chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: Tingling on the left side of her face; broke out into blisters/hard for the patient to open her eye, blister under the eye; nerve pain on the left side of her face; left side of her face is also swollen; her left eye is swollen shut; Eye infection; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number MR75G, expiry date 13th July 2023) for prophylaxis.   On 16th June 2022, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tingling, blisters, facial neuralgia, facial swelling, eye swelling and eye infection. The patient was treated with valaciclovir hydrochloride (Valtrex), ophthalmologicals (nos) (Eye Ointment (Ingredients Or Trade Name Unknown)) and ophthalmologicals (nos) (Eye Drop (Nos)). On an unknown date, the outcome of the tingling, blisters, facial neuralgia, facial swelling and eye infection were unknown and the outcome of the eye swelling was not recovered/not resolved.   It was unknown if the reporter considered the tingling, blisters, facial neuralgia, facial swelling, eye swelling and eye infection to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and experienced tingling and nerve pain on the left side of her face and then broke out into blisters.  The left side of her face was also swollen and her left eye was swollen shut.  The patient went to the walk-in clinic and was prescribed Valtrex. She also went to the eye doctor and was prescribed eye drops and eye ointment just in case of an infection.  The patient had another appointment with the eye doctor.  The outcome of initial visit with the eye doctor was that everything looks okay with her eye, but she needs to went back so the doctor could get a better look.  It was hard for the patient to open her eye as she had a blister under the eye. The reporter consented to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lip swelling, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: Swollen face; Swollen lips; Swollen throat; Welts on the left side of her stomach and under her arm; Blisters on the left side of her stomach and under her arm; This case was reported by a consumer via call center representative and described the occurrence of welts in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tooth abscess and pain in jaw (began about 1 month prior). Previously administered products included COVID vaccine. Concomitant products included amoxicillin (Amoxycillin) and prednisone.   On 28th June 2022, the patient received the 1st dose of Shingrix. On 30th June 2022, 2 days after receiving Shingrix and an unknown time after starting Amoxycillin, the patient experienced welts and blister. In July 2022, the patient experienced swelling face, swollen lips and throat swelling. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the welts, blister, swelling face, swollen lips and throat swelling were unknown.   It was unknown if the reporter considered the welts, blister, swelling face, swollen lips and throat swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: The patient received Shingrix vaccine in right arm.  About 2 days later she noticed that she had welts/blisters on the left side of her stomach and under her arm.   She went to the Emergency room on the same day because she was having pain in her jaw that began about 1 month prior.  She was treated for an abscessed tooth and was prescribed prednisone and amoxicillin.  The prednisone dose was 20mg daily for 7 days, and the amoxicillin was completed at the time of the call.   She also showed the Healthcare professional in the Emergency room her welts on her body but forget to mention that she had the Shingrix shot 2 days prior.   She was told to use oatmeal soak.  On July 3rd, she went back to the Emergency room to seek treatment for her blisters/welts. She did not had Chicken Pox or Shingles.  She was told to take Benadryl, which she took Benadryl on July 3 and July 4. Subsequently, less than 2 weeks after receiving Shingrix, she began experiencing swollen face, swollen lips and throat. She had to follow up for dental appointment on Friday. The consent to follow up was given.  The patient gave consent to follow up with Healthcare professional (pharmacy).  The patient had limited contact information for pharmacy.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Accidental underdose, Needle issue
Clinical narrative: underdose of Boostrix via needle leak on; administered underdose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 70-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 1st July 2022, the patient received Boostrix. On 1st July 2022, unknown after receiving Boostrix, the patient experienced accidental underdose. On an unknown date, the patient experienced needle leak. On an unknown date, the outcome of the accidental underdose and needle leak were unknown.   Additional Information: GSK Receipt Date: 6-Jul-2022 Reporter's Comments: The pharmacist reported that the patient was administered an underdose of Boostrix  The pharmacist stated administered an underdose of Boostrix via needle leak. Adverse event contained all reported information by health care professional. HCP gave consent for safety team follow up. Additional Supportive Information: The patient was administered an underdose of Boostrix, which led to accidental underdose.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Soreness at the injection site/pain with mobility; warmth at the injection site as well as in the opposite (right) arm; Redness at the injection site; Swelling at injection site; Pain upon movement; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2022).   On 4th July 2022, the patient received the 2nd dose of Shingrix. On 5th July 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site swelling and pain upon movement. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site swelling and pain upon movement were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site swelling and pain upon movement to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine into left arm and experienced soreness, pain with mobility, soreness at the injection site, redness at the injection site, and warmth at the injection site as well as in the opposite (right) arm.  The patient stated that all symptoms started on the day after dose was received. The patient reported all symptoms on the left arm had got progressively worse.  The patient reported all symptoms on the right arm had been consistent. The patient also stated that all symptoms were ongoing. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: 2nd dose, small amount dripped, received 90%; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intercostal). On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments:  Reporter stated that that the patient received the 2nd dose of Shingrix and whilst injecting a small amount dripped out and the patient felt did not received the full dose. Reporter reported that the patient received at least 90 percent of the dose. Pharmacist did not want to provide patient information. Additional supportive information As patient administered 90 percent of dose which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: some of the vaccine leaked out onto the patient's arm; some of the vaccine leaked out onto the patient's arm; some of the vaccine leaked out onto the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 06-July-2022. Reporter's Comments: The reporter mentioned that while administering a dose of Shingrix some of the vaccine leaked out onto the patient's arm. The reporter consented to follow up. The lot and expiration date but it was deleted during updation of another field by reporter. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The vaccine leaked out onto the patient's arm, which led to inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 23 month old patient received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 23-month-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th July 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 6-July-2022 Reporter's comment: The reporter reported that a 23-month-old patient received Kinrix. The reporter consented to follow up. Additional supportive information: The 23-month-old patient received Kinrix which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: vaccine dripped out of the syringe; dripped out, made her pants wet; dripped out, made her pants wet; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a female 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 accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments: The reporter was a HCP, stated that he/she was administrating the 1st round of the Shingrix vaccine to a patient and some of the vaccine dripped out of the syringe, enough that it made her pants wet, but could not tell how much was not given. The reporter wanted to know what would be the recommended course of action in this case The HCP who did not provide any additional information. Email address provided for follow up although follow up permission was not obtained due to the nature of the request. Additional Supportive Information: While administrating the 1st round of the Shingrix vaccine to a patient some of the vaccine dripped out of the syringe, enough that it made her pants wet, but could not tell how much was not given, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Hot flush, Insomnia
Clinical narrative: Fever; Headache; Nausea; Lethargy; Sleeping difficulty; pain with movement of the head; debilitating; Chills; Hot flashes; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 1st July 2022, 10 hrs after receiving Shingrix, the patient experienced chills. On 2nd July 2022, the patient experienced fever, headache, nausea, lethargy, difficulty sleeping, pain upon movement and weakness. In July 2022, the patient experienced hot flashes. On an unknown date, the outcome of the chills, headache, nausea, lethargy, difficulty sleeping, pain upon movement, hot flashes and weakness were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chills, fever, headache, nausea, lethargy, difficulty sleeping, pain upon movement, hot flashes and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments: The patient self-reported this case. The patient received second dose of Shingrix around noon on 01st July 2022 and experienced chills around 10pm that night, that lasted throughout the night. The patient woke up on 02nd July 2022 with a 102 fever, severe headache, nausea, and lethargy. The patient further stated that the severe headache caused sleeping difficulty and pain with movement of the head. The patient also experienced hot flashes in the past couple of days, which alternate with experiencing chills. The patient reported that the fever had resolved and all other symptoms were ongoing, but to a lesser degree. The patient stated that the headache still felt debilitating, but was no longer lasting 24 hours a day, but then comes and goes. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Headache; Nausea; Lethargy; Sleeping difficulty; pain with movement of the head; debilitating; Chills; Hot flashes; This case was reported by a consumer via call center representative and described the occurrence of chills in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 1st July 2022, the patient received the 2nd dose of Shingrix. On 1st July 2022, 10 hrs after receiving Shingrix, the patient experienced chills. On 2nd July 2022, the patient experienced fever, headache, nausea, lethargy, difficulty sleeping, pain upon movement and weakness. In July 2022, the patient experienced hot flashes. On an unknown date, the outcome of the chills, headache, nausea, lethargy, difficulty sleeping, pain upon movement, hot flashes and weakness were not recovered/not resolved and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chills, fever, headache, nausea, lethargy, difficulty sleeping, pain upon movement, hot flashes and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-Jul-2022 Reporter's Comments: The patient self-reported this case. The patient received second dose of Shingrix around noon on 01st July 2022 and experienced chills around 10pm that night, that lasted throughout the night. The patient woke up on 02nd July 2022 with a 102 fever, severe headache, nausea, and lethargy. The patient further stated that the severe headache caused sleeping difficulty and pain with movement of the head. The patient also experienced hot flashes in the past couple of days, which alternate with experiencing chills. The patient reported that the fever had resolved and all other symptoms were ongoing, but to a lesser degree. The patient stated that the headache still felt debilitating, but was no longer lasting 24 hours a day, but then comes and goes. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: pain at the injection site; muscle aches; weakness; dizziness; fever; shivering; headache; fatigue; joint pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 2nd dose of Shingrix. On 6th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, weakness, dizziness, fever, shivering, headache, fatigue and joint pain. On an unknown date, the outcome of the injection site pain, muscle pain, weakness, dizziness, fever, shivering, headache, fatigue and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, weakness, dizziness, fever, shivering, headache, fatigue and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient reported that evening post vaccination he developed muscle aches, pain at the injection site, weakness, dizziness, fever, shivering, headache, fatigue and joint pain.  The patient stated none of his symptoms had resolved. The reporter gave permission to follow up with health care professional. The reporter consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: pain at the injection site; muscle aches; weakness; dizziness; fever; shivering; headache; fatigue; joint pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th July 2022, the patient received the 2nd dose of Shingrix. On 6th July 2022, less than a day after receiving Shingrix, the patient experienced injection site pain, muscle pain, weakness, dizziness, fever, shivering, headache, fatigue and joint pain. On an unknown date, the outcome of the injection site pain, muscle pain, weakness, dizziness, fever, shivering, headache, fatigue and joint pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, muscle pain, weakness, dizziness, fever, shivering, headache, fatigue and joint pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's Comments: The patient was self-reported case.  The patient reported that evening post vaccination he developed muscle aches, pain at the injection site, weakness, dizziness, fever, shivering, headache, fatigue and joint pain.  The patient stated none of his symptoms had resolved. The reporter gave permission to follow up with health care professional. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 10/11/2019 and 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix on 11th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: The pharmacist reported that the patient (wife) had not been administered 2nd dose yet. The Healthcare Professional (HCP) did not had lot number or expiration date of Shingrix first dose. The Vaccine administration facility was the same as primary reporter. 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. This case was linked with case US2022103849 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103849:Same reporter
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: second dose when the patient was 14yo only; first dose Jan 14th 2015, second dose Nov 12th 2018; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 14th January 2015 unknown batch number.).   On 12th November 2018, the patient received the 2nd dose of Menveo. On 12th November 2018, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's Comment:  Reporter stated that the patient received second dose of Menveo at the age 14 years only. Now the patient was 18 years old and requested a booster vaccine for the college, but Doctor realized that the second dose was too early. The reporter consented to follow up by email. Additional supportive information: The 14 year old patient received 2nd dose of Menveo, earlier than recommended interval, which led to inappropriate age at vaccine administration and shortening of vaccination schedule.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site pain, Vaccine positive rechallenge
Clinical narrative: soreness (arm); redness at the injection site; first dose 4 years ago, second dose this week; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 5j27j, expiry date 6th May 2023) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (4 year ago patient received 1st dose of Shingrix for tolerance refer case US2022AMR104136).   In July 2022, the patient received the 2nd dose of Shingrix (intramuscular). In July 2022, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site redness and drug dose administration interval too long. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site redness were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain and injection site redness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR104136   Additional Information: GSK Receipt Date: 28-Mar-2022 Reporter's Comments: The patient who received her second dose of SHINGRIX this week. She states that she received her first dose of SHINGRIX 4 years ago.  The patient states that after her first dose of SHINGRIX, she experienced soreness and redness at the injection site which eventually resolved.  The patient received shingrix in left arm and she experienced the same soreness and redness at the injection site within 48 hours of the second dose.  The soreness and redness at the injection site has not yet resolved after the second dose. The reporter did not gave consent to follow up. Additional supportive Information: The patient received 2nd dose of SHINGRIX 4 years after 1st dose which leads to lengthening of vaccination schedule; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104136:same report, 1st dose
Age: 61.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of Havrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th July 2022, the patient received Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 5th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Jul-2022 Reporter's comment: The pharmacist reported that the patient was administered a dose of Havrix in left arm which was expired on 14th June 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used. This was 1 out of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103865:Same reporter. Patient 2
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: daughter received HAVRIX 7 days prior 6 month interval; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a child female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received one dose of Havrix on an unknown date).   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: The patient's father reported that the patient received her dose of Havrix, 7 days prior of to intended 6 month interval scheduled. The exact date was unknown. The patient was provided with medical advised disclaimer and referred to Healthcare Professional (HCP). The reporter refused to provide mailing address. The reporter did not consent to follow-up. Additional supportive information: The patient received her dose of Havrix (booster) 7 days prior of to intended 6 month interval scheduled, which led to shortening of vaccination schedule.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Product use in unapproved indication, Rash, Vaccination failure
Clinical narrative: second dose of SHINGRIX 9 months ago, shingles gotten worse; Shingles; Rash; Received her second dose of Shingrix 9 months ago while she had an active shingles rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and drug use for unapproved indication. On an unknown date, the outcome of the vaccination failure, shingles, rash and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix. It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-JUL-2022 Reporters comment: The patient received her second dose of Shingrix 9 months ago while she had an active shingles rash.  The patient stated that since after receiving the second dose her shingles had progressively got worsened.  The patient was provided medical advise disclaimer and referred to Healthcare professional. The patient did not consent to follow-up. Limited information was provided. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The patient received her second dose of Shingrix 9 months ago while she had an active shingles rash which led to drug use for unapproved indication and circumstance or information capable of leading to medication error.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 18Dec2019, 2nd dose 12Aug2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 18th December 2019).   On 12th August 2020, the patient received the 2nd dose of Shingrix. On 12th August 2020, 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: 08-JUL-2022 Reporter's Comments: The pharmacist reported that the patient received second dose on 12th August 2020. No reactions reported. The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 0.83
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: administered after the expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent) (batch number 2E43L, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st July 2022, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On 1st July 2022, unknown after receiving FluLaval Quadrivalent and Flulaval 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: 08-JULY-2022 Reporter's comment: The reporter stated that Flulaval was administered to a patient after the expiration date. Reporter consented to follow up. Additional supportive narrative: As patient administered expired vaccine which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2019, 2nd dose Jul2022/At time of call pharmacist had not administered the 2nd dose of Havrix; 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 female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix  (received 1st dose on 15th October 2019).   On an unknown date, the patient received the 2nd dose of Havrix. On 11th July 2022, unknown after receiving Havrix, 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: 11-Jul-2022 Reporter's comment: The pharmacist reported the administration of Havrix beyond 6 months. The patient was back for 2nd dose of Havrix on the day of reporting. At time of call pharmacist had not administered the 2nd dose of Havrix. The reporter consented to follow-up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Havrix, which led to incomplete course of vaccination. As it was reported that at the time of call the patient did not receive the 2nd dose therefore incomplete course of vaccination was coded as event. Suspect was coded as reported narrative.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered to a pt after the expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2022, the patient received Havrix 1440 and Havrix Pre-Filled Syringe Device. On 8th July 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: 11-July-2022 Reporter's Comments: The reporter stated that Havrix was administered to a patient after the expiration date. The reporter consented to follow up via postal. Additional supportive information: The patient received vaccine after the expiration date, which led to expired vaccine used.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: numb on his left arm; This case was reported by a pharmacist via call center representative and described the occurrence of numbness of upper extremities in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th July 2022, the patient received the 1st dose of Shingrix. On 11th July 2022, less than a day after receiving Shingrix, the patient experienced numbness of upper extremities. On an unknown date, the outcome of the numbness of upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the numbness of upper extremities to be related to Shingrix.  Additional Information: GSK Receipt Date: 11-July-2022. Reporter's Comments: The immunocompetent patient received Shingrix and after that he experienced numb on his left arm. At the moment of the call, the patient had this symptom. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3 SHINGRIX vaccines, dose 3 on Aug 30, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th November 2020) and Shingrix (2nd dose received on 24th February 2021).   On 30th August 2021, the patient received the 3rd dose of Shingrix. On 30th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's comment: Pharmacy intern reported that a patient received 3 Shingrix vaccines. The patient received 3rd dose of Shingrix vaccine into left arm. No symptoms or other information provided. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 3 doses of Shingrix vaccine, which led to extra dose administered.
Age: 53.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient received the Havrix that expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th July 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's Comments: The health care professional reported that a dose of Havrix was given to the patient and it was already expired. No reactions reported.  The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up by email. Additional supportive information: The patient received Havrix dose which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a third dose in error; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) (batch number 5H29X, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (received first dose on 12th October 2021) and Shingrix (received second dose on 7th January2022).   On 8th July 2022, the patient received the 3rd dose of Shingrix. On 8th July 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 13-JUL-2022 Reporter's comment: The nurse reported that the patient received his 3rd dose of Shingrix in error. The nurse also asked if there was any action that need to be taken. The reporter consented to follow-up. Additional supportive information: The patient had received 3rd dose of Shingrix in error, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had his first SHINGRIX vaccine about 3 years ago, has not received dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received his first Shingrix vaccine about 3 years 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: 13-JUL-2022 Reporter's comment: The patient reported that he did not receive dose 2 yet. The reporter provided education as per the content and was referred to an Healthcare Professional (HCP). The Medical information (MI) number was also provided. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received the adjuvant without the active antigen; received the adjuvant without the active antigen; 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) 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: 13-JUL-2022 Reporter's Comments: The pharmacist reported that the patient who received the Shingrix adjuvant without the active antigen component.  Lot numbers were unknown.  The reporter had limited information. Additional Supportive Information: The pharmacist reported that the patient received adjuvant portion of Shingrix without the active antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2022AMR106414 and US2022AMR106415, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR106414:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR106415:Same case/same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: possible first dose April 14 2022, May 9th second dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 9th May 2022, the patient received the 2nd dose of Shingrix. On 9th May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 13-JUL-2022 Reporter's comment: The pharmacist intern had reported that the patient received his first dose on 14th April 2022 and on 9th May 2022 the second dose. The Healthcare Professional (HCP) does not know if the patient was immunocompromised or not. They were evaluating to give a third dose because they were not sure about the first dose. At the moment of the call, patient had have only two Shingrix dose. The reporter consented to follow-up by email. Additional supportive information: The patient received the second dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the diluent portion of Shingrix; administered only the diluent portion of Shingrix; 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) for prophylaxis.   On 13th July 2022, the patient received Shingrix. On 13th July 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: 13-JUL-2022 Reporter's Comments: The pharmacist reported that the patient received only the diluent portion of Shingrix. The reporter consented to follow up. Additional Supportive Information: The pharmacist reported that the patient received only the diluent portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.