chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Herpes zoster, Nervous system disorder
Clinical narrative: stroke; neurological issues; herpes zoster; Information has been received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unknown age. Information about the pt's concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster, neurological issues and a stroke. As a result of these symptoms, the pt was seen and treated by medical providers and at the time of report was still under their care. As a direct and proximate result of the defective zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the suspect product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered/not resolved. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of stroke was determined to be medically significant. The events of herpes zoster, neurological issues and stroke were considered to be disabling.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered
Clinical narrative: No additional AE; The nurse called to evaluate the potency of an expired ROTATEQ vaccine that was administered to a patient; Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 01-FEB-2022, the patient received rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as directed for the prevention of rotavirus, lot number: T028130 with expiration date 28-JAN-2022 (strength, dose and frequency were not reported) that was expired (expired vaccine used).  The nurse called to evaluate the potency of the expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; more than one year having passed since the first dose; This spontaneous report was received from the patient's mother and refers to her daughter a 10-year-old female patient.  The patient's concurrent conditions included Guillain-Barre syndrome. Her medical history, and concomitant therapies were not provided.      The patient was 9 years old and had her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in approximately February of 2021 for prophylaxis (dose, route of administration, lot#, and expiration date were not reported).   The mother could not specify which specific date she had the first dose. She could not rule out the possibility of more than one year having passed since the first dose (Frequency: 0, 6 to 12 months) (inappropriate schedule of product administration). The mother stated that her daughter had not had any symptoms since receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: Patient denied having any side effects from vaccine; Patient is 49 years old and knows he is older than the recommended age but his doctor chose to do it anyway; This spontaneous report was received from a 49-year-old male patient, reporting on himself.    The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1 for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On 28-DEC-2021, the patient stated he knew he was older than the recommended age but his doctor chose to do it anyway (off label use).  Patient denied having any side effects from vaccine (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 12 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 13-DEC-2021, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection,1 dose, lot # U024221, expiring on 04-OCT-2023, for prophylaxis (strength, route and site of administration were not provided). The administered dose of the vaccine experienced a temperature excursion of 39.55F for 10 hours (product storage error). The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no further ae reported; Temp excursion occurred 11/22/21; This spontaneous report was received from a nurse referring to a 43 years old, male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  Temperature excursion occurred on 22-NOV-2021. On 03-JAN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously in the left arm (lot U010398, expiration date 01-APR-2023) (strength and dose were not provided) and measles (+) mumps (+) and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously in the right arm (lot T034389, expiration date 08-OCT-2022) (strength and dose were not provided)  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pulmonary embolism
Clinical narrative: Breakthrough PE; This is a spontaneous report received from a contactable reporter(s) (Physician) from License Party. Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2022-013982 (Company).  This spontaneous case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (breakthrough PE) in 70-year-old male patient who received apixaban (Eliquis) for Cerebrovascular accident prophylaxis. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for COVID-19 prophylaxis. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced PULMONARY EMBOLISM (seriousness criterion medically significant). The action taken with Eliquis(Oral) was unknown. At the time of the report, PULMONARY EMBOLISM outcome was unknown. The strength of apixaban was 5 mg. Rep reported that patient experienced a break through PE after receiving vaccination for Covid (date unknown). For Eliquis(Oral), the reporter did not provide any causality assessments.  Apixaban (Eliquis) is under agreement with a Company.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Cpmpany medical evaluation comment: This 70-year-old patient had pulmonary embolism after receiving apixaban therapy and COVID-19 vaccination. Elderly age and underlying thromboembolic susceptibility are risk factors for the reported event, hence considered not related to apixaban. Pfizer comment: Based on the information provided, a contributory role of the suspect product Covid-19 Vaccine to the reported pulmonary embolism cannot be excluded. It was noted that patient experienced a break through PE after receiving vaccination for Covid. Vaccination date and event onset dates were not provided. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: 16 Weeks Pregnant Given Heplisav-B; Initial Report Received on 08-Dec-2021   A licensed practical nurse reported that a 30 year-old female patient (race, and ethnicity unknown) who was 16-weeks pregnant received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported. The patient had allergies to amoxicillin (mild rash).   No concomitant medications were reported.   On 07-Dec-2021, the patient received the one dose of HEPLISAV-B (Lot # 935848, expiration date 02 Dec-2022, and NDC # 43528-003-01) in the right deltoid.  No adverse events associated with this event were reported. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave Two Patients who are Under 18 Years Old; Initial Report Received on 13-Dec-2021  A registered medical assistant reported that a 17 year-old male patient (race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient had no known drug allergies.  No relevant concomitant medications were reported.    On 13-Dec-2021, the patient, who was under 18 years-old, received a dose of HEPLISAV-B (Lot # 934975, expiration date 13-Aug-2022, and NDC # 43528-003-01) in the right deltoid from the registered medical assistant. The wrong vaccine was chosen instead of the pediatric vaccine. It was a "human error." The patient had no adverse reactions at the time of the injection and there were no other adverse events associated with this event.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Gave Two Patients who are Under 18 Years Old; Initial Report Received on 13-Dec-2021  A registered medical assistant reported that a 14 year-old female patient (race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported. The patient had no known drug allergies.  No relevant concomitant medications were reported.    On 13-Dec-2021, the patient, who was under 18 years-old, received a dose of HEPLISAV-B (Lot # 935843, expiration date 08-Oct-2022, and NDC # 43528-003-01) in the left deltoid from the registered medical assistant. The wrong vaccine was chosen instead of the pediatric vaccine. It was a "human error." The patient had no adverse reactions at the time of the injection and there were no other adverse events associated with this event.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received Engerix-B as Her 2nd Dose; Initial Report Received on 13-Jan-2022  A pharmacist in the reported that a 29-year-old female patient (race and ethnicity unknown) received Engerix-B as her second dose.  No medical history was reported.   Concomitant medications were reported as unknown.  On 24-Nov-2021, the patient received the first dose of HEPLISAV-B (Lot # 935841, expiration date 17 Sep-2022, serial # 424027557240, and NDC # 43528-003-05) in the left deltoid.   On 13-Jan-2022, 51 days after having received the first dose of HEPLISAV-B vaccination, the patient accidently received Engerix-B as the second dose (Lot #, expiration date, and NDC # unknown) in the left deltoid.  The patient was not pregnant and there were no adverse effects reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Expired Dose of Heplisav-B Given to Patient Under the Age of 18; Expired Dose of Heplisav-B Given to Patient Under the Age of 18; Initial Report Received on 14-Jan-2022  A medical assistant in the US (UT) reported that a 9-month old female patient (race and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history was reported. Allergies were unknown.  Concomitant medications were reported as unknown.  On 26-Oct-2021, the patient received the first dose of HEPLISAV-B (Lot # 933623, expiration date 22 Aug-2021, serial # and NDC # unknown) intramuscularly in the left thigh by the medical assistant. It was realized later while going through the billing process. No adverse reactions were reported from the injection. No additional information was provided at time of reporting.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pediatric Patient Received Dose of Heplisav-B; Initial Report Received on 19-Jan-2022   A nurse practitioner in the reported that a 6-month-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   No medical history was reported. Allergies were unknown.   No concomitant medications were reported.   On 19-Jan-2022, the patient received the first dose of HEPLISAV-B (Lot # 934975, expiration date 13 Aug-2022, and NDC # 43528-003-05) in the right thigh by a medical assistant. No adverse reactions were reported. No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, HEPAB, MENB, RAB
Symptoms: Product storage error
Clinical narrative: Exposed under temperature excursion; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis A vaccine for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and RABIES VACCINE (RABAVERT) for prophylaxis.   On an unknown date, the patient received DTaP vaccine, Hepatitis B vaccine, Hepatitis A vaccine, Kinrix, Kinrix Pre-Filled Syringe Device, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device and RABAVERT. On an unknown date, unknown after receiving DTaP vaccine, Hepatitis B vaccine, Hepatitis A vaccine, Kinrix, Kinrix Pre-Filled Syringe Device, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Bexsero and Bexsero 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not applicable to this report. The reporter stated that the vaccines were exposed under temperature excursion, which led to incorrect storage of drug. The reporter stated that there were actually a lot of vaccine included DTaP and Kinrix and there were also few of them which was the Hepatitis B vaccine for pediatric and adult, Hepatitis A vaccine for also pediatric and adult, Twinrx, RabAvert, Pediarix and Bexsero. The reporter further did not clarify if the vaccines were administered to any patient after the excursion and wanted to know if they were still viable. The reporter did not have any further information.
Sex: U
Vaccine: VARZOS
Symptoms: Eye infection, Visual impairment
Clinical narrative: Lost most of the vision in left eye; Serious eye infection; This case was reported by a consumer via interactive digital media and described the occurrence of low vision, one eye 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 low vision, one eye (serious criteria GSK medically significant) and eye infection (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the low vision, one eye and eye infection were unknown.   It was unknown if the reporter considered the low vision, one eye and eye infection to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient warned and stated that he/she took the shingles vaccine and it triggered a serious eye infection, lost most of the vision in his/her left eye. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Migraine
Clinical narrative: Headaches; Migraines; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 1st dose of Shingrix. In February 2022, 2 days after receiving Shingrix, the patient experienced headache and migraine. On an unknown date, the outcome of the headache and migraine were not recovered/not resolved.   It was unknown if the reporter considered the headache and migraine to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and 2 days later started experiencing headaches and migraines. Consent to follow up was not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Cardiac ablation, Illness
Clinical narrative: Very sick; Atrial fibrillation, led to having an ablation; This case was reported by a physician via sales rep and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2020, the patient received Shingrix. On 5th July 2020, 2 days after receiving Shingrix, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the patient experienced sickness. On an unknown date, the outcome of the atrial fibrillation and sickness were unknown.   It was unknown if the reporter considered the atrial fibrillation and sickness to be related to Shingrix.  Additional details were provided as follows: The physician himself reported the case. The age at vaccination was not reported. The reporter received one dose of Shingrix and on 5th July 2020 ,experienced atrial fibrillation which led to having an ablation.  The reporter claimed to had been very sick following administration of Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Migraine
Clinical narrative: Migraines; This case was reported by a consumer via interactive digital media and described the occurrence of migraine 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 migraine. On an unknown date, the outcome of the migraine was unknown.   It was unknown if the reporter considered the migraine to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received Shingrix. The patient was asking that his/her migraines was a reaction to Shingrix. The follow-up could not be possible as no contact details were available.
Age: 58.0
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Neck pain
Clinical narrative: Muscle pain in shoulders and neck, worsened; Joint pain in shoulders and neck, worsened; Typical pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th January 2022, the patient received the 2nd dose of Shingrix. In January 2022, 72 hrs after receiving Shingrix, the patient experienced pain. On an unknown date, the patient experienced muscle pain and arthralgia multiple. On an unknown date, the outcome of the pain, muscle pain and arthralgia multiple were not recovered/not resolved.   It was unknown if the reporter considered the pain, muscle pain and arthralgia multiple to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The patient had his/her Shingrix vaccine and encountered typical pain and some manageable other side effects for about 72 hours after. However, muscle and joint pain in his/her shoulders and neck had continued and even worsened during since the last two weeks. The patient asked if side effects continue one month later, if it was normal.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine/ Has had shingles twice after the shot/Suspected vaccination failure; She has had shingles twice after the shot; She has had shingles twice after the shot; 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), shingles and shingles. On an unknown date, the outcome of the vaccination failure, shingles and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  This case was reported by patient's daughter/son.                                       The age at vaccination was not reported. The patient had the Shingle vaccine and so far she has had shingles twice after the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Bell's palsy, Herpes zoster, Incomplete course of vaccination
Clinical narrative: Mild bell's palsy-type of reaction,no paralysis took place; I have had 9 episodes of shingles; Received 1 dose/I had a bad reaction, not receive a 2nd dose.; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included splenectomy (had spleen removed in 2012) and shingles (had 9 episodes of shingles).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant), shingles and incomplete course of vaccination. On an unknown date, the outcome of the bell's palsy, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in 2020 and had shingles and a mild case of bell's palsy type reaction but not paralysis. The patient stated that the vaccine did not prevent further breakouts of shingles. The patient had a bad reaction so did not receive a 2nd dose, which led to incomplete course of vaccination. The patient stated that he/she should checked titer prior to receiving this dose.
Age: 25.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Shingrix given instead of Varivax; Shingrix given to a 25 y/o patient; This case was reported by a nurse via other manufacturer and described the occurrence of wrong vaccine administered in a 25-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2022, the patient received Shingrix. On 9th February 2022, unknown after receiving Shingrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received a dose of Shingrix instead of Varivax at the age of 25 years, which led to wrong vaccine administered and inappropriate age at vaccine administration. Lot number, expiry date, dose and frequency of Shingrix were unknown. No additional adverse events and product quality complaint were reported.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024238:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: given Hiberix reconstituted with sterile water; given Hiberix reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 594CF, expiry date 13th July 2022) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. A nurse reported that, it was possible that, the patient was given Hiberix that might have been incorrectly reconstituted with sterile water instead of saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Healthcare professional did not have specific patient information or dates administered at the time of report.  The healthcare professional stated that, the specific lot was administered over a range of a couple of months.  The reporter consented to follow up. This was 1 of 9 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR024234:Same reporter US-GLAXOSMITHKLINE-US2022AMR024237:Same reporter US-GLAXOSMITHKLINE-US2022022662:Same reporter US-GLAXOSMITHKLINE-US2022AMR024236:Same reporter US-GLAXOSMITHKLINE-US2022AMR024235:Same reporter US-GLAXOSMITHKLINE-US2022AMR024239:Same reporter US-GLAXOSMITHKLINE-US2022AMR024241:Same reporter US-GLAXOSMITHKLINE-US2022AMR024240:Same reporter
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Gingival blister, Incomplete course of vaccination, Lip blister, Oral mucosal blistering
Clinical narrative: Second dose has not be received; blisters on their gums, inside their top and bottom lip, and on the inside of both cheeks; Blisters were very painful; Blisters were red; This case was reported by a consumer via call center representative and described the occurrence of blistering of mouth in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2021, several hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced blistering of mouth, pain and erythema. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the blistering of mouth, pain and erythema were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the blistering of mouth, pain and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and few hours later experienced blisters in mouth, on gums, in upper and lower lips and inside both cheeks which were very painful and red. Blisters were recovered in 2 days. The patient did not receive second dose yet, which led to incomplete course of vaccination. Consent to follow up was granted.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Second dose has not be received; blisters on their gums, inside their top and bottom lip, and on the inside of both cheeks; Blisters were very painful; Blisters were red; This case was reported by a consumer via call center representative and described the occurrence of blistering of mouth in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In February 2021, several hours after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced blistering of mouth, pain and erythema. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the blistering of mouth, pain and erythema were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the blistering of mouth, pain and erythema to be related to Shingrix.  Additional details were reported as follows: The patient received a dose of Shingrix and few hours later experienced blisters in mouth, on gums, in upper and lower lips and inside both cheeks which were very painful and red. Blisters were recovered in 2 days. The patient did not receive second dose yet, which led to incomplete course of vaccination. Consent to follow up was granted.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Incomplete course of vaccination, Pruritus
Clinical narrative: area, faded red color; first 3-31-2021, never received second; shingles, buttocks, back and thigh; mild pinpoint itching; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 31st March 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 13th January 2022, 288 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and pruritus. On an unknown date, the patient experienced skin red and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the skin red and incomplete course of vaccination were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin red and pruritus to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose of Shingrix in an unknown arm. The patient did not receive 2nd dose of Shingrix within recommended time interval because he forgot about it, which led to incomplete course of vaccination. The patient stated that, after vaccination with 1st dose, shingles appeared on his left buttocks and back upper left thigh, the shingles appear to have cleared up and the area where the shingles were a faded red color, no bumps. The patient reported that, occasionally felt a mild pinpoint itching that only lasts a few seconds. The reporter did not consent to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product prescribing error
Clinical narrative: 2nd dose planned to be given on February 10th 2022 but health care provider wasn't sure since that dose of Kinrix expires on February 8th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug prescribing error in a patient who received DTPa-IPV (Kinrix) 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 DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On an unknown date, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error 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 details were reported as follows: Age at vaccination was not reported. The patient received 1st dose of Kinrix with expiration date 8th February 2022.  The second dose was planned to be given on February 10th 2022 with same expiration date so HCP (Health Care Professional) was concerned about this situation and wanted to know how to proceed, which led to drug prescribing error. Consent to follow up was denied.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Breast pain, Muscle spasms, Neck pain, Nodule
Clinical narrative: Vomiting; Ears ringing; Right breast pain; Pain in back of neck; Painful knot on top of shoulder; Muscles knotting up; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced vomiting, ringing in ears, breast pain, neck pain, shoulder pain and muscle spasm. On an unknown date, the outcome of the vomiting, ringing in ears, breast pain, neck pain, shoulder pain and muscle spasm were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, ringing in ears, breast pain, neck pain, shoulder pain and muscle spasm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and since receiving it experienced vomiting, ears ringing, right breast pain, pain in back of neck, painful knot on top of shoulder and muscles knotting up. The patient was still experiencing these above side effects. No lot number or expiration date was provided. Provided medical disclaimer and referred her to her HCP (health care professional). No (health care professional) HCP information was provided. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus, Vomiting
Clinical narrative: Vomiting; Ears ringing; Right breast pain; Pain in back of neck; Painful knot on top of shoulder; Muscles knotting up; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st February 2022, the patient received the 1st dose of Shingrix. In February 2022, less than a week after receiving Shingrix, the patient experienced vomiting, ringing in ears, breast pain, neck pain, shoulder pain and muscle spasm. On an unknown date, the outcome of the vomiting, ringing in ears, breast pain, neck pain, shoulder pain and muscle spasm were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, ringing in ears, breast pain, neck pain, shoulder pain and muscle spasm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and since receiving it experienced vomiting, ears ringing, right breast pain, pain in back of neck, painful knot on top of shoulder and muscles knotting up. The patient was still experiencing these above side effects. No lot number or expiration date was provided. Provided medical disclaimer and referred her to her HCP (health care professional). No (health care professional) HCP information was provided. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2020, not received second; This case was reported by a nurse 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 1st dose in October 2020).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter had no information regarding patient (initials, gender, or date of birth).  The reporter did not have lot number or expiry date, route and date of administration, and dose for the first shot of Shingrix. The reporter consented to follow up with herself.