chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; adult received pediatric Engerix-B on 14Jun2022 and 14Jul2022; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 42-year-old female patient who received HBV (Engerix B 10 mcg) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   Co-suspect products included HBV (Engerix B 10 mcg) (batch number FB9RH, expiry date 21st January 2024) for prophylaxis.   On 14th July 2022, the patient received the 2nd dose of Engerix B 10 mcg. On 14th June 2022, the patient received the 1st dose of Engerix B 10 mcg. On 14th June 2022, not applicable after receiving Engerix B 10 mcg and unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On 14th July 2022, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose, adult use of a child product, underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's Comments: The reporter stated that adult patient received two doses of pediatric Engerix B. The reporter consented to follow up. Additional supportive information: An adult patient was administered a 2 pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered expired dose of Bexsero to a patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 20th June 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 15th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comments: The case was reported by the medical assistant. Reporter administered an expired dose of Bexsero to the patient. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 12.0
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received on 14 Jul 2022 a dose of Engerix-B that had expired on 1 Jun 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old patient who received HBV (Engerix B) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   On 14th July 2022, the patient received Engerix B. On 14th July 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comments: The patient received the dose of Engerix-B on 14 July 2022 that had been expired on 01 June 2022. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used. This case was linked with case US2022107249, reported by the same reporter.; Sender's Comments:  US-GSK-US2022107249:Same reporter, same case
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain lower, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: High fever, will alternately return to normal, then spike 102; Headache; Pain in lower right abdomen was so severe they thought they were experiencing appendicitis; Fatigue; Chills; Sweats; Pain at the injection site; 1st dose Oct/2021 and 2nd dose 08/Jul/2022; General feeling of malaise, confined to bed from Monday through Thursday; Lose of appetite shortly after symptoms began and only being able to consume small amounts of cereal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October of 2021 refer case US2022AMR107457).   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On 11th July 2022, the patient experienced fever, headache, lower abdominal pain, fatigue, chills and sweating. In July 2022, the patient experienced malaise and appetite lost. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR107457   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment:  The patient received Shingrix vaccine in left arm.  The patient immediately experienced pain at the injection site after second dose.  The patient felt fine over the weekend, with just a general feeling of malaise.  The patient experienced chills, sweats, high fever, headache, pain in lower right abdomen, and fatigue after second dose, which started on Monday, 11 July 2022.  The patient confined to bed from Monday through Thursday, 14 July 2022.  The patient experienced loss of appetite shortly after symptoms began and only was able to consume small amounts of cereal.  The patient had pain in lower abdomen which was so severe they thought they had experienced appendicitis.  The patient had fever which would alternately return to normal, then spike to 102.  The patient had all symptoms which had improved, but are still present.  The consent to follow up was given. Additional Supportive Information: The patient received first dose of Shingrix in October of 2021 and second dose on 8th July 2022, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR107457:Same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Inappropriate schedule of product administration, Injection site pain, Malaise, Pyrexia
Clinical narrative: High fever, will alternately return to normal, then spike 102; Headache; Pain in lower right abdomen was so severe they thought they were experiencing appendicitis; Fatigue; Chills; Sweats; Pain at the injection site; 1st dose Oct/2021 and 2nd dose 08/Jul/2022; General feeling of malaise, confined to bed from Monday through Thursday; Lose of appetite shortly after symptoms began and only being able to consume small amounts of cereal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October of 2021 refer case US2022AMR107457).   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On 11th July 2022, the patient experienced fever, headache, lower abdominal pain, fatigue, chills and sweating. In July 2022, the patient experienced malaise and appetite lost. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR107457   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment:  The patient received Shingrix vaccine in left arm.  The patient immediately experienced pain at the injection site after second dose.  The patient felt fine over the weekend, with just a general feeling of malaise.  The patient experienced chills, sweats, high fever, headache, pain in lower right abdomen, and fatigue after second dose, which started on Monday, 11 July 2022.  The patient confined to bed from Monday through Thursday, 14 July 2022.  The patient experienced loss of appetite shortly after symptoms began and only was able to consume small amounts of cereal.  The patient had pain in lower abdomen which was so severe they thought they had experienced appendicitis.  The patient had fever which would alternately return to normal, then spike to 102.  The patient had all symptoms which had improved, but are still present.  The consent to follow up was given. Additional Supportive Information: The patient received first dose of Shingrix in October of 2021 and second dose on 8th July 2022, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR107457:Same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: High fever, will alternately return to normal, then spike 102; Headache; Pain in lower right abdomen was so severe they thought they were experiencing appendicitis; Fatigue; Chills; Sweats; Pain at the injection site; 1st dose Oct/2021 and 2nd dose 08/Jul/2022; General feeling of malaise, confined to bed from Monday through Thursday; Lose of appetite shortly after symptoms began and only being able to consume small amounts of cereal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October of 2021 refer case US2022AMR107457).   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On 11th July 2022, the patient experienced fever, headache, lower abdominal pain, fatigue, chills and sweating. In July 2022, the patient experienced malaise and appetite lost. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR107457   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment:  The patient received Shingrix vaccine in left arm.  The patient immediately experienced pain at the injection site after second dose.  The patient felt fine over the weekend, with just a general feeling of malaise.  The patient experienced chills, sweats, high fever, headache, pain in lower right abdomen, and fatigue after second dose, which started on Monday, 11 July 2022.  The patient confined to bed from Monday through Thursday, 14 July 2022.  The patient experienced loss of appetite shortly after symptoms began and only was able to consume small amounts of cereal.  The patient had pain in lower abdomen which was so severe they thought they had experienced appendicitis.  The patient had fever which would alternately return to normal, then spike to 102.  The patient had all symptoms which had improved, but are still present.  The consent to follow up was given. Additional Supportive Information: The patient received first dose of Shingrix in October of 2021 and second dose on 8th July 2022, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR107457:Same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: High fever, will alternately return to normal, then spike 102; Headache; Pain in lower right abdomen was so severe they thought they were experiencing appendicitis; Fatigue; Chills; Sweats; Pain at the injection site; 1st dose Oct/2021 and 2nd dose 08/Jul/2022; General feeling of malaise, confined to bed from Monday through Thursday; Lose of appetite shortly after symptoms began and only being able to consume small amounts of cereal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October of 2021 refer case US2022AMR107457).   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On 11th July 2022, the patient experienced fever, headache, lower abdominal pain, fatigue, chills and sweating. In July 2022, the patient experienced malaise and appetite lost. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR107457   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment:  The patient received Shingrix vaccine in left arm.  The patient immediately experienced pain at the injection site after second dose.  The patient felt fine over the weekend, with just a general feeling of malaise.  The patient experienced chills, sweats, high fever, headache, pain in lower right abdomen, and fatigue after second dose, which started on Monday, 11 July 2022.  The patient confined to bed from Monday through Thursday, 14 July 2022.  The patient experienced loss of appetite shortly after symptoms began and only was able to consume small amounts of cereal.  The patient had pain in lower abdomen which was so severe they thought they had experienced appendicitis.  The patient had fever which would alternately return to normal, then spike to 102.  The patient had all symptoms which had improved, but are still present.  The consent to follow up was given. Additional Supportive Information: The patient received first dose of Shingrix in October of 2021 and second dose on 8th July 2022, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR107457:Same reporter
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperhidrosis, Injection site pain, Lethargy, Malaise, Pyrexia
Clinical narrative: High fever, will alternately return to normal, then spike 102; Headache; Pain in lower right abdomen was so severe they thought they were experiencing appendicitis; Fatigue; Chills; Sweats; Pain at the injection site; 1st dose Oct/2021 and 2nd dose 08/Jul/2022; General feeling of malaise, confined to bed from Monday through Thursday; Lose of appetite shortly after symptoms began and only being able to consume small amounts of cereal; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number KJ937, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received in October of 2021 refer case US2022AMR107457).   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, immediately after receiving Shingrix, the patient experienced injection site pain and drug dose administration interval too long. On 11th July 2022, the patient experienced fever, headache, lower abdominal pain, fatigue, chills and sweating. In July 2022, the patient experienced malaise and appetite lost. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, fever, headache, lower abdominal pain, fatigue, chills, sweating, malaise and appetite lost to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR107457   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comment:  The patient received Shingrix vaccine in left arm.  The patient immediately experienced pain at the injection site after second dose.  The patient felt fine over the weekend, with just a general feeling of malaise.  The patient experienced chills, sweats, high fever, headache, pain in lower right abdomen, and fatigue after second dose, which started on Monday, 11 July 2022.  The patient confined to bed from Monday through Thursday, 14 July 2022.  The patient experienced loss of appetite shortly after symptoms began and only was able to consume small amounts of cereal.  The patient had pain in lower abdomen which was so severe they thought they had experienced appendicitis.  The patient had fever which would alternately return to normal, then spike to 102.  The patient had all symptoms which had improved, but are still present.  The consent to follow up was given. Additional Supportive Information: The patient received first dose of Shingrix in October of 2021 and second dose on 8th July 2022, which led to lengthening of the vaccine schedule.; Sender's Comments:  US-GSK-US2022AMR107457:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebrovascular accident, Incomplete course of vaccination
Clinical narrative: Stroke; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of stroke in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix and received the 1st dose of Shingrix. On an unknown date, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the stroke and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the stroke to be related to Shingrix.     Additional Information: GSK Receipt Date:15-Jul-2022. Reporter's Comments: The patient's wife reported case on behalf of her husband. The patient received the first dose of Shingrix 3-4 years before the date of reporting. The patient had a stroke two years ago (adverse event -Symptomatic) and wanted to know if patient need to restart the vaccine series. It was also inquired if there was any assistance paid for Shingrix. The patient was provided medical disclaimer and referred to healthcare professional. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Pharmacist reported received on 15 Jul 2022 a dose of Havrix that had expired on 18 Jun 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comments: The case was reported by patient who was pharmacist. The Pharmacist received the dose of Havrix on 15 July 2022 that had been expired on 18 June 2022. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Nurse administered an expired dose of Bexsero to a patient on 15 Jul 2022; 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 ABXB29BA, expiry date 30th June 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 15th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Jul-2022 Reporter's comments: Nurse administered an expired dose of Bexsero to the patient on 15 Jul 2022.  The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: pain at the injection site; experienced a red, painful spot; experienced a red, painful spot,the area is a little sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2022, the patient received the 2nd dose of Shingrix (intramuscular). In July 2022, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, redness and pain. On an unknown date, the outcome of the injection site pain and redness were recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, redness and pain to be related to Shingrix.     Additional Information: GSK receipt date: 15-Jul-2022 Reporter's comment: The patient received suspect vaccine on unknown arm. The reporter reported that few days later after 2nd dose patient experienced a red, painful spot about 2 inches below the injection site. The area was a little sore. The patient had nothing else to report.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: welts under arms on her back; severe rash; This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J27J, expiry date 6th May 2023) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Shingrix. On 11th July 2022, less than a day after receiving Shingrix, the patient experienced welts and rash. On an unknown date, the outcome of the welts and rash were unknown.   It was unknown if the reporter considered the welts and rash to be related to Shingrix.     Additional Information: GSK receipt date: 18-Jul-2022 Reporters comment: The pharmacist reported that the patient had a severe rash and welts under arms and on her back.   The patient did not have anaphylaxis reaction.  The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 432S2, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 15th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 15th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-JUL-2022 Reporter's Comment: The reporter reported that, a pediatric patient received an expired dose of Rotarix. The reporter consented to follow up. Additional Supportive Information: A pediatric patient received an expired dose of Rotarix, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Underdose
Clinical narrative: At least half of the dose was administered / small amount left in the syringe; few drops were on the patient's arm; few drops were on the patient's arm; 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 Herpes zoster (Shingrix) (batch number 252JX, expiry date 14th September 2023) for prophylaxis.   On 18th July 2022, the patient received the 1st dose of Shingrix. On 18th July 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comments: The patient inadvertently received less than a full dose of Shingrix because a few drops were fell on the patient's arm after administering the vaccine. There was also a small amount left in the syringe. The vaccine had leaked out of an unknown site (unknown if injection site or the syringe).  At least half of the vaccine dose was administered. The reporter consented to follow-up via phone. Additional Supportive Information: The patient received half of the vaccine dose, because a few drops were fell on the patient's arm and small amount left in the syringe, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Rotarix expired dose was administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-week-old female patient who received Rota (Rotarix lyophilized formulation) (batch number AB445, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 18th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 18th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:18-JUL-2022 Reporter's Comments: The patient was administered with expired dose Rotarix. The reporter consent to follow up. Additional Supportive Information: The patient received expired dose of Rotarix, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: Pharmacist had some splash in her eye; Pharmacist had some splash in her eye; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 18th July 2022, the patient received Menveo. On 18th July 2022, unknown after receiving Menveo, the patient experienced occupational exposure while preparing product for administration and exposure via eye contact. On an unknown date, the outcome of the occupational exposure while preparing product for administration and exposure via eye contact were unknown.   Additional Information: GSK Receipt Date: 18-Jul-2022 Reporter's comment: Pharmacist reported that today she was going to administer a Menveo vaccine and had some splash in her eye. She had rinsed with contact solution. Pharmacist did not had the lot number information available at the time of reporting. The consent to follow up was given. Additional Supportive Information: Pharmacist reported that today she was going to administer a Menveo vaccine and had some splash in her eye, which led to Occupational exposure while preparing product and exposure via eye contact. Concomitant product contact solution was not coded due to limitation of dictionary.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Jul-2022 Reporter's comments: Licensed Vocational Nurse called to asked how to proceed?  Licensed Vocational nurse reported that patient was inadvertently administered an expired dose of Kinrix. The reporter did not consented to follow up. Additional Supportive Information: The patient was given an expired dose of Kinrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose 09/25/2020. Second dose not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th September 2020, expiry date 25th March 2022, Batch number NT7YR).   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 Information: GSK Receipt Date: 18-July-2022 Reporter's comment: The reporter reported a late second dose of Shingrix. Second dose not yet administered at time of call. The reporter consented to follow up.  Additional supportive information: Till the time of reporting the patient had not received 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: boostrix expired administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 7th July 2022, the patient received Boostrix. On 7th July 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: HCP (Health Care Professional) reported that an expired dose of Boostrix was administered to patient. The reporter consented to follow-up via phone. Additional Supportive Information: The patient received a dose of Boostrix vaccine which was already expired, which led to expired vaccine used.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to a 3 year old patient; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :18 July 2022 Reporters comment: The three year old patient received Kinrix.  The no symptoms reported. The reporter consented to follow-up. Additional Supportive information: Three year old patient received Kinrix, which led to inappropriate age at vaccine administration.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose; adult patient received a pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 62-year-old female patient who received HBV (Engerix B) (batch number lp724, expiry date 18th May 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 8th July 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 8th July 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date :GSK receipt date: 18-Jul-2022 Reporters comment:  The medical assistant reported that the adult patient received a pediatric dose of Engerix-B as second dose. The reporter consent to follow-up. Additional Supportive information: The adult patient received a pediatric dose of Engerix-B which led to underdose and adult use of child product.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Found Menveo powder without the diluent; gave a patient only the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 Information: GSK receipt date: 18-Jul-2022 Reporter's comment: The nurse reported that one of the clinics found a Menveo powder without the diluent. They thought they gave a patient only the diluent and the powder were still in the box but they were still researching.  The reporter stated that they narrowed it down to being 1 of the last 5 patients who may had received only the diluent. The reporter wants to know there be any side effects/harm in giving all patients another dose. The lot or expiration date was not available and no patient details to share. The reporter consented to follow up. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Child was given adult dose; Child was given adult dose; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 4-year-old male patient who received HAV (Havrix 1440) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th July 2022, the patient received Havrix 1440 (intramuscular) 1 mg/ml and Havrix Pre-Filled Syringe Device. On 18th July 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's comments: The nurse reported that a male child was given the adult dose of HAVRIX today instead of the pediatric dose. She had failed to obtain the patient's initials. The Vaccine Administration Facility is the same as Primary Reporter. Additional supportive information: The patient was given adult dose instead of the pediatric dose, which led to accidental overdose and inappropriate age at vaccine administration.
Age: 0.25
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old received BEXSERO; 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 3-month-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.   On 5th May 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 5th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment:  Three month old patient received one dose of Bexsero. Additional Supportive Information: Three month old patient was administered a dose of Bexsero, which led to inappropriate age at vaccine administration and wrong vaccine administered. Discrepancy- The age of the patent was reported as 6 months but as per date of birth it was considered as 3 months.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Administered after being reconstituted with sterile water; Administered after being reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Reporter's Comments: The healthcare professional (HCP) reported that Hiberix was administered after being reconstituted with sterile water. No reactions was reported. The reporter consented to follow up. The vaccine administration facility was same as primary reporter PII, lot and expiration date was not provided in follow up email. Additional Supportive Information: The patients received Hiberix vaccines reconstituted with sterile water which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 30th September 2021) for prophylaxis.   On 15th July 2022, the patient received the 2nd dose of Shingrix. On 15th July 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 18-Jul-2022 Reporters comment: The reporter was a healthcare professional from doctor's office. The reporter reported that the patient received by error a Shingrix expired dose. The reporter consented to follow up. Additional Supportive Information: The patient received Shingrix vaccine, which was already expired, which led to expired vaccine used. This case was linked with case US2022104395, reported by the same reporter.; Sender's Comments:  US-GSK-US2022104395:Same reporter
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Extra dose administered
Clinical narrative: received extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 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 15th July 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: Nurse reported that a patient inadvertently received an extra dose of Bexsero (a third dose). The reporter consented to follow-up via postal mail. Additional Supportive Information: The patient inadvertently received an extra dose of Bexsero, which led to extra dose administered.
Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose of expired Havrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 17th July 2022, the patient received Havrix. On 17th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 19-Jul-2022 Reporter's comment: Personal assistant reported that a dose of expired Havrix was administered to the patient. The patient did not ask about follow up but email was above. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.