chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Diarrhoea, Fatigue, Mobility decreased
Clinical narrative: extreme fatigue; couldn't get out of bed, still lingering; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE QUAD) for prophylaxis.   Previously administered products included Prevnar with an associated reaction of no adverse event (He had many vaccines over his whole life including Prevnar (and states he has never had a problem any prior vaccine)). Concurrent medical conditions included asthma and chronic obstructive pulmonary disease. Concomitant products included fluticasone furoate + vilanterol trifenatate (Breo Ellipta).   On 3rd September 2022 15:00, the patient received the 1st dose of Shingrix (intramuscular) and FLUZONE QUAD (intramuscular). On 3rd September 2022, less than a day after receiving Shingrix, the patient experienced fatigue and mobility decreased. In September 2022, the patient experienced diarrhea. On an unknown date, the outcome of the fatigue and diarrhea were not recovered/not resolved and the outcome of the mobility decreased was unknown.   The reporter considered the fatigue, diarrhea and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The reporter was the patient and stated that he had got the Shingrix 1st shot on Saturday 3rd September 2022 around 3:00 intramuscularly in the left deltoid. (He also got Fluzone Quad on Saturday 03-Sep-2022 around 3:00 intramuscularly in the right deltoid). He was not able to find the lot number or expiration date of the Shingrix administered but had provided the contact information for the pharmacy that had administered the product. They should have that information on file. From Saturday to Monday he had such extreme fatigue that he could not get out of bed. It took every ounce of energy to climb out of bed. As of the day of the report (Wednesday 7th September 2022) he indicated that the fatigue had not resolved completely yet. It was still lingering. Less than a week after receiving the Shingrix and FLUZONE QUAD the patient was also still experiencing fatigue, diarrhea and mobility decreased. It was unknown if the reporter considered the fatigue, mobility decreased and diarrhea to be related to FLUZONE QUAD. The reporter had consented to follow-up
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Device leakage, Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: a leaky vial of Shingrix; leaked out of the vial and got on her hands; Exposure via skin contact; This case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while administering product in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number Zg744, expiry date 28th August 2023) and (batch number AY7BP, expiry date unknown) for prophylaxis. This case was associated with a product complaint.   On 7th September 2022, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 7th September 2022, unknown after receiving Shingrix, the patient experienced occupational exposure while administering product and exposure via skin contact. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 07-SEP- 2022 Reporter's Comments: The reporter stated that they have a leaky vial of Shingrix. She stated that after reconstituting the vaccine, she went to pull up the vaccine and it leaked out of the vial and got on her hands. The lot number on the adjuvant vial was AY7BP. The reporter inject air from the syringe into the vial during preparation. About 0.6 mL of air was injected into the vial when going to pull up the reconstituted vaccine, the leak was coming from the stopper at the neck. The reporter said there was no vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation. The reporter said the metal skirt was still intact. The plastic flip top was removed prior to reconstitution. There was no any evidence of leakage in package or carton. The pharmacist was an experienced user of Shingrix. She stated that she shook the vial to reconstitute the vaccine and then held it upside down to withdraw the vaccine. The picture did not need to be sent in this case. The reporter did not consent to follow-up. Additional Supportive Information:  The reporter stated that after reconstituting the vaccine, she went to pull up the vaccine and it leaked out of the vial and got on her hands, which led to Occupational exposure while administering product and Exposure via skin contact.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 1 month old received adult (1 mL) dose; 1 month old received adult (1 mL) dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-month-old male patient who received HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On 6th September 2022, the patient received the 2nd dose of Engerix B adult 1 ml. On 6th September 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 07-SEP-2022 Reporter's comment: The medical assistant reported that a 1 month old patient received an adult (1 mL) dose of Engerix. No symptoms were reported. The reporter consented to follow-up via email. Additional Supportive Information: 1 month old patient received an adult (1 mL) dose of Engerix, which led to overdose and adult product administered to child.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Needle issue, Underdose
Clinical narrative: Needle failure, injected volume less than 0.45ml; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number PA77M, expiry date 24th September 2023) for prophylaxis.   On 7th September 2022, the patient received the 2nd dose of Shingrix. On 7th September 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 07-Sept-2022 Reporter's comment: The health care professional experienced a needle failure while she was injecting Shingrix second dose. To be on the safe side the reporter stated that the final volume injected was less than 0.45 ml. The permission to create a Medical information account was declined. The reporter did not consent to follow-up. Additional supportive information: The patient received less than 0.45 ml of Shingrix vaccine due to needle failure, which led to incomplete dose administered.
Age: 7.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Kinrix to 7 year old; 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 7-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 7th September 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: 7-Sept-2022 Reporter's comment: The medical assistant reported that Kinrix was administered to 7 years old patient. The reporter unable to provide additional adverse event details at the time. The adverse event report contains all information. The reporter was ok for safety team to follow-up. The reporter consented to follow-up. Additional supportive information: The patient received Kinirx at inappropriate age which led to inappropriate age at vaccine administration.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: completed 2 dose series in 2019, shingles in 2022; shingles; He developed a rash was diagnosed with shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chicken pox (Had chicken pox as a child).   On 29th October 2019, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 29th August 2019, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 07-Sep--2022 Reporters comment:  The reporter reported that the patient received both shingrix vaccine and experienced shingles. Both doses were given intramuscularly in the deltoid. Reporter did not have the lot numbers for the SHINGRIX vaccines which were administered but did provide the pharmacy contact information. The pharmacy should had the lot numbers on file. Both shots were given at the same pharmacy. Vaccination Failure- Patient completed Shingrix 2 dose series in 2019 yet developed shingles in 2022. (He developed a rash was diagnosed with shingles and had been prescribed a medication to treat it).  The reporter consent to follow-up. Additional Supportive information: Valacyclovir coded as treatment drug for shingles .
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Needle issue
Clinical narrative: Needle leaked, unsure how much product patient received; Part of the vaccine run down patient's arm; Part of the vaccine run down patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 68-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 7th September 2022, the patient received the 1st dose of Havrix. On 7th September 2022, unknown after receiving Havrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK receipt date: 7-Sept-2022 Reporter's comment: The reporter was unsure how much of the product the patient actually received.  This was the first dose in the series for this patient.  The reporter consented to follow-up. Additional supportive information: The pharmacist reported that she was administering a dose of Havrix to patient on the day of reporting, when the needle leaked causing part of the vaccine to run down the patient's arm, which led incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: syringe  uncapped, needle attached, stored in fridge then administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th September 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 Information: GSK receipt date: 8-Sept-2022 Reproter's comment: The clinical director reported that Pediarix syringe was uncapped and a needle was attached. The dose was stored in the refrigerator overnight for 16 to 18 hours and the dose was then administered to a patient. The reporter did not knew patient's gender, date of birth or initials.  The reporter had nothing else to report. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Pediarix after being stored in the in the refrigerator overnight for 16 to 18 hours, which led to incorrect storage of drug.
Age: 62.0
Sex: F
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: Engerix-B 31may2022,  Twinrix jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 62-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.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   In July 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. In July 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The lot/ expiration dates were not available. The reporter consented to follow-up. Additional supportive information: The registered pharmacist received one dose of Engerix-B and one dose of Twinrix (late 2nd dose for Hepatitis B) which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Muscular weakness, Myalgia
Clinical narrative: redness at the injection site; itching; blisters; pain; got both Shingrix vaccines, and shingles/suspected vaccination failure; shingles; whole right arm had muscle pain and weakness for about 2 days; whole right arm had muscle pain and weakness for about 2 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic kidney disease stage 4.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix (intramuscular) .5 ml. On 4th September 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced injection site erythema, myalgia upper extremities, weakness of arms, pruritus, blister and pain. On an unknown date, the outcome of the vaccination failure, pruritus, blister and pain were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the injection site erythema, myalgia upper extremities and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site erythema, pruritus, blister and pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, myalgia upper extremities, weakness of arms, pruritus, blister and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comment: The case was self-reported by the patient. The patient received both of the Shingrix doses in 2019 into right arm and got both times patient had a site reaction. After the first dose of Shingrix her whole right arm had muscle pain and weakness for about 2 days. After the second dose of Shingrix, she only had some redness at the injection site for a few days.  The patient also reporting that she currently had shingles and she also experienced itching, blisters, and pain with shingles. The reporter did not consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Vaccination failure
Clinical narrative: redness at the injection site; itching; blisters; pain; got both Shingrix vaccines, and shingles/suspected vaccination failure; shingles; whole right arm had muscle pain and weakness for about 2 days; whole right arm had muscle pain and weakness for about 2 days; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic kidney disease stage 4.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix (intramuscular) .5 ml. On 4th September 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced injection site erythema, myalgia upper extremities, weakness of arms, pruritus, blister and pain. On an unknown date, the outcome of the vaccination failure, pruritus, blister and pain were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the injection site erythema, myalgia upper extremities and weakness of arms were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site erythema, pruritus, blister and pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, myalgia upper extremities, weakness of arms, pruritus, blister and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's Comment: The case was self-reported by the patient. The patient received both of the Shingrix doses in 2019 into right arm and got both times patient had a site reaction. After the first dose of Shingrix her whole right arm had muscle pain and weakness for about 2 days. After the second dose of Shingrix, she only had some redness at the injection site for a few days.  The patient also reporting that she currently had shingles and she also experienced itching, blisters, and pain with shingles. The reporter did not consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming shingles was unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st given over 6 monts ago, 2nd not yet; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose ( 0.5 ml via intramuscular route) has been over 6 months).   On an unknown date, the patient  did not receive 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: 08-SEP-2022 Reporter's Comments:  The patient stated she received 1st dose (did not provided date) but she did not get 2nd dose yet and it had been over 6 months. She did not want to disclose any personal information. Education and website provided. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine after 1st dose, which led to incomplete course of vaccination.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 23FEB2022, 2nd dose on 12AUG2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 23rd February 2022).   On 12th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 12th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-Sept-2022 Reporter's comment: The pharmacist reported that the patient received 2nd dose delay due to unknown reason. Nothing else was reported. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix reconstituted with other diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 5Y9N9, expiry date 27th July 2023) 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. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Hiberix dose reconstituted with a diluent from another vaccine, which led to wrong solution used in drug reconstitution.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered dose 08Sep2022, expiration date of 07Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number XQ39D, expiry date 7th August 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 8th September 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 8th September 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 Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The pharmacist reported that a nurse came to her stating that the patient was administered a dose of Twinrix on the day of reporting, which had an expiration date of 7th August 2022. The reporter did not had any of the patient information, so she did not knew which dose number in the series this was, patient's age, or gender.   At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: expired Sep 2nd 2022, administered to patient Sep 8th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2AJ32, expiry date 2nd September 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 8th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Pediarix and Pediarix 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: 8-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
Sex: F
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: tremors; This case was reported by a physician via sales rep and described the occurrence of tremor in a female patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced tremor. On an unknown date, the outcome of the tremor was unknown.   It was unknown if the reporter considered the tremor to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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: 07-SEP-2022 Reporter's comment: The patient was given dose of Bexsero and had experienced tremors. The vaccine administration facility is the same as primary reporter. The reporter had consented to follow-up.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: given of Kinrix instead of Boostrix; 11 year old given a dose of Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-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 2nd September 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     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: 8-Sept-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody, Product administered to patient of inappropriate age, Underdose
Clinical narrative: 49yo patient received pediatric formulation; 49yo patient received pediatric formulation; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 49-year-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 3rd September 2022, the patient received the 1st dose of Engerix B pediatric. On 3rd September 2022, unknown after receiving Engerix B pediatric, 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 Information: GSK receipt date: 08-Sept-2022 Reporter's comment: The clinic quality manager reported that due to low titers, an adult patient received Engerix B first dose of  pediatric formulation. The reporter consented to follow-up via email. Additional supportive information: The patient received an pediatric dose of Engerix B which led to underdose and adult use a child product. Follow-up request was raised to confirm whether patient had received any series for Hepatitis B in past before the antibody test.
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Exposure via skin contact, Underdose
Clinical narrative: Patient received 1/2 the dose; 1/2 ran down their arm; 1/2 ran down their arm; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adolescent female patient who received Flu Seasonal QIV (FluLaval Quadrivalent) (batch number 2GR7X, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the underdose, exposure via skin contact and inadvertent exposure to vaccine 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: 08-SEP-2022 Reporter's Comment: The pharmacy intern reported that the patient received a half dose of FluLaval Quadrivalent and half of the dose ran down the patient's arm. The reporter consented to follow up. Additional Supportive Information: The patient received a half dose of FluLaval Quadrivalent and half of the dose ran down patient's arm, which led to underdose, exposure via skin contact and inadvertent exposure to vaccine.
Age: 8.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a dose of Pediarix on 30Aug2022; 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 8-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 30th August 2022, unknown after receiving Pediarix and Pediarix 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:08-Sep-2022 Reporters comment: The 8 years old patient received pediarix vaccine, patient was not previously received any vaccines, started getting vaccinated on 30th Aug2022. Clinic was trying to get her caught up on vaccines and administered a dose of Pediarix. The Vaccine Administration Facility is the same as Primary Reporter. Reporter gave permission for follow-up The reporter gave consent to follow-up. Additional Supportive information: 8 year patient received pediarix vaccine, which led to inappropriate age at vaccine administration. .
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired Pediarix dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 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 8th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Pediarix and Pediarix 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: 08-SEP-2022 Reporter's comments: The nurse practitioner reported that the patient was administered an expired dose of Pediarix. The vaccine administration facility was the same as primary reporter The consent to follow-up was given by email if needed. Additional Supportive Information: The patient received expired Pediarix, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: 1st dose on 01Apr2021, 3rd dose on 07Sep2022; Patient received adult dose of Engerix (1st and 2nd); Patient received adult dose of Engerix (1st and 2nd); Patient received adult dose of Engerix (1st and 2nd); Patient received adult dose of Engerix (1st and 2nd); This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) for prophylaxis and HBV (Engerix B adult) for prophylaxis.   On 7th September 2022, the patient received the 3rd dose of Engerix B pediatric. On 29th April 2021, the patient received the 2nd dose of Engerix B adult. On 1st April 2021, the patient received the 1st dose of Engerix B adult. On 1st April 2021, not applicable after receiving Engerix B pediatric and Engerix B adult and unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On 29th April 2021, the patient experienced overdose and adult product administered to child. On 7th September 2022, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the overdose, adult product administered to child, overdose, adult product administered to child and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's comments: The reporter was patient's parent. The reporter reported that an 18 years patient received 1st and 2nd dose an adult dose of Engerix. She received a late 3rd dose (pediatric dose) at the age of 19 years old. The reporter stated the patient received the vaccinations at a different pharmacy. The reporter did not have the lot number and expiry date of vaccines. The reporter was consented to follow up. No symptoms reported. Additional Supportive Information: The patient received 1st and 2nd dose as adult dose of Engerix B, which led to overdose and adult product administered to child. The patient received a late 3rd Engerix B dose (pediatric dose) at the age of 19 years old, which led to lengthening of the recommended interval between vaccine doses.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: staff member inadvertently administered Havrix today after the expiration date; 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 J95h7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th September 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: 08-Sep-2022 Reporters comment:  The reporter reported that another staff member inadvertently administered Havrix on 8th September 2022 after the expiration date 22th May 2022. The reporter did consent to follow-up. The health care professional was very pressed for time during the call. The caller declined to provide additional information. Additional Supportive information: The staff member inadvertently administered Havrix which was already expired on 22th May 2022 which led to Expired vaccine used.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrated powder with Non-GSK supplied diluent; administrated powder with Non-GSK supplied diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amca725c, expiry date 30th September 2022) for prophylaxis.   On 7th September 2022, the patient received Menveo. On 7th September 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 Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: The reporter reported that, a patient was administrated with the powder component of Menveo with a Non-GSK supplied diluent. No adverse event was reported. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient was administrated with the powder component of Menveo with a Non-GSK supplied diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: burning in the site of the administration; pain in the site of the administration; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a elderly female 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 injection site burning and injection site pain. On an unknown date, the outcome of the injection site burning and injection site pain were unknown.   It was unknown if the reporter considered the injection site burning and injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comments: The pharmacist reported that the patient experienced burning and pain in the site of the Shingrix administration.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Men B NVS (Bexsero) (batch number ABXB37AA, 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 8th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th September 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: 09-SEP-2022 Reporter's Comments: The nurse reported that the patient was administered with an expired dose of Bexsero since July 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Sep 3rd 2020, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd September 2020).   On an unknown date, the patient did not receive 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: 09-SEP-2022 Reporter's Comments: The pharmacist had a patient that never received Shingrix second dose and received First dose only. The reporter consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 9th September 2022, unknown after receiving Infanrix and Infanrix 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: 09-SEP-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received an expired dose of Infanrix vaccine. The reporter consented to follow up. Additional supportive information: The patient received a Infanrix which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient is a year behind for 2nd dose; This case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose of Shingrix on an unknown date).   On an unknown date, the patient did not receive 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: 09-SEP-2022 Reporter's Comment: The reporter submitted the following to Medical Information as an inquiry from a physician, Shingrix: what was the protocol around a patient who had received a first dose of Shingrix and had been well past the 2 to 6 windows.  How long could a patient go between doses.  The reporter had a patient a year behind. The possible duplicate was adverse event.  As reported that, medical information did not speak with the physician at any point.  The reporter consent for follow-up from safety was not provided.  Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2022AMR131182, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR131182:Same reporter/ master file
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 18Sep2019, did not receive 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 18th September 2019).   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: 09-September-2022 Reporters comment:  The reporter reported that the patient received 1st dose shingrix but did not received the second dose but planned to will received the second dose 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.