it.; This spontaneous report was received from a nurse referring a 33-year-old male patient.   His medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On 24-Oct-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe (batch/lot number Y012864 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration reported as 19-Jan-2026 but upon internal validation established as 29-May-2026), dose number 1, 0.5 mL (anatomical location and route of administration were not reported). On 21-Nov-2024, he was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) injection pre-filled syringe (batch/lot number 1965045 has been verified to be a valid batch lot number for Human Papillomavirus 9-valent Vaccine, Recombinant, expiration reported and upon internal validation established as 19-Jan-2026), dose number 2, 0.5 mL (anatomical location and route of administration were not reported) (inappropriate schedule of product administration.) Both vaccine doses were administered as prophylaxis.  Patient returned for dose 3 on 01-May-2025 (reported as "today"), but he had not yet received it. Nurse did not report any side effects/symptoms (no adverse event). No additional details were provided.
Vaccine: HPV9
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Additional AE/PQC; Consumer calling to report that their child was given GARDASIL 9 instead of PROQUAD. Consumer did not report any side effects. Permission to contact HCP was given. No Additional AE/PQC; This spontaneous report was received from a Consumer on 15-MAY-2025 and refers to a child patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-MAY-2025, the patient was vaccinated  with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (dose, dose number, frequency, anatomical location, route of administration, lot#, and expiration date were not reported) instead of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, dose number, frequency, anatomical location, route of administration, lot#, and expiration date were not reported) with Product sterile diluent Solution for injection (dose, dose number, frequency, anatomical location, route of administration, lot#, and expiration date were not reported) for prophylaxis. Consumer did not report any side effects.   Lot # will be requested and will be submitted if received.
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient received an expired dose of GARDASIL 9 today 05/15/2025; This spontaneous report was received from a medical assailant on 15-MAY-2025 and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On 15-MAY-2025, the patient was vaccinated with an expired dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (lot #W010661, expiration date: 19-OCT-2024) , dose: 0.5 mL (0.5ml/ series) (dose number, route of administration and anatomical location were not reported)  for prophylaxis (Expired product administered) No symptomatic events were reported. No additional information was provided.
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: I have recently received a Gardasil 9 vaccine and would like to verify its authenticity; No additional AE; This spontaneous report was received from an other health professional on 19-May-2025 and refers to a patient of unknown age and gender.   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 was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) (lot #Y007843, expiration date: 17-Nov-2026) as prophylaxis.   The patient would like to verify its authenticity (Suspected counterfeit product). The patient wanted to confirm whether this batch was an original product manufactured by the company and intended for distribution. Also, if possible, the patient wanted to confirm which country it was distributed to. No additional AE (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Nausea
Clinical narrative: Generalized symptoms. Extreme tiredness; Generalized symptoms nausea; This non-serious case was reported by a other health professional via sales rep and described the occurrence of tiredness in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-MAY-2025, the patient received Shingrix. On 02-MAY-2025, 1 days after receiving Shingrix, the patient experienced tiredness (Verbatim: Generalized symptoms. Extreme tiredness) and nausea (Verbatim: Generalized symptoms nausea). On 04-MAY-2025, the outcome of the tiredness was resolved and the outcome of the nausea was resolved (duration 2 days).   It was unknown if the reporter considered the tiredness and nausea to be related to Shingrix.     It was unknown if the company considered the tiredness and nausea to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2025 The patient had generalized symptoms extreme tiredness and nausea after Shingrix vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Tingling skin which travels from her arms, then to her back, then to her feet/legs; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling skin in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-MAY-2025, the patient received Shingrix. On 05-MAY-2025, 1 days after receiving Shingrix, the patient experienced tingling skin (Verbatim: Tingling skin which travels from her arms, then to her back, then to her feet/legs). The outcome of the tingling skin was not resolved.   It was unknown if the reporter considered the tingling skin to be related to Shingrix.     It was unknown if the company considered the tingling skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 The patient self-reported this case. The patient received her Shingrix vaccine and on next day she began feeling a tingling sensation on her skin, which travelled from her arms, then to her back, then to her feet or legs.  The patient refused to provide any additional information.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Heart rate irregular, Nausea
Clinical narrative: Rash; Headache; Chills; Nausea; Dizziness; Irregular heart beat; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), headache (Verbatim: Headache), chills (Verbatim: Chills), nausea (Verbatim: Nausea), dizziness (Verbatim: Dizziness) and heart rate irregular (Verbatim: Irregular heart beat). The outcome of the rash, headache, chills, nausea, dizziness and heart rate irregular were unknown.   It was unknown if the reporter considered the rash, headache, chills, nausea, dizziness and heart rate irregular to be related to Shingrix.     It was unknown if the company considered the rash, headache, chills, nausea, dizziness and heart rate irregular to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 The patient self-reported this case The patient received her first dose of Shingrix yesterday morning and after the dose, she experienced irregular heartbeat, rash, headache, chills, nausea, and dizziness.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; Headache; Chills; Nausea; Dizziness; Irregular heart beat; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-MAY-2025, the patient received the 1st dose of Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash), headache (Verbatim: Headache), chills (Verbatim: Chills), nausea (Verbatim: Nausea), dizziness (Verbatim: Dizziness) and heart rate irregular (Verbatim: Irregular heart beat). The outcome of the rash, headache, chills, nausea, dizziness and heart rate irregular were unknown.   It was unknown if the reporter considered the rash, headache, chills, nausea, dizziness and heart rate irregular to be related to Shingrix.     It was unknown if the company considered the rash, headache, chills, nausea, dizziness and heart rate irregular to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 The patient self-reported this case The patient received her first dose of Shingrix yesterday morning and after the dose, she experienced irregular heartbeat, rash, headache, chills, nausea, and dizziness.
Sex: M
Vaccine: TDAP
Symptoms: Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: Product complaint; medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle; underdose; vaccine leaked onto patient's arm; vaccine leaked onto patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC, expiry date 19-MAR-2027) for prophylaxis. This case was associated with a product complaint.   On 07-MAY-2025, the patient received Boostrix. On 07-MAY-2025, an unknown time after receiving Boostrix, the patient experienced underdose (Verbatim: underdose), exposure via skin contact (Verbatim: vaccine leaked onto patient's arm) and accidental exposure while administering drug (Verbatim: vaccine leaked onto patient's arm). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product complaint) and syringe connection issue (Verbatim: medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle). The outcome of the underdose, exposure via skin contact, accidental exposure while administering drug, pharmaceutical product complaint and syringe connection issue were not applicable.   It was unknown if the reporter considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-MAY-2025 14-MAY-2025 Other HCP reported about a defective prefilled syringe. When she started to administer the injection the medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle. The medication leaked onto reporter's hand and the patient's arm, which led to Accidental exposure while administering drug and exposure via skin contact. Needle was securely attached to the syringe. Return of needle used was not available. This case is linked with US2025AMR059513 reported by same reporter.; Sender's Comments:  US-GSK-US2025AMR059513:Same reporter/Diffrent patient
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Break through case; residual PHN; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Break through case) and post herpetic neuralgia (Verbatim: residual PHN). The outcome of the vaccination failure was resolving and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   The reporter considered the vaccination failure and shingles to be related to Shingrix. It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. The company considered the shingles to be related to Shingrix. It was unknown if the company considered the post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAY-2025 The patient had been approximately 70 years old. The patient received subsequent dose of the Shingrix vaccine and experienced vaccine failure which was ongoing but in recovering state and it was not serious. It had been a breakthrough case (shingles), but very mild. The patient had been prescribed antivirals right away but had still experienced 2/10 pain and some residual postherpetic neuralgia (PHN).  No other products received by the patient. 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: 66 years old patient received priorix; Drug administered via inappropriate route; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of subcutaneous injection formulation administered by other route in a 66-year-old female patient who received MMR (Priorix) (batch number 4n222, expiry date 13-SEP-2026) for prophylaxis.   On 15-MAY-2025, the patient received the 1st dose of Priorix (intramuscular, left arm). On 15-MAY-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Drug administered via inappropriate route). On an unknown date, the patient experienced inappropriate age at vaccine administration (Verbatim: 66 years old patient received priorix). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter reported that the 66 years old patient received 1st dose of Priorix intramuscularly which led to inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Lethargy, Mobility decreased
Clinical narrative: Allergic reaction; Lethargic; Could not get up; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a elderly male patient who received Herpes zoster (Shingrix) (batch number 75GZ7) for prophylaxis.   Concurrent medical conditions included parkinson's disease.   On 14-MAY-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm). In MAY-2025, less than a week after receiving Shingrix, the patient experienced allergic reaction (Verbatim: Allergic reaction), lethargy (Verbatim: Lethargic) and mobility decreased (Verbatim: Could not get up). The outcome of the allergic reaction, lethargy and mobility decreased were resolving.   The reporter considered the allergic reaction, lethargy and mobility decreased to be related to Shingrix.     The company considered the allergic reaction, lethargy and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2025 The reporter is a pharmacist called to report that the wife of a male patient stated that the patient had an allergic reaction, got lethargic, and could not get up (no specific date provided). The patient was taken to the emergency room, was checked at the emergency room, and was discharged (no specific date provided). The reporter did not know if the patient had an overnight stay at the Emergency Room. The patient was told at the emergency room that he was experiencing side effects from receiving the second dose of Shingrix. The patient was now back home and doing okay. The reporter had notified the patient's physician, and provided consent to follow up with the patient's physician. The reporter stated that they do not fill the patient's prescription medications, and he had no prescription history to provide.
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; had shingle twice and the autoimmune disease from the vaccine is worse; I have had shingle twice and the autoimmune disease from the vaccine is worse; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), autoimmune disorder (Verbatim: had shingle twice and the autoimmune disease from the vaccine is worse) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingle twice and the autoimmune disease from the vaccine is worse). The outcome of the vaccination failure, autoimmune disorder and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the autoimmune disorder to be related to Shingles vaccine.     The company considered the vaccination failure, autoimmune disorder and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had shingle twice and the autoimmune disease from the vaccine was worse. 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster and Autoimmune disorder are unlisted events which are considered unrelated to GSK Shingles vaccine. "
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: shot hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAY-2025 This case was reported by a patient via interactive digital media. Reporter stated that get the shingles vaccine, the shot hurt but it is better than shingles.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: they both made me 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: they both made me 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: 06-MAY-2025 This case was reported by a patient via interactive digital media.  Patient stated they both made them sick. This case is 1 of 2 cases created for both doses.
Age: 67.0
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; had that 3 times; 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.   The patient's past medical history included covid-19.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: had that 3 times). 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 and respiratory syncytial virus infection to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 08-MAY-2025 The case was received from the patient via interactive digital media.  The reporter got an RSV vaccine.  The reporter got it when he/she was 67 from his/her great granddaughters.  The reporter reported that it was way worse than Covid and he/she had that 3 times. Plus the reporter lost his/her mother, brother and sister in law within 21 days to Covid.  RSV was the last vaccine the reporter got but he/she glad he/she did.  There were a few times the reporter thought he/she was going to die when he/she had RSV. This case was considered as suspected vaccination failure as details regarding time to onset for respiratory syncytial virus infection and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK RSV vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK RSV vaccine."
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had it 3 times; 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: I had it 3 times). 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: 09-MAY-2025 The case was received from the patient via interactive digital media. The reporter had it 3 times but very mild because he/she had the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; have shingles now; 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.   On an unknown date, the patient 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: have shingles now). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAY-2025 The case was received from the patient via interactive digital media. The reporter had both Shingles shots but had shingles now. It was a mild case with a rash and some itching. Hopefully would just go away soon.  The reporter advice to get shots. He/she was convinced it helped. 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  primary vaccination schedule,  time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Vaccine: TDAP
Symptoms: Device leakage, Occupational exposure to product
Clinical narrative: medication leaked out of the prefilled syringe around the plastic; Product complaint; medication leaked onto my hand; medication leaked onto my hand; This non-serious case was reported by a other health professional and described the occurrence of occupational exposure via skin contact with product in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number M77CC) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Boostrix. On 07-MAY-2025, an unknown time after receiving Boostrix, the patient experienced occupational exposure via skin contact with product (Verbatim: medication leaked onto my hand) and inadvertent exposure to vaccine (Verbatim: medication leaked onto my hand). On an unknown date, the patient experienced syringe connection issue (Verbatim: medication leaked out of the prefilled syringe around the plastic) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the occupational exposure via skin contact with product, inadvertent exposure to vaccine, syringe connection issue and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the syringe connection issue to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 09-MAY-2025 Other healthcare professional reported about a defective prefilled syringe. When she started to administer the injection the medication leaked out of the prefilled syringe around the plastic portion that attaches to the needle. The medication leaked onto reporter's hand and the patient's arm, which led to occupational exposure via skin contact with product, inadvertent exposure to vaccine and syringe connection issue. Needle was securely attached to the syringe. This case is linked with US2025057149 reported by same reporter for the patient.; Sender's Comments:  US-GSK-US2025057149:Same reporter/Diffrent patient
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: inadvertently administered a pediatric dose of ENGERIX-B by GSK (GlaxoSmithKline) to an adult patient.; Underdose; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of adult use of a child product in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: inadvertently administered a pediatric dose of ENGERIX-B by GSK (GlaxoSmithKline) to an adult patient.) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose were not applicable.   Additional Information: GSK Receipt Date: 13-MAY-2025 Inadvertently administered a pediatric dose of Engerix-B to a patient, which led adult use of a child product and underdose.