chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: M
Vaccine: PNC20
Symptoms: Gaze palsy, Metabolic function test, Seizure, Urine analysis
Clinical narrative: On 9/24/24 at 1227H, patient had his prevnar20 given to right arm by RN. At 1500H, patient did have seizure episodes x 2 in WC and then x 1 in bed with intervals.  He was rolling eyes with BUE jerky movements. There was no other drugs given to him prior to the seizure but just the prevnar 20. Per family, he had history of fall with hitting head 6-7 mos ago but there was no injury noted.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 5 year-old received Vaxelis. No adverse events.
Age: 6.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 year-old received PedvaxHib. No adverse events.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site haemorrhage, Injection site swelling
Clinical narrative: Upon withdrawing syringe a stream of blood squirted out and injection site swelled some.  Swelling went down within a few minutes and no more blood came out after initial withdrawing of syringe. Patient stated felt fine after injection. Patient was called a few hours after injection and he stated still felt fine. Patient is on a blood thinner and has not slept in 2 days.
Age: 15.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Wrong product administered
Clinical narrative: Pneumovax was given instead of the ordered Gardasil-9.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Decreased appetite, Diarrhoea, Dysphonia
Clinical narrative: on Sept 20, started feeling tired, towards evening started muscular aches.  Next day coughing, diarrhea  extreme exhaustion, hoarse voice, eyes hurt, weak, started getting cold sores in the roof of mouth.  Sept 24  went to Dr. got prescription for Z pack and Acyclovir for cold sores. Sept 25, still tired and achy, eyes still feeling tender, lack of appetite only slight diarrhea.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Fatigue, Myalgia, Oral herpes, Pain
Clinical narrative: on Sept 20, started feeling tired, towards evening started muscular aches.  Next day coughing, diarrhea  extreme exhaustion, hoarse voice, eyes hurt, weak, started getting cold sores in the roof of mouth.  Sept 24  went to Dr. got prescription for Z pack and Acyclovir for cold sores. Sept 25, still tired and achy, eyes still feeling tender, lack of appetite only slight diarrhea.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Feeling hot, Pain, Urticaria
Clinical narrative: Pt with one hive that started the day after, heat, and pain
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy
Clinical narrative: Donor reports having a swollen lymph node in the Left axilla after receiving the tetanus immunization on 09/20/2024. Donor did not seek outside care.
Age: 87.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Fall, Feeling abnormal, Haemoptysis
Clinical narrative: Patient started to say she was feeling bad. Within a couple seconds fell to floor face first. I rolled her carefully on the side while she was coughing up blood. Ambulance was called and arrived within minutes carrying her away.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles
Clinical narrative: 1-2 cm fluid filled vesicle at injection site
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: no treatment needed
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Syncope
Clinical narrative: Patient received flu vaccine in the school-based flu pod from Health Department this morning at school. Patient received vaccine with no incident at the time of administration. Patient returned to classroom. Approximately 15 min after injection given, the teacher notified school nurse that child had fainted in classroom upon returning to class. She states he all of a sudden became pale and sweating and then passed out.  School nurse brought patient back to the flu vaccine pod clinic with Health Department nurses. Nurses sat patient back and lifted legs above heart, placed icepack on neck. Patient's mother was in the school in different location. Mother was alerted and came to check on her child. Mom once arriving stated that patient had passed out last year with a vaccine, she thinks it was a COVID vaccine and not the flu vaccine, so she had not marked previous history of fainting on flu consent form. We monitored patient for about 30 min and Mom states she felt comfortable bringing patient home. Patient states he was feeling back to normal. I called mother to check on patient and how he was doing this afternoon. Mother states he had returned to his baseline and had felt ok at home. No further symptoms or issues. I told mother to let us know if she had any other questions or concerns related to the flu vaccine and also to be aware in future of his history of fainting with vaccines so healthcare personnel can be aware and plan for that. Mother verbalized understanding.
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: WAS GIVEN A THIRD DOSE THAT WAS NOT NEEDED
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Dtap/IPV vaccine administered by wrong route, subcutaneously to L arm. Pt observed for 30 minutes without signs of adverse reaction. Reviewed emergency signs with parent and encouraged to call clinic or for emergency help with any signs of adverse reaction.
Age: 1.33
Sex: M
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: Patient given wrong vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Patient with history of HSP presents for a follow up visit for possible vaccine reaction. Patient was in office Monday 9/23/24 and received Quadracel (Dtap/IPV) & Proquad (MMR/Varicella). Patient has developed large rash on both thighs that are red, a little swollen, and bumpy/rash looking that that grandmother states happened late Monday night possibly or Tuesday. She states that it looks much better than it did yesterday Accompanied by Grandmother  Notes: Pt with likely vaccine reaction. Will treat left quadracep for cellulitis. Instructed grandmother to give zyrtec PO once daily (has a previous rx for this) for itching and allergic reaction symptoms and to give tylenol/motrin prn pain or discomfort. For worsening symptoms, decrease in activity level, letheragy notify clinic immediately.Instrcuted due to HSP and this reaction to avoid all vaccines from now on. Will consider Tdap at age 11.Of note pt recieved MMRV in right leg and Dtap-IPV in left leg on Monday 9/23/25.No hx of prior vaccine reactions. Will report to VAERS for vaccine reaction
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: Red rashes on neck and arms described as hot to the touch.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Seizure, Syncope
Clinical narrative: Patient presented to clinic this afternoon to received 2nd of 3 total Gardasil9 vaccine doses. She was accompanied by her mother. Patient received the 1st dose 4 weeks ago in clinic, and had a syncopal episode that resulted in a concussion. Having been aware of this situation, I made sure to have patient lay down when receiving this 2nd dose. Within 5 seconds of administering the 2nd Gardasil9 dose, patient went visibly pale and began having a convulsive syncopal episode that lasted less than 15 seconds. patient opened her eyes spontaneously, was alert and oriented. I had patient remain in supine position and applied cold packs to her forehead and posterior neck. B/P was 110/70, pulse at 72, O2 sat of 99%, respirations of 18. After at least 5 minutes of laying supine, patient slowly sat up and remained sitting for at least another 5 minutes. The patient had no concerns. She stated she was feeling well, same as before she had the vaccine. She denied feeling dizzy, lightheaded, unusually hot or cold, or having a fuzzy feeling in the head. Patient stood up, and still felt well after several minutes. She was informed that she was free to leave, however, if she started to feel unusual or unwell, to say something right away, and either sit in a chair, or squat to the floor if a chair was unavailable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: PATIENT WAS ADMINISTERED AN MMRV (PROQUAD) THAT EXPIRED ON 9/4/24.  THERE WERE NO SIGNS OF DISTRESS OR ADVERSE REACTIONS NOTED.  PARENT WAS INFORMED THAT A REPEAT DOSE OF MMRV WOULD NEED TO BE ADMINISTERED AFTER 28 DAYS.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased
Clinical narrative: Patient called and talked to one of the staff pharmacists to discuss a potential adverse reaction to a vaccine. A note was left to the pharmacy manager to call the patient back. When manager called the patient back, the patient stated that he received both the Comirnaty and Fluad vaccine at the same time on Thursday 09/19/2024 and on Friday 09/20/2024 at 9 am, he noticed that his blood sugars where very elevated more than normal, in the mid 200's. He called his primary doctor and his primary told him to go the ER immediately. Upon going to ER he was given insulin and was told that his blood sugars reached 400. They were able to manage him there and after six hours, was discharged and told to follow up with his primary. His primary placed patient on Metformin. When asked if the patient has ever had elevated blood sugars, he stated never that high. Manager told the patient that he will submit a VEARs report to be looked into further.
Age: 49.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pt came to pharmacy today with a prescription for prednisone, which is being used for "injection site pain" he stated that it is due to his IMZ received 3 weeks ago on  8/30/24.  He is now having pain in shoulder and has to have follow up care with a specialist for further evaluation
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS SAND SWELLING 1 WEEK LATER. LASTED FOR 4 DAYS
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: PATIENT ARRIVED AT PHARMACY AND FILLED OUT PAPERWORK NEEDING FLU AND RSV VACCINATIONS. I ADMINISTERED THE FLU AND RSV VACCINES. I WAS NOT AWARE THAT THE PATIENT HAD ALREADY RECIEVED RSV VACCINATION ON 09/25/23. I DID NOT DISCOVER THE DUPLICATION  UNTIL REPORTING TO SYSTEM ON 09/25/2024, AND SAW HE HAD BEEN GIVEN SAME VACCINE ON 09/23/24. I CALLED PFIZER AND THEY STATE THEY HAVE NO PERTINENT INFORMATION TO REPORT, AND I FILLED OUT A SAFETY REPORT WITH THEIR SAFETY TEAM, AND THEY SAID TO CALL CDC. I CALLED CDC AND THEY DID NOT HAVE ANY INFORMATION EITHER AND ENCOURAGED ME TO FILL OUT VAERS. PER PATIENTS WIFE PATIENT HAD REPORTED SORE ARMS ( SHE ALSO STATES HE USUALLY GETS SORE ARMS FROM VACCINES). I WAS UNABLE TO REACH PT VIA PHONE TO FOLLOW UP LATER IN THE DAY 09/25/24, I LEFT A MESSAGE FOR HIM TO CALL US BACK AND I WILL BE SURE TO ENCOURAGE HIM TO REPORT ANY ADDITIONAL ADVERSE EFFECTS (IF ANY).  I WILL CALL HIS PRIMARY CARE PROVIDER TOMORROW 09/26/24 (THEY ARE CLOSED NOW) AND REPORT THIS TO THEM IN CASE ANY FURTHER FOLLOW UP IS NECESSARY.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, DTAPIPVHIB, FLU3, MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: RN ordered  pentacel, quadracel and flu instead of proquad. It was not realized until after administration of vaccines RN then spoke with provider, Dr., on what to look for and if okay to still give proquad. RN then gave proquad to patient. Patient with no signs or symptoms of reaction in office.   RN talked to patient about error. Parent verbalized understanding on when to call office if any symptoms of adverse reactions.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 10.0
Sex: F
Vaccine: HEPA, HPV9, MMR, VARCEL
Symptoms: Conjunctivitis, Oropharyngeal pain, Pain, Pruritus, Pyrexia
Clinical narrative: Fever, sore throat, papulo vesicular rash, conjunctivitis roughly ten days after varicella immunization. Symptomatic treatment for itchiness and pain.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV9, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Fever, sore throat, papulo vesicular rash, conjunctivitis roughly ten days after varicella immunization. Symptomatic treatment for itchiness and pain.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: ADULT RECEIVED PEDIATRIC DOSE, NO ADVERSE OUTCOME
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: pt recieved 2 covid vaccine without 1 week. vaccine of pfizer recieved both on 8/29/24 and 9/5/24
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no symptomatic adverse event to report/ No AE; On 12-JUN-2024, the patient was vaccinated with the first dose of GARDASIL 9/ On 05-SEP-2024, she was vaccinated with the second dose; This spontaneous report has been received from a nurse practitioner (NP) concerning to a 11-year-old female patient. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 12-JUN-2024, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis (dose, scheme frequency, routed and anatomical location of administration, lot number and expiration date were not provided). On 05-SEP-2024, she was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter once, lot# X026926 that was verified to be a valid lot # (expiration date reported and validated as 10-APR-2026) for prophylaxis (route and anatomical location of administration not provided). The second dose was administered earlier than the indicated schedule (inappropriate schedule of product administration). It was confirmed that there was no symptomatic adverse event to report. No additional information was provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Syringe issue
Clinical narrative: no additional AE/PQC; finger flange broke off while administering the vaccine to the patient; finger flange broke off while administering the vaccine to the patient; This spontaneous report was received from a nurse and refers to an unspecified patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-SEP-2024, the nurse was administering a dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, 0.5 milliliter, lot #Y004552, expiration date: 14-OCT-2026, administered intramuscularly for prophylaxis (strength was not provided) and the finger flange broke off while administering the vaccine to the patient. The administering nurse repositioned her finger to administer the remainder of the vaccine and the patient received the whole dose (poor quality device used).  No additional adverse event was reported.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Death, Pyrexia, Respiratory arrest, Resuscitation, Seizure
Clinical narrative: Sudden infant death syndrome; found her not breathing; seizure; fever; This spontaneous report was received from a consumer via other company and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided); polio vaccine inact 3v (vero) (IMOVAX POLIO) suspension for injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered for immunisation (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), administered for immunisation (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided) (also reported as got 6 shots on 6th).  On unknown date after received the vaccines, the patient had 102-degree fever (Pyrexia) and the doctor reassured her mom it was okay. 3 days later the babysitter found the patient not breathing/respiratory arrest (Apnoea) and did corrective treatment cardiopulmonary resuscitation (CRP) for her. Once rushed to the emergency room (ER), the patient started having seizure (latency:3 days). Final diagnosis was sudden infant death syndrome. The patient died due to event sudden infant death syndrome on unknown date. It was unknown if autopsy was done. The cause of death was reported as sudden infant death syndrome. The patient was hospitalized due to events of sudden infant death syndrome, seizure and not breathing/respiratory arrest.  At the time of reporting, the outcome of events of fever, not breathing/respiratory arrest, seizure was unknown. The action taken with all suspect vaccines was not applicable. The causal relationship between all events and all suspect vaccines were not provided.  Upon internal review, the events of sudden infant death syndrome, not breathing/respiratory arrest and seizure were determined to be medically significant. The reporter considered the event of sudden infant death syndrome to be life threatening.  Additional information was not expected.; Reported Cause(s) of Death: Sudden infant death syndrome
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Sudden infant death syndrome
Clinical narrative: Sudden infant death syndrome; found her not breathing; seizure; fever; This spontaneous report was received from a consumer via other company and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided); polio vaccine inact 3v (vero) (IMOVAX POLIO) suspension for injection, administered for immunisation (strength, dose description, lot #, expiry date, and route of administration were not provided); pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), administered for immunisation (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), administered for immunisation (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided) (also reported as got 6 shots on 6th).  On unknown date after received the vaccines, the patient had 102-degree fever (Pyrexia) and the doctor reassured her mom it was okay. 3 days later the babysitter found the patient not breathing/respiratory arrest (Apnoea) and did corrective treatment cardiopulmonary resuscitation (CRP) for her. Once rushed to the emergency room (ER), the patient started having seizure (latency:3 days). Final diagnosis was sudden infant death syndrome. The patient died due to event sudden infant death syndrome on unknown date. It was unknown if autopsy was done. The cause of death was reported as sudden infant death syndrome. The patient was hospitalized due to events of sudden infant death syndrome, seizure and not breathing/respiratory arrest.  At the time of reporting, the outcome of events of fever, not breathing/respiratory arrest, seizure was unknown. The action taken with all suspect vaccines was not applicable. The causal relationship between all events and all suspect vaccines were not provided.  Upon internal review, the events of sudden infant death syndrome, not breathing/respiratory arrest and seizure were determined to be medically significant. The reporter considered the event of sudden infant death syndrome to be life threatening.  Additional information was not expected.; Reported Cause(s) of Death: Sudden infant death syndrome
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reporting temperature excursion. This case has been opened for administered dose of VARIVAX.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-SEP-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X006982, expiration date: 07-MAR-2025, administered for prophylaxis (strength, dose, and route of administration were not provided) after temperature excursion at -13 degree Celsius for 18 minutes (Product storage error). There was previous temperature excursion. No product quality concern (PQC). No additional information.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; Medical assistant reported VARIVAX was administered after a temperature excursion to patient. Date of administration: Sep 23, 2024. No further information provided.  This AE case is for one out of five patients. Cross reference case: 02676376. No add; This spontaneous report was received from medical assistant 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-SEP-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, lot #Y009956, expiration date: 28-MAY-2026, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 33.3 degree Farenheit for 12 hours, 34.9 degree Farenheit for 13 hours, in 27 degree Farenheit for 5 hours, in 16.3 degree Farenheit for 10 hours and in 13.1 degree Farenheit for 8 hours (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; itch; Pain; Feels like sunburn; 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), shingles (Verbatim: Shingles), pruritus (Verbatim: itch), pain (Verbatim: Pain) and burning sensation (Verbatim: Feels like sunburn). The outcome of the vaccination failure was not reported and the outcome of the shingles, pruritus, pain and burning sensation were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, pain and burning sensation 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, pruritus, pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was reported by a patient via interactive digital media. The patient got the vaccines and had now come down with rash less shingles. No rash but felt like a sunburn with itch and pain. Going on 3 weeks now. The patient stated that, really sucks. 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, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've had 3 out breaks; 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: I've had 3 out breaks). 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.     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: 18-SEP-2024 The case was received from the patient via interactive digital media. The patient had both shingles shots.  The patient reported that since he/she had 3 outbreaks. 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 details regarding time to onset and laboratory confirmation regarding disease) is considered unrelated to GSK vaccine(dose 1 and 2) .
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles; 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: shingles). 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.   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: 18-SEP-2024 This case was reported by a patient via interactive digital media. The reporter reported that he/she was unlucky person who had shingles, got the shots and yeah. The patient got the shingles a second time. 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine(dose 1 and 2).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got 2 sets of shots and mine still comes back/suspected vaccination failure; I got 2 sets of shots and mine still comes back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: I got 2 sets of shots and mine still comes back/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got 2 sets of shots and mine still comes 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 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: 18-SEP-2024 This case was reported by a patient via interactive digital media. The patient got 2 sets of shots and his/her still comes back. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset 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.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: made me feel sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female 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 sickness (Verbatim: made me feel sick). The outcome of the sickness was resolved (duration 2 days).   The reporter considered the sickness to be related to Shingrix.     The company considered the sickness to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-SEP-2024 This case was reported by a patient via interactive digital media. The patient stated that, she was never so happy to get her shots though they made her feel sick. It only lasted 2 days and minimal compared to shingles. The reporter watched both her in-laws suffer through shingles.
Age: 37.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult female accidentally given Pediatric dose of Engerix-B; adult female accidentally given Pediatric dose of Engerix-B; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 37-year-old female patient who received HBV (Engerix B pediatric) (batch number K4JH7, expiry date 09-JUL-2026) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult female accidentally given Pediatric dose of Engerix-B) and adult use of a child product (Verbatim: adult female accidentally given Pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 11-SEP-2024 The nurse reported that a 37 year old adult female was accidentally injected with a pediatric dose of Engerix-B to the left deltoid which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020).   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: 2nd dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2024 A pharmacist called to ask if a patient got her 1st dose of Shingrix on 2020 and now she wanted to receive the next dose, did she needs to repeat the series. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal discomfort, Abdominal pain, Pain, Ultrasound scan normal, Urine analysis normal
Clinical narrative: pain and burning sensation located in his right mid abdomen; pain and burning sensation located in his right mid abdomen; generalized soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 49-year-old male patient who received HAB (Twinrix adult) (batch number 4KF75, expiry date 03-JAN-2025) for prophylaxis.   On 02-JUL-2024, the patient received the 1st dose of Twinrix adult (intramuscular, left arm). On 04-JUL-2024, 2 days after receiving Twinrix adult, the patient experienced abdominal pain (Verbatim: pain and burning sensation located in his right mid abdomen), burning sensation in abdomen (Verbatim: pain and burning sensation located in his right mid abdomen) and general body pain (Verbatim: generalized soreness). In JUL-2024, the outcome of the abdominal pain and burning sensation in abdomen were resolved (duration 2 days) and the outcome of the general body pain was resolved (duration 1 week).   It was unknown if the reporter considered the abdominal pain, burning sensation in abdomen and general body pain to be related to Twinrix adult and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the abdominal pain, burning sensation in abdomen and general body pain to be related to Twinrix adult and Twinrix 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.   Linked case(s) involving the same patient:  US2024AMR114575   Additional Information: GSK Receipt Date: 13-SEP-2024 The patient self reported this case. The reporter reported that after receiving the first dose of Twinrix adult, 48 hours after the first dose in his left arm he had pain and a burning sensation located in his right mid abdomen that lasted 2 days and then resolved. The reporter reported when the symptoms resolved a generalized soreness remained in the area for a week. The patient went back to the urgent care to report symptoms. The urine kidney analysis and ultrasound were performed with normal results. For tolerance of 2nd dose refer case US2024AMR114575.; Sender's Comments:  US-GSK-US2024AMR114575:Same patient/Dose 2
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: received 2 doses of Bexsero at age 11. Now patient is 16 year old and received another dose; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 16-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 2 doses of Bexsero at 11 years of age).   On an unknown date, the patient received the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced extra dose administered (Verbatim: received 2 doses of Bexsero at age 11. Now patient is 16 year old and received another dose). The outcome of the extra dose administered was unknown.   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: 13-SEP-2024 The physician reported that she had a patient who had received 2 doses of Bexsero vaccine and now (during the reporting days) received another dose, which led to extra dose administered. The health care provider asked if the patient needed an extra dose.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: Additional Dose Given Inadvertently to a pregnant patient; Additional Dose Given Inadvertently to a pregnant patient; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 38-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 12-SEP-2024, the patient received the 2nd dose of Boostrix. On 12-SEP-2024, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: Additional Dose Given Inadvertently to a pregnant patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Additional Dose Given Inadvertently to a pregnant patient). The outcome of the vaccine exposure during pregnancy and extra dose administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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: 16-SEP-2024 The practice manager called to report an additional dose of Boostrix given inadvertently to a pregnant patient. 1st dose was administered on 28th August 2024 and second dose the one its being reported in this case was administered on 12th September 2024 which led to vaccine exposure during pregnancy and extra dose administered. The practice manager wanted to know any concerns about this dose administration. Nevertheless, due to a system error in the practice managers end did not provide any detail about it at all. No further information was provided from the practice managers end.
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: administered Arexvy on September 21, 2023 and another dose on September 8, 2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) and (batch number KD424, expiry date 27-JAN-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 21st September 2023).   On 08-SEP-2024, the patient received the 2nd dose of Arexvy. On 08-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: administered Arexvy on September 21, 2023 and another dose on September 8, 2024.). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-SEP-2024 The pharmacist reported that the administration of a 2nd dose of Arexvy to the patient was administered Arexvy on 21st September 2023 and another dose on 08th September 2024 which led to extra dose administered. This case has been linked to the US2024114963 case reported by the same reporter.; Sender's Comments:  US-GSK-US2024114963:Same reporter,Different patient
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised state/ started T-Cell transfer therapy after Shingrix series; This serious case was reported by a pharmacist via call center representative and described the occurrence of immunocompromised in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced immunocompromised (Verbatim: immunocompromised state/ started T-Cell transfer therapy after Shingrix series) (serious criteria GSK medically significant and clinically significant/intervention required). The outcome of the immunocompromised was unknown.   It was unknown if the reporter considered the immunocompromised to be related to Shingrix and Shingrix.     The company considered the immunocompromised to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-SEP-2024 The pharmacist reported that the patient had received both doses of Shingrix (approximate date would have been 2020-2021).  Since being vaccinated, the patient has had a T-Cell transfer therapy in September 2023 and had been advised by her oncologist that they might need to be revaccinated for shingles considering their immunocompromised state and reset of their immune system and t-cells. The reporter had researched on the website that GlaxoSmithKline provide as well as through other studies pertaining to Shingrix but have not found any evidence or definitive answer as to if this was recommended or safe to repeat vaccination. The reporter wanted to know if there was any way that GSK could help answer that question for him/her would greatly appreciate it.; Sender's Comments: Immunodeficiency is an unlisted event which is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Pneumonia legionella
Clinical narrative: She has been on antibiotics for Legionnaires' disease since a week and a half; This serious case was reported by a consumer via call center representative and described the occurrence of legionnaire's disease in a elderly female 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 legionnaire's disease (Verbatim: She has been on antibiotics for Legionnaires' disease since a week and a half) (serious criteria GSK medically significant). The patient was treated with chloramphenicol (Antibiotic). The outcome of the legionnaire's disease was unknown.   It was unknown if the reporter considered the legionnaire's disease to be related to Shingles vaccine.     The company considered the legionnaire's disease to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 18-SEP-2024 Patient stated that she received Shingles vaccine about 2 years ago.  She had been on antibiotics for Legionnaires' disease since a week and a half.  She did not knew the name of the vaccine.  Consented to follow up.; Sender's Comments: Pneumonia legionella is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID Vaccine. Past adverse reactions to the above products included No adverse effect with Pfizer COVID Vaccine.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant medication was not provided. Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by a non-health professional, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) AESI of Cerebrovascular accident, which occurred on an unknown date after an unspecified dose of SPIKEVAX COVID-19 VACCINE NOS. Prior dose of Pfizer vaccine for COVID-19 was received. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed.  No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of COVID-19 (Covid-19) in an 85-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: SPIKEVAX (Dose 1, Intramuscular, Left arm) on 13-Jan-2021, SPIKEVAX (Dose 2, Intramuscular, Left arm) on 09-Feb-2021, SPIKEVAX (Dose 3, Intramuscular, Left arm) on 25-Oct-2021, SPIKEVAX (Dose 4, Intramuscular, Left arm) on 09-Apr-2022, SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5 (Dose 5, Intramuscular and Left arm) on 27-Sep-2022. Past adverse reactions to the above products included No adverse effect with SPIKEVAX, SPIKEVAX, SPIKEVAX, SPIKEVAX and SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4-5.    On 14-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Aug-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-Aug-2024 to 21-Aug-2024 at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2024, SARS-CoV-2 test: Positive.         Date of birth was reported as ??-???-1937. Concomitant medication was not provided.