chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Unable to contact by phone. due to speaking only. Letter mailed to patient No response from letter mailed. Chart is flagged that patient needs repeat Hepatitis B vaccine.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shot given too soon; misread calendar.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Planning to become pregnant
Clinical narrative: Patient reported they were attempting to become pregnant; unfortunately, they were given the Heplisav-B vaccination.  The error was noted on 4/17/2024 when they came for the final vaccine of the Hepatitis B vaccine series.  The error was noted at that time, and patient reported that they had not become pregnant in that interval time.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: Provider did reach out to patient to let them know what had happened and what to look for in case there is a reaction to the vaccine.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Vomiting
Clinical narrative: swelling of the arm, redness, vomiting,
Age: 11.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to Health Department due to a power outage. The power came back on around 9:30a.m. when I arrived to work but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by CRNP. The vaccine was transported back to Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into system for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. Letter was mailed to patient. Patient returned on 05/22/2024. Tdap was repeated due to vaccine undergoing a temp excursion. Patient was counseled.
Age: 22.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pt was given a Moderna Covid 19 vaccine that was pass the use by date. Manufacture EXP was still with in date, but it was pass use by date recommended. No adverse event report after vaccine was administered
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Product storage error
Clinical narrative: On January 9, 2024 the vaccines in the clinic were moved to County Health Department due to a power outage. The power came back on around 9:30a.m. When I arrived to work, but I was advised by my supervisor to move the vaccine still in case it took a while for the refrigerator to return to the proper temperature. Vaccines were packed with ice packs and bubble wrap and transported by, CRNP. The vaccine was transported back to County Health Department that afternoon. A temperature excursion was noted on the digital data logger. Once returned to clinic the data logger was found to be beside the ice packs instead of by the vaccine. The vaccine manufacturers of the affected vaccine were notified and made aware of the temperature excursion. I notified the companies that the vaccine reached a temperature of 1.8 degrees Celsius. The max temperature that the vaccine reached during transport was 12.0 degrees Celsius. Per the vaccine companies, the only vaccine that was not recommended to use was the opened vial of IPOL and the opened MDV of Fluzone. They were discarded per the vaccine companies? recommendations.  Moving forward to April 10, 2024. The vaccine was transported again to County Health Department due to inclement weather that day. Vaccine was transported by my supervisor and returned on April 12, 2024. Another temperature excursion occurred when the vaccine was transported back to the clinic. The vaccine companies were again contacted for recommendations on viability of the vaccine. When contacting the vaccine companies, I was asked if any of the vaccines had undergone a previous temperature excursion. It was then when I pulled my documentation from the previous excursion that I realized I had read the temperature log incorrectly and that the vaccine had reached a temperature of negative 1.8 degrees Celsius instead of what I reported to the vaccine companies of a +1.8 Degrees Celsius. Therefore, in fact there were two 2 temp excursions one on January 9, 2024 and the other on April 12th, 2024.  A list of all patients that received vaccines between January 9-April 12th was compiled. The list was sorted through as to what patients received the affected vaccine. Patients were notified of questionable viability of vaccines and were offered and recommended to be revaccinated if desired. Notes were added into immprint for outside providers.  The process of packing vaccine during transport during emergencies had been reviewed by all staff to include packaging with conditioned water bottles instead of frozen ice packs. 04/30/2024-Nurse attempted phonecall. Letter to patient. Chart flagged. No response back from letter mailed. Patient needs repeat HPV due to vaccine undergoing a temperature excursion.
Age: 0.75
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Cough, Human rhinovirus test positive, Pyrexia, Respiratory tract congestion
Clinical narrative: She started with fever, 102.6 rectally 7 hrs after vaccines. Mom gave Motrin which brought temperature down. She did have cough & congestion the next day.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Rash developed a day after vaccine given
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist reported patient received first and second dose of GARDASIL 9 in 2019 and has now came back requesting to receive third dose of GARDASIL 9. No further information provided. No additional AE reported. No PQC reported.; Pharmacist reported patient received first and second dose of GARDASIL 9 in 2019 and has now came back requesting to receive third dose of GARDASIL 9. No further information provided. No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist and refers to a 23-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2019, the patient received the first and second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis, operator of device: health professional (strength, dose, lot #, expiry date, and route of administration were not provided).   On 22-APR-2024 (reported as now), the patient had come back requesting to receive third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration). No further information provided. No additional adverse event reported (No adverse event).
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse experience was reported; 1 dose of ProQuad given in error to an 18 yr old female; This spontaneous report was received from an Other Health Professional and referred to an 18-year-old female patient.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 16-MAY-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, 1 dosage form, lot #Y003883, expiration date: 08-MAY-2025, administered subcutaneously for prophylaxis (strength was not provided) in error.  The patient was an 18-year-old female, which was above the approved age in the prescribing information of 12 years (Product administered to patient of inappropriate age). No adverse experience was reported.  The reporter was calling to ask if the dose could be counted as valid or did the antigens need to be repeated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (MMRII) and varicella virus vaccine live (Oka/Merck) (VARIVAX).  The reporter later found her answer via a website.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Registered nurse called to report an expired dose of MMR II that was administered to one patient.; This spontaneous report was received from an other health professional (registered nurse) and refers to a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 16-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) injection, lot #W033285, expiration date: 03-MAY-2024, administered for prophylaxis (dose number, exact dose, anatomical location, and route of administration were not provided). Expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered to the patient (expired product administered). Call was disconnected before expired outcome could be delivered. No temperature excursion on the product was reported. No additional adverse event (AE) was reported (no adverse event).
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No side effects were reported. No additional AE reported; HCP calling to report inadvertently 4-year-old male patient received VARIVAX 2 days apart; HCP calling to report inadvertently 4-year-old male patient received VARIVAX 2 days apart; This spontaneous report was received from a physician and refers to a 4-year-old male patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 14-MAY-2024, the patient was vaccinated with the first dose varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #X026320, expiration date: 07-NOV-2025 (strength, exact dose and route of administration were not provided) administered for prophylaxis. It was the first time the 4-year-old boy was receiving varicella virus vaccine live (oka/merck) (VARIVAX) (Product administered to patient of inappropriate age).   On 16-MAY-2024, the patient inadvertently 4-year-old male patient received another dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection 2 days apart (Inappropriate schedule of product administration), lot #X026320, expiration date: 07-NOV-2025 (strength, exact dose and route of administration were not provided). No side effects were reported. No other information was provided by the reporter. No additional adverse event reported. No product quality complaint reported.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE; HCP called after administering VARIVAX and PROQUAD to two 12-month-old children see other AE case 02604857. Also requested information on adverse effects see request case 02604847. Consent to contact is yes. No adverse side effects were reported. No; This spontaneous report was received from a nurse referring to a 12-month-old patient (date of birth reported as "14-MAY-2025", discrepant information) of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 20-MAY-2024 (reported as "20-MAY-2025", discrepant information), the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Albumin status rHA Lot # x024913 with expiration date 14-APR-2025 and with varicella virus vaccine live (oka/merck)(VARIVAX) Lot # X026320 with expiration date 07-NOV-2025; both for prophylaxis (strength, dose, route of administration and anatomical location were not provided for the suspect vaccines) (inappropriate schedule of product administration). No additional adverse event (AE) was reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient has not had any symptoms. No additional AE; Nurse called and reported that an expired dose of ROTATEQ was administered to a patient.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 20-MAY-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose, lot #1947634, expiration date reported and confirmed as 05-MAY-2024 (strength and exact dose were not provided) administered orally for prophylaxis (Expired product administered). Nurse reported that an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid was administered to a patient and stated that patient had not had any symptoms. The product was not involved in any temperature excursions. No additional adverse event nor product quality complaint reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: received two doses of shingrix, within a month was diagnosed with a severe case of shingles; Painful Rash on right side of rib cage; This serious case was reported by a other health professional via sales rep and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on unknown date).   On an unknown date, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced shingles (Verbatim: received two doses of shingrix, within a month was diagnosed with a severe case of shingles) (serious criteria other: As per reporter) and painful rash (Verbatim: Painful Rash on right side of rib cage) (serious criteria other: As per reporter). The outcome of the shingles was unknown and the outcome of the painful rash was not reported.   The reporter considered the shingles to be related to Shingrix. It was unknown if the reporter considered the painful rash to be related to Shingrix.     The company considered the shingles to be related to Shingrix. It was unknown if the company considered the painful rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2024 The reporter reported patient received two doses of shingrix vaccine and within a month she was diagnosed with a severe case of shingles.  The patient had primary disease of painful rash on right side of her rib cage.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Post-acute COVID-19 syndrome, Serotonin syndrome
Clinical narrative: Serotonin Syndrome; Worsened shortness of breathe; Covid condition; This serious case was reported by a consumer and described the occurrence of serotonin syndrome in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eye dryness. Concomitant products included lifitegrast (Xiidra).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced serotonin syndrome (Verbatim: Serotonin Syndrome) (serious criteria GSK medically significant), shortness of breath (Verbatim: Worsened shortness of breathe) and covid-19 (Verbatim: Covid condition). The outcome of the serotonin syndrome and covid-19 were not reported and the outcome of the shortness of breath was not resolved.   It was unknown if the reporter considered the serotonin syndrome, shortness of breath and covid-19 to be related to Shingrix.     It was unknown if the company considered the serotonin syndrome, shortness of breath and covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-MAY-2024 The patient self-reported the case. The patient believed the Serotonin Syndrome occurred due to the long Covid condition after receiving the first dose of Shingrix shingles vaccine. The patient experienced worsened shortness of breath.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Flank pain, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; itching; continued sharp stabbing pain in my stomach and side is almost unbearable; 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.   The patient's past medical history included chickenpox (when the patient was young).   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), itching (Verbatim: itching) and stomach pain (Verbatim: continued sharp stabbing pain in my stomach and side is almost unbearable). The outcome of the vaccination failure was unknown and the outcome of the shingles and stomach pain were not resolved and the outcome of the itching was not reported.   It was unknown if the reporter considered the vaccination failure, shingles, itching and stomach pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, itching and stomach pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2024 This case was reported by a patient via interactive digital media. The patient got shingles shot a couple years ago and the patient have had shingles for 8 weeks and it was horrible.  The patient managed never to scratch the itching but the continued sharp stabbing pain in his/her stomach and side was almost unbearable. The patient would not wish this on his/her worst enemy if the patient had one. His/her heart went out to anyone that had to go through this. The patient hope relief came soon for all suffering with this. 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.
Sex: F
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure / came down with RSV; My mother took the shot and came down with RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure / came down with RSV) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: My mother took the shot and came down with RSV). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection was not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.   It was unknown if the company considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2024 This case was reported by a patient's child via interactive digital media. The patient took the RSV vaccine and came down with RSV (Respiratory syncytial virus infection). This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of respiratory syncytial virus infection were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Depressed mood, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles every six months; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles every six months). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 18-MAY-2024 The patient received two shots, three years ago, maybe. Now, the patient get shingles at least every six months. The patient was not happy, about this and considering calling lawyer. This case was considered as suspected vaccination failure as details regarding laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles every six months; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles every six months). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 18-MAY-2024 The patient received two shots, three years ago, maybe. Now, the patient get shingles at least every six months. The patient was not happy, about this and considering calling lawyer. This case was considered as suspected vaccination failure as details regarding laboratory confirmation for shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Depressed mood, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles at least 6 times; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult 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 (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles at least 6 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 20-MAY-2024 Consumer called stating she was completely vaccinated with Shingrix several years ago and since that times she has developed shingles at least 6 times (lack of effect.)  The patient stated  the shingles were in the same spot every time she has an episode on her bottom.  The first time she had shingles was approximately 6 months after completion of vaccine series. The consumer was unable to provide lot number or dates of vaccination, but stated she would call back with that information.  The patient was currently experiencing a case of shingles that began about 3 or 4 days ago.  The patient stated when she was vaccinated, the vaccine was administered in the left arm.. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter did provide consent for follow up.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; developed shingles at least 6 times; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult 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 (left arm) and the 1st dose of Shingrix (left arm). On an unknown date, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: developed shingles at least 6 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 20-MAY-2024 Consumer called stating she was completely vaccinated with Shingrix several years ago and since that times she has developed shingles at least 6 times (lack of effect.)  The patient stated  the shingles were in the same spot every time she has an episode on her bottom.  The first time she had shingles was approximately 6 months after completion of vaccine series. The consumer was unable to provide lot number or dates of vaccination, but stated she would call back with that information.  The patient was currently experiencing a case of shingles that began about 3 or 4 days ago.  The patient stated when she was vaccinated, the vaccine was administered in the left arm.. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. The reporter did provide consent for follow up.
Sex: U
Vaccine: RVX
Symptoms: Malaise
Clinical narrative: made me so sick still sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: made me so sick still sick). The outcome of the sickness was not resolved.   The reporter considered the sickness to be related to RSV vaccine.  The company considered the sickness to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 14-MAY-2024 This case was reported by a patient via interactive digital media. The patient stated that do not got the shots and get all shots but RSV vaccine made him/her so sick still sick. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: unbearable pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: unbearable pain). The outcome of the pain was resolved (duration 28 days).   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2024 This case was reported by a patient via interactive digital media. The patient got vaccinated 4 years ago and experienced unbearable pain for 28 days.
Sex: M
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: received 3 doses of Hep-B vaccine when he was young but now that he got his titers and was negative for Hep-B; received 2nd dose on 25-OCT-2002 and 3rd dose on 28-FEB-2003; received 1st dose on 04-JUN-2002 and 2nd dose on 25-OCT-2002; This non-serious case was reported by a nurse via call center representative and described the occurrence of therapy non-responder in a 22-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 04-JUN-2002, the patient received the 1st dose of Hepatitis B vaccine. On 25-OCT-2002, the patient received the 2nd dose of Hepatitis B vaccine. On 28-FEB-2003, the patient received the 3rd dose of Hepatitis B vaccine. On 25-OCT-2002, not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, an unknown time after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: received 1st dose on 04-JUN-2002 and 2nd dose on 25-OCT-2002). On 28-FEB-2003, the patient experienced drug dose administration interval too short (Verbatim: received 2nd dose on 25-OCT-2002 and 3rd dose on 28-FEB-2003). On an unknown date, the patient experienced therapy non-responder (Verbatim: received 3 doses of Hep-B vaccine when he was young but now that he got his titers and was negative for Hep-B). The outcome of the therapy non-responder, drug dose administration interval too long and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 08-MAY-2024 The licensed practical nurse reported that the patient had received 3 doses of Hepatitis-B vaccine when he was young but now that he got his titers and it was negative for Hepatitis-B, which led to, therapy non-responder. The hospital recommended an accelerated series of Twinrix or Hepatitis-B because he would go to school soon. The medical information placed an outbound call to clarify if the 3 prior Hepatitis B vaccines were Engerix-B, the reporter explained it was not written in the vaccination card, neither the lot numbers, but provided dates of vaccination. The reporter reported that if vaccines were Engerix-B, it did not correspond with schedule from PI. The reporter also mentioned that the patient ended up administering Twinrix vaccine on 8th May 2024 following indications from patient's healthcare provider of a fast track schedule. The patient received 2nd dose of Hepatitis-B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Hepatitis-B vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled. The reporter consented the follow up.
Sex: M
Vaccine: RSV
Symptoms: Product preparation error
Clinical narrative: a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,; a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FK5AC, expiry date 23-MAR-2025) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,) and inappropriate dose of vaccine administered (Verbatim: a patient received a dose of Arexvy but it had been reconstituted with the wrong diluent,). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAY-2024 The director of operations (other healthcare professional) called and requested on how to proceed after the patient received a dose of Arexvy but it had been reconstituted with the wrong diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked if the previous question was true what risks were present if a second dose was given and asked what would be the time frame that would be recommended in this scenario. They did clarify that there was a possibility that 1 patient out of 4 had been affected but were unsure as to whom and were also unsure about the vaccination date, stating it could have taken place between November 2023 and March 2024.  They provided data for the 4 patients and vaccine. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2024060819:Same reporter / different patient US-GSK-US2024060817:Same reporter / different patient US-GSK-US2024060818:Same reporter / different patient
Age: 0.33
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Fever; wanting to know information on giving Boostrix to a 4 month old; giving Boostrix to a 4 month old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fever in a 4-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Polio vaccine for prophylaxis.   In MAR-2024, the patient received Boostrix, Hepatitis B vaccine and Polio vaccine. In MAR-2024, an unknown time after receiving Boostrix and not applicable after receiving Hepatitis B vaccine, the patient experienced accidental underdose (Verbatim: wanting to know information on giving Boostrix to a 4 month old) and inappropriate age at vaccine administration (Verbatim: giving Boostrix to a 4 month old patient). On an unknown date, the patient experienced fever (Verbatim: Fever). The outcome of the fever, accidental underdose and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the fever to be related to Boostrix and Hepatitis B vaccine.     It was unknown if the company considered the fever to be related to Boostrix and Hepatitis B vaccine.   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: 14-MAY-2024 and 17-MAY-2024 The pharmacist wanted to know information on giving Boostrix to a 4 month old which led to inappropriate age at vaccine administration and accidental underdose. The pharmacist called the parents of the patient to notify them of the mistake and they said, the patient was okay just the normal fever for the vaccines. The patient had Tdap, hepatitis b and polio vaccine in March 2024. The pharmacist clarified that, the patient not had any symptoms, except for a fever on Tuesday. It was unknown if the reporter considered the fever to be related to Polio vaccine. The vaccine administration facility was the same as primary reporter. This case had been link with US2024060830, reported by the same reporter.; Sender's Comments:  US-GSK-US2024060830:Same reporter
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G increased
Clinical narrative: elevated IgG levels after 2 doses of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of immunoglobulin g increased in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (unsure got chicken pox in the past). Previously administered products included Shingrix (received 1st dose Shingrix on 23-JAN-2020).   On 09-JUN-2020, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced immunoglobulin g increased (Verbatim: elevated IgG levels after 2 doses of Shingrix). The outcome of the immunoglobulin g increased was not resolved.   It was unknown if the reporter considered the immunoglobulin g increased to be related to Shingrix.     It was unknown if the company considered the immunoglobulin g increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2024 The nurse practitioner had a patient who was unsure got chicken pox in the past, received 2 doses of Shingrix and his igG (immunoglobulin g) levels were elevated now (at the time of reporting).
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received the 1st dose of Engerix-B in June 2023 and received their second dose today; 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 long in a 45-year-old female patient who received HBV (Engerix B adult) (batch number 3X937, expiry date 07-DEC-2025) for prophylaxis.   Previously administered products included Engerix B (The patient received first dose of Engerix B vaccine on June 2023).   On 15-MAY-2024, the patient received the 2nd dose of Engerix B adult. On 15-MAY-2024, an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: patient received the 1st dose of Engerix-B in June 2023 and received their second dose today). 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: 15-MAY-2024 The other health professional reported that the female patient received the 1st dose of Engerix B in June 2023. The patient received their second dose of Engerix B at the time of reporting, which led to drug dose administration interval to long. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received the first dose of Shingrix more than 2 years ago needed to re start the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient who received the 1st dose of Shingrix more than 2 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received the first dose of Shingrix more than 2 years ago needed to re start the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2024 The healthcare professional asked if a patient who received the 1st dose of Shingrix more than 2 years ago needed to re start the series. The HCP did not provide exact date of administration for the first dose. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 15-MAY-2024, the patient received Priorix. On 15-MAY-2024, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used 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: 15-MAY-2024 A medical assistant informed that a Priorix vaccine was given on the day of reporting and it actually turned out to be expired by a couple days. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A female patient got his first dose of Shingrix on October 2020 and the second dose of Shingrix on February 2024.; 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 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in October 2020).   In FEB-2024, the patient received the 2nd dose of Shingrix. In FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: A female patient got his first dose of Shingrix on October 2020 and the second dose of Shingrix on February 2024.). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-MAY-2024 The patient received second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule. The vaccine administration facility was the same as primary reporter.