chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine, had shingles twice/Suspected vaccination failure; shingles/got the vaccine, has had shingles twice; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 8-Oct-2022 Reporter's comment: The case was received from the patient's children via interactive digital media.  The patient got the vaccine and has had shingles twice since then. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/had vaccine, still had a light case eyebrow; had light case on eyebrow, went into eye; painful; had light case on eyebrow, went into eye; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), pain and shingles. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, pain and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the vaccine but still had a light case on his/her eyebrow that went into his/her eye.  The patient stated that it as painful but not as bad as it could have been. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shot in July 2018, did not get a second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient had his/her first Shingrix shot in July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: The patient reported that he/she had his/her first Shingrix shot in July 2018 and did not got the second shot yet. The reporter had also asked a question whether he/she should get the second shot asap or do he/she needed to restart the series. The reporter had consented to follow-up. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site pain, Pruritus, Rash erythematous, Rash papular
Clinical narrative: I have been breaking out in hives; raised red bumps; raised red bumps; Burning skin in my hands waist, groin, butt and legs; Itchy skin in my hands waist, groin, butt and  legs; sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 2nd dose of Shingrix. On 6th September 2022, 5 days after receiving Shingrix, the patient experienced burning sensation and pruritus. On 13th September 2022, the patient experienced hives, raised rash and red rash. In September 2022, the patient experienced injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the hives, burning sensation, pruritus, raised rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, hives, burning sensation, pruritus, raised rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 and 04-OCT-2022 Reporter's Comment: The case was reported by the patient and reported that, he received his Shingrix vaccine in the left arm.  The patient was reporting a side effect from the Shingrix vaccine.  The patient had been breaking out in hives, burning itchy skin in hands, waist, groin, butt and legs for one month almost every day since second vaccine dose. The patient wanted to be contacted by someone from GlaxoSmithKline regarding this. The reporter reported that, his left arm was sore at the injection site for about 3 days.  The patient reported that, on 6th September 2022, his hands felt extremely itchy on the tops of his hands and between his fingers.  The reporter noted that, there were no bumps or redness on his hands.  The reporter reported that, warm water seemed to resolve the itching, but that it kept coming back for a month now.  About 13th September 2022, the patient reported he had hives (raised red bumps) on the back of his legs, waist, groin and butt.  The reporter reported that, he rides his bicycle about 15 to 20 miles a day but had had to cut back due to the discomfort from the hives.  The reporter reported that, he had not gone to the doctor but had an appointment on 19th October 2022.  The patient reported that, he took 1 Benadryl capsule last night for the first time since this started in September.  The reporter would like to know if this was related to the Shingrix vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: I have been breaking out in hives; raised red bumps; raised red bumps; Burning skin in my hands waist, groin, butt and legs; Itchy skin in my hands waist, groin, butt and  legs; sore at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 2nd dose of Shingrix. On 6th September 2022, 5 days after receiving Shingrix, the patient experienced burning sensation and pruritus. On 13th September 2022, the patient experienced hives, raised rash and red rash. In September 2022, the patient experienced injection site pain. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the hives, burning sensation, pruritus, raised rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, hives, burning sensation, pruritus, raised rash and red rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 and 04-OCT-2022 Reporter's Comment: The case was reported by the patient and reported that, he received his Shingrix vaccine in the left arm.  The patient was reporting a side effect from the Shingrix vaccine.  The patient had been breaking out in hives, burning itchy skin in hands, waist, groin, butt and legs for one month almost every day since second vaccine dose. The patient wanted to be contacted by someone from GlaxoSmithKline regarding this. The reporter reported that, his left arm was sore at the injection site for about 3 days.  The patient reported that, on 6th September 2022, his hands felt extremely itchy on the tops of his hands and between his fingers.  The reporter noted that, there were no bumps or redness on his hands.  The reporter reported that, warm water seemed to resolve the itching, but that it kept coming back for a month now.  About 13th September 2022, the patient reported he had hives (raised red bumps) on the back of his legs, waist, groin and butt.  The reporter reported that, he rides his bicycle about 15 to 20 miles a day but had had to cut back due to the discomfort from the hives.  The reporter reported that, he had not gone to the doctor but had an appointment on 19th October 2022.  The patient reported that, he took 1 Benadryl capsule last night for the first time since this started in September.  The reporter would like to know if this was related to the Shingrix vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site nodule, Injection site pain, Pyrexia
Clinical narrative: pain at the injection site; Knot formed at injection site; fever of 103 degrees and would not decrease/ took her to ER; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 17-year-old 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, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain, injection site nodule and fever. On an unknown date, the outcome of the injection site pain and injection site nodule were unknown and the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site nodule and fever 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: 03-OCT-2022 Reporter's Comment: The reporter reported that the patient received Bexsero vaccine during the week of 26th September 2022. The reporter stated that after recieving Bexsero vaccine the patient experienced pain at the injection site, knot formed at the injection site and fever of 103 degrees, fever was not decreased so parents took the patient to the emergency room. The reporter did consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received part of it due to error. I got the diluent half.; only received part of it due to error. I got the diluent half.; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2022, the patient received the 1st dose of Shingrix. On 28th September 2022, unknown after receiving Shingrix, 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: 03-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received his/her first vaccination of Shingrix on Wednesday (from the date of reporting). Today (on the day of reporting), the healthcare providers nurse called to inform him/her that only received part of it due to error. The patient got the diluent half. They said to return in 4-6 weeks to get the shot again. Additional Supportive information: The patient received first dose of shingrix vaccine and the reporter (Nurse)informed to him /her received only part of it due to error. The patient got the diluent half, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 3rd October 2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient asked if it was normal to get fever after getting Shingrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first vax almost a year ago, never got 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (1st dose received almost a year ago from the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient never got the 2nd one. The patient asked did he/she need to start over or could he/she still get 2nd. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine, which led to Incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Administered expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th September 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 3rd October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd October 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: 03-OCT-2022 Reporter's comment: Nurse reported that the patient was administrated with an expired dose of Bexsero. The vaccine was expired on 30th September 2022. No adverse event was reported. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Bexsero which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: shot was painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot (took last year 1 other shingles shot).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the dose of shingles vaccine. The shot was painful for old folk but going for dose 2 in about a week. The patient did not want this shingles heard bad things. Now the patient did took just last year 1 other shingles shot, but was told was not strong enough, take these new ones. Additional Supportive Information: The follow up would not possible, as no contact, details were available. This case is linked to the case US2022AMR142464, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR142464:other folks case
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via representative and described the occurrence of pain in arm in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022142126   Additional Information: GSK Receipt Date: 04-Oct-2022 Reporter's Comments: The consumer called and states that patient got her first dose and experienced a sore arm. The reporter consent to follow up. Additional supportive information: For tolerance of 2nd dose refer case US2022142126.; Sender's Comments:  US-GSK-US2022142126:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Nausea
Clinical narrative: Headache; Nausea; Upset stomach; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 days after receiving Shingles vaccine, the patient experienced headache, nausea and upset stomach. On an unknown date, the outcome of the headache, nausea and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the headache, nausea and upset stomach to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-Oct-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient was having headache, nausea and upset stomach five days later. The patient knew it was not common, but could that be happened. Additional supportive information: The follow-up would not possible, as no contact details were available.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: itchy rash on arm, has increased in size; This case was reported by a consumer and described the occurrence of itchy rash in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number D9CB9, expiry date unknown) for prophylaxis.   On 29th September 2022, the patient received the 2nd dose of Shingrix. On 2nd October 2022, 3 days after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved.   The reporter considered the itchy rash to be related to Shingrix.  Additional Information: GSK Receipt Date: 06-OCT-2022 Reporter's Comment: The case was reported by the patient.  The patient had Shingrix shot.  As a result of 2nd shot, she had a rash on the underside of shot arm.  The patient was concerned as the rash as increased in size and was itchy.  This was not one of the side effects that was listed for this vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Myalgia; Chills; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and chills. On an unknown date, the outcome of the myalgia and chills were recovered/resolved.   It was unknown if the reporter considered the myalgia and chills to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR144039   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The reporter mentioned that, she gave the Shingrix to a patient and he mentioned that, he had myalgia and chills.  The reporter stated that the side effects that the patient experienced were less severe after the 2nd dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline. Additional Supportive Information: This case has been linked with the case US2022AMR144039, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR144039:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Myalgia
Clinical narrative: Myalgia; Chills; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a 92-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of myalgia (For tolerance of 1st dose, refer case US2022AMR144027).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia and chills. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the myalgia and chills were unknown.   It was unknown if the reporter considered the myalgia and chills to be related to Shingrix.  Linked case(s) involving the same patient:US2022AMR144027   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: The reporter mentioned that, she gave the Shingrix to a patient and he mentioned that, he had myalgia and chills.  Also stated that, he experienced less severe after the 2nd dose of Shingrix. The reporter stated that the side effects that the patient experienced were less severe after the 2nd dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2022AMR144027:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose over a year ago, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix vaccine over a year ago).   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-OCT-2022 Reporter's Comment: This case was received from the patient via interactive digital media. The patient wanted to know if he/she could get the second shot of Shingrix vaccine. Additional Supportive Information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received only1 vaccination 4 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose of shingles vaccination 4 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: This case was received from the patient via interactive digital media. The patient received only one vaccination over 4 years ago. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The case had been linked to US2022AMR144727, reported by the same reporter, for different patients. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR144727:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received only1 vaccination 4 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received a dose of shingles vaccination 4 years ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comment: This case was received from the consumer via interactive digital media. The reporter reported that the patients received only one vaccination over 4 years ago. Additional Supportive Information: Till the time of reporting, the patients did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The case had been linked to US2022AMR144725, reported by the same reporter, for different patient. The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR144725:Same reporter
Age: 1.75
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, Syringe issue, Underdose
Clinical narrative: syringe lose volume while admiistered; This case was reported by a physician via call center representative and described the occurrence of incomplete dose administered in a 21-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) (batch number K7752, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete 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: 03-Oct-2022 Reporter's comment: The physician reported that the patient was receiving a Fluarix vaccine, but the syringe lose some volume while the vaccine was administered. The reporter consented to follow up. Additional Supportive Information: The syringe lose volume while the vaccine was administered, which led to incomplete dose administered.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered an expired Havrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HAV (Havrix adult) (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 3rd October 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 03-Oct-2022 Reporter's comment: The registered nurse called to inquire what to look for. The registered nurse reported that they inadvertently administered an expired Havrix. The reporter did not consented to follow up. Additional Supportive Information The patient was inadvertently administered an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number unknown, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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: 03-OCT-2022 Reporter's comment: The reporter reported that expired dose of Fluarix was administered to the patient which was expired on 30th June 2022. The Fluarix dose administered was from season 2022-2023. That season was not an option available on the Adverse event (AE) form. Healthcare Professional (HCP) had no other AE information besides what was listed on the AE form. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Fluarix which was already expired, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: HEPA
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 1-year-old female patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   On 4th October 2022, the patient received Havrix. On 4th October 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: 04-OCT-2022 Reporter's Comment: The reporter was a nurse. Nurse reports a patient was administered an expired dose of Havrix.  Additional supportive information. The patient received a Havrix which was already expired, which led to expired vaccine used. The reporter did consent to follow up via email.
Age: 31.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 4th October 2022, the patient received Havrix. On 4th October 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: 04-OCT-2022 Reporter's Comment: The nurse asked and reported that a dose of Havrix given to the patient and it was already expired.  The reporter asked if the patient had to be re-vaccinated. The reporter did not consent to follow up.  Additional Supportive Information: The use of Havrix dose, which was already expired on 30th September 2022, which led to expired vaccine used.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Havrix to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female 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 4th October 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Havrix 1440 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: 04-Oct-2022 Reporter's comment: The registered nurse stated that she administered an expired dose of Havrix to an patient. The consent was given for follow up via postal. The consent to follow-up was granted. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiver an earlier 3rd dose of Engerix-b. the third dose was given at 2 months instead of the sixth month; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 04-Oct-2022 Reporter's comment: The pharmacist reported on 4th October 2022 that an adult patient received an earlier 3rd dose of Engerix B. The third dose was given at 2 months instead of the sixth month. There was no adverse event reported. There were no patient's identifiers provided. There was no lot number and expiration date provided. There was no vaccination date provided The consent to follow-up was granted. Additional supportive information: The patient received the 3rd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: incorrectly reconstituted Menveo / Lyophilized vial was reconstituted with sterile diluent; incorrectly reconstituted Menveo / Lyophilized vial was reconstituted with sterile diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 20th October 2023) for prophylaxis.   On 4th October 2022, the patient received Menveo. On 4th October 2022, unknown after receiving Menveo, 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: GSK Receipt Date: 04-Oct-2022 Reporter's comment: The nurse reported that the patient received a dose of incorrectly reconstituted Menveo on 04th October 2022. The lyophilized vial was reconstituted with a sterile diluent. There were no symptoms reported. The consent to follow-up was granted. Additional Supportive Information: The nurse reported that the patient received a dose of incorrectly reconstituted Menveo and also the lyophilized vial was reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late 2nd dose is to get it as soon as possible; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   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: 04-Oct-2022 Reporter's Comments: The received from pharmacist during business hours he/she know the recommendation for a late 2nd dose was to got it as soon as possible and not to restart.  The reporter had a prescriber telling patients they need to restart because they did have enough immunity.  The reporter wanted to know that did you had any resources regarding this he/she could provide. The reporter did not provide further details.  The reporter submitting for potential late second doses and potential third doses. 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: 41.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HAB (Twinrix) (batch number x239d, 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 10th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th August 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: 04-OCT-2022 Reporter's Comments: The reporter was Practice manager. The reporter stated that the expired twinrix administered on 10th Aug 2022. The reporter gave consent to follow up. Additional Supportive Information: The patient received expired twinrix vaccine which lead to Expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Headache, Injection site pain, Nausea
Clinical narrative: 3rd dose administered; injection site pain after 3rd dose; Mild nauseas after 3rd dose; headache after 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date in the doctor's office).   On 29th August 2022, the patient received the 3rd dose of Shingrix. On 29th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced injection site pain, nausea and headache. On an unknown date, the outcome of the injection site pain, nausea and headache were recovered/resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the injection site pain, nausea and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The pharmacist reported that the patient received two doses of Shingrix in the doctor's office and the pharmacy was not aware, therefore they have administered a third dose of Shingrix and the patient developed pain at the injection site, headache and mild nauseas that lasted for 24 hours.  The pharmacist attributed this symptom to common adverse events post Shingrix vaccination. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a third dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2011, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 48-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.   Previously administered products included Twinrix (received 1st dose back in 2011).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: The registered pharmacist reported that the patient never finished series of Twinrix (nnever received 2nd and 3rd doses). The reporter inquired for Twinrix, did the patient need to restart series, or any guidance on administering 2nd and 3rd doses. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero Administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 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 3rd October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd October 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: 05-OCT-2022 Reporter's Comment: A pharmacist called to ask for information regarding the administration of an expired dose of Bexsero to a patient. Reporter asked for recommendation about patient re-vaccination. Consented to follow up. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.
Age: 47.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 47-year-old male patient who received HAV (Havrix) (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 5th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 5th October 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: 05-OCT-2022 Reporter's comment: Pharmacist reported that a patient received an expired dose of Havrix. The reporter consented to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used.
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix reconstituted with steril water administration; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old male patient who received Hib (Hiberix) (batch number FY4E9, expiry date 20th June 2023) for prophylaxis.   On 3rd October 2022, the patient received Hiberix. On 3rd October 2022, 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: 06-OCT-2022 Reporter's Comment: The reporter reported that, a patient received the lyophilized powder of Hiberix reconstituted with diluent not provided by GlaxoSmithKline (sterile water). The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient received the lyophilized powder of Hiberix reconstituted with diluent not provided by GlaxoSmithKline (sterile water), which led to wrong solution used in drug reconstitution. This was 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022143256:Same reporter