chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: No adverse event
Clinical narrative: Caller reported an AE for GARDASIL and GARDASIL 9. The caller said they had a patient who received their first dose of GARDASIL on 5/17/2011. The patient received GARDASIL 9 on 7/25/2023 which was the patient's second dose of an HPV vaccine. Confirm; first dose of GARDASIL on 5/17/2011. The patient received GARDASIL 9 on 7/25/2023 which was the patient's second dose of an HPV vaccine; No other AE.; This spontaneous report was received from a pharmacist and refers to a 25-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2011, the patient started therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 25-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered and interchange of vaccine products). No addtional adverse event was reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No further AE; Medical assistant calls to report TE yesterday 7/25/2023.; This spontaneous report was received from a medical assistantand refers to a 22-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, one time, lot #x004813, expiration date: 28-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion on 25-JUL-2023, before administration to a patient. Temperature excursion took place in 50.5 Farenheit (F) for 54 hours 15 minutes (Product storage error). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event
Clinical narrative: No additional AE/PQC.; Merck Employee called to report HCP administered GARDASIL 9 to an 8 year old patient because the HCP states the mother passed on HPV to patient at birth and HCP was using the GARDASIL 9 as a method of treatment.  HCP did confirm permission to contact; This spontaneous report was received from Company Representative and refers to an 8-year-old of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 25-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On 25-JUL-2023, Merck Employee called to report HCP administered GARDASIL 9 to an 8 year old patient because the HCP states the mother passed on HPV to patient at birth and HCP was using the GARDASIL 9 as a method of treatment. HCP did confirm permission to contact, but not by phone or email. No additional AE/PQC.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Sepsis, Urinary tract infection
Clinical narrative: Severe pain and infection; urinary tract infection/Infection; Fever; patient became septic; This serious case was reported by a consumer and described the occurrence of sepsis in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. On 14-JUL-2023, less than a day after receiving Shingrix, the patient experienced pain (Verbatim: Severe pain and infection) (serious criteria hospitalization) and urinary tract infection (Verbatim: urinary tract infection/Infection) (serious criteria hospitalization). In JUL-2023, the patient experienced sepsis (Verbatim: patient became septic) (serious criteria hospitalization and GSK medically significant) and fever (Verbatim: Fever) (serious criteria hospitalization). The patient was treated with ceftriaxone sodium (Rocephin) and vancomycin. The outcome of the sepsis, pain, urinary tract infection and fever were not reported.   The reporter considered the sepsis, pain, urinary tract infection and fever to be related to Shingrix.     The company considered the sepsis, pain, urinary tract infection and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-JUL-2023 The reported stated, after the first dose of Shingrix patient complaint about the severe pain and fever. The patient was admitted to the hospital due to severe pain and fever. The patient was also hospitalized due to urinary tract infection. She was treated with a course of antibiotics included Rocephin and vancomycin. Because of a subsequent urinary tract infection the patient became septic. Expiry date of Shingrix was unknown. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had all my shots and I still got shingles/suspected vaccination failure; I had all my shots and I still got shingles; had a lot of painful things, but this has been the worst; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had all my shots and I still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I had all my shots and I still got shingles) and pain (Verbatim: had a lot of painful things, but this has been the worst). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient had all his/her shingles shots and he/she still got shingles.  The reporter stated that health wise he/she had a lot of painful things but this had been the worst. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash erythematous, Rash pruritic, Vaccination failure
Clinical narrative: took the shingles shot,but it did not help/ Suspected vaccination failure; have had them several times; They are painful; itchy red rash.; Itchy red rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shingles shot,but it did not help/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: have had them several times), pain (Verbatim: They are painful), itchy rash (Verbatim: itchy red rash.) and red rash (Verbatim: Itchy red rash). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, itchy rash and red rash were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, itchy rash and red rash to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain, itchy rash and red rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she had them several times, they were terrible, they were painful, itchy red rash. The reporter reported that he or she took the Shingles shot, but it did not help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I have had the shot and I still have the shingles/suspected vaccination failure; I have had the shot and I still have the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have had the shot and I still have the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had the shot and I still have the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-JUL-2023 The case was received from the patient interactive digital media. The patient had the shot and still had the shingles (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Impaired driving ability, Loss of consciousness
Clinical narrative: Passed out; I felt faint; I was driving and I got so dizzy; This serious case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 hrs after receiving Shingles vaccine, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), faint (Verbatim: I felt faint) (serious criteria GSK medically significant) and dizziness (Verbatim: I was driving and I got so dizzy). The outcome of the passed out, faint and dizziness were resolved.   It was unknown if the reporter considered the passed out, faint and dizziness to be related to Shingles vaccine.     It was unknown if the company considered the passed out, faint and dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that getting vaccinated was very good, but he or she had a horrible reaction. The patient reported that 7 hours after received Shingles vaccine he or she passed out completely, got some rest and on the next day he or she went to the work and he or she was driving and  got so dizzy that he or she felt faint luckily he or she had immediate help, otherwise he or she would had an accident, ask the nurse about the reactions, so we should be careful. Follow-up would not possible as no contact details were available.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: instance of off-label use we wanted to flag.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In JUL-2023, the patient received Bexsero. In JUL-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: instance of off-label use we wanted to flag.). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 20 Jul 2023 This case was reported by a consumer via interactive digital media. The reporter patient's parent. The reporter stated that his/her son got bexsero at his well visit last week. The practice was pro any preventative care and it was brought up as a  recommended one for him and we did it. When  the reporter was in college there was an out break and it was pretty scary and many of us got  vaccinated on campus right away. The reporter believed this was a mistake on the commentor's side and they were talking about the ACWY vaccine, but in case it was an instance of off-label use. The patient received bexsero instead of ACWY vaccine which led to wrong vaccine administered
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pyrexia
Clinical narrative: pain where they gave me the vaccine; headache; slight temperature; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: pain where they gave me the vaccine), headache (Verbatim: headache) and fever (Verbatim: slight temperature). The outcome of the injection site pain and fever were not reported and the outcome of the headache was resolved.   It was unknown if the reporter considered the injection site pain, headache and fever to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain, headache and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-JUL-2023 This case was reported by patient via interactive digital media. The patient states that he/she felt like that and when he/she received it 4 days ago they did not told he/she anything about that, just a slight temperature, a headache but only that day and pain where they gave me the vaccine.  Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: excruciating pain; useless arm for at least a year; shingles shot was incorrectly administered into my shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included eye operation. Concurrent medical conditions included trigeminal neuralgia (had surgery on eye which caused TGN. It seems to had gone into remission).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: excruciating pain), mobility decreased (Verbatim: useless arm for at least a year) and vaccine administered at inappropriate site (Verbatim: shingles shot was incorrectly administered into my shoulder). The outcome of the pain and mobility decreased were resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.     It was unknown if the company considered the pain and mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient stated that the Shingles shot was incorrectly administered into his/her shoulder which caused excruciating pain and a useless arm for at least a year. The patient received Shingles shot incorrectly in shoulder, which led to vaccine administered at inappropriate site.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Headache, Pain, Pyrexia
Clinical narrative: very intense headache; lot of pain; Fever; pain in my bones; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (received first dose on unknown date).   On 19-JUL-2023, the patient received the 2nd dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: very intense headache), pain (Verbatim: lot of pain), fever (Verbatim: Fever) and bone pain (Verbatim: pain in my bones). In JUL-2023, the outcome of the fever and bone pain were resolved (duration 2 days). The outcome of the headache and pain were not reported.   It was unknown if the reporter considered the headache, pain, fever and bone pain to be related to Shingles vaccine.     It was unknown if the company considered the headache, pain, fever and bone pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 The case was received from the patient via interactive digital media. The patient had already received the first dose of vaccine. On 19th July 2023 patient received the second dose and experienced lots of pain and very intense severe headache. But its better to be vaccinated. The follow-up would not required per process.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Nerve injury, Neuralgia, Rash
Clinical narrative: diagnosed with nerve damage; Neuropathic pain; rash was located on patient's left torso extending to his back (spinal cord); 2nd dose of Shingrix received on 03-Jul-2023; Shingles rash/diagnosed with shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number P45M9) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number L7F7E, expiry date 22-NOV-2020) for prophylaxis.   On 03-JUL-2023, the patient received the 2nd dose of Shingrix (injection, right deltoid). On 02-SEP-2018, the patient received the 1st dose of Shingrix (injection, right deltoid). In APR-2023, not applicable after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles rash/diagnosed with shingles). On 03-JUL-2023, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose of Shingrix received on 03-Jul-2023). On an unknown date, the patient experienced nerve damage (Verbatim: diagnosed with nerve damage), neuropathic pain (Verbatim: Neuropathic pain) and rash (Verbatim: rash was located on patient's left torso extending to his back (spinal cord)). The patient was treated with gabapentin. The outcome of the shingles, nerve damage and rash were not reported and the outcome of the neuropathic pain was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the shingles, nerve damage, neuropathic pain and rash to be related to Shingrix.  It was unknown if the company considered the shingles, nerve damage, neuropathic pain and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JUL-2023 The case was reported by patient's wife. The reporter stated that that the patient was diagnosed with Shingles approximately 3 months ago and was experiencing neuropathic pain, nerve damage and shingles rash. The patient was diagnosed by a dermatologist and was currently taking Gabapentin for neuropathic pain with no improvement.  The rash was located on patient's left torso extending to his back (spinal cord). The patient stated that the patient was diagnosed with nerve damage. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 90.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Feeling hot, Oropharyngeal pain, Tremor
Clinical narrative: Shakes; Felt hot; Sore Throat; lost balance; Loss of energy; This non-serious case was reported by a consumer via call center representative and described the occurrence of tremor in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid) .5 ml. On 17-MAY-2023, less than a day after receiving Shingrix, the patient experienced tremor (Verbatim: Shakes), feeling hot (Verbatim: Felt hot), sore throat (Verbatim: Sore Throat), loss of balance (Verbatim: lost balance) and loss of energy (Verbatim: Loss of energy). On 18-MAY-2023, the outcome of the tremor, feeling hot, sore throat and loss of balance were resolved (duration 1 day). The outcome of the loss of energy was not resolved.   It was unknown if the reporter considered the tremor, feeling hot, sore throat, loss of balance and loss of energy to be related to Shingrix.     It was unknown if the company considered the tremor, feeling hot, sore throat, loss of balance and loss of energy to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter stated him and his wife both were on the call. They both had the first dose of Shingrix. The customer (husband) reported that he had all the symptoms on evening when he administered the first dose of Shingrix. The symptoms were resolved except the loss of energy. The patient was not feeling the same since then. The reporter did not consented to follow up.
Age: 72.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Nurse reporting expired dose of Engerix-B was administered on 07/24/2023. Dose expired on 07/03/2023.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HBV (Engerix B) (batch number F73DG, expiry date 03-JUL-2023) for prophylaxis.   On 24-JUL-2023, the patient received Engerix B. On 24-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Nurse reporting expired dose of Engerix-B was administered on 07/24/2023. Dose expired on 07/03/2023.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 Nurse reported patient was administered with expired dose of Engirix B vaccine. The vaccine administration facility was the same as primary reporter. The patient received an expired dose of Engirix B vaccine, which led to expired vaccine used. The reported consented to follow up for safety team.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: an expired dose of Havrix 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 18-month-old female patient who received HAV (Havrix) (batch number AT47C, expiry date 28-APR-2023) for prophylaxis.   On 14-JUN-2023, the patient received Havrix. On 14-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: an expired dose of Havrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The medical assistant called to reported that patient was administered with expired dose of Havrix vaccine. The patient received an expired dose of Havrix vaccine, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAV (Havrix) (expiry date JAN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Havrix. On 12-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The pharmacist reported that male patient was administered an expired dose of Havrix on which led to expired vaccine used. Pharmacist did not have vaccine lot number at the time of reporting, but knew the vaccine expired in January 2023. The reporter did not have any patient details available at time of reporting. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter. The case is linked with US2023101232, same reporter.
Sex: F
Vaccine: MENB
Symptoms: Rash, Urticaria
Clinical narrative: experienced Urticaria/  patient now have welts; Rash developed; This non-serious case was reported by a physician via call center representative and described the occurrence of welts in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Additional patient notes included No difficulty breathing.   On 24-JUL-2023, the patient received Bexsero. On 24-JUL-2023, less than a day after receiving Bexsero, the patient experienced welts (Verbatim: experienced Urticaria/  patient now have welts) and rash (Verbatim: Rash developed). The patient was treated with benadryl (nos) (Benadryl) and prednisone. The outcome of the welts was not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the welts and rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the welts and rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-Jul-2023 The Doctor of Medicine reported that the patient received and experienced urticarial, O2 saturation was good, rash developed, and the patient now (at the recent time) had welts. Patient received Benadryl, oral prednisone but no difficulty breathing. The physician was in a hurry and did not provide any additional details about the adverse events. The physician agrees to follow-up for more information.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 1st dose of Engerix-B administered to the patient was a pediatric dose; 1st dose of Engerix-B administered to the patient was a pediatric dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 70-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12-MAY-2024) for prophylaxis.   On 12-JAN-2023, the patient received the 1st dose of Engerix B pediatric. On 12-JAN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 1st dose of Engerix-B administered to the patient was a pediatric dose) and adult use of a child product (Verbatim: 1st dose of Engerix-B administered to the patient was a pediatric dose). The outcome of the underdose and adult use of a child product 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: 24-JUL-2023 The patient came and received her 3rd dose of Engerix-B and when he looked back at the records. The reporter consented to follow up via postal. The Vaccine Administration Facility was the same as Primary Reporter. The first dose of Engerix-B administered to the patient was a pediatric dose, which led to underdose and adult use of a child product.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose when patient was 5).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 24-JUL-2023 The nurse stated that a patient received her first dose of Havrix when she was five.  The patient is now 19 and the second dose has not yet been given. The nurse enquired how to proceed with the second dose and what dosage should be given. Till the time of reporting, the patient did not receive 2nd dose of Havrix which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Underdose; Engerix-B pediatric dose to adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21-JAN-2024) for prophylaxis.   On 22-JUN-2023, the patient received Engerix B pediatric. On 22-JUN-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Engerix-B pediatric dose to adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 24-Jul-2023 The nurse called to report a pediatric dose of Engerix B was administered to an adult patient which led to underdose and adult use of a child product. The reporter consented to follow up via email.
Age: 0.5
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old female received a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 31-JAN-2023, the patient received Kinrix. On 31-JAN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 6 month old female received a dose of Kinrix). 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: 24-JUL-2023 The reporter was the medical assistant. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal mail. The patient received Kinirix vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received Menveo with an unapproved diluent; patient received Menveo with an unapproved diluent; This non-serious case was reported by a nurse 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 an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received Menveo with an unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: patient received Menveo with an unapproved diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-JUL-2023 The reporter consented to follow up. The patient received Menveo with an unapproved diluent, which led to which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inappropriate age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 42-year-old female patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: inappropriate age). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 25-JUL-2023 It was given in error and was supposed to be administered to a different patient. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.  The patient received Shingrix at inappropriate age, which led to inappropriate age at vaccine administration
Sex: U
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: adult patient was accidentally given a pediatric dose of Engerix-B; adult patient was accidentally given a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   On 24-JUL-2023, the patient received Engerix B pediatric. On 24-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: adult patient was accidentally given a pediatric dose of Engerix-B). The outcome of the accidental underdose and adult use of a child product 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: 25-JUL-2023 They did not have information about the patient nor vaccine but did allow for follow-up, preferably via e-mail. The Vaccine Administration Facility was the same as Primary Reporter. The reporter called to report that an adult patient was accidentally given a pediatric dose of Engerix-B, which led to accidental underdose and adult use of a child product.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late dose/The first dose was administered before the pandemic; This non-serious 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 male patient who received Herpes zoster (Shingrix) (batch number 5954H) for prophylaxis.   Previously administered products included Shingrix (first dose was administered before the pandemic).   On 24-JUL-2023, the patient received the 2nd dose of Shingrix. On 24-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: late dose/The first dose was administered before the pandemic). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter consented to follow up via email. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Havrix instead of Twinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a male patient who received HAV (Havrix) for prophylaxis.   On 25-JUL-2023, the patient received Havrix. On 25-JUL-2023, an unknown time after receiving Havrix, the patient experienced wrong vaccine administered (Verbatim: Havrix instead of Twinrix). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter was a pharmacy technician. The reporter did not consent to follow-up. The reporter called to inform that earlier that day, a patient who wanted to receive Twinrix received only Havrix (due to insurance only paying for HepA and HepB vaccines separately), which led to wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant; Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   On 25-JUL-2023, the patient received Shingrix. On 25-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant) and inappropriate dose of vaccine administered (Verbatim: Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was the medical assistant. The Shingrix vaccine reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUL-2023, the patient received the 1st dose of Shingrix. On 25-JUL-2023, 6 hrs after receiving Shingrix, the patient experienced muscle soreness (Verbatim: muscle soreness). The outcome of the muscle soreness was unknown.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     It was unknown if the company considered the muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was patient. The patient called to asked for advice on how to handle her muscle soreness after administration of Shingrix vaccine. The reporter did not want to provide personal information, so all they were able to gather was her telephone and zip code. The reporter requested to consent the follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the 2nd after 12 months; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received the 2nd after 12 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-JUL-2023 The health care professional (HCP) reported that, if patient received one dose of Shingrix and had not received the 2nd after 12 months, do they need to start the series over? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra Dose of Vaccine; 1st dose received on 6th october 2021 and 2nd dose on 21-october 2022; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 432T3, expiry date 18-AUG-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th October 2021).   On 26-JUL-2023, the patient received the 3rd dose of Shingrix (intramuscular). On 21-OCT-2022, the patient received the 2nd dose of Shingrix. On 21-OCT-2022, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose received on 6th october 2021 and 2nd dose on 21-october 2022). On 26-JUL-2023, the patient experienced extra dose administered (Verbatim: Extra Dose of Vaccine). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was the pharmacy student. The vaccine administration facility was the same as primary reporter. The patient received extra dose of Shingrix vaccine in error, which led to extra dose administered. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received her second dose; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 6 months ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Never received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-JUL-2023 The reporter reported that the patient started her Shingrix vaccine series over 6 months ago. The reporter stated that the patient never received her 2nd dose of Shingrix vaccine. The reporter wanted to know do we had to start over the series. No additional details were available. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Hypospadias, Micropenis
Clinical narrative: Fetal anomalies ( Hypospadias, microphallus, bifid scrotum); fetal anomalies ( Hypospadias, microphallus, bifid scrotum); This literature-non-study case was reported in a literature article and describes the occurrence of HYPOSPADIAS (Fetal anomalies ( Hypospadias, microphallus, bifid scrotum)) and MICROPENIS (fetal anomalies ( Hypospadias, microphallus, bifid scrotum)) in a foetus male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     Concurrent medical conditions included Maternal exposure during pregnancy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOSPADIAS (Fetal anomalies ( Hypospadias, microphallus, bifid scrotum)) (seriousness criteria medically significant and congenital anomaly) and MICROPENIS (fetal anomalies ( Hypospadias, microphallus, bifid scrotum)) (seriousness criteria medically significant and congenital anomaly). At the time of the report, HYPOSPADIAS (Fetal anomalies ( Hypospadias, microphallus, bifid scrotum)) and MICROPENIS (fetal anomalies ( Hypospadias, microphallus, bifid scrotum)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  The patient's mother was having a gestation period of 20 weeks at the time of childbirth and the genetic diagnosis of the patient was confirmed.  No treatment information was reported.  Company Comment: This is a literature non-study case concerning a male foetus patient with no reported medical history, who experienced the serious (due to medically significant and congenital) unexpected, events of Hypospadias and Micropenis, which occurred related to the first dose of mRNA-1273 vaccine. Foetus was diagnosed as having a lethal fetal anomaly (Hypospadias, microphallus, bifid scrotum) and underwent pregnancy termination at 20 weeks. There was a Confirmed genetic diagnosis but no result not provided. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2023-734559 (E2B Linked Report). This case was linked to MOD-2023-734492 (Parent-Child Link).   See case MOD-2023-734492 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Follow up received included: Updated event term, updated patient details and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734559:same report master case