chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion for VARIVAX; This spontaneous report was received from an office manager and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date, varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dosage form, lot #W025277, expiration date: 10-AUG-2024) was underwent a temperature excursion of minus 22.3degree Fahrenheit (F) for 1 hour 9 minutes. No previous temperature excursion.  On 02-MAY-2023, the improperly stored vaccine was administered to patient for prophylaxis (strength and route were not provided) (product storage error). No additional adverse events (AEs).
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; patient was given a dose of GARDASIL 9 after the dose was stored improperly; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 06-MAY-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, "0.5ml/ series", (lot #W004648, expiration date: 06-OCT-2024 and lot# 1775827 with expiration date 27-JUN-2023; it was not reported which one of lot# was administered to the patient) (strength, dose#, route and anatomical site of vaccination were not provided) for prophylaxis (product storage error). On 2nd May of unknown year, for suspect vaccines, the temperature excursion was 34 Fahrenheit for 7 hours, and on 6th May on an unknown year was 33.72 Fahrenheit for 6 hours. It was not reported if the suspect vaccines underwent previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product use issue
Clinical narrative: No additional AE; Patient received their third dose of GARDASIL 9 prematurely (8 weeks early than recommended dosing interval). Received 1st dose on 27-FEB-2023, 2nd dose on 04-APR-2023, and 3rd dose 09-MAY-2023; Patient older than 45 years old (56 years old at time of administration) received GARDASIL 9; This spontaneous report was received from a registered nurse referring to a 56-year-old patient of an unknown gender and race.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-FEB-2023, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) (product use issue). On 04-APR-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided). On 09-MAY-2023, the patient was prematurely vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical location, and route of administration were not provided) as it was given 8 weeks earlier than the recommended dosing interval (inappropriate schedule of product administration). No additional adverse events (no adverse event) were reported.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: arm pain; difficulty moving the vaccinated arm; This spontaneous report was received from a physician via company representative and referred to a 73-year-old male patient. The patient's concurrent condition, concomitant therapy, medical history, drug reactions/allergies were unknown.  On 28-MAR-2023, the patient was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, route, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On 28-MAR-2023, the patient experienced arm pain and difficulty moving the vaccinated arm after vaccination. It was unknown if the patient sought medical attention and gave treatment for events. The outcome of all events was not provided. The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and all events was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reporting an expired MMRII was administered to a patient.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's concomitant medication, current condition, pertinent medical history and drug reactions/ allergies were not reported.  On 12-MAY-2023, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant human albumin (rHA)) (M-M-R II) (0.5 milliliter, lot # U011149, expiration date 08-APR-2023, strength and route of administration were not provided) for prophylaxis (Expired product administered). There was no temperature excursion before administration. No additional adverse event (AE).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; expired dose of PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 16-MAY-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) prefilled syringe, 0.5 mL, intramuscularly (IM), lot # U018632 with expiration date 11-JAN-2023, intramuscularly, for prophylaxis (strength and anatomical location were not reported). No additional adverse event was reported.
Sex: F
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: HEP A 06/20/2013; Information has been received from a Physician regarding a case in litigation referring to a 5-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 08-JAN-2009, the patient started therapy with hepatitis a vaccine, inactivated (manufacturer unknown) for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 21-JUL-2009, the patient received the second dose and on 20-JUN-2013, a third dose was administered (extra dose administered). No further details provided.  The patient subsequently experienced several adverse events in the context of a litigation process for  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).; Sender's Comments:  US-009507513-2203USA007241:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shingles shot and still came down with Shingles/suspected vaccination failure; Shingles; was so very painful/still had pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingles shot and still came down with Shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: was so very painful/still had pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not resolved.   The reporter considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine.     The company considered the vaccination failure, shingles and pain to be possibly related to Shingles vaccine.   Additional Information: GSK receipt date: 16-MAY-2023 The case was received from the patient via interactive digital media. The patient said she got the Shingles shot and still came down with Shingles virus. It was so very painful. The reporter thought that the event might have been related to the vaccine. The patient said it lasted almost a month, she still had pain for a couple of weeks after that. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bell's palsy, Dizziness, Facial paralysis, Herpes zoster oticus
Clinical narrative: He then developed facial paralysis; he had Bell's Palsy; he had Ramsay Hunt syndrome; He then developed dizziness; He then developed weakness; This serious case was reported by a physician via sales rep and described the occurrence of facial paralysis in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial paralysis (Verbatim: He then developed facial paralysis) (serious criteria GSK medically significant), bell's palsy (Verbatim: he had Bell's Palsy) (serious criteria GSK medically significant), ramsay-hunt syndrome (Verbatim: he had Ramsay Hunt syndrome) (serious criteria GSK medically significant), dizziness (Verbatim: He then developed dizziness) and weakness (Verbatim: He then developed weakness). The outcome of the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness were not reported.   The reporter considered the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness to be related to Shingrix.     The company considered the facial paralysis, bell's palsy, ramsay-hunt syndrome, dizziness and weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023  The reporter was a field staff employee. The first dose of Shingrix was received about a month prior to the reporting. The patient was with no comorbid conditions received a dose of Shingrix and then developed dizziness, weakness and facial paralysis.  The patient sought care from a neurologist and was told that he had Bell's Palsy or Ramsay Hunt syndrome. The Neurologist told it was caused by the Shingrix vaccine.  The patient had no other vaccines on the same day. The patient was now in physical therapy and his balance was better. The reporter agrees to follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine but still got shingles/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the vaccine but still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be possibly related to Shingles vaccine.     The company considered the vaccination failure and shingles to be possibly related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that she received Shingles vaccine and still experienced Shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headaches last after receiving the second dose of the shingles vaccine; This non-serious case was reported by a consumer and described the occurrence of headache in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.  On 25-FEB-2023, the patient received the 2nd dose of Shingrix. On 12-MAY-2023, 76 days after receiving Shingrix, the patient experienced headache (Verbatim: headaches last after receiving the second dose of the shingles vaccine).  The outcome of the headache was not resolved.  It was unknown if the reporter considered the headache to be related to Shingrix.  It was unknown if the company considered the headache to be related to Shingrix.  Additional Information: GSK Receipt Date: 16-MAY-2023 This report was submitted by public reporting reference via the online direct entry reporting system. The patient had self-reported that, the headaches lasted from 12 May 2023 to Ongoing. He had also asked that how long the headaches last after receiving the second dose of the shingles vaccine and the symptoms were not treated. The reporter had consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neck pain, Nerve compression, Pain, Rash
Clinical narrative: Pinched nerve; severe pain; rash developed; it was shingles; four days of neck pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In APR-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: it was shingles). On an unknown date, the patient experienced neck pain (Verbatim: four days of neck pain), pinched nerve (Verbatim: Pinched nerve), pain (Verbatim: severe pain) and rash (Verbatim: rash developed). The outcome of the shingles and pain were not resolved and the outcome of the neck pain was resolved (duration 4 days) and the outcome of the pinched nerve and rash were not reported.   The reporter considered the shingles, neck pain, pinched nerve, pain and rash to be unrelated to Shingles vaccine.   The company considered the shingles, neck pain, pinched nerve, pain and rash to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2023. This case was reported by a patient via interactive digital media. The patient got shingles after she had the 1st vaccine. The patient suffering with it now, and this was week 3, so patient guess it could be worse. The patient was in misery and wonder just how long this would go on. It all started with four days of neck pain. The doctor initially thought patient had a pinched nerve.  But then patient pain worsened, and a rash developed. It was shingles.  The reporter stated that dealing with the severe pain caused by shingles was tough. Knowing more about shingles would had been incredibly helpful. People over 50 be proactive. Talk to a doctor or pharmacist about shingles prevention. The reporter did not thought that the events might had been related to the drugs. The reporter did not consent to follow up.
Sex: U
Vaccine: HEP, HEP
Symptoms: Therapy non-responder
Clinical narrative: Patient fails to develop immunity after 2 rounds of Hep B; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of therapy non-responder in a patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder (Verbatim: Patient fails to develop immunity after 2 rounds of Hep B). The outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 15-May-2023 The reporter called to discuss the appropriate steps to take when a current patient fails to develop immunity after 2 rounds of Hepatitis B vaccinations prior to starting Kesimpta.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain of skin, Sensitive skin
Clinical narrative: Painful skin; Skin sensitivity on my upper back(left side), my left side, and my left breast; Miserable; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on an unknown date).   On 11-MAY-2023, the patient received the 2nd dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced skin pain (Verbatim: Painful skin), sensitive skin (Verbatim: Skin sensitivity on my upper back(left side), my left side, and my left breast) and feeling miserable (Verbatim: Miserable). The outcome of the skin pain, sensitive skin and feeling miserable were not reported.   It was unknown if the reporter considered the skin pain, sensitive skin and feeling miserable to be related to Shingrix.     It was unknown if the company considered the skin pain, sensitive skin and feeling miserable to be related to Shingrix.   Additional Information: GSK receipt date: 15-May-2023 The patient received second dose of Shingrix on Thursday. The patient developed very painful skin and skin sensitivity on upper back left side and left breast. The patient feels miserable and wonder if he/she had Shingles.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Received Trumenba in 2021 and then got Bexsero; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of interchange of vaccine products in a 19-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number CW3115) for prophylaxis.   Previously administered products included Menactra (received Menactra on 22nd June 2021 in left arm).   On 16-MAY-2023, the patient received Bexsero (intramuscular, left deltoid) .5 ml. On 22-JUN-2021, the patient received the 1st dose of TRUMENBA (intramuscular, right deltoid) .5 ml. On 16-MAY-2023, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: Received Trumenba in 2021 and then got Bexsero). The outcome of the interchange of vaccine products 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: 16-MAY-2023 The medical assistant called on behalf of nurse practitioner. The patient was a healthy person. The patient had no other conditions. The patient had no investigations. The patient had no other products. NDC number and expiry date of Trumenba was unknown. NDC number and expiry date of Bexsero was not Provided. The reporter reported a patient received Trumenba in 2021 and then got Bexsero at the day of reporting. The reporter called to find out if there was any reaction or if the series for Trumenba needs to be restarted. The agent was able to address inquiry. The reporter confirmed contact details upon transfer. The patient received only one dose of Trumenba. It was not administered at their office, it was administered at a different physician office.  The reporter only had lot number to provide. The patient received Trumenba and then got Bexsero, which led to interchange of vaccine products.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Dermatitis acneiform, Peripheral swelling, Skin warm
Clinical narrative: burning sensation; swelling; rash on the arm; hot to touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose received on 18th January 2023).   On 09-MAY-2023, the patient received the 2nd dose of Shingrix. On 10-MAY-2023, 1 days after receiving Shingrix, the patient experienced burning sensation (Verbatim: burning sensation), swollen arm (Verbatim: swelling), rash (Verbatim: rash on the arm) and skin warm (Verbatim: hot to touch). The patient was treated with ibuprofen. The outcome of the burning sensation, swollen arm, rash and skin warm were not resolved.   It was unknown if the reporter considered the burning sensation, swollen arm, rash and skin warm to be related to Shingrix.     It was unknown if the company considered the burning sensation, swollen arm, rash and skin warm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023068695   Additional Information: GSK Receipt Date: 12-MAY-2023 The consumer stated that she received her second dose of Shingrix and the following day she experienced rash on the arm with a burning sensation that was hot to touch with swelling.  The patient took Ibuprofen to treat these symptoms. The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023068695:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: Near fatal anaphylactic reaction; This serious case was reported by a consumer via market research programs and described the occurrence of anaphylactic reaction in a elderly female patient who received Flu unspecified (Flu vaccine unspecified) for prophylaxis.   On an unknown date, the patient received Flu vaccine unspecified. On an unknown date, an unknown time after receiving Flu vaccine unspecified, the patient experienced anaphylactic reaction (Verbatim: Near fatal anaphylactic reaction) (serious criteria GSK medically significant and life threatening). The outcome of the anaphylactic reaction was not reported.   The reporter considered the anaphylactic reaction to be possibly related to Flu vaccine unspecified.   The company considered the anaphylactic reaction to be possibly related to Flu vaccine unspecified.   Additional Information: GSK Receipt Date: 17-MAY-2023 This case was reported by the consumer via research programs. The patient had near fatal anaphylactic reaction to a Flu shot. The reporter thought that the event might have been related to the vaccine. The reporter consented to follow-up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired dose administered; This was the patient's fourth DTaP and IPV dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired product administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 09-MAY-2023, the patient received the 4th dose of Kinrix. On 09-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired product administered (Verbatim: Expired dose administered) and inappropriate schedule of vaccine administered (Verbatim: This was the patient's fourth DTaP and IPV dose). The outcome of the expired product administered and inappropriate schedule of vaccine administered 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: 09-May-2023 The nurse reported that the patient received a dose of Kinrix, which had an expiration date of 07 May 2023.  This was the patient's fourth DTaP and IPV dose.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient was administered an expired fourth dose of Kinrix, which led to expired vaccine used and this was the patient's fourth DTaP and IPV dose which led to inappropriate schedule of vaccine administered.
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incorrect dose administered, Interchange of vaccine products, Product preparation issue
Clinical narrative: Patient accidentally received the liquid portion of Menveo without reconstitution; Patient accidentally received the liquid portion of Menveo without reconstitution; the first vaccine being Menactra; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 44-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 01-MAR-2024) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 08-MAY-2023, the patient received the 2nd dose of Menveo. On an unknown date, the patient received MENACTRA. On 08-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Patient accidentally received the liquid portion of Menveo without reconstitution), inappropriate dose of vaccine administered (Verbatim: Patient accidentally received the liquid portion of Menveo without reconstitution) and interchange of vaccine products (Verbatim: the first vaccine being Menactra). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and interchange of vaccine products were unknown.   Additional Information: GSK Receipt Date: 09-MAY-2023  The reported wished to know how to proceed. They provided information about the vaccine, vaccination and patient. The vaccine administration facility was the same as primary reporter. The call was escalated to second line, but agent did not answer, thus the reporter consented to receiving a call back. The reporter consented to follow up. The patient accidentally received the liquid portion of Menveo without reconstitution with the first vaccine being Menactra, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and interchange of vaccine products. This case US2023066924 was identified as duplicate to case US2023066923, thus this case US2023066924 was deleted. All future correspondence will be submitted to case US2023066923.
Age: 0.5
Sex: M
Vaccine: HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Engerix-B third dose received on 05May2023; Expired Product Used; Inappropriate Schedule of Vaccine/had a dose documented on 05Jun2020 and 16Nov2020; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 6-month-old male patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received first dose on 5th June 2020).   On 05-MAY-2023, the patient received the 3rd dose of Engerix B. On 16-NOV-2020, the patient received the 2nd dose of Engerix B. On 11-NOV-2020, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine/had a dose documented on 05Jun2020 and 16Nov2020). On 05-MAY-2023, the patient experienced drug dose administration interval too long (Verbatim: Engerix-B third dose received on 05May2023) and expired drug used (Verbatim: Expired Product Used). The outcome of the drug dose administration interval too long, drug dose administration interval too long and expired drug used 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: 09-MAY-2023 The patient was currently 3 years old. The reporter believed that this was patients' third dose in the series. The patient had no record of a third dose. At the time of reporting, expired dose had not been repeated. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up but requested no patient information via email.  The patient received 2nd and 3rd dose of Engerix-B later than the recommended schedule and 3rd dose was administered after expiration date, which led to lengthening of vaccination schedule and expired vaccine used.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact
Clinical narrative: Most of the medicine came out of her arm and only a small amount entered the arm; most of the medicine came out of her arm; most of the medicine came out of her arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (unknown arm). In MAR-2023, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: Most of the medicine came out of her arm and only a small amount entered the arm), exposure via skin contact (Verbatim: most of the medicine came out of her arm) and inadvertent exposure to vaccine (Verbatim: most of the medicine came out of her arm). The outcome of the accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK Receipt Date: 10-MAY-2023 The patient self-reported this case. The patient received 1st dose of Shingrix at the end of March. Reported that first injection was lost during administration, the medicine came out of her hand and only a small amount entered the arm. The patient was unaware of the reason, but the regular pharmacist gave the patient a new dose, was administered correctly. The patient got reminder for 2nd dose and asked if she should get that dose now, 2 months after 1st dose or need to until the 6-month mark. The education was provided as per content, medical disclaimer was provided and referred to the health care professional. The reporter did not consent to follow up. The patient received 1st dose was lost during administration, which led to accidental underdose. The medicine came out of the patient arm, which led to exposure via skin contact and inadvertent exposure to vaccine
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Urinary incontinence
Clinical narrative: Urinary incontinence increased; This non-serious case was reported by a consumer via call center representative and described the occurrence of urinary incontinence aggravated in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included urinary incontinence.   On 12-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular). On 13-MAY-2023, 1 days after receiving Shingrix, the patient experienced urinary incontinence aggravated (Verbatim: Urinary incontinence increased). The outcome of the urinary incontinence aggravated was not resolved.   It was unknown if the reporter considered the urinary incontinence aggravated to be related to Shingrix.     It was unknown if the company considered the urinary incontinence aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2023. Consumer was calling to asked if urinary incontinence was a known side effect of Shingrix.  The reporter stated that he did have urinary incontinence and that it became worse one day after receiving his first Shingrix dose.  The reporter referred to health care professional.  The reporter did not provide consent to contact his health care professional.  The reporter did not consent to follow-up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired dose administered.; This non-serious 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 female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   On 15-MAY-2023, the patient received Kinrix. On 15-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2023 Nurse called to inform that a patient accidentally received a dose of Kinrix that had already expired back in 7th May 2023. The Vaccine Administration Facility was the same as primary reporter. The reporter did consent to follow up.
Sex: F
Vaccine: DTAPHEPBIP, DTAPHEPBIP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired dose of Pediarix given; Wrong vaccination schedule; Wrong vaccination schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 8-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included PEDIARIX.   On 15-MAY-2023, the patient received the 3rd dose of Pediarix. On 13-FEB-2023, the patient received the 2nd dose of Pediarix. On 13-FEB-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too short (Verbatim: Wrong vaccination schedule). On 15-MAY-2023, the patient experienced expired vaccine used (Verbatim: Expired dose of Pediarix given) and drug dose administration interval too long (Verbatim: Wrong vaccination schedule). The outcome of the expired vaccine used, drug dose administration interval too long and drug dose administration interval too short 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: 15-MAY-2023 The information about vaccine, patient and event were provided.  Even though the reporter did not provide information about the incorrect vaccination schedule, adverse event was collected. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.. The patient received 2nd dose of Pediarix earlier than recommended interval and 3rd dose of Pediarix later than the recommended interval after expiration date, which led to shortening of vaccine schedule, lengthening of vaccine schedule and expired vaccine used.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash erythematous, Rash pruritic, Skin disorder
Clinical narrative: Skin is bumpy/ skin felt leathery; Red skin; Digging at back, upper legs, and arms; Red rash; Itchy rash; Rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-JAN-2023, the patient received the 1st dose of Shingrix. In FEB-2023, between 1 and 2 weeks after receiving Shingrix, the patient experienced red rash (Verbatim: Red rash), itchy rash (Verbatim: Itchy rash) and rash (Verbatim: Rash). On an unknown date, the patient experienced skin disorder (Verbatim: Skin is bumpy/ skin felt leathery), skin red (Verbatim: Red skin) and pruritus (Verbatim: Digging at back, upper legs, and arms). The patient was treated with steroids nos (Steroids). The outcome of the red rash, itchy rash, rash, skin disorder, skin red and pruritus were not resolved.   The reporter considered the red rash, itchy rash, rash, skin disorder, skin red and pruritus to be possibly related to Shingrix.     The company considered the red rash, itchy rash, rash, skin disorder, skin red and pruritus to be possibly related to Shingrix.   Additional Information: GSK Receipt Date:16-May-2023 The reporter was the wife of the patient. The reporter reported that the patient received 1st dose of Shingrix and about one and half weeks after received Shingrix vaccine the patient experienced an itchy and red rash on the left side of his lower back and the back of his legs.  The rash then spread across the middle of his back and then to his shoulder blade and was on both the left and right side.  The nurse could not determine what the rash was and prescribed a topical steroid cream, steroid shot, oral steroids, and also took oral allergy pills. The patient was changed laundry detergents to a sensitive skin laundry detergent and tried oral hair, skin and nail gummies to help with the rash, and nothing was worked. The reporter stated the patient rash was continues to be there today and seems to be traveling his body.  The rash was appeared on the backs of both of his upper legs and inner thighs, the side of his stomach and also the fronts of his legs and on both of his arms. afterwards some areas will clear up for a couple of days, and then comes back blood red and the patient skin was bumpy, red and felt leathery when the rash was going on.  The rash flairs up, it might be in the same spot or a new spot. The last couple of days the patient had been digging at his back, upper legs and arms and this was all still going on. The reporter did not know the location where the patient injection was administered but stated that she thought the arm. The reporter thinks all this came from the vaccine as the patient did not have any of this before the vaccine, and nothing else changed. The reporter did consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Pain
Clinical narrative: Shaking; Aching; Slept for a really long time; fatigue/ tiredness; Bad Headache; Chills; 105 Fahrenheit Fevers/ 106 Fahrenheit Fever; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 95252, expiry date 18-JUN-2024) for prophylaxis.   The patient's past medical history included shingles and rash.   On 24-APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 25-APR-2023, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue/ tiredness), headache (Verbatim: Bad Headache), chills (Verbatim: Chills) and fever (Verbatim: 105 Fahrenheit Fevers/ 106 Fahrenheit Fever). On 30-APR-2023, the patient experienced tremor (Verbatim: Shaking), pain (Verbatim: Aching) and sleep excessive (Verbatim: Slept for a really long time). In MAY-2023, the outcome of the fatigue, headache, chills, fever, tremor, pain and sleep excessive were resolved.   It was unknown if the reporter considered the fatigue, headache, chills, fever, tremor, pain and sleep excessive to be related to Shingrix.     It was unknown if the company considered the fatigue, headache, chills, fever, tremor, pain and sleep excessive to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 As per the patient's physician, the patient recently had shingles and the physician wanted the rash cleared before vaccine.  The physician advised to wait 30 days after rash had gone away before vaccine.  Registered pharmacist reported that the patient administered the dose of Shingrix. The next day the patient experienced, tiredness, headache, fatigue, chills and a 106 Fahrenheit fever.  Registered pharmacist stated that they know that this was common after Shingrix, and patient felt better for next couple of days.  Then a couple of days later, on 30th April 2023, 6 days after vaccination, the patient experienced shaking, chills, 105 F fever, bad headache, aching and tiredness and the patient slept for a really long time.  It was like the patient had 2 reactions within a couple days.  Since then, it had resolved over the weekend, but the patient was kind of hesitant in getting the second dose. Registered pharmacist stated that he thought that the patient did not wait long enough after having Shingles for the vaccine.  The reporter inquired if any information was available if this was common. The reporter did not consent to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaking; Aching; Slept for a really long time; fatigue/ tiredness; Bad Headache; Chills; 105 Fahrenheit Fevers/ 106 Fahrenheit Fever; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 95252, expiry date 18-JUN-2024) for prophylaxis.   The patient's past medical history included shingles and rash.   On 24-APR-2023, the patient received the 1st dose of Shingrix (left deltoid). On 25-APR-2023, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: fatigue/ tiredness), headache (Verbatim: Bad Headache), chills (Verbatim: Chills) and fever (Verbatim: 105 Fahrenheit Fevers/ 106 Fahrenheit Fever). On 30-APR-2023, the patient experienced tremor (Verbatim: Shaking), pain (Verbatim: Aching) and sleep excessive (Verbatim: Slept for a really long time). In MAY-2023, the outcome of the fatigue, headache, chills, fever, tremor, pain and sleep excessive were resolved.   It was unknown if the reporter considered the fatigue, headache, chills, fever, tremor, pain and sleep excessive to be related to Shingrix.     It was unknown if the company considered the fatigue, headache, chills, fever, tremor, pain and sleep excessive to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2023 As per the patient's physician, the patient recently had shingles and the physician wanted the rash cleared before vaccine.  The physician advised to wait 30 days after rash had gone away before vaccine.  Registered pharmacist reported that the patient administered the dose of Shingrix. The next day the patient experienced, tiredness, headache, fatigue, chills and a 106 Fahrenheit fever.  Registered pharmacist stated that they know that this was common after Shingrix, and patient felt better for next couple of days.  Then a couple of days later, on 30th April 2023, 6 days after vaccination, the patient experienced shaking, chills, 105 F fever, bad headache, aching and tiredness and the patient slept for a really long time.  It was like the patient had 2 reactions within a couple days.  Since then, it had resolved over the weekend, but the patient was kind of hesitant in getting the second dose. Registered pharmacist stated that he thought that the patient did not wait long enough after having Shingles for the vaccine.  The reporter inquired if any information was available if this was common. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: accidentally administered only the diluent portion of Menveo; accidentally administered only the diluent portion of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-MAY-2023, the patient received Menveo. On 17-MAY-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered only the diluent portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: accidentally administered only the diluent portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2023 The reporter reported that a patient accidentally administered only the diluent portion of Menveo and wished to know how to proceed. They did not have information about vaccine or patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient accidentally administered only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old female patient who received HBV (Engerix B) (batch number M4KE9, expiry date 29-APR-2023) for prophylaxis.   On 09-MAY-2023, the patient received Engerix B. On 09-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expired dose of Engerix-B was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2023 The medical assistant reported that an expired dose of Engerix-B was administered to a patient.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 74.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix: 3rd dose earlier than recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 74-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 18th November 2022). Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 17-MAR-2023, the patient received the 3rd dose of Twinrix. On 17-MAR-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: Twinrix: 3rd dose earlier than recommended interval). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-MAY-2023 The reporter reported that a patient got the 3rd dose of Twinrix early at month 4 instead of the recommended 6month interval. The reporter consented to follow up. The patient received 3rd dose of Twinrix earlier than the recommended schedule, which led to shortening of vaccination schedule.