chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: HPV4, HPV9
Symptoms: Injection site pain
Clinical narrative: he can feel an indentation; after receiveind the second dose the soreness eventualy went away as well / however this time the soreness returned / the soreness is present when he "pushes on it with a finger"; he later receied a 2nd dose and experienced soreness again; the patient is unable to clarify if he received GARDASIL or GARDASIL 9 vaccines / the patient was over the age of 45 at the time of his first vaccine; he experienced soreness on his arm at the injection site; This spontaneous report was received from a physician and a 48-year-old male patient referring to himself. The patient's medical history included diagnosis of (HPV), effects to the vaccine in his tight and his shoulder when he was an infant and a rash to Jerhen's soap/ shampoo. The patient's concurrent conditions included flaxseed allergy, hyperlipidemia, depression, pain and diabetes. Concomitant therapies included atorvastatin, (VIIBRYD), pregabalin and metformin.  On an unknown date in August 2021 (reported as about 6 or 7 months ago), the patient received the first dose of an unidentified Merck hpv vaccine (name and lot number not provided) administered intramuscularly for prophylaxis (product administered to patient of inappropriate age). On an unknown date in 2021, the patient experienced soreness on his arm at the injection site and after an unspecified amount of time the soreness went away. On 27-JAN-2022 (reported also as "about 2 months ago), the patient received a 2nd dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, administered intramuscularly in the left deltoid region, lot # T039467, expiration date 20-MAY-2023 for prophylaxis and on the same day, he experienced soreness/ pain at injection site (reported also as vaccine reaction). On an unknown date in 2022, the soreness eventually went away as well. On an unknown date in February 2022 (reported as about a month ago), the soreness returned and the patient could feel it when he "pushed on it with a finger". The patient reported he also felt an indentation. The patient sought medical attention and was advised to use a warm compress. At the time of the report, the patient did not recover from the event of the indentation and soreness when he "pushed on it with a finger".   The physician considered the soreness/ pain at injection site (vaccine reaction) that occurred after the second dose of the vaccine to be related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The casualty assessment between the soreness on the patient's arm after the first dose, the indentation that the patient could feel, the soreness that the patient could feel when he "pushed on it with a finger" and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. The casuality assessment between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event; A dose of M-M-R II was reconstituted with a sterile diluent that is used to reconstitute Act HIB; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant therapies were not reported.    On 03-MAR-2022, a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (rHA) (lot # U011149,  expiration date: 08-APR-2023) was reconstituted with a sterile diluent used to reconstitute ActHIB and administered to the patient (0.5 milliliter, unknown route) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about concomitant medications, concurrent conditions, allergies and medical history was not provided.  On 08-MAR-2022, the patient was vaccinated with 1 dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD), lot# U022729, expiration date: 16-JAN-2023 (route of administration not provided) for prophylaxis (improper storage of product in use). The vaccine was improperly stored at 13 degrees Fahrenheit (F) for 4 hours. No previous temperature excursions. Data logger was not used to capture the temperature excursion.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported; On 04-DEC-2021, the patient received VARIVAX and On 23-DEC-2021, the patient received MMR/Interruption in schedule; This spontaneous report was received from a nurse referring to herself as a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 08-NOV-2021, the patient received the first dose of varicella virus vaccine live (Oka/Merck). On 04-DEC-2021, the patient received the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX). On 23-DEC-2021, the patient received the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). On 21-JAN-2022, the patient received the second dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (doses, routes of administration, lot numbers and expiration dates were not reported for any dose). Both vaccines were given as prophylaxis.  The nurse reported that her records were flagged with a interruption in the schedule (Inappropriate schedule of product administration). No additional adverse events reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred; an expired dose of MMRII was administered to a patient; This spontaneous report was received from Certified Medical Assistant and refers to the patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.   On 09-MAR-2022, the patient was vaccinated with expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II), dose: 1 dose, lot# T006166 , expiration date: 19-FEB-2022 (route of administration was not provided) for prophylaxis (expired product administered). The reporter confirmed that the vaccine did not have any temperature excursions prior to administration and no other additional adverse event occurred (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No further AE; reported administration of pediatric dose of RECOMBIVAX HB; reported administration of pediatric dose of RECOMBIVAX HB; This spontaneous report was received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 10-DEC-2021, the patient was vaccinated with pediatric dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) 5MCG/0.5ML PED PF SYR CARTON OF 10 lot # U001837, expiration date reported as "21-NOV-2022", but upon internal validation established as 28-APR-2023, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). No further adverse event (AE) was reported.  This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2203USA004333: US-009507513-2203USA004547:
Sex: F
Vaccine: VARZOS
Symptoms: Mydriasis
Clinical narrative: Blown pupil; This case was reported by a nurse via sales rep and described the occurrence of dilated pupils in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dilated pupils. On an unknown date, the outcome of the dilated pupils was unknown.   It was unknown if the reporter considered the dilated pupils to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced blown pupil after receiving the first dose and was advised not to take second dose. The reporter denied for further follow up. Note: GSK receipt date was conservatively kept as 8 March 2022, clarification already raised.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: normal arm pain; This case was reported by a consumer and described the occurrence of pain in arm in a 77-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022035993, US2022AMR045957   Additional information was provided as follows: The patient experienced normal arm pain for 2 days after receiving Shingrix vaccine. No other information was provided. This case linked with US2022AMR045957, US2022035993, reported for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022035993:Same patient US-GLAXOSMITHKLINE-US2022AMR045957:Same patient
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019) and Shingrix (received 2nd dose in 2019).   On 10th March 2022, the patient received the 3rd dose of Shingrix. On 10th March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case was reported by Registered Nurse. The age at vaccination was not reported. The patient received 3rd dose of Shingrix on the day of reporting, which led to extra dose administered.  The reporter requested information on safety in patients receiving three doses of Shingrix.  The request was submitted to Medical Affairs. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: suspected Vaccination failure; 3rd outbreak got Ramsay Hunt syndrome, permanent effects to my face; Shinlges, this is 4th time. 3rd was in roof of mouth; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ramsay-hunt syndrome (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ramsay-hunt syndrome and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ramsay-hunt syndrome and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient asked for advice on what a person should do that had the two Shingrix shots in 2018 and just developed shingles again. This was the 4th time the patient had been diagnosed with shingle. The 3rd episode was on the roof of the mouth and developed into Ramsay Hunt Syndrome which cause permanent effect on his/her face. The patient stated that his/her healthcare provider did not expressed much interest. The patient had several nurses in family also had PhD in Biology. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got vaccine and got 2nd one 2 weeks later; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received 2nd dose of  Shingrix vaccine two weeks later after receiving 1st dose, which led to shortening of the recommended interval between vaccine doses. The reporter received first one and was told to get her second one in 3 to 6 months.  Someone made a mistake. The reporter asked which one was right. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first shot 2/14/21, never received 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on 14th February 2021).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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. The patient received first shot back on 14th February 2021, with everything going on he/she had never received the second shot, therefore till the time of reporting the patient had not received their 2nd dose which led to incomplete course of vaccination. The reporter inquired if it was too late or do they have to get the both doses over again.
Sex: U
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received pediatric dose; Adult patient received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received HAV (Havrix) (batch number EP478, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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 details were provided as follows: The age at vaccination was not reported. The reporter reported that adult patient received inadvertently a pediatric dose of Havrix, which led to accidental underdose and adult use of a child product. The reporter asked that we could administer another pediatric dose to make up an adult dose. The demographics from patient weren't available at the moment of the reporting. The reporter consented to follow up.
Age: 57.0
Sex: U
Vaccine: MNQ, MNQ
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 57yo at first dose in 2019, second dose 08-mar-2022; 57yo at first dose in 2019, second dose 08-mar-2022; 57yo at first dose in 2019, second dose 08-mar-2022; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 57-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included eculizumab (Soliris).   On 8th March 2022, the patient received the 2nd dose of Menveo. On 24th June 2019, the patient received the 1st dose of Menveo. On 24th June 2019, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On 8th March 2022, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, drug dose administration interval too short and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The age at vaccination was unknown for the 2nd dose. The reporter stated that the patient was vaccinated with first dose of Menveo at 57 years of age, which led to inappropriate age at vaccine administration.  The patient was administered 2nd dose of Menveo earlier than the recommended interval and at inappropriate age not as per recommended package insert, which led to inappropriate age at vaccine administration and drug dose administration interval too short. The patient was taking medication Soliris that was why they were getting this at that age. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose in 2017, third dose was Infanrix on 13-aug-2021.; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 6-year-old male patient who received DTPa (Infanrix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (DTaP vaccine) and DTPa (DTaP vaccine).   On 13th August 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving DTaP vaccine and DTaP vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient was on the DTaP catch up schedule. The patient received DTaP 1st and 2nd dose in 2017. The patient received the 3rd dose as Infanrix on 13th August 2021, which led to lengthening of vaccination schedule. The reporter stated that the Lot number was from agency.  The reporter did not know for sure if the first two doses were Infanrix (but that was what they had in stock).
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Tenderness and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional details reported were as follows: The case was self reported by the patient. The patient received Shingrix in September of last year. The patient had tenderness and soreness at the injection site that resolved 2 days later. The representative spoke from content and package insert. The reporter consented to follow up. Consent obtained to contact health care professional and consumer for follow-up. For tolerance of 2nd dose, refer case US2022AMR045382.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR045382:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: After vaccination patient contracts herpes simplex virus.; This case was reported by a nurse via call center representative and described the occurrence of herpes simplex in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that after taking Shingrix vaccine a patient contracted herpes simplex virus. The reporter did not consent to follow-up.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received an expired dose of Bexsero which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness
Clinical narrative: dizziness; weakness all over; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced dizziness and weakness generalized. On an unknown date, the outcome of the dizziness was recovered/resolved and the outcome of the weakness generalized was unknown.   It was unknown if the reporter considered the dizziness and weakness generalized to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR045208  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 experienced weakness all over and dizziness. The patient was referred to HCP (health care professional). The patient had no HCP (health care professional) currently. The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR045208:2nd dose case - same reporter same patient
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered an expired Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HAB (Twinrix adult) (batch number 57E3G, expiry date 28th February 2022) 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 10th March 2022, the patient received Twinrix adult and Twinrix Pre-Filled Syringe Device. On 10th March 2022, unknown after receiving Twinrix adult 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 was provided as follows: Pharmacist called in to inquire and report about expired Twinrix dose. The reporter reported that they inadvertently administered an expired Twinrix dose to a patient. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: pregnant patient given Bexsero, Menveo, Havrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis and Men ACWY-CRM NVS (Menveo) (batch number AMVA638A, expiry date 30th November 2022) for prophylaxis.   On 9th March 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Havrix and Menveo. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Bexsero at an unknown time during the pregnancy. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Havrix and Menveo, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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 provided as follows: The reporter was medical assistant. The reporter reported that pregnant patient given Bexsero, Menveo, and Havrix ,which led to vaccine exposure during pregnancy. The reporter consented to follow up with health care professional.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a dose of Shingrix on 20January2022 and records indicate that he received a dose in September 2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (First dose received on an unknown date in September 2020).   On 20th January 2022, the patient received the 2nd dose of Shingrix. On 20th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter stated that the patient received a dose of Shingrix late which led to lengthening of vaccination schedule. The reporter stated that the patient told, he had not received a dose in September 2020 and wanted another dose. The reporter stated that the records indicate that patient had received a dose in September 2020. The reporter was not having the lot at the time of report. The reporter consented to follow up via email.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Sensory disturbance
Clinical narrative: Unusual feeling in her feet/Ice running through feet,iciness in hands and feet; This case was reported by a physician via call center representative and described the occurrence of abnormal sensation of limbs in a 68 years old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in October 2021).   On 8th March 2022, the patient received the 2nd dose of Shingrix. In March 2022, 24 hrs after receiving Shingrix, the patient experienced abnormal sensation of limbs. On an unknown date, the outcome of the abnormal sensation of limbs was not recovered/not resolved.   It was unknown if the reporter considered the abnormal sensation of limbs to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient's husband, who was physician. The patient received the 2nd dose of Shingrix vaccine in left upper arm, 2 days ago from the day of reporting and 24 hours later experienced an unusual feeling in her feet ice running through her feet (iciness in hands and feet), that was still on going.  The reporter would like to know if this had been reported.  Health care professional (HCP) did not had lot number and expiration date available.  The representative spoke from content and provided package insert (PI).  The reporter was provided Medical Information's telephone number and website.  Call abandoned by reporter whist transferring call. Consent obtained from reporter to contact for follow-up with consumer and HCP. The reporter gave consent for safety team to follow up.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired dose to a patient on 14-jan-22; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received HBV (Engerix B) (batch number P7294, expiry date 3rd January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 14th January 2022, unknown after receiving Engerix B and Engerix B 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 details were provided as follows: The case was reported by Practice Administrator. The reporter stated that, they inadvertently administered an expired Engerix dose to the patient, whic led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received first dose on 21-may-2018. Never received the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 21st May 2018).   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. Details were reported for 1st dose.  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. No other details of vaccine were provided. The vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Woke up with fever; Chills; Headache; Body aches; Sever pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2022, the patient received the 1st dose of Shingrix. On 10th March 2022, less than a day after receiving Shingrix, the patient experienced injection site pain. On 11th March 2022, the patient experienced fever, chills, headache and general body pain. On an unknown date, the outcome of the injection site pain, fever, chills, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, headache and general body pain to be related to Shingrix.  Additional details reported were as follows: The age at vaccination was not reported. On the day before the reporting the patient received Shingrix. The patient reported sever pain at injection site. One day after receiving Shingrix, the patient woke up with fever, chills, headache and body aches.  The patient refused to give any other details. The patient was referred to healthcare professional who spoke per Shingrix FAQ but the patient abruptly hung up and ended call. The patient did not consent to follow-up.  The report was filed with limited information
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose more than 6 months ago, have not received their 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (first dose received more than 6 months ago from the date of reporting).   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. The reporter stated that, till the time of reporting, 1 or 2 patients did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter had no patient identifiers for patients and did not provide any additional information. The reporter did not consent to follow up.
Age: 20.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Inadvertently administered an expired Havrix dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix adult) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th March 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 11th March 2022, unknown after receiving Havrix adult 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 details were provided as follows: The licensed practical nurse stated that they inadvertently administered an expired Havrix dose to a patient on the day of reporting, the vaccine was expired on 26th February 2022, which led to expired vaccine used. The reporter inquired that whether the patient had to be revaccinated. The reporter denied for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant ONLY was given to patient; adjuvant ONLY was given to patient; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate dose of vaccine administered 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 dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The reporter was a GlaxoSmithKline representative who was reporting a Shingrix adverse event, that she was made aware of on the day of reporting, on behalf of healthcare professional. The reporter had minimal information to report. The reporter stated that the Shingrix adjuvant only was given to an unknown patient in the last 2 weeks, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The healthcare professional did not want to be contacted at this point by GlaxoSmithKline, as she was currently doing an investigation as to how that happened. The reporter had the case number and might call back to add further information to the case. The healthcare professional phone number was not provided. The reporter denied for further follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on February 10, 2022 and 2nd dose on February 24, 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 24th February 2022, the patient received the 2nd dose of Shingrix. On 24th February 2022, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The reporter was the patient's wife. The patient received 2nd dose of Shingrix in left arm. The patient received 2nd dose of Shingrix, earlier than the recommended schedule, which led to shortening of vaccination schedule. This adverse event was reported due to the incorrect vaccination schedule that was applied. The reporter did not have further information regarding the 2nd dose of Shingrix. The call center representative spoke per PI, offered PI, gave Medical Advice Disclaimer and referred to healthcare professional.   Offered phone number to MI for healthcare professional to call on patient's behalf.  The reporter did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Engerix-B in 2019, second in January of 2022.; second and last in January of 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a adult female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for an unknown indication and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on an unknown date in 2019).   In January 2022, the patient received the 3rd dose of Engerix B, the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. In January 2022, not applicable after receiving Engerix B and unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long and drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short 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 details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient did not gave permission to use her date of birth (DOB) in the report, but did confirm she was well over 21 years old. The patient received her first Engerix-B vaccine in 2019 and received the second and last dose in January of 2022.  The patient received 2nd dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule The patient also received 3rd dose of Engerix-B within a month after 2nd dose, earlier than recommended interval, which led to shortening of vaccination schedule The patient was not sure if she should restart the series or take a titer.  The patient's health care professional (HCP) would call medical information(MI). The patient did not gave permission to contact HCP, but GlaxoSmithKline could contact patient by email provided. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired Twinrix administered to a patient.; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 66-year-old female patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) 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 10th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th March 2022, 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 details were reported as follows: The registered nurse reported the use of Twinrix dose to a patient, as the vaccine was already expired on 8th February 2022, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Headache, Malaise, Nausea, Pyrexia
Clinical narrative: nausea; fever; malaise; headache; abdominal pain; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2022, the patient received the 2nd dose of Shingrix. On 8th March 2022, 1 days after receiving Shingrix, the patient experienced nausea, fever, malaise, headache and abdominal pain. On an unknown date, the outcome of the nausea, fever, malaise, headache and abdominal pain were not recovered/not resolved.   It was unknown if the reporter considered the nausea, fever, malaise, headache and abdominal pain 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 her second dose of Shingrix on Monday and on Tuesday the patient experienced nausea, fever, malaise, headache, and abdominal pain. All symptoms were unresolved. The reporter did not consent to follow-up
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Underdose
Clinical narrative: received partial dose of BOOSTRIX; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43jh7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th March 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 11th March 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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 provided as follows: The reporter stated that the patient received partial dose of Boostrix vaccine, which led to underdose. The patient did not receive 0.1ml dose of Boostrix. The reporter consented to follow up.
Age: 21.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received an expired HAVRIX; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAV (Havrix 1440 adult) (batch number EK59B, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Havrix 1440 adult (intramuscular) and Havrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Havrix 1440 adult 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 details were provided as follows: The reporter stated that, a patient received an expired Havrix vaccine in right arm, which led to expired vaccine used. The reporter wanted to know what to do about this situation. The reporter also stated that, the patient had not been informed that they have received an expired vaccine. Spoke from content and warm transferred call to Medical Information. Provided phone number for future reference. The reporter consented to follow up.