chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Spinal cord compression, Urinary tract infection, Urine analysis
Clinical narrative: Here is a summary of the medical events for your VAERS application:  Vaccine: 2/21/21 Booster 5/12/21 Symptoms Started: June 6, 2021 - woke up with sore forearms, difficulty swallowing, facial pulling, and slow speech. Urgent Care: June 7, 2021 ? Admitted, diagnosed with dehydration, given IV fluids and antibiotics for diarrhea. Symptoms Continued: June 7?10, 2021 ? Symptoms did not improve, continued diarrhea. Primary Doctor Appointment: June 10, 2021 ? Sent to ER. Tests: Blood work, EKG, heart test, chest X-ray, CT scan, urine sample. Diagnosis: Severe UTI, treated with antibiotics (oral and shot), advised to follow up with a neurologist for GBS. Follow-up: June 12, 2021 ? Felt the same, ER visit for an MRI as recommended by the primary doctor. Admission: June 12, 2021 ? Admitted received MRI of head and neck, spinal CT scan, and morphine for head pain. Transfer to CCU: June 13, 2021 ? Possible surgery for spinal cord compression, but doctors decided to delay surgery. Additional tests ordered to determine infection type. Lumbar Test: June 14, 2021 ? Fluid removed from spine, experienced tingling down the left leg and a cold sensation on the head. Severe headache treated with 100mg Tylenol, some relief. Symptoms Returned: June 14, 2021 ? Felt better in the morning but some symptoms, like a heavy head, returned in the evening after a visit from Dr. Status Update: June 15, 2021 ? Woke up feeling fair, PA updated on the status of the condition. diagnosed with GBS disease and attended Physical Therapy for months after
Age: 73.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received DTap (Kinrix) instead of Tdap (Boostrix). Patient was aware. No adverse reactions noted. Patient will come back for correct dose.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Ocular discomfort, Pain in extremity
Clinical narrative: Very sore arm overnight, persistent pain/pressure behind one eye (feelings of a migraine)
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine.  10-week expiration date was 12/31/2024
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 25Oct2024, outcome "unknown", described as "Not feeling well".  Additional information: The patient received his COVID-19 shot on the same day as his wife. He started feeling unwell that evening.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202500007730 same reporter, drug, different patient and event;UM-PFIZER INC-202500043036 same patient, same product, same dose and different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Not feeling well; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 25Oct2024, outcome "unknown", described as "Not feeling well".  Additional information: The patient received his COVID-19 shot on the same day as his wife. He started feeling unwell that evening.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202500007730 same reporter, drug, different patient and event;UM-PFIZER INC-202500043036 same patient, same product, same dose and different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: a light case of COVID-19/ sick/ like the flu; a light case of COVID-19/ sick/ like the flu; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2025, outcome "unknown" and all described as "a light case of COVID-19/ sick/ like the flu". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2025) light case of covid-19. The patient received his COVID-19 shot on the same day as his wife. He started feeling unwell that evening. After the patient's wife found out she had covid-19 on 08Jan2025, she did a home test kit on the patient and it showed he might have had a light case of covid-19. He was sick, but it was like the flu.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-202500043035 same patient, same product, same dose and different events;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: a light case of COVID-19/ sick/ like the flu; a light case of COVID-19/ sick/ like the flu; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 25Oct2024 as dose 1, 0.3 ml single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2025, outcome "unknown" and all described as "a light case of COVID-19/ sick/ like the flu". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2025) light case of covid-19. The patient received his COVID-19 shot on the same day as his wife. He started feeling unwell that evening. After the patient's wife found out she had covid-19 on 08Jan2025, she did a home test kit on the patient and it showed he might have had a light case of covid-19. He was sick, but it was like the flu.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-202500043035 same patient, same product, same dose and different events;
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired vaccine administered; This spontaneous report was received from a/an Consumer or other non health professional and refers to a(n) 76-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date, the patient started therapy with Pneumococcal Vaccine, Polyvalent (23-valent) (lot #X018278, expiration date: 24-Nov-2024) 0.5 mL (1 syringe / 0.5-mL dose), for an unknown indication.  On 06-Feb-2025, the patient experienced expired vaccine administered. On an unknown date, the patient experienced No additional AE reported.   At the reporting time, the outcome of expired vaccine administered and No additional AE reported was unknown.   The action taken with Pneumococcal Vaccine, Polyvalent (23-valent) was reported as not applicable.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Accident at work, Skin laceration, Syringe issue
Clinical narrative: 1 of 10 PFS were damaged; The medical assistants were cut by the glass; This spontaneous report was received from a consumer referring to a female patient of unknown age. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient, a medical assistant, was cut by the glass of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot# was unable to be confirmed, could be lot#: Y008843 with expiration date of 27-NOV-2026 or lot#: Y012776 with expiration date of 08-JAN-2027 (Injury associated with device). The prefilled syringe was damaged (syringe broken).
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Skin laceration, Syringe issue
Clinical narrative: injured by broken GARDASIL 9 PFSs; injured by broken GARDASIL 9 PFSs; This spontaneous report was received from a/an Consumer or other non health professional (reported as office manager) referring to a female patient (medical assistant) of unknown age.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On an unknown date, the patient was injured by broken Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) prefilled syringes (PFSs) (injury associated with device, syringe broken). The patient was cut by the glass and no patients were involved. It was reported that there were 2 different lots of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) involved; lot #Y008843, expiration date: 27-Nov-2026, 1 of 10 PFS were damaged and lot #Y012776, expiration date: 08-Jan-2027, 2 of 10 PFS were damaged. It was unable to identify which lot # was caused the injury to this patient.
Age: 58.0
Sex: F
Vaccine: PNC21
Symptoms: Myelitis transverse, Paraesthesia
Clinical narrative: Reported called on behalf of HCP who reported a 58-year-old female patient experienced tingling below her neck down to her breast (side of body unknown by reporter) after being administered CAPVAXIVE.  Patient administered vaccine on 2/4/2025 and reported; This spontaneous report was received from a physician referring to a 58-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On 04-FEB-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine Solution (CAPVAXIVE) injection, 0.5 ml administered intramuscularly (vaccination scheme frequency, and anatomical location were not provided; invalid lot number Y013099, with expiration date on 17-NOV-2028). On an unknown date, after being vaccinated, the patient experienced tingling below her neck down to her breast of body. On 17-FEB-2025, the patient reported the adverse event to the physician, and the physician stated he feels symptoms are due to transverse myelitis.   It was not reported if the patient received any treatment for this adverse event. The physician reported the patient was sent and admitted to the hospital for a neurological workup. At the time of the reporting, the outcome of the event was unknown.   The causal relationship between the event and the suspect vaccine was not reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Syncope, Vaccine positive rechallenge
Clinical narrative: faint; fainting; This spontaneous report was received from a pharmacist and referring a female patient of unknown age.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) for prophylaxis (dose, expiration date, and lot # were not reported). And the patient was fainting after the vaccination (syncope). On approximately December 2024 (reported as about 2 months ago), the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) for prophylaxis (dose, expiration date, and lot # were not reported). And patient fainted (syncope). At the reporting time, the outcome of both events was not reported.   The causal relationship between both events and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was unknown/not reported/not provided.   Upon internal review, the events of faint and fainting were determined to be medically significant.
Sex: M
Vaccine: RVX
Symptoms: Cough, Malaise, Pyrexia, Respiratory syncytial virus infection, Respiratory syncytial virus test positive
Clinical narrative: sick; Vaccination failure; consumer reports he tested positive for RSV/lack of effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In NOV-2024, the patient received RSV vaccine (left arm). On 02-JAN-2025, between 2 and 3 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: consumer reports he tested positive for RSV/lack of effect). On an unknown date, the patient experienced sickness (Verbatim: sick). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection and sickness to be unrelated to RSV vaccine.   Additional Information: GSK receipt date: 24-FEB-2025 The patient was vaccinated with an RSV vaccine sometime in November of 2024.  The consumer experienced coryza, excessive mucus production, cough and low-grade fever.  Consumer stated he was sick for approximately one month but was not hospitalized.  The consumer stated that he did not know which RSV vaccine he received in left arm. Consumer declined to provide any demographic information.  No further information was provided including lot number, date of vaccination, vaccine name/manufacturer.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Respiratory syncytial virus infection and Illness are unlisted event which is considered unrelated to GSK RSV vaccine.
Sex: M
Vaccine: RVX
Symptoms: Rhinitis, Secretion discharge, Vaccination failure
Clinical narrative: sick; Vaccination failure; consumer reports he tested positive for RSV/lack of effect; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In NOV-2024, the patient received RSV vaccine (left arm). On 02-JAN-2025, between 2 and 3 months after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: consumer reports he tested positive for RSV/lack of effect). On an unknown date, the patient experienced sickness (Verbatim: sick). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported and the outcome of the sickness was resolved.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and sickness to be related to RSV vaccine.     The company considered the vaccination failure, respiratory syncytial virus infection and sickness to be unrelated to RSV vaccine.   Additional Information: GSK receipt date: 24-FEB-2025 The patient was vaccinated with an RSV vaccine sometime in November of 2024.  The consumer experienced coryza, excessive mucus production, cough and low-grade fever.  Consumer stated he was sick for approximately one month but was not hospitalized.  The consumer stated that he did not know which RSV vaccine he received in left arm. Consumer declined to provide any demographic information.  No further information was provided including lot number, date of vaccination, vaccine name/manufacturer.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix. Respiratory syncytial virus infection and Illness are unlisted event which is considered unrelated to GSK RSV vaccine.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: first dose of SHINGRIX 8 years ago; diagnosed as shingles; This non-serious case was reported by a consumer via patient support programs and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: diagnosed as shingles) and incomplete course of vaccination (Verbatim: first dose of SHINGRIX 8 years ago). The patient was treated with valaciclovir hydrochloride (Valtrex). The outcome of the shingles was resolved (duration 1 day) and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter stated he was vaccinated with his first dose of Shingrix 8 years ago. Consumer stated he had not had a second dose of Shingrix. Consumer stated last week he had a rash that was diagnosed as shingles. Consumer stated he was prescribed Valtrex and the rash cleared up in one day.  Consumer stated he went to a different doctor and was told that he most likely did not have shingles. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Injection site pain and redness; Injection site pain and redness; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-FEB-2025, the patient received the 2nd dose of Shingrix (unknown arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain and redness) and injection site erythema (Verbatim: Injection site pain and redness). The outcome of the injection site pain and injection site erythema were resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingrix.     The company considered the injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-FEB-2025 The nurse reported that a  patient received Shingrix vaccine after that experienced injection site pain and redness.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore for 5 days, that's it; This non-serious case was reported by a consumer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: arm was sore for 5 days, that's it). The outcome of the pain in arm was resolved (duration 5 days).   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-FEB-2025 The reporter reported that he/she took the Shingrix vaccine, arm was sore for 5 days, that's it.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Got sick with the shingles shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Got sick with the shingles shot). 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: 21-FEB-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she took the shingles shot and got sick. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Pain in extremity
Clinical narrative: my arm is so sore; I feel weak; tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19-FEB-2025, the patient received the 1st dose of Shingles vaccine. In FEB-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm is so sore), weakness (Verbatim: I feel weak) and tiredness (Verbatim: tired). The outcome of the pain in arm, weakness and tiredness were not reported.   It was unknown if the reporter considered the pain in arm, weakness and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, weakness and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-FEB-2025. This case was reported by a patient via interactive digital media. Patient got first shot yesterday and patient arm was so sore.  Patient felt weak and tired.  The reporter asked if  this was the side effects to getting that shot.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspect 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.   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: suspect 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.     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: 23-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that they were vaccinated but still got shingles. The reporter had a request please did get vaccinated so at least it will be a milder case. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Age: 5.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Engerix-B was given earlier; Second dose of Havrix was given a month earlier; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 5-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Havrix (received 1st dose of vaccine on 15th march 2023 with batch number W023937 and expiry date 6th December 2023). Concomitant products included HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX B).   On 16-AUG-2023, the patient received the 2nd dose of Havrix. On an unknown date, the patient received the 2nd dose of Engerix B. On 16-AUG-2023, an unknown time after receiving Havrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Second dose of Havrix was given a month earlier). On an unknown date, the patient experienced drug dose administration interval too short (Verbatim: Second dose of Engerix-B was given earlier). The outcome of the drug dose administration interval too short and drug dose administration interval too short 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: 30-JAN-2025 On 30th January  2025, a reporter called to report that a male child patient had received the first dose of Havrix in March 2023 and the second dose on 16th August 2023. Second dose of Havrix had been given a month earlier, which led to Drug dose administration interval too short. They asked if the vaccine needed to be redone and if the patient needed a booster dose.  They also mentioned that it was the same scenario for Engerix-B. Second dose of Engerix-B was given earlier, which led to Drug dose administration interval too short.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: it sprayed out from the tip onto the patient skin; it sprayed out from the tip onto the patient skin; sprayed out from the tip; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of exposure via skin contact in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced exposure via skin contact (Verbatim: it sprayed out from the tip onto the patient skin), inadvertent exposure to vaccine (Verbatim: it sprayed out from the tip onto the patient skin), syringe leak (Verbatim: sprayed out from the tip) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the exposure via skin contact, inadvertent exposure to vaccine, syringe leak and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the syringe leak to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the syringe leak 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: 03-FEB-2025 The other health professional reported that Boostrix vaccine was administered by a experienced nurse.  The nurse states that as the medication was being administered it sprayed out from the tip onto the patient skin which led to inadvertent exposure to vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Poor quality product administered, Product complaint, Wrong technique in product usage process
Clinical narrative: Product Complaint; Injection hurt; bubbles like a soda/it was too bubbly; pharmacist did not shake the vial, it was gently swirled; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number 4H79Y, expiry date 13-NOV-2026) and (batch number HA5HL) for prophylaxis. This case was associated with a product complaint.   On 03-FEB-2025, the patient received Shingrix. On 03-FEB-2025, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection hurt), poor quality vaccine administered (Verbatim: bubbles like a soda/it was too bubbly) and wrong technique in drug usage process (Verbatim: pharmacist did not shake the vial, it was gently swirled). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain was unknown and the outcome of the poor quality vaccine administered, wrong technique in drug usage process and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-FEB-2025 The pharmacist reported that during and after reconstitution, the Shingrix solution bubbles like a soda. The pharmacist floats to other pharmacies and had noticed this lately when reconstituting Shingrix, confirmed that the pharmacist did not shake the vial, it was gently swirled which led to wrong technique in drug usage process.  The pharmacist reported, 2 doses day before reporting were from lot 4H79Y (adjuvant HA5HL) that was very bubbly which led to poor quality vaccine administered. The pharmacist had to discard one dose because she was unable to withdraw a full dose because it was too bubbly (was only able to withdraw 0.2 to 0.3 milliliters).  The other she was able to eliminate most of bubbles from the syringe and administer a full dose.  However, the patient complained that the injection hurt because the pharmacist left one small bubble. The defect was discovered during preparation for administration; after half way through the multipack. One dose was discarded (not administered), the other was administered.  There was no visible damage present on the vial. There were no temperature excursions during storage. Bak Snap, 25 gauge, 1 inch needle was used. The particle observed when the adjuvant was introduced into the antigen vial.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: adjuvant portion of the Shingrix vaccine was administered to a patient; adjuvant portion of the Shingrix vaccine was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 334T3, expiry date 29-OCT-2026) for prophylaxis.   On 23-JAN-2025, the patient received Shingrix. On 23-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: adjuvant portion of the Shingrix vaccine was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: adjuvant portion of the Shingrix vaccine was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 10-FEB-2025 On 10th February 2025, reporter called to report that only the adjuvant portion of the Shingrix vaccine was administered to a patient on 23th January 2025, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Incomplete 2nd dose; Vaccine in contact with the patient skin; Vaccine in contact with the patient skin; the needle was not secure enough; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2024).   On 07-FEB-2025, the patient received the 2nd dose of Shingrix. On 07-FEB-2025, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Incomplete 2nd dose), exposure via skin contact (Verbatim: Vaccine in contact with the patient skin), inadvertent exposure to vaccine (Verbatim: Vaccine in contact with the patient skin) and wrong technique in product usage process (Verbatim: the needle was not secure enough). The outcome of the incomplete dose administered, exposure via skin contact, inadvertent exposure to vaccine and wrong technique in product usage process were not applicable.   Additional Information: GSK Receipt Date: 17-FEB-2025 On 17th February 2025 a registered pharmacist called and reported the following that they had an incident, where they were administering the 2nd dose for Shingrix vaccine, and the needle wasn't secure enough which led to wrong technique in product usage process, so when they injected the vaccine some squirted out for in-between the needle and the syringe which led to incomplete dose administration. Do they need to readminister the 2nd dose? The vaccine administration facility was the same as primary reporter. The 1st dose was administered in October 2024, but never specified the date. Healthcare professional mentioned that due to the situation the vaccine got in contact with the patient's skin which led to exposure via skin contact and inadvertent exposure to vaccine.
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received their second dose of Twinrix 6 months after the first; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received their second dose of Twinrix 6 months after the first ). The outcome of the drug dose administration interval too long 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: 20-FEB-2025 The pharmacist reported that a patient received their second dose of Twinrix 6 months after the first dose. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 12 month old patient received an adult dose of Havrix; 12 month old patient received an adult dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-month-old male patient who received HAV (Havrix adult) (batch number 2345B, expiry date 02-FEB-2026) for prophylaxis.   The patient's past medical history included thrombocytopenia.   On 17-FEB-2025, the patient received Havrix adult. On 17-FEB-2025, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: 12 month old patient received an adult dose of Havrix) and adult product administered to child (Verbatim: 12 month old patient received an adult dose of Havrix). The outcome of the accidental overdose and adult product administered to child 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: 21-FEB-2025 The healthcare provider reported that a 12 month old patient received an adult dose of Havrix which led to accidental overdose and adult product administered to child. The reporter mention that patient has history of thrombocytopenia.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix early second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number E3XT9, expiry date 19-JUN-2026) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 21-AUG-2024, the patient received the 2nd dose of Shingrix. On 21-AUG-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix early second dose). The outcome of the drug dose administration interval too short was not applicable.   Additional Information: GSK Receipt Date: 25-FEB-2025 The pharmacist asked if a patient should be revaccinated with Shingrix after she had the second dose 50 days after the first dose which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: A 43 years old female patient received the first dose of Twinrix on 10/17/2023 and did not came back for the 2nd and 3rd dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 43-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 17-OCT-2023 with batch number H3SG9 and lot expiry 03-JAN-2025).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: A 43 years old female patient received the first dose of Twinrix on 10/17/2023 and did not came back for the 2nd and 3rd dose.). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-FEB-2025 The pharmacist reported that a patient received the first dose of Twinrix but never came back for the 2nd and the 3rd dose.  The reporter was ask what would be the dosing schedule. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of Twinrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 52-year-old female patient who received HAB (Twinrix) (batch number B9279, expiry date 12-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix on 6th May 2023 with batch number 2PG309 and expiry date 19th September 2025).   On 09-JAN-2025, the patient received the 2nd dose of Twinrix. On 09-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Patient received second dose of Twinrix late). The outcome of the drug dose administration interval too long was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 25-FEB-2025 The reporter contacted GlaxoSmithKline to report that a 52 year old female patient received a dose of Twinrix on 6th May, and the second one on 9th January 2025  They wanted to know how the second dose should have been administered. Patient received second dose of Twinrix late, which led to Drug dose administration interval too long. This case is linked with US2025023743, reported by same reporter; Sender's Comments:  US-GSK-US2025023743:same reporter
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: had mini strokes; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had mini strokes) in a 57-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had mini strokes) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (had mini strokes) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported.  It was reported that, the reporter filled for her sister a years ago but never heard back from anyone. The patient was not able to live on her own. They had to retire her from her job and sold her home. She lived in a home then so others could help take care of her because it got too stressful for her to live with their other sister.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Severe tinnitus, both ears and middle ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Severe tinnitus, both ears and middle ear) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Severe tinnitus, both ears and middle ear). At the time of the report, TINNITUS (Severe tinnitus, both ears and middle ear) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: they had 2 abrysvo and it broke apart when they tried to enter the diluent into it; This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: LG9829, Expiration Date: Oct2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "they had 2 abrysvo and it broke apart when they tried to enter the diluent into it".  Causality for "they had 2 abrysvo and it broke apart when they tried to enter the diluent into it" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The pharmacist on the line was calling about Abrysvo and reported that they had 2 abrysvo and it broke apart when they tried to enter the diluent into it. They are seeking replacement. One of the Abrysvo was just broke. The top of the diluent was broken. She just needs the diluent replaced. It broke apart before they even inserted it into the vial. She was not dealing with the second one and doesn't know how it broke, but the diluent broke on that one as well. The caller said that both of the Abrysvo were all from the same box. The caller confirmed no patient involvement.
Sex: M
Vaccine: COVID19
Symptoms: Vitiligo
Clinical narrative: vitiligo; This is a spontaneous report received from a Physician from a sales representative.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURE UNKNOWN), for COVID-19 immunisation. The following information was reported: VITILIGO (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of vitiligo. Additional information: the patient was convinced it was related to COVID-19 vaccination.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: PNC20
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itching; rash; hives; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 65-year-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; RASH (non-serious), outcome "unknown"; URTICARIA (non-serious), outcome "unknown", described as "hives". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.