chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site reaction, Rash vesicular
Clinical narrative: vesicular lesions at the site of injection; Lesions were uncomfortable; lesion, pruritic; lesion, mildly painful, stinging sensation; vesicular lesions at the site of injection; This case was reported by a physician and described the occurrence of injection site reaction in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site reaction (1st dose received on an unknown date, refer case US2022AMR127520).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced injection site reaction, injection site discomfort, injection site itching, injection site pain and vesicular eruption. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site reaction and vesicular eruption were not recovered/not resolved and the outcome of the injection site discomfort, injection site itching and injection site pain were unknown.   It was unknown if the reporter considered the injection site reaction, injection site discomfort, injection site itching, injection site pain and vesicular eruption to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR127520   Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's comment: The patient received dose of Shingrix vaccine and approximately 2 weeks after the vaccination experienced vesicular lesions at the site of injection. The lesions were uncomfortable (pruritic and mildly painful - stinging sensation). The reporter stated that currently the lesions were still active. The reporter consented to follow-up.; Sender's Comments:  US-GSK-US2022AMR127520:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: was down for a couple days with 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 (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 fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 01-SEP-2022 Reporter's Comment: This case was reported by the patient via  interactive digital media. The patient received a dose of Shingles vaccine and patient was down for a couple of days with fever but better than getting shingles. The patient would do it again for sure. Additional Supportive Information: This case had been linked with US2022AMR127532 reported by same reporter.  The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Induration, Pain in extremity
Clinical narrative: Felt like got slugged in the arm; arm hard; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and induration. On an unknown date, the outcome of the pain in arm and induration were unknown.   It was unknown if the reporter considered the pain in arm and induration to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just got his/her second shingles vaccine a couple days ago. The patient felt like he/she got slugged in the arm, hard. The patient stated that, it was better than getting shingles again Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: being sick, terrible reaction; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In August 2022, the patient received the 2nd dose of Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine 3 days ago from the date of reporting and had a terrible reaction to the vaccine, but he/she would deal with 2 days of being sick versus actually getting shingles itself. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: severe neck pain; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain 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 neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 4-SEP-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter asked was severe neck pain a side effect of the injection. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Feverish; Felt bad; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feeling bad. On an unknown date, the outcome of the fever and feeling bad were recovered/resolved.   It was unknown if the reporter considered the fever and feeling bad to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-SEP-2022 Reporter's Comment: This case was reported by the patient's wife via interactive digital media. The reporter stated that the patient had a reaction to his second shot. The patient was feverish and felt bad for about a day or two, which was far better than what shingles was like. Additional supportive information: The follow-up would not possible, as no contact, details were available. This case has been linked with cases US2022AMR129222 and US2022AMR129233, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR129222:Same reporter US-GSK-US2022AMR129233:Same reporter
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion of Menveo; Patient only received  diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28th February 2023) for prophylaxis.   On 25th August 2022, the patient received Menveo (intramuscular). On 25th August 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: 29-Aug-2022 Reporter's comment: The pharmacist reported that the patient only received the diluent (liquid conjugate) portion of the Menveo vaccine. Additional supportive information: The patient received only diluent of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage patient got 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 49-year-old female patient who received Herpes zoster (Shingrix) (batch number 3545x, expiry date 31st August 2023) for prophylaxis.   On 11th June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2022 Reporter's Comment: The pharmacist reported that the patient received first dose of Shingrix into the left arm. It was determined when the patient came back to the pharmacy on the day of reporting to receive her second Shingrix vaccine that she did not fall into the category of being immunocompromised and was underage.  The reporter attempted to contact the patient's health care professional and they would not provide any information due to Health Act.  The patient reported that her health care professional would give her the second dose of Shingrix.  The reporter consented to follow up. Additional Supportive Information: The underage patient received a dose of Shingrix, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles despite being vaccinated/Suspected vaccination failure; recurrent shingles; This case was reported by a other health professional via sales rep and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comments: Personal Assistant (PA) had asked, whether there was a way for his/her to get an advice on a patient with recurrent shingles 1-2 times per year despite being vaccinated. It was not clear whether the patient was vaccinated with Shingrix or not (but the question was coded as Shingrix by field representative). There was no additional information available with regard to this adverse event. The reporter had consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was reported at the time of reporting.  Suspect coded as shingrix as given in structured field conservatively.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2 years ago, 2nd Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received the first dose of Shingrix 2 years ago from reporting).   In July 2022, the patient received the 2nd dose of Shingrix. In July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The reporter unable to provide additional details on patient or vaccine. The reporter did not consent to follow-up. Additional Supportive Information: The patient received the 2nd dose later than recommended time interval, which led to lengthening of vaccination schedule.
Age: 88.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Paraesthesia, Vaccination failure
Clinical narrative: Completed series about 3 months ago, last week shingles rash/ Suspected vaccination failure; Shingles rash; Neck tingling; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (dose received years prior to the reporting). Concurrent medical conditions included peripheral neuropathy.   In May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 23rd August 2022, 3 months after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and tingling. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles and tingling were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and tingling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment:  The reporter reported that the patient received zostavax years prior to the reporting and completed Shingrix vaccine series about 3 months prior to the reporting. The reporter stated that on last week the patient developed shingles rash and along that had neck tingling. But the physician believes neck tingling may be related to neuropathy. The reporter did not have the dates of the Shingrix vaccine doses and zostavax dose at the time of reporting as these were administered at pharmacy/drug store and not at reporter's facility. The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: late for the second dose, first dose February 2 2022; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old male 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.   Previously administered products included Engerix B (the patient received 1st dose of Engerix B on 2nd February 2022, batch number: 9ax5p).   On an unknown date, the patient did not receive the 2nd 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 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: 30-AUG-2022 Reporter's Comment:The reporter reported that, a patient was late for the second dose of Engerix-B. No adverse event was reported. No expiration date was provided. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: outside of 6 month window for second dose, yet to receive it; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 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: 30-AUG-2022 Reporter's Comments: The reporter was the patient.  The reporter reported the patient was outside of the 6 month window for their second dose of Shingrix and had yet to receive the second dose. The reporter did not 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.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: developed a rash after 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of rash in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash (The patient received 1st dose of shingrix in May 2022. Refer case US2022AMR125990.).   In July 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Linked case(s) involving the same patient:  US2022125565, US2022AMR125990   Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comments: The reporter stated that a Patient developed a rash after 2nd dose also.  The reporter gave consent to follow up.; Sender's Comments:  US-GSK-US2022125565:Same reporter - FU1
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Shingrix administered subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2022, the patient received Shingrix (subcutaneous). On 30th August 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.    Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comments: The pharmacist called and reported that one of her colleagues had received Shingrix vaccination subcutaneously instead of intramuscularly. It was reported that as this happened on a different facility. The HCP did not provide any details from the situation reported. The health care professional (HCP) reported that he/she thought  it was today in regards of when was the patient vaccinated. No lot number and expiration date was provided. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up. Additional Supportive Information: The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Rash
Clinical narrative: Body pain; Rash on abdomen and back; Sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than 3 weeks after receiving Shingrix, the patient experienced general body pain, rash and sleeplessness. On an unknown date, the outcome of the general body pain and sleeplessness were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the general body pain, rash and sleeplessness to be related to Shingrix.     Additional Information: GSK receipt date:30-AUG-2022 Reporters comment: The patient experienced body pain, rash on his abdomen and back and sleeplessness.  The reporter given consent to follow-up. The emergency visit was required.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Breast pain, Chest pain, Dyspnoea, Injection site erythema
Clinical narrative: Uses an inhaler, has a hard time taking a deep breath; pain in her left arm pit; Injection site is red; Injection site is swollen; moved to more severe pain on her chest and left breast to the sternum; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arthritis.   On 22nd August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2022, less than a week after receiving Shingrix, the patient experienced radiating pain. On 22nd August 2022, the patient experienced injection site erythema and injection site swelling. On 24th August 2022, the patient experienced difficulty breathing and axillary pain. The patient was treated with tramadol, oxycodone hydrochloride + paracetamol (Percocet) and medication unknown (Inhaler (Nos)). On 24th August 2022, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the radiating pain and difficulty breathing were not recovered/not resolved and the outcome of the axillary pain was unknown.   The reporter considered the injection site erythema and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the radiating pain, difficulty breathing and axillary pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The patient received first dose of Shingrix into left arm and experienced injection site was red and swollen for the first couple days. The patient reported that pain in left arm pit started two days after injection and now it had moved to more severe pain on chest and left breast to the sternum. The patient used an inhaler and had a hard time taking a deep breath from the inhaler. The patient took Tramadol and Percocet patient normally used for her arthritis because the pain was so severe. The reporter did not consent to follow up. The caller does not give permission to contact her health care professional.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain
Clinical narrative: Uses an inhaler, has a hard time taking a deep breath; pain in her left arm pit; Injection site is red; Injection site is swollen; moved to more severe pain on her chest and left breast to the sternum; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included arthritis.   On 22nd August 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2022, less than a week after receiving Shingrix, the patient experienced radiating pain. On 22nd August 2022, the patient experienced injection site erythema and injection site swelling. On 24th August 2022, the patient experienced difficulty breathing and axillary pain. The patient was treated with tramadol, oxycodone hydrochloride + paracetamol (Percocet) and medication unknown (Inhaler (Nos)). On 24th August 2022, the outcome of the injection site erythema and injection site swelling were recovered/resolved. On an unknown date, the outcome of the radiating pain and difficulty breathing were not recovered/not resolved and the outcome of the axillary pain was unknown.   The reporter considered the injection site erythema and injection site swelling to be related to Shingrix. It was unknown if the reporter considered the radiating pain, difficulty breathing and axillary pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-AUG-2022 Reporter's Comment: The patient received first dose of Shingrix into left arm and experienced injection site was red and swollen for the first couple days. The patient reported that pain in left arm pit started two days after injection and now it had moved to more severe pain on chest and left breast to the sternum. The patient used an inhaler and had a hard time taking a deep breath from the inhaler. The patient took Tramadol and Percocet patient normally used for her arthritis because the pain was so severe. The reporter did not consent to follow up. The caller does not give permission to contact her health care professional.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Administered to a child under 10 years old; Administered to a child under 10 years old; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 57DE9, expiry date 12th November 2023) for prophylaxis.   On 30th August 2022, the patient received Boostrix. On 30th August 2022, unknown after receiving Boostrix, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 30-Aug-2022 Reporter's comments: Nurse practitioner reported that Boostrix was administered to a child under 10 years of age on 30th August 2022. The reporter had consented to follow-up with the safety team. Additional supportive information: The patient who had received Boostrix was younger than 10 years which had led to underdose and inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: dose was given 1 day post expiration; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd August 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 22nd August 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: 31-AUG-2022 Reporter's comment: Registered nurse reported that a dose of Havrix was given to the patient 1 day post expiration. The reporter chatted into Medical Information and disconnected before providing any patient demographics. 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: 0.08
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Bexsero instead of Engerix-B; one month old received Bexsero; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-month-old male patient who received Men B NVS (Bexsero) (batch number KL472, expiry date 30th September 2024) 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 31st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Bexsero and Bexsero 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: 31-AUG-2022 Reporter's Comment: The nurse reported that, a one month old baby received a Bexsero vaccine instead of Engerix-B. The permission to store personal information in Medical Information database declined. The follow up permission was denied. Additional Supportive Information: The patient received Bexsero vaccine instead of Engerix-B at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient, pregnant, received Infanrix; Infanrix instead of Tdap; 30 year old received Infanrix; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a 30-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Tdap vaccine (received 1st dose on 21st January 2020).   On 30th August 2022, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On 30th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The health care professional reported that the patient who was 27 weeks and 4 days pregnant received a dose of Infanrix instead of Tdap (Boostrix). The reporter consented to follow up. Additional Supportive Information: The 30 years old pregnant patient received a dose Infanrix instead of Tdap (Boostrix) which led to wrong vaccine administered, inappropriate age at vaccine administration and vaccine exposure during pregnancy. This case had been linked with US2022124956 reported by same reporter.; Sender's Comments:  US-GSK-US2022124956:Same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Nausea
Clinical narrative: fatigue; intermittent nausea / nausea; backache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sarcoidosis, covid-19 and asthma.   On 24th August 2022, the patient received the 1st dose of Shingrix. On 25th August 2022, 1 days after receiving Shingrix, the patient experienced fatigue, nausea and back pain. On an unknown date, the outcome of the fatigue, nausea and back pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, nausea and back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The patient received the first of two doses of Shingrix vaccine on 24.August 2022 and on 25. August 2022, experienced fatigue, intermittent nausea and backache which have all resolved. The reporter inquiring if these symptoms were side effects of Nucala or Shingrix. The reporter had notified her HCP. Reporter had given consent to follow up with her HCP. Spoke from content for Shingrix package insert. Declined safety statement. Provided medical advice disclaimer and HCP referral.  Provided product education.  Lot numbers and expiration dates were not known for Shingrix. Patient has given consent to follow up with her HCP.  Consented to follow up.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Boostrix (tdap) on 10/15/2020 instead of DTaP.; 2 years ago received Boostrix (tdap) on 10/15/2020 instead of DTaP; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9AN49, expiry date 25th March 2022) for prophylaxis.   On 15th October 2020, the patient received Boostrix. On 15th October 2020, unknown after receiving Boostrix, 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.      Additional Information: GSK receipt date - 31-Aug-2022 Reporters comment: The reporter reported that 2 years ago patient received Boostrix (tdap) instead of DTaP vaccine. The reporter stated that did not know if patient needs a Dtap. No additional details provided.  The reporter wanted to know how to proceed with DTaP series. The reporter did not consent for follow-up. Additional Supportive information: The patient received Boostrix (tdap) instead of DTaP vaccine which led to wrong vaccine administered and inappropriate Age at vaccine administration
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Erythema, Feeling hot, Incomplete course of vaccination, Peripheral swelling
Clinical narrative: first in november of 2019, has not yet gotten second; left upper arm swelled up; left upper arm got hot; left upper arm got red; arm blisters; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient did not receive the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling arm, feeling hot, erythema, blister and incomplete course of vaccination. On an unknown date, the outcome of the swelling arm, feeling hot, erythema and blister were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the swelling arm, feeling hot, erythema and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-Aug-2022 Reporter's comments: The caller was the patient who stated that she got her 1st Shingrix vaccine in left arm and had not yet got her second vaccine, but plans on it. She also stated that after her 1st vaccine, her left upper arm swelled up, got hot and red, and was covered in little blisters. She said these reactions lasted for about 2 weeks. The reporter did not consent 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.
Age: 0.17
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Received 1/2 of the adult formulation; 2nd dose received on 29-Apr-2022 and 3rd dose Engerix B adult received on 29-Aug-2022; second Hepatitis B injection given late; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old male patient who received HBV (Engerix B adult) (batch number AC397, expiry date 8th August 2023) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (1st dose received on 21 February 2022).   On 29th August 2022, the patient received the 3rd dose of Engerix B adult (intramuscular). On 29th April 2022, the patient received the 2nd dose of Hepatitis B vaccine. On 29th April 2022, not applicable after receiving Engerix B adult and unknown after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long. On 29th August 2022, the patient experienced adult product administered to child and drug dose administration interval too short. On an unknown date, the outcome of the adult product administered to child, drug dose administration interval too short and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the 6 month old child patient received Engerix B adult vaccine. The reporter stated that the patient received second dose of Hepatitis B vaccine On 29 April 2022 after 2 months of received first dose of Hepatitis B vaccine. The reporter did consent to follow up. Additional supportive information: The child patient was administered a 1/2 of the formulation(0.5ml) of adult dose of Engerix B on 29th August 2022, which led to adult product administered to child  The patient received 2nd dose of Hepatitis B vaccine late than recommended time frame, which led to which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix B adult vaccine early than recommended time frame, which led to which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: required second dose, first was given on Mar 2nd 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd March 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: 31-AUG-2022 Reporter's comment: The pharmacist reported that a male patient required the second dose of Shingrix. The reporter consented 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: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: infant received Havrix adult dose; infant received Havrix adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 29th August 2022, the patient received Havrix. On 29th August 2022, unknown after receiving Havrix, 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: 31-AUG-2022 Reporter's comment: The reporter stated that an infant patient was administered an adult dose of Havrix. The vaccine administration facility was the same as primary reporter. The reporter did not answer if follow up was ok but did not decline. Additional Supportive Information: The patient was administered an adult dose of Havrix, which led to overdose and adult product administered to child.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix admiistered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The lead medical assistant stated that an expired dose of Kinrix was administered to a patient on Monday. The reporter consented to follow up via postal. Additional Supportive Information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Injection site pain, Wrong technique in product usage process
Clinical narrative: Intense pain at injection site/ injection site very sore; Bleeding at injection site; went through 4 layers of muscle/ paused while injecting/ dose incorrectly given; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2022, the patient received the 1st dose of Shingrix. On 30th August 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site hemorrhage and wrong technique in product usage process. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site hemorrhage was recovered/resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain and injection site hemorrhage to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment:  The patient stated that the vaccine was administered incorrectly, the patient was felt as though needle went deeper than it should and went through or 4 layers of muscle before being administered.  The healthcare professional who administered dose paused as they were injecting the dose as oppose to sticking it straight in, as had been the case of all her vaccines administered. The patient reported that after received shingrix vaccine, she experienced intense pain at the injection site and informed their was bleeding from the injection site while dose had being administering, the patient did not saw the blood as they did not look while the vaccine administered, so the patient did not knew how much it bled. The healthcare professional inquired as to whether they had took any medication such as Tylenol prior to receiving dose, the patient stated she did not received. The patient stated the bleeding ceased once they returned home and removed bandage and she barley being able too see the injection site once they arrived at home and believed that it could not had bled much, based on small amount of blood on bandage. The patient stated the injection site was very sore on the day of reporting. The reporter consented to follow up. Additional supportive information: The Shingrix vaccine was administered incorrectly to the patient, which led to wrong technique in product usage process.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: 1 shingrix box has 1 missing diluent; may received only diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 9DM72, expiry date 28th January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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: 31-AUG-2022 Reporter's comment: Pharmacist reported that 1 box of Shingrix had 1 missing diluent. Pharmacist assumed that the patient might had received only the diluent of Shingrix. The reporter consented to follow-up. Additional Supportive Information: The patient might had received only the diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff calf muscle; This case was reported by a consumer via call center representative and described the occurrence of muscle stiffness in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2022, the patient received the 1st dose of Shingrix. In August 2022, 1 day after receiving Shingrix, the patient experienced muscle stiffness. On an unknown date, the outcome of the muscle stiffness was unknown.   It was unknown if the reporter considered the muscle stiffness to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comment: The case was self-reported by the patient. The patient received first dose of Shingrix two weeks ago before reporting and next morning patient woke up and his calf muscle was very stiff. The reporter consented to follow up.