chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Weight
Clinical narrative: Tested covid 19 positive for the second time Jan2022; Tested covid 19 positive for the second time Jan2022; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old male patient received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid 19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Tested covid 19 positive for the second time Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jan2022) Positive, notes: Tested covid 19 positive for the second time; Weight: (unspecified date) losing 30, notes: losing 30 lbs.  Clinical course: Reporter stated He received 2nd Pfizer covid vaccine Sep2021. Episode of acute pancreatitis Dec2021. Tested covid 19 positive for the second time Jan2022. Diagnosed with exocrine pancreatic insufficiency after several months of diarrhea, losing 30 lbs, and other classical signs of EPI. Health 32 year old male with no preexisting hx documented by regular pcp visits. Pfizer was given less than 1 year to produce vaccine and now more info comes out. Who would be accountable further asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and  Covid 19 cannot be ruled out.
Age: 42.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Given booster instead of initial vaccination
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Nurse reports improperly stored PROQUAD was administered.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were not reported. Concomitant medication included sterile diluent.   On 13-NOV-2022, the vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot #W012730 with expiration date 16-OCT-2023 had an excursion of temperature -14 degree Celsius up to -10 degree Celsius (-13.7 degree Celsius) at a time frame of 5 hours 15 minutes 0 seconds, with no previous temperature excursion. On 10-JAN-2023, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) administered for prophylaxis (strength, dosage, route of administration and anatomical location were not provided) (product storage error). No additional adverse event (AE) reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2301USA008920: US-009507513-2301USA008846: US-009507513-2301USA008948:
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: no additional adverse event; VAQTA dministered after a temperature excursion; This spontaneous report was received from a medical assistant concerning a 13-month-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-DEC-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W017343, expiration date: 13-DEC-2023, administered intramuscularly on the left thigh as prophylaxis (strength was not provided), after a temperature excursion on 01-DEC-2022 at a temperature of 47.9 Fahrenheit degrees for 47 minutes. No additional adverse events were reported (product storage error).   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2301USA009943:
Age: 0.83
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Pedvaxhib administered after temperature excursion; This spontaneous has been received from a medical assistant, concerning a 10-months old male patient. The patient's medical history, concurrent conditions, concomitant medications, previous drug reactions, and allergies were not provided.   On 16-DEC-2022, the patient was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular Injection, intramuscularly on the left thigh (lot number W006596 has been verified to be valid; expiration date reported and established as 11-OCT-2024) (strength and dose were not provided). The administered dose of the vaccine was stored at a temperature of 47.9 degrees Fahrenheit (F), during a time frame of 47 minutes, as recorded by a digital data logger. There was not a previous temperature excursion reported. There was no adverse effect reported.
Age: 70.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; LPN calling for stability evaluation of vaccines with multiple TEs dating back to 03FEB2023. Caller reports that vaccines were administered. No additional AEs. no PQCs reported.; This spontaneous report was received from a nurse and refers to a 70-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2023, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter, lot #W017819, expiration date: 27-DEC-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). There were multiple temperature excursions dating back to 03-FEB-2023. There was no adverse event reported.  This is one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA004298: US-009507513-2302USA004552: US-009507513-2302USA004361: US-009507513-2302USA004511:
Age: 17.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs; PROQUAD was accidentally administered to a 17 year old patient; This spontaneous report was received from Medical Assistant, referring to a 17 year old male patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 13-FEB-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (0.5ml/once, strength, route, lot# and expire date were not reported) for prophylaxis (inappropriate age at vaccine administration). No additional adverse events or product quality complaints were reported.
Sex: U
Vaccine: HEPA, MMR
Symptoms: Product storage error
Clinical narrative: No additional AE reported; products that experienced temperature excursion over the weekend were administered to a patient; 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.  On13-FEB-2023, the patient was vaccinated with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot # W012118 has been verified to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live; expiration date: 24-DEC-2023; which was reconstituted with sterile diluent solution for injection/infusion (strength, dose description, lot #, and expiry date were not provided); and of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot # W029899 has been verified to be valid for hepatitis a vaccine, inactivated; expiration date: 16-MAY-2024, both administered for prophylaxis (strengths, and routes of administration were not provided).  The administered doses of the vaccines experienced a temperature excursion above 9 degrees Celsius (°C) (13.25 C) for 2 hours 32 minutes and 0 seconds. No previous temperature excursion was reported. There was no adverse event reported. No product quality complaint was involved.
Age: 8.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist reports patient was accidently administered an expired dose of PNEUMOVAX 23 on Feb 15, 2023.; This spontaneous report was received from a pharmacist and refers to an 8-year-old female patient. There was no information regarding the patient's medical history, concurrent condition and concomitant therapies details.  On 15-FEB-2023, the patient was accidently vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, once, lot #U018309, expiration date: 08-JAN-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). Product had no prior temperature excursions. No further information provided. No additional adverse event or product quality complaint was reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Visual impairment
Clinical narrative: postherpetic neuralgia; vision issues; multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) who at the time of report was approximately 67 years old. No information was provided regarding the pt's medical history, concurrent conditions, or concomitant medications. On or about 04-OCT-2016, the pt was vaccinated at her local pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues. The outcome of the events was not reported.  The lawyer considered the events of multiple outbreaks of herpes zoster, postherpetic neuralgia and vision issues to be related to zoster vaccine live (ZOSTAVAX).
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection, Vaccination failure
Clinical narrative: reported getting HPV despite receiving GARDASIL 9; reported getting HPV despite receiving GARDASIL 9; This spontaneous report has been received from a consumer via Company representative concerning a currently 26-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date (also reported as receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at the age of 19-years), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, administered as prophylaxis (frequency, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient reported experiencing Human papillomavirus (HPV) (Papilloma viral infection) despite vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Vaccination failure). Outcome of the events papilloma viral infection and vaccination failure was not provided. No additional information was provided.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event papilloma viral infection was not provided. Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event vaccination failure was related.   This was one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA006375:
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Papilloma viral infection, Vaccination failure
Clinical narrative: reported getting HPV despite receiving GARDASIL 9; reported getting HPV despite receiving GARDASIL 9; This spontaneous report has been received from a consumer via Company representative concerning a currently 26-year-old female patient. Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date (also reported as receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at the age of 19-years), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL, administered as prophylaxis (frequency, route of administration, lot number and expiration date were not provided).   On an unknown date, the patient reported experiencing Human papillomavirus (HPV) (Papilloma viral infection) despite vaccination with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (Vaccination failure). Outcome of the events papilloma viral infection and vaccination failure was not provided. No additional information was provided.  Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event papilloma viral infection was not provided. Causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the event vaccination failure was related.   This was one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2302USA006343:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Nurse reporting that a dose of PNEMOVAX23 with a labeled expiry of 1/28/2023 was inadvertently administered to a patient on 2/14/2023; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender.   No medical history, concurrent conditions nor concomitant medications were reported.  On 14-FEB-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (0.5 mL, lot # U026796, expiration date 28-JAN-2023, route of administration and anatomical location were not provided) for prophylaxis (Expired vaccine used), inadvertent administration of vaccine beyond expiry date. It was reported no known temperature excursion involved. No additional information was provided. No additional adverse event (AE) or product quality complaint (PQC) was reported at the time of reporting.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Pediatric Patient was administered expired VAQTA; This spontaneous report was received from Pharmacist and refers to a pediatric patient (gender not reported).   The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 20-FEB-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot #U012007 with expiration date: 18-JAN-2023) administered for prophylaxis (strength, dose and route of administration were not provided). No additional adverse events were reported. No Temperature Excursion reported prior to or at the time of this report.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Death, Myocardial infarction, Nausea, Vomiting
Clinical narrative: Fatal heart attack, passed away.; Nausea followed by heart attack; vomiting all night; This case was reported by a consumer and described the occurrence of heart attack in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced nausea and vomiting. On 28th July 2020 06:00, the patient experienced heart attack (serious criteria death, GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the heart attack was fatal and the outcome of the nausea and vomiting were unknown. The patient died on 28th July 2020. The reported cause of death was heart attack.   It was unknown if the reporter considered the heart attack, nausea and vomiting to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comment: The case was reported by patient's husband. The patient received Shingrix and experienced nausea and vomiting all night and the patient suffered a heart attack and passed away.  The patient suffered a fatal heart attack within 18 hours of a Shingrix vaccine injection and nausea followed by heart attack. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023029284:FU1 same reporter; Reported Cause(s) of Death: Heart attack
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: In the Hospital with Atrial fibrilation; This case was reported by a consumer via interactive digital media and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 hrs after receiving Shingles vaccine, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient took the shot and four hours later in hospital with atrial fibrillation. The reporter reported that be careful what you put in your body. Additional Supportive Information: The follow-up could not be possible as no contact details were available. Narrative was not clear about the hospital situation it was unknown if patient stayed at least overnight. Since no contact information was available the Hospitalization was selected as a Seriousness criteria.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had shot  still had shingles, shot is 30% effective, Suspected vaccination failure; still 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 (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 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: 18-FEB-2023: Reporter's comment: This case was reported by a consumer via interactive digital media. The reporter said she had shingles shot and still had Shingles. The reporter said the shot was only 30 percent effective. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Not reconstituting the vaccine; Only adjuvant administered; This case was reported by a physician via sales rep 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: 14-Feb-2023 Reporter's Comments: A physician stated in his office one day before the reporting date that a nurse that no longer worked at the practice, administered the Shingrix adjuvant only, without reconstituting the vaccine, to 3 different patients in the physician's office.  The reporter did not have any further information about this incident, nor any information about lot number, date this happened or any differing factors for any of the 3 patients.  The reporter told to the GlaxoSmithKline field representative that the physician's office did contact the 3 patients, and it had all been taken care of.  The reporter consented to follow up with health care professional was obtained.  Additional supportive information: The patient received only adjuvant of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This 2 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023025414:Same reporter US-GSK-US2023AMR026706:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered the adjuvant onlywithout reconstituting the vaccine; Only adjuvant administered; This case was reported by a physician via sales rep 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: 14-Feb-2023 Reporter's Comments: A physician stated in his office one day before the reporting date that a nurse that no longer worked at the practice, administered the Shingrix adjuvant only, without reconstituting the vaccine, to 3 different patients in the physician's office.  The reporter did not have any further information about this incident, nor any information about lot number, date this happened or any differing factors for any of the 3 patients.  The reporter told to the GlaxoSmithKline field representative that the physician's office did contact the 3 patients, and it had all been taken care of.  The reporter consented to follow up with health care professional was obtained.  Additional supportive information: The patient received only adjuvant of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This 3 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR026705:Same reporter US-GSK-US2023025414:Same reporter
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Antibody test abnormal, Therapeutic response decreased
Clinical narrative: Titers were low after 3 dose series; This case was reported by a pharmacist via call center representative and described the occurrence of therapeutic response decreased in a 14-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included dialysis.   On an unknown date, the patient received the 3rd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 2nd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-Feb-2023: Reporter comment: The pharmacist called to inquire how to proceed with Engerix dosing for this patient. The pharmacist stated they have a 14 years old patient on dialysis and they would like to give the patient a Engerix booster dose because Titers were low.  The pharmacist was asking for any guidance on dosing. The pharmacist stated that the patient completed Engerix primary 3 dose series be-fore but unable to provide any details on patient or dates.  The reporter did not consent to follow up. Additional supportive information:  The reporter would like to give the patient a Engerix booster dose because titers were low Shingrix, which led to therapeutic response decreased.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Fatigue, Somnolence
Clinical narrative: feel faint; feel weak; tired; sleepy; This case was reported by a consumer via call center representative and described the occurrence of felt faint in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2023, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 14th February 2023, 1 days after receiving Shingrix, the patient experienced felt faint, feelings of weakness, tiredness and sleepiness. On an unknown date, the outcome of the felt faint, feelings of weakness, tiredness and sleepiness were not recovered/not resolved.   It was unknown if the reporter considered the felt faint, feelings of weakness, tiredness and sleepiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The reporter was the husband of the patient. The patient received second dose of Shingrix and reported that this morning she got out of bed and felt faint and weak. The reporter reported that the patient sat herself down on the ground but did not faint. The reporter reported that the patient drank something and then went back to bed because she was tired and sleepy. Education provided per content. The reporter offered package insert and website. The reporter provided medical disclaimer and medical information phone number. The reporter referred to healthcare professional. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Havrix 1440 and Havrix 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: 14-Feb-2023. Reporter's Comment: The reporter stated Havrix was administered after the expiration date. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired Havrix 1440, which led to expired vaccine used.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 2KK72, expiry date 17th June 2024) for prophylaxis.   On 14th February 2023, the patient received the 3rd dose of Shingrix. On 14th February 2023, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's comments: The pharmacy manager had reported that, not immunocompromised patient received a third dose of Shingrix. The reporter had consented to follow-up. Additional supportive information: At the time of reporting, the patient who was not immunocompromised had received a third dose of Shingrix vaccine, which had led to extra dose administered.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: Engerix-B administered after temp excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received HBV (Engerix B 10 mcg) (batch number CM294, expiry date 19th April 2024) for prophylaxis.   On 13th February 2023, the patient received the 2nd dose of Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The clinic manager stated that the Engerix-B was exposed to 30.9 F for 4 hrs, 30 minutes and was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional supportive information: The vaccine was exposed to 30.9 F for 4 hours, 30 minutes, which led to incorrect storage of vaccine. Note: Engerix B 10 mcg was not coded as Pfs as its is not available. The case had been linked with US2023025429 and US2023025426 reported by same reporter.; Sender's Comments:  US-GSK-US2023025426:Same reporter - Engerix B case US-GSK-US2023025429:Same reporter - Engerix B case
Sex: U
Vaccine: MMR
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received MMR (Priorix) for prophylaxis.   Co-suspect products included mmr vaccine pre-filled syringe device (Priorix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Priorix and Priorix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Priorix and Priorix Pre-Filled Syringe Device, 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.   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-FEB-2023 Reporter's comment: The medical assistant reported that only the diluent was given to a patient. No other information available will call back later.  The reporter consent to follow up. Additional Supportive Information: The patients received Priorix vaccines but only the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Not reconstituting the vaccine; Only adjuvant administered; This case was reported by a physician via sales rep 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: 14-Feb-2023 Reporter's Comments: A physician stated in his office one day before the reporting date that a nurse that no longer worked at the practice, administered the Shingrix adjuvant only, without reconstituting the vaccine, to 3 different patients in the physician's office.  The reporter did not have any further information about this incident, nor any information about lot number, date this happened or any differing factors for any of the 3 patients.  The reporter told to the GlaxoSmithKline field representative that the physician's office did contact the 3 patients, and it had all been taken care of.  The reporter consented to follow up with health care professional was obtained.  Additional supportive information: The patient received only adjuvant of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This 1 of 3 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GSK-US2023AMR026705:Same reporter US-GSK-US2023AMR026706:Same reporter
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix was administered to a female patient.; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 15th February 2023, unknown after receiving Havrix and Havrix 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: 15-FEB-2023  Reporter's Comments: The reporter consented to follow up via email  Additional Supportive Information: On the day of reporting, the patient received an expired dose of Havrix vaccine, which had led to expired vaccine used.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: FluLaval given after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 3-year-old male patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number 5M2H2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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-FEB-2023 Reporter's Comment: The reporter reported that 2 male patients received a FluLaval Quadrivalent administration after a below temperature excursion.  HCP called in yesterday 14th February 2023 to report a similar situation that involved Engerix B, but they realized that Flulaval QIV was also involved.  The reporter consented to follow up via email. Additional supportive information: The patient received FluLaval Quadrivalent vaccine after a below temperature excursion, which led to incorrect storage of drug. This case is linked with case US2023025429, US2023024476 reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2023025429:Same reporter - other male patient US-GSK-US2023024476:Same reporter - Engerix B case
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Blood test normal, Immunisation reaction, Magnetic resonance imaging, Metamorphopsia
Clinical narrative: optic nerve inflamed, causing vision obstructed; Optic ischemic neuropathy; Vission still distorted; loss of vision, center field of vision; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st September 2022, 3 days after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the patient experienced optic neuritis (serious criteria GSK medically significant), ischemic optic neuropathy (serious criteria GSK medically significant) and distorted vision. The patient was treated with prednisone. On an unknown date, the outcome of the loss of vision was recovering/resolving and the outcome of the optic neuritis and ischemic optic neuropathy were unknown and the outcome of the distorted vision was not recovered/not resolved.   It was unknown if the reporter considered the loss of vision, optic neuritis, ischemic optic neuropathy and distorted vision to be related to Shingrix.     Additional Information: GSK Receipt date: 16-Feb-2023. Reporter's Comment: The patient self-reported this case. Patient received Shingrix on left deltoid and 3 to 5 days later he started losing vision in his left eye in the center field of vision. The patient went to his eye doctor, specialist in retina care, who reported the optic nerve was inflamed causing the vision to be obstructed but not sure why.  The eye doctor ordered 3 magnetic resonance imaging and bloodwork.  The eye specialist though he could have multiple sclerosis, but the bloodwork did not confirm this. The eye specialist sent him to another eye specialist who started him on large doses of Prednisone.  On the return visit to the second eye specialist, he happens to mention he received the Shingrix vaccine.  At that point, the specialist saw where there had been 3 cases of optic ischemic neuropathy reported in the Shingrix package insert.  The eye specialist at that point thought the Shingrix vaccine had caused this.  The reporter reported his vision has gotten better, but it was still distorted. The reporter gives permission to contact the all the doctor's in this case. The reporter consented to follow-up. Additional Supportive Information: The case was linked with case US2023AMR027483, US2023AMR027496 and US2023AMR027497, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR027483:Same reporter US-GSK-US2023AMR027496:Same reporter US-GSK-US2023AMR027497:Same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Optic ischaemic neuropathy, Optic neuritis, Visual field defect
Clinical narrative: optic nerve inflamed, causing vision obstructed; Optic ischemic neuropathy; Vission still distorted; loss of vision, center field of vision; This case was reported by a consumer via call center representative and described the occurrence of loss of vision in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st September 2022, 3 days after receiving Shingrix, the patient experienced loss of vision (serious criteria GSK medically significant). On an unknown date, the patient experienced optic neuritis (serious criteria GSK medically significant), ischemic optic neuropathy (serious criteria GSK medically significant) and distorted vision. The patient was treated with prednisone. On an unknown date, the outcome of the loss of vision was recovering/resolving and the outcome of the optic neuritis and ischemic optic neuropathy were unknown and the outcome of the distorted vision was not recovered/not resolved.   It was unknown if the reporter considered the loss of vision, optic neuritis, ischemic optic neuropathy and distorted vision to be related to Shingrix.     Additional Information: GSK Receipt date: 16-Feb-2023. Reporter's Comment: The patient self-reported this case. Patient received Shingrix on left deltoid and 3 to 5 days later he started losing vision in his left eye in the center field of vision. The patient went to his eye doctor, specialist in retina care, who reported the optic nerve was inflamed causing the vision to be obstructed but not sure why.  The eye doctor ordered 3 magnetic resonance imaging and bloodwork.  The eye specialist though he could have multiple sclerosis, but the bloodwork did not confirm this. The eye specialist sent him to another eye specialist who started him on large doses of Prednisone.  On the return visit to the second eye specialist, he happens to mention he received the Shingrix vaccine.  At that point, the specialist saw where there had been 3 cases of optic ischemic neuropathy reported in the Shingrix package insert.  The eye specialist at that point thought the Shingrix vaccine had caused this.  The reporter reported his vision has gotten better, but it was still distorted. The reporter gives permission to contact the all the doctor's in this case. The reporter consented to follow-up. Additional Supportive Information: The case was linked with case US2023AMR027483, US2023AMR027496 and US2023AMR027497, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR027483:Same reporter US-GSK-US2023AMR027496:Same reporter US-GSK-US2023AMR027497:Same reporter
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrixadministered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) 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.   On 16th February 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 16th February 2023, unknown after receiving Twinrix and Twinrix 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: 16-FEB-2023 Reporter's Comment: The reporter was medical assistant. The reporter called to report that a patient received an expired Twinrix dose at the time of reporting. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up via email/ fax. Additional Supportive Information: The reporter called to report that a patient received an expired Twinrix dose, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: Pediarix given instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9552X, expiry date 26th October 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th February 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 14th February 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The nurse reported that a patient accidentally received a dose of Pediarix instead of Infanrix.  The HCP (Health care professional) declined to provide his last name. The vaccine was given at clinic or reporting agency. The reporter consent to follow up. Additional Supportive Information: The patient received Pediarix instead of Infanrix, which led to wrong vaccine administered.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness on right arm.; tingling on the right arm.; This case was reported by a nurse via sales rep and described the occurrence of numbness of upper extremities in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced numbness of upper extremities and tingling of extremity. On an unknown date, the outcome of the numbness of upper extremities and tingling of extremity were recovered/resolved.   It was unknown if the reporter considered the numbness of upper extremities and tingling of extremity to be related to Shingrix.     Additional Information: GSK receipt date: 16-FEB-2023 Reporter's comment: The field representative called to relay an adverse event reported to him by a nurse practitioner.  The nurse practitioner stated that a patient received the first dose of Shingrix and began experiencing numbness and tingling on the backside of the right arm.  This was reported to the nurse practitioner on 3rd Feb 2023 during a follow up visit and the events had resolved. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.