chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Neck pain, Pain
Clinical narrative: Friday Night 11/4/2022: extreme body aches - head to toe - different than previous 3 shots - considered emergent urgent care but stayed home. Saturday 11/5/2022: body aches, fevers, arm pain all day noticed red spot developing on arm below injection site and bruising at injection site. Sunday 11/6/2022: body aches, fevers, arm pain continued, and red site continued to grow, swell and became hard and hot and painful.  Monday 11/7/2022: tried to go to work and was continuing to have all of the above symptoms including developing shooting pain in my arm (red site was continuing to get larger and was still hot, hard and tender). Was encouraged by employee health (I work at a hospital - where I got the vaccine) to go to urgent care. Urgent care advised continued NSAID and Tylenol use and cold compress on arm and monitoring for signs that would require emergency room visit. Tuesday: symptoms continued; fever worsened otherwise other symptoms were the same. Did not go to work. Was contacted to follow up on my responses and advised to fill out a VAERS form. Wednesday: symptoms seem to be mildly improving. Arm is less red - some areas are bruised, and it is still tender. Body is still painful mostly in shoulders, armpits, and neck. Still feverish. Did not work today.
Age: 22.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Friday Night 11/4/2022: extreme body aches - head to toe - different than previous 3 shots - considered emergent urgent care but stayed home. Saturday 11/5/2022: body aches, fevers, arm pain all day noticed red spot developing on arm below injection site and bruising at injection site. Sunday 11/6/2022: body aches, fevers, arm pain continued, and red site continued to grow, swell and became hard and hot and painful.  Monday 11/7/2022: tried to go to work and was continuing to have all of the above symptoms including developing shooting pain in my arm (red site was continuing to get larger and was still hot, hard and tender). Was encouraged by employee health (I work at a hospital - where I got the vaccine) to go to urgent care. Urgent care advised continued NSAID and Tylenol use and cold compress on arm and monitoring for signs that would require emergency room visit. Tuesday: symptoms continued; fever worsened otherwise other symptoms were the same. Did not go to work. Was contacted to follow up on my responses and advised to fill out a VAERS form. Wednesday: symptoms seem to be mildly improving. Arm is less red - some areas are bruised, and it is still tender. Body is still painful mostly in shoulders, armpits, and neck. Still feverish. Did not work today.
Age: 8.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: N/A - Reporting incorrect vaccine administered
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Localized erythema, swelling, itching approximately 2 cm area at vaccination site to left deltoid.
Age: 81.0
Sex: M
Vaccine: FLUA4
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine. The vaccine was punctured on 11/4/22 at 1500 and expired 11/5/22 at 0300. Patient was given a dose from this same vial at 12:35pm on 11/6/22.
Age: 11.0
Sex: F
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: N/A - Reporting incorrect vaccine given - COVID booster
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: arm pain since date of vaccine, could not raise arm first two days, able to raise arm now but painful, shoulder hurts, will wake her at night, states the vaccine was given higher in the arm than it was previous years
Age: 75.0
Sex: F
Vaccine: FLU4
Symptoms: Sleep disorder
Clinical narrative: arm pain since date of vaccine, could not raise arm first two days, able to raise arm now but painful, shoulder hurts, will wake her at night, states the vaccine was given higher in the arm than it was previous years
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Received Pfizer 5-11 monovalent. Should have received Pfizer 5-11 Bivalent.
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4, HPV9, MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: N/A - Reporting incorrect vaccine given - COVID booster
Age: 13.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event
Clinical narrative: Mother did not report any adverse effect so far as this was admisnitered today. I encouraged the mother to monitor closely for any major adverse events
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This writer was informed by the clinical site lead RN, that the covering physician approved an first booster Novavax for the patient. This writer noted that it has not been 6 months since the patient last dose. This writer informed clinical site lead RN of this, Clinical site lead RN, informed this writer, that he verified with the covering physician, it was okay to vaccinate the patient. This writer repeated himself and verified that the covering physician approved the Novavax booster for the patient on 11/8/2022 even though it's has not been 6 months. Per clinical site lead RN, This writer received the okay to vaccinate patient with the Novavax booster with the covering physician approval even though it has not been 6 months.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE GIVEN  NO SIGNS AND SYMPTOMS REPORTED FROM PATIENT.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: no additional AEs; Caller reports that MMR II lot expired on 10/08/22 and was administered on 10/11/22; This spontaneous report was received from a clinical administrator and refers to a 9-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) subcutaneous injection, at a dose of 0.5 ml, once, lot # T034391 with expiration date of 08-OCT-2022 for prophylaxis (dose #, route of administration and anatomical location were not provided). No adverse event was reported.; Sender's Comments:  US-009507513-2210USA004126: US-009507513-2210USA004097:
Age: 18.0
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No AE; administration of expired vaccine; This spontaneous report was received from a medical assistant and refers to an 18-year-old male.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-NOV-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #T013724, expiration date: 21-APR-2022, therapy type rHA, administered for prophylaxis (strength and route of administration were not provided) (expired product administered).  No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported. No PQC reported; HCP reports patient was accidently administered an expired dose of PNEUMOVAX 23 on Oct 21, 2022; 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, and concomitant therapies were not reported.  On 21-OCT-2022, the patient was inadvertently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe, lot #U003306, expiration date: 15-OCT-2022 (strength, anatomical location, and route of administration were not provided) as prophylaxis. No adverse event was reported.
Age: 66.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; VAQTA that had undergone temperature excursion was administered to a patient; This spontaneous report was received from a nurse, concerning a 66-year-old female patient. Information regarding the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.  On an unknown date, there was a temperature excursion of 71 Fahrenheit degrees, for 8 hours and 36 minutes, registered for hepatitis a vaccine, inactivated (VAQTA). It was reported that there was no previous temperature excursion.  On 03-NOV-2022, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, product quantity: 1, lot #W008110, has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date: 27-OCT-2023 (dose, route of administration and anatomical location were not provided), administered for prophylaxis (product storage error).  There was no additional adverse event reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a vaccine was administered while undergoing a temperature excursion; This spontaneous report was received from an office manager (customer) referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 31-OCT-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, albumin status recombinant Human albumin (rHA)) (PROQUAD) (0.5 mL, lot # W023868, expiration date: 24-JAN-2024; strength, route and anatomical location was not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of minus 10 degree Celsius (C) up to 8 C for 35 hours 0 minutes 0 seconds and 9 C to 25 C (21.1 C) for 52 hours 0 minutes 0 (product storage error). The patient had no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant calling for TE evaluation states one dose of PROQUAD was administered to one patient on 11/3/2022.    ?    Names of vaccines involved (including lot/exp) PROQUAD  W010064  9/20/2023        ?    Temperature -10°C up to 8°C (-2.; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent.   On 03-NOV-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W010064, expiration date: 20-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided) following a temperature excursion of -10 degree Celsius up to 8 C (-2.7C) for 4 hours (product storage error), there was stated that no previous temperature excursion occurred. No additional adverse event were reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: The vaccine was administered after a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot # U032086 has been verified to be a valid lot number pneumococcal vaccine, polyvalent (23-valent), expiration date reported and establish as 29-AUG-2023) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 29.92° Fahrenheit (F) for 200 hours respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.
Sex: F
Vaccine: BCG, FLUX, HEP, HEPA, IPV, MMR, TTOX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous report has been received from a consumer via Pfizer, regarding to herself, a 49-years-old female patient. The patient's pertinent medical history included asthma, gastroesophageal reflux disease (GERD), aneurysm and irritable bowel syndrome as current condition, concomitant medications included omeprazole and amitriptyline. The patient's previous drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) subcutaneous injection, BCG vaccine (BCG VACCINE) powder for injection (reported as TB vaccine), Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (reported as Hepatitis A vaccine), Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) intramuscular injection (reported as Hepatitis B vaccine), a tetanus vaccine (unspecified), flue vaccine (unspecified) and a polio vaccine (unspecified) all as prophylaxis (strengths, doses, schemes, routes and anatomical locations of administration, lot numbers and expiration dates were not reported).  On an unspecified date, the patient experienced sore arm (Pain in extremity), which was reported as being a result of these previously mentioned vaccines. The outcome of Pain in extremity was not reported.   The causal relationship between Pain in extremity and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), BCG vaccine (BCG VACCINE), Hepatitis A Vaccine, Inactivated (VAQTA), Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), tetanus vaccine (unspecified), flue vaccine (unspecified) and a polio vaccine (unspecified) was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other information or concern noted; Nurse calling to report that a patient was administered expired dose of MMR II on 11/7/2022.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-NOV-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) valid lot #T034389, expiration date: 08-OCT-2022 (strength, dose, frequency, anatomical location, and route of administration were not provided) for prophylaxis. Additional information or adverse event were not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information was provided; an adult patient was accidentally given a pediatric dose of VAQTA; an adult patient was accidentally given a pediatric dose of VAQTA; This spontaneous report was received from registered nurse and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 07-NOV-2022, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml, administered for prophylaxis (strength, lot number, expiration date, and route of administration were not provided) (incorrect dose administered, product administered to patient of inappropriate age). No additional adverse event information was provided (no adverse event).
Sex: F
Vaccine: FLUN4, FLUN4
Symptoms: COVID-19
Clinical narrative: BAD CASE OF COVID; A spontaneous report has been received from a consumer concerning a female patient (age not provided) of Unknown ethnic origin.    The patient's past and current medical history included autism (ongoing). The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received FluMist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route for flu vaccination on an unknown date. The patient received FluMist Quadrivalent (influenza vaccine live reassort 4v) (batch number UNKNOWN) once/single administration, via nasal route for flu vaccination on an unknown date.     A Unknown administered Flumist Quadrivalent. No malfunction has been reported for this combination product.   A Unknown administered Flumist Quadrivalent. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced bad case of covid (preferred term: COVID-19).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shingles after having both Shingrex shots/Suspected vaccination failure; Had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had shingles after having both Shingrix shots. The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: Had both shots for shingles, still got them/suspected vaccination failure; Still got them (shingles); They hurt like heck; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots for shingles and still got them even through they were not to severe, they hurt like heck. The patient's friend texted her that she was diagnosed with shingles. She could not believe how painful and uncomfortable the rash was. The patient mentioned that she was at a chapter in her life where she should be enjoying it to the fullest, date nights, brunch with friends, playing with grandchildren, traveling. All the fun things. The patient did not want to be on the sidelines because of shingles. The reporter did not consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; suffering because of getting this vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included polycystic kidney.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter's husband was suffering because of getting this vaccine and to add insult to injury.  The reporter asked if one could not be guaranteed that a vaccine would not prevent shingle in each person, why recommend it for a person with polycystic kidney disease. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. The polycystic kidney disease was considered as current condition conservatively as per description.  The case was considered as valid and shingles conservatively.  Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/Got the vaccine, two/ three years later got the shingles; Got the shingles; It does hurt; This 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got the vaccine a few years ago and about three years after that he/she got the shingles. The patient stated that it did hurt for sure. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As this case was received from interactive digital media page and follow-up could not be performed, therefore in worst approach, the case was processed based upon the latest comment depend upon time hours of post.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: alleviate the pain; This 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, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient asked how could they alleviate the pain. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received vaccine 2 YEARS ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 31-Oct-2022 Reporter's comment: The patient received overlooked the second vaccination. The patient asked that he/she need to start over with the first or should he/she go ahead with the second one even though it was been 2 years. A pharmacy advised the patient to just get the second one, however, the patient's primary physician said he/she should start over.  The patient asked for advise. Additional supportive information: Till the time pf reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: had 1st dose, now have shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's Comment: Reporter stated that the patient had 1st dose of Shingrix six weeks ago. But now patient had active case of shingles. Patient asked that if he/she need to go forward with the 2nd dose of Shingrix or  he/she should wait until shingles clears up before taking the 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid adjuvant portion of Shingrix; Received only the liquid adjuvant portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient might had received only the liquid adjuvant portion of the Shingrix vaccine without it being reconstituted with the powder component. The reporter stated that this could had been 1 or 2 doses of adjuvant only for these patients, the reporter was unsure at this time, the review of the medical records to confirm was pending. The reporter did not had the dates of administration, lot number, expiration date and any patient information at the time of the reporting. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information:  The reporter gave by error Shingrix adjuvant diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR159620:same report, other patient US-GSK-US2022159157:same report, other patient
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Received only the liquid adjuvant portion of Shingrix; Received only the liquid adjuvant portion of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient might had received only the liquid adjuvant portion of the Shingrix vaccine without it being reconstituted with the powder component. The reporter stated that this could had been 1 or 2 doses of adjuvant only for these patients, the reporter was unsure at this time, the review of the medical records to confirm was pending. The reporter did not had the dates of administration, lot number, expiration date and any patient information at the time of the reporting. The vaccine administration facility was the same as the primary reporter. The reporter did consent to follow up. Additional supportive information: The reporter gave by error Shingrix liquid adjuvant diluent portion only withput powder component ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2022159157:same report, other patient US-GSK-US2022AMR159619:same report, other patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex
Clinical narrative: herpes simplex every 6 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of herpes simplex in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the 2 shingles shot and stated that he/she still gets herpes simplex on his/her lower back every 6 weeks and wanted to know if he/she should get another shot. Additional Supportive Information: The follow-up would not be possible as no contact details were available.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Patient needs the 3rd dose; 1st dose April 2022, 2nd on 24Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a elderly female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on April 2022).   On 24th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 24th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were 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: 31-OCT-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received Twinrix vaccine late than recommended time frame. The reporter stated that the patient did not reported the symptoms. The reporter did not had the patient full date of birth, exact date of the first dose, lot and expiration date of the 2nd dose. The reporter reported that the patient need the 3rd dose but reporter did not know if the patient should restart the series. The reporter consented to follow up. Additional supportive information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix vaccine, which led to incomplete course of vaccination. This case has been linked with case US2022118619 reported by same reporter.; Sender's Comments:  US-GSK-US2022118619:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Swelling at the injection site; soreness at the injection site; Tiredness; Headaches; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site swelling, injection site pain, tiredness and headache. On an unknown date, the outcome of the injection site swelling, injection site pain, tiredness and headache were unknown.   It was unknown if the reporter considered the injection site swelling, injection site pain, tiredness and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Oct-2022 Reporter's comment: The caller was a patient.   The caller stated that she experienced tiredness, headaches, swelling and soreness at the injection site for which adverse event was reported. The reporter did not consent to follow-up. No additional details were provided by the caller.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: when they count the vaccines in the box, the number of lyophilized vials and diluent vials do not match; Hiberix was reconstituted with another diluent and administered to a child; This 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 4-month-old female patient who received Hib (Hiberix) for prophylaxis.   On 17th October 2022, the patient received Hiberix. On 17th October 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-OCT-2022 Reporter's comment: The administrator had stated that, it was possible that the Hiberix was reconstituted with another diluent and was administered to a child patient. She stated that when they had counted the vaccines in the box, the number of lyophilized vials and the diluent vials does not matched. The nurse who had administered the vaccine also does not remembered, if she had used Normal Saline (NS) or another diluent. No lot number or expiration date was available at time of call. The reporter consented to follow-up via mail. Additional supportive information: The patient was administered the Hiberix vaccine with another diluent, which had led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Received 2 shots one day apart; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a adult male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 26th October 2022, the patient received the 2nd dose of Boostrix. On 26th October 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.       Additional Information: GSK receipt date: 31-OCT-2022 Reporter's comment: The patient was around 40 years age. The pharmacist called to report that there was possible mistake with a patient and the Boostrix vaccine.  The pharmacist stated that the patient received a Boostrix vaccine and the next day of vaccination received another Boostrix shot by mistake.  The reporter consent to follow-up by email. Additional supportive information: The next day of vaccination, the patient received another Boostrix shot by mistake, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 07Dec2018, never received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 7th December 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The pharmacist reported that the patient never receive a second dose. Another dose was planned for on the day of reporting but has not been administered.   The reporter ended chat before any further details could be obtained. The reporter declined to had contact information saved in database. Additional supportive information: Till the time of reporting, the patient did not second dose of Shingrix, which led to incomplete course of vaccination.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles on her left back; This case was reported by a physician via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th October 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 31st October 2022, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's comment: The physician reported that the patient received first dose of Shingrix into left deltoid and the patient broke out in shingles on left back.  The reporter consented to follow up.
Age: 13.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 13-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 28th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 1-Nov-2022 Reporter's comment: The medical assistant called to asked how to proceed with this patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month-old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 25th May 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included PEDIARIX.   On 1st November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 1-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Groin pain, Herpes zoster, Rash, Vaccination failure
Clinical narrative: 1st and 2nd dose in 2019, has shingles/suspected vaccination failure; shingles rash internal and external from groin area to her knee/shingles rash on her left leg; severe groin pain; severe abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix (intramuscular) .5 ml. On 14th October 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, groin pain and abdominal pain. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, groin pain and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, groin pain and abdominal pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: The case was self reported by the patient. The patient received both the first and second dose of Shingrix in 2019 according to schedule into an unknown arm and more than 2 years she awoke to severe groin and abdominal pain and a shingles rash on left leg. The patient's daughter drove her to the emergency room and the patient was diagnosed with shingles both internal and external. The patient reported she was still in pain (abdominal and groin) and still had a shingles rash from her groin area down to just below her left knee.  The ER doctor gave her pain medications and antivirals. The reporter did not give permission to contact HCP. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test and time to onset confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: FLUX
Symptoms: Immunisation reaction
Clinical narrative: Hospitalized with severe flu vaccine reaction; This case was reported by a physician via call center representative and described the occurrence of hospitalization in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 02-Nov-2022 Reporter's comment: Physician reported that the patient received unknown Flu vaccine and was hospitalized with severe Flu vaccine reaction. The patient had since been discharged home. No further details were available at time of call. The specialist attempted to obtain further patient details, but physician could not locate patient information while speaking with specialist.  The specialist attempted to clarify brand of vaccine, but physician noted it was not clear in documentation which Flu vaccine was given. The reporter consented to follow-up.