chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEP
Symptoms: Pregnancy, Product use issue, Vaccination error
Clinical narrative: Pregnant Female Received HEPLISAV-B in Error; Pregnant Female Received HEPLISAV-B in Error; Initial Report Received on 22-Dec-2021 and 09-Feb-2022  A reporter from a clinic reported that a pregnant female patient (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 22-Dec-2021, the pregnant patient came into the clinic and received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) through an unspecified route and site. The clinic reported it as an immunization error to the registry.  The patient did not enroll in the registry and no additional information was reported.   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: Inappropriate schedule of product administration
Clinical narrative: Received 2nd Dose 3 Months After 1st Dose; Initial Report Received on 30-Dec-2021   A pharmacist reported that a 26-year-old male patient (race and ethnicity unknown) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 3 months after the first dose.   No relevant medical history was reported.    No relevant concomitant medications were reported.     On 12-Mar-2021, the patient received the first dose of HEPLISAV-B (Lot # 934601, expiration date 16 Mar 2022, and NDC # 43528-003-05) in the left deltoid from the pharmacist.   Three months later, in June-2021 (exact date unknown), the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site unknown) from a different pharmacy. 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: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Left arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of painful l arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2022, the patient received Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced painful l arm. On an unknown date, the outcome of the painful l arm was not recovered/not resolved.   It was unknown if the reporter considered the painful l arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that the left arm still hurts 15 days after shingles shot. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Ear pain, Injection site pain, Muscle spasms, Myalgia, Neck pain
Clinical narrative: Muscle pain on left arm where vaccine was administered; Generalized muscle pain; Muscle spams on left shoulder blade and neck; Cervical pain; Left ear ache; Tingling of left side of head, mouth and throat; Tingling of left side of head, mouth and throat; Tingling of left side of head, mouth and throat; This case was reported by a consumer and described the occurrence of injection site muscle pain in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site muscle pain, generalized muscle aches, muscle spasm, cervical pain, ear pain, tingling, tingling mouth and tingling throat. On an unknown date, the outcome of the injection site muscle pain, generalized muscle aches, muscle spasm, cervical pain, ear pain, tingling, tingling mouth and tingling throat were recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, generalized muscle aches, muscle spasm, cervical pain, ear pain, tingling, tingling mouth and tingling throat 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 on left arm and had side effects lasting two weeks included generalized muscle pains and side effects lasting three weeks included muscle pain on left arm where vaccine was administered; muscle spasms on left shoulder blade and neck; cervical pain; left ear ache; tingling of left side of head, mouth and throat.
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Muscle pain on left arm where vaccine was administered; Generalized muscle pain; Muscle spams on left shoulder blade and neck; Cervical pain; Left ear ache; Tingling of left side of head, mouth and throat; Tingling of left side of head, mouth and throat; Tingling of left side of head, mouth and throat; This case was reported by a consumer and described the occurrence of injection site muscle pain in a 80-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site muscle pain, generalized muscle aches, muscle spasm, cervical pain, ear pain, tingling, tingling mouth and tingling throat. On an unknown date, the outcome of the injection site muscle pain, generalized muscle aches, muscle spasm, cervical pain, ear pain, tingling, tingling mouth and tingling throat were recovered/resolved.   It was unknown if the reporter considered the injection site muscle pain, generalized muscle aches, muscle spasm, cervical pain, ear pain, tingling, tingling mouth and tingling throat 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 on left arm and had side effects lasting two weeks included generalized muscle pains and side effects lasting three weeks included muscle pain on left arm where vaccine was administered; muscle spasms on left shoulder blade and neck; cervical pain; left ear ache; tingling of left side of head, mouth and throat.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: been 3 year from the first Shingrix; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years before 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 reported as follows: The case was self reported by the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter reported that if it had been 3 year from the first Shingrix vaccine was there a need to start over. Follow up would not be possible, as contact details were not provided.
Sex: F
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Circumstance or information capable of leading to medication error; not administered, but will vaccinate with 1 mL dose; not administered, but will vaccinate with 1 mL dose; This case was reported by a physician via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 19-year-old female patient who received HBV (Engerix B) (batch number 9AX5P, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B 1 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced circumstance or information capable of leading to medication error, adult product administered to child and overdose. On an unknown date, the outcome of the circumstance or information capable of leading to medication error, adult product administered to child and overdose 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 applicable for this report. The patient did not have history of hemodialysis. Physician stated that, 19-years patient was in clinic and needed to receive 2n dose of Engerix-B.   MD stated that, they only had 1 mL doses on hand.   Physician thought she had read this dose was ok for a 19-years-old but wanted to make sure before it was administered. She was administering it based off the alternate schedule in the PI. At the time of reporting, 1 ml was drawn up but was not administered but based off the alternate schedule healthcare professional stated that she would vaccinate using the 1 ml dose which would led to circumstance or information capable of leading to medication error as adult product administered to child and overdose.  The patient received 0,1- and 6-month schedule of Engerix B.  The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 0.33
Sex: F
Vaccine: HIBV, UNK
Symptoms: Overdose
Clinical narrative: received two doses Hib; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received Hib (Hiberix) (batch number h52t9, expiry date 29th December 2022) for prophylaxis.   Co-suspect products included DTAP-IPV-HIB for prophylaxis.   On 1st March 2022, the patient received Hiberix and DTAP-IPV-HIB. On 1st March 2022, unknown after receiving Hiberix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were provided as follows: On the same day the patient received two doses of Haemophilus influenzae type b (Hib), one from Sanofi (containg dtap-IPV-hib) and one from GlaxoSmithKline (Hiberix), which led to overdose. No further events were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up.
Age: 58.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered dose with expiration date of 28Feb2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 58-year-old female patient who received HAB (Twinrix) (batch number GG3S5, 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 2nd March 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd 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 provided as follows: The reporter stated that patient was administered a expired dose of Twinrix, which led to expired vaccine used. At the time of reporting, dose had not been repeated. The reporter consented to follow up.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: received Pediarix after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KB4B, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported a patient received the Pediarix vaccine in right thigh after a temperature excursion, which led to incorrect storage of drug.  The reporter consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:Same reporter. US-GLAXOSMITHKLINE-US2022039275:Same reporter US-GLAXOSMITHKLINE-US2022039277:Same reporter
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received a kinrix vaccine after a temperature excursion, which led to incorrect storage of drug. The reporter consented to follow-up. This case has been linked to US2022039273, US2022039274, US2022039271, US2022039278 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039274:Same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:Same reporter. US-GLAXOSMITHKLINE-US2022039277:same reporter
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Vaccination after a temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KB4B, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient received a pediarix vaccine after a temperature excursion in the right thigh, which led to incorrect storage of drug. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039274:Same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:Same reporter. US-GLAXOSMITHKLINE-US2022039275:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose about 18 months ago and has not yet received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 18 months before 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 patient self-reported this case. The age at vaccination was not applicable for this report. The patient stated that she had not yet received the second dose till the time of reporting, which led to incomplete course of vaccination. The patient planned to receive the second dose soon, she had nothing else to report.
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Kinrix administered to 34 month old baby instead of Dtap (infanrix).; Kinrix administered to 34 month old baby instead of Dtap (infanrix).; inappropriate schdeule of vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 34-month-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the 34 months old patient received Kinrix instead of Dtap (infanrix), which led to inappropriate age at vaccine administration and wrong vaccine administered. Kinrix was administered as 4th dose of dtap and 4th dose of ipv, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up. This case has been linked with case US2022039282 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039282:same reporter
Age: 49.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: inadvertently administered an expired Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 49-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 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 1st March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st 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 reported as follows: The reporter was a practice manager. The reporter stated that they inadvertently administered an expired Bexsero dose to the patient, the vaccine was expired on 28th February 2022, which led to expired vaccine used. The reported called to inquired for any recommendation for such situation. The reporter did not consent to follow up.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose of Havrix; adult patient received a pediatric dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of underdose in a adult patient who received HAV (Havrix 720) (batch number 2k57n, expiry date 22nd December 2022) for prophylaxis.   On 2nd March 2022, the patient received Havrix 720. On 2nd March 2022, unknown after receiving Havrix 720, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details reported were as follows: The age at vaccination was not reported. The adult patient received a pediatric dose of Havrix, which led to underdose and adult use of a child product. The healthcare professional could not provide patient demographics. The consent to follow up was given.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose earlier than recommended; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) (batch number 333TE, expiry date 15th April 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 10th November 2021, the patient received the 2nd dose of Shingrix. On 10th November 2021, unknown 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 reported as follows: The age at vaccination was not applicable for this report. The patient was not immunocompromised. The patient received the first dose of Shingrix on 15th October 2021. The patient received second dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule. The reporter consented to follow up. This case has been linked to US2022040258, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040258:Same reporter.
Sex: U
Vaccine: DTAPIPV, HEP, MENB, MNQ, TDAP
Symptoms: No adverse event
Clinical narrative: temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included 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, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd March 2022, the patient received Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Boostrix, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Boostrix, Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Nurse manager reporting updated temperature excursion of 49 Fahrenheit for possible 90 days for Menveo, Bexsero, Engerix-B, Boostrix, Kinrix, which led to incorrect storage of drug. Health care professional did not had pertinent adverse event information at this time, but gave permission for safety to follow up for additional information. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only diluent portion; received only diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 21st October 2022) for prophylaxis.   On 3rd March 2022, the patient received Menveo. On 3rd March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, the patient had received only diluent portion of Menveo, without being reconstituted, which led to the inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. Vaccine administration facility is same as primary reporter. This case has been linked to US2022040277, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040277:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Hypoacusis, Myelitis
Clinical narrative: myelitis; hearing problems; balance issues; multiple outbreaks of herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, myelitis, hearing problems and balance issues. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient 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 patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The events were determined to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of myelitis was considered to be medically significant. The events of multiple outbreaks of herpes zoster, myelitis, hearing problems and balance issues were determined to be disabling.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: fever blisters, they're quite big / I must have herpes duplex; This case was reported by a consumer via call center representative and described the occurrence of fever blister in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was not recovered/not resolved.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a second Shingrix shot a week ago (from the day of reporting) and experienced two fever blisters. The reporter inquired that whether that was a common occurrence or just coincidence. The reporter stated about reading all the possible side effects on the website before contacting and did not believe that they ever had two fever blisters at the same time before and were quite big. The reporter mistakenly thought the zoster virus and herpes simplex were related and must have herpes duplex.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: seven months instead of six between shingles shots; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose of shingles received 7 months ago from the time of reporting).   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 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 reported as follows: The case was self reported by the patient. The age at vaccination was not reported. The reporter reported that if he/she went 7th months instead of 6th months between his/her Shingles vaccine shot 1st and 2nd was he/she ok, which led to lengthening of vaccination schedule. Follow up would not be possible as contact details were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2018, yesterday received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix, 4 years ago from reporting date, in 2018).   On 2nd March 2022, the patient received the 2nd dose of Shingrix. On 2nd March 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 reported as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the second dose, later than the recommended interval, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been linked to US2022040255, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040255:Same reporter.
Age: 60.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: never received a 3rd dose; First dose on 2nd March 2021 and Dose 2 on April 20th 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 20th April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 20th April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device and an unknown time after receiving TWINRIX, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination for 3rd dose was not applicable. The patient received the first dose of Twinrix on 2nd March 2021. The patient received the second dose Twinrix later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacy intern reported that patient never received a 3rd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Rash, Rash pruritic
Clinical narrative: rash, center to left side of back; rash became very itchy; pain in arm; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraines.   On an unknown date, the patient received the 1st dose of Shingrix 50 µg. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm, fatigue, localised rash and itchy rash. On an unknown date, the outcome of the pain in arm and fatigue were recovered/resolved and the outcome of the localised rash and itchy rash were unknown.   It was unknown if the reporter considered the pain in arm, fatigue, localised rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient had a reaction after her first dose of Shingrix that was given into her left arm.. Immediately after the injection she experienced pain in her arm and fatigue which lasted 2 to 3 days.  Five to six days after the vaccine, she developed a rash on the center to left side of her back under her bra area.  A day later the rash became very itchy.  The patient reported she had a history of migraines (unrelated, prior to receiving Shingrix) which might have contributed to her fatigue . The reporter chose to remain anonymous and did not want to provide her name, DOB (Date of birth), address, phone or any other identifying information.  The reporter was not able to collect lot or expiration date of the vaccine given because when the patient found out that GlaxoSmithKline was unable to give medical advice for her rash, she disconnected from the call. The reporter did not consent to follow-up. GSK note- there was discrepancy in the reported information about time to onset of rash and itchiness. In structured field it was reported as 5 and 6 days respectively but in narrative it is stated like rash appeared five to six days later. TTO for these events captured as per structured fields. Similarly event outcomes captured according to case narrative.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in NOV2021, second not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 16th November 2021, batch no: X239D, expiry date: 7th August 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable for this report. The pharmacist reported that the patient received the first dose of Twinrix and the second dose had not been administered yet. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 5F3T5, expiry date 26th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 16th August 2021) and Shingrix (received 2nd dose on 18th November 2021).   On 4th March 2022, the patient received the 3rd dose of Shingrix. On 4th 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: Nursing assistant at clinic reported that, the patient received first two doses of Shingrix and had no symptoms reported. On the day of reporting, the patient received third dose of Shingrix, which led to extra dose administered. The reporter requested additional information on possible side effects of third dose being administered, warm transferred. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: achy joints; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd March 2022, the patient received the 2nd dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The patient reported case for herself. The reporter was inquiring if this was a potential side effect of the Shingrix vaccine. Provided medical advice disclaimer. The reporter did not consent to follow-up. No additional details were provided.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose was administrated; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HBV (Engerix B) (batch number 9p9b5, expiry date 7th February 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 28th February 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 28th February 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 reporter stated that, an expired dose of Engerix B was administered to the patient. The vaccine administration facility was the same as primary reporter No further events were reported. Consented to follow up was provided.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired twinrix was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number unknown, 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 3rd March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 3rd 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 provided as follows: The age at vaccination was not reported. The reporter reported that, Twinrix was expired on 8th February 2022 and was administered to the patient. The reporter did not have permission to give out any details of patient. Consented to follow was provided.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Administered dose, expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 23-year-old female patient who received HAB (Twinrix) (batch number GG3S5, 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.   Concurrent medical conditions included transgender (male at birth but identified as female at the time of reporting).   On 4th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th 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 provided as follows: The patient received an expired dose of Twinrix, which led to expired vaccine used. At the time of reporting, the patient had not been re-dosed. The reporter consented to follow up. Note- Healthcare professional reported that, the patient's gender was male at birth, but identified as female at the time of reporting, hence gender was selected as female in Argus.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with an expired dose of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 22nd 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 2nd March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd 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 age at vaccination was not reported. The patient was administrated with an expired dose of Bexsero, which led to expired vaccine used.  No adverse event was reported. No patient's identifiers and lot number were provided. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 12.0
Sex: M
Vaccine: DTAP, TDAP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Boostrix and Infanrix on the same day; Received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   On 23rd February 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and Boostrix. On 23rd February 2022, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device and Boostrix, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration 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 patient received a dose of Boostrix and Infanrix on the same day, which led to overdose. The patient received Infanrix at the age of 12 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: occurrence of GBS; This case was reported by a nurse via call center representative and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were provided as follows:                                       The age at vaccination was not reported. The patient received Shingrix vaccine and experienced guillain barre syndrome. The reporter consented to follow up.