chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Adenoidectomy, Anxiety, Coordination abnormal, Dyscalculia, Dysgraphia
Clinical narrative: After receiving vaccines on 9/8/17, my child began experiencing trouble walking, loss of coordination, and weakening of leg muscles, which were significant enough to cause concern, This issue gradually improved after undergoing an intense holistic detox treatment, which seemed to alleviate the symptoms. In addition to the leg muscle issues, my child developed the following long-term health conditions after receiving a total of 25 vaccines from 8/8/17 through 1/10/23, which began shortly after vaccination: Specific Learning Disorders (diagnosed with Dyslexia, Dysgraphia, and Dyscalculia; Eczema (diagnosed); Anxiety (diagnosed); and Allergies (disgnoased, requiring adenoid removal and ongoing medication). These health conditions have persisted and worsened over time, leading to chronic issues and requiring continuous medication and therapy managment. Treatments Received: Leg Muscle Weakness- underwent an intense holistic detox treatment, which improved walking, loss of coodination, and leg muscle strength; Specific Learning Disorders- ongoing educational interventions and accommodations; Eczema- ongoing topical treatments to manage flare-ups; Anxiety- ongoing therapy and behavioral support; Allergies- adenoid removal surgery and ongoing medication to manage chronic allergy symptoms. Outcome: These adverse events, including the leg muscle weakness and development of ongoing conditions, have permantently impacted my child's health. The leg muscle weakness improved with holistic detox treatment, but the other conditions - Specific Learning Disorders, Eczema, Anxiety, and Allergies - have persisted and require ongoing medical and educational managment. These conditions continue to significantly affect my child's daily life and functioning, and they have required long-term intervention.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Dyslexia, Eczema, Gait disturbance, Hypersensitivity, Learning disorder
Clinical narrative: After receiving vaccines on 9/8/17, my child began experiencing trouble walking, loss of coordination, and weakening of leg muscles, which were significant enough to cause concern, This issue gradually improved after undergoing an intense holistic detox treatment, which seemed to alleviate the symptoms. In addition to the leg muscle issues, my child developed the following long-term health conditions after receiving a total of 25 vaccines from 8/8/17 through 1/10/23, which began shortly after vaccination: Specific Learning Disorders (diagnosed with Dyslexia, Dysgraphia, and Dyscalculia; Eczema (diagnosed); Anxiety (diagnosed); and Allergies (disgnoased, requiring adenoid removal and ongoing medication). These health conditions have persisted and worsened over time, leading to chronic issues and requiring continuous medication and therapy managment. Treatments Received: Leg Muscle Weakness- underwent an intense holistic detox treatment, which improved walking, loss of coodination, and leg muscle strength; Specific Learning Disorders- ongoing educational interventions and accommodations; Eczema- ongoing topical treatments to manage flare-ups; Anxiety- ongoing therapy and behavioral support; Allergies- adenoid removal surgery and ongoing medication to manage chronic allergy symptoms. Outcome: These adverse events, including the leg muscle weakness and development of ongoing conditions, have permantently impacted my child's health. The leg muscle weakness improved with holistic detox treatment, but the other conditions - Specific Learning Disorders, Eczema, Anxiety, and Allergies - have persisted and require ongoing medical and educational managment. These conditions continue to significantly affect my child's daily life and functioning, and they have required long-term intervention.
Age: 4.0
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Muscular weakness
Clinical narrative: After receiving vaccines on 9/8/17, my child began experiencing trouble walking, loss of coordination, and weakening of leg muscles, which were significant enough to cause concern, This issue gradually improved after undergoing an intense holistic detox treatment, which seemed to alleviate the symptoms. In addition to the leg muscle issues, my child developed the following long-term health conditions after receiving a total of 25 vaccines from 8/8/17 through 1/10/23, which began shortly after vaccination: Specific Learning Disorders (diagnosed with Dyslexia, Dysgraphia, and Dyscalculia; Eczema (diagnosed); Anxiety (diagnosed); and Allergies (disgnoased, requiring adenoid removal and ongoing medication). These health conditions have persisted and worsened over time, leading to chronic issues and requiring continuous medication and therapy managment. Treatments Received: Leg Muscle Weakness- underwent an intense holistic detox treatment, which improved walking, loss of coodination, and leg muscle strength; Specific Learning Disorders- ongoing educational interventions and accommodations; Eczema- ongoing topical treatments to manage flare-ups; Anxiety- ongoing therapy and behavioral support; Allergies- adenoid removal surgery and ongoing medication to manage chronic allergy symptoms. Outcome: These adverse events, including the leg muscle weakness and development of ongoing conditions, have permantently impacted my child's health. The leg muscle weakness improved with holistic detox treatment, but the other conditions - Specific Learning Disorders, Eczema, Anxiety, and Allergies - have persisted and require ongoing medical and educational managment. These conditions continue to significantly affect my child's daily life and functioning, and they have required long-term intervention.
Age: 64.0
Sex: M
Vaccine: PNC21
Symptoms: Dizziness, Erythema, Feeling cold, Injection site induration, Injection site mass
Clinical narrative: patient experienced arm pain/dizziness/feeling cold start night of immunization. Patient came in today big red patch traveling down arm and has hard lump by injection site. Also arm is itchy
Age: 64.0
Sex: M
Vaccine: PNC21
Symptoms: Pain in extremity, Pruritus
Clinical narrative: patient experienced arm pain/dizziness/feeling cold start night of immunization. Patient came in today big red patch traveling down arm and has hard lump by injection site. Also arm is itchy
Age: 81.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had previously received the shot in 2022. Patient is not experiencing any side effects.
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Quadracel was given instead of Menactra that he was due for
Age: 11.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Quadracel was given instead of the Menactra he was due for
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong patient received product
Clinical narrative: Patient was miss-identified and received a dose of Shingrix intended for her mother. She has already received 2 doses of Shingrix in prior months
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Cutaneous T-cell lymphoma, Exfoliative rash, Pruritus, Rash
Clinical narrative: Initially, itching over most of body, then red blotches over body, finally scaly rash on lower back
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urticaria
Clinical narrative: Initially, itching over most of body, then red blotches over body, finally scaly rash on lower back
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: unnecessary vaccine given. series previously completed
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pericardial effusion, Pleural effusion
Clinical narrative: Per patient she was very short of breath the next day.  She went to her MD and has been on Lasix ever since.  She believes the vaccine has caused her to retain fluid on her heart and lungs
Age: 82.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: fever for 2 days post injection and redness around injection site.  still some redness 5 days later
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse events reported by patient. called on 3/16/25
Age: 0.33
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Officer for further Immunization plan and will contact mother back with plan on next business day Monday March 17. Mother was called back with this plan via phone Interpreter. No further questions from patients mother.
Age: 85.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received a second dose of an RSV vaccine, first dose was administered in Jan. 2024. Pharmacy corporate team notified the store about the duplication. Pt has been notified, nothing to report to us at this time no issues at all.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: patient stated sore, red, and swollen arm at site of injection
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Death, Intensive care, Resuscitation, Unresponsive to stimuli
Clinical narrative: Infant was found at home unresponsive around 1900 on March 13, 2025, father began CPR and infant was brought to nearest hospital where the infant was then stabilized for transfer to a facility with an available pediatric provider. Infant slowly declined and was no longer responsive to treatments in ICU. Infant was pronounced deceased March 14, 2025 at 0814.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site erythema
Clinical narrative: Crepitus at injection site- popping started to occur with any movement in right arm. This popping was frequent when performing circular cleaning motions with shoulder or any circular motion at the shoulder joint. This popping decreased over a span of 2 years but transitioned to pain in the shoulder joint. Popping still presently happening in shoulder in 2025
Age: 15.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Patient experienced a seizure approximately 2-3 minutes following receiving vaccines while I was attempted to place a tuberculin skin test. I did not inject the tuberculin because he started to seize. Patient had a first time witnessed seizure lasting 10-15 seconds. Seizure was tonic clonic. He did not experience any post-ictal symptoms. Patient's vitals were normal following seizure. He reported that he felt normal following seizure. EMS was called and patient was transferred to the emergency department for evaluation.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody, C-reactive protein increased, Full blood count normal, Metabolic function test normal, Urticaria
Clinical narrative: rash; pain all over; Hives; swollen joints/ right ankle joint was extremely swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date in September 2024 and had mild common systems as far as pain and redness at the injection site, for tolerance of 1st dose refer case US2025022951).   On 28-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 28-JAN-2025, immediately after receiving Shingrix, the patient experienced rash (Verbatim: rash), general body pain (Verbatim: pain all over), hives (Verbatim: Hives) and swollen joints (Verbatim: swollen joints/ right ankle joint was extremely swollen). The patient was treated with antibiotics. The outcome of the rash, general body pain, hives and swollen joints were not resolved.   The reporter considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   The company considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   Linked case(s) involving the same patient:  US2025022951   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient was the reporter. The patient received the 2nd dose of Shingrix on 28th January 2025 and almost immediately started having rash, pain all over and hives. A little longer afterwards reporter reported swollen joints, right ankle joint was extremely swollen. Reporter had been to a few doctors including her dermatologist, Local healthcare professional. Reporter was placed on steroids and was given antibiotic injection today on 24th February 2025. at the healthcare professional office. Reporter asked a couple of her adverse event report be emailed to her.; Sender's Comments:  US-GSK-US2025022951:SAME PATIENT
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Antinuclear antibody positive, Arthralgia, Biopsy skin, Blood test, Chills
Clinical narrative: rash; pain all over; Hives; swollen joints/ right ankle joint was extremely swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date in September 2024 and had mild common systems as far as pain and redness at the injection site, for tolerance of 1st dose refer case US2025022951).   On 28-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 28-JAN-2025, immediately after receiving Shingrix, the patient experienced rash (Verbatim: rash), general body pain (Verbatim: pain all over), hives (Verbatim: Hives) and swollen joints (Verbatim: swollen joints/ right ankle joint was extremely swollen). The patient was treated with antibiotics. The outcome of the rash, general body pain, hives and swollen joints were not resolved.   The reporter considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   The company considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   Linked case(s) involving the same patient:  US2025022951   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient was the reporter. The patient received the 2nd dose of Shingrix on 28th January 2025 and almost immediately started having rash, pain all over and hives. A little longer afterwards reporter reported swollen joints, right ankle joint was extremely swollen. Reporter had been to a few doctors including her dermatologist, Local healthcare professional. Reporter was placed on steroids and was given antibiotic injection today on 24th February 2025. at the healthcare professional office. Reporter asked a couple of her adverse event report be emailed to her.; Sender's Comments:  US-GSK-US2025022951:SAME PATIENT
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling, Ultrasound Doppler
Clinical narrative: rash; pain all over; Hives; swollen joints/ right ankle joint was extremely swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date in September 2024 and had mild common systems as far as pain and redness at the injection site, for tolerance of 1st dose refer case US2025022951).   On 28-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 28-JAN-2025, immediately after receiving Shingrix, the patient experienced rash (Verbatim: rash), general body pain (Verbatim: pain all over), hives (Verbatim: Hives) and swollen joints (Verbatim: swollen joints/ right ankle joint was extremely swollen). The patient was treated with antibiotics. The outcome of the rash, general body pain, hives and swollen joints were not resolved.   The reporter considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   The company considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   Linked case(s) involving the same patient:  US2025022951   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient was the reporter. The patient received the 2nd dose of Shingrix on 28th January 2025 and almost immediately started having rash, pain all over and hives. A little longer afterwards reporter reported swollen joints, right ankle joint was extremely swollen. Reporter had been to a few doctors including her dermatologist, Local healthcare professional. Reporter was placed on steroids and was given antibiotic injection today on 24th February 2025. at the healthcare professional office. Reporter asked a couple of her adverse event report be emailed to her.; Sender's Comments:  US-GSK-US2025022951:SAME PATIENT
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Joint swelling, Pain, Rash, Urticaria
Clinical narrative: rash; pain all over; Hives; swollen joints/ right ankle joint was extremely swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on an unknown date in September 2024 and had mild common systems as far as pain and redness at the injection site, for tolerance of 1st dose refer case US2025022951).   On 28-JAN-2025, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 28-JAN-2025, immediately after receiving Shingrix, the patient experienced rash (Verbatim: rash), general body pain (Verbatim: pain all over), hives (Verbatim: Hives) and swollen joints (Verbatim: swollen joints/ right ankle joint was extremely swollen). The patient was treated with antibiotics. The outcome of the rash, general body pain, hives and swollen joints were not resolved.   The reporter considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   The company considered the rash, general body pain, hives and swollen joints to be unrelated to Shingrix.   Linked case(s) involving the same patient:  US2025022951   Additional Information: GSK Receipt Date: 24-FEB-2025 The patient was the reporter. The patient received the 2nd dose of Shingrix on 28th January 2025 and almost immediately started having rash, pain all over and hives. A little longer afterwards reporter reported swollen joints, right ankle joint was extremely swollen. Reporter had been to a few doctors including her dermatologist, Local healthcare professional. Reporter was placed on steroids and was given antibiotic injection today on 24th February 2025. at the healthcare professional office. Reporter asked a couple of her adverse event report be emailed to her.; Sender's Comments:  US-GSK-US2025022951:SAME PATIENT
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, X-ray limb
Clinical narrative: Severe pain beginning the next day (9/13/2024) and continuing to present. Limited mobility especially in raising arm overhead. Pain with sitting if elbow not supported. I saw my orthopedist on 10/29/2024 and was given an injection for pain. We discussed the possibility of SIRVA as there had been no trauma or pain in my LEFT shoulder until receiving this vaccine. I shared with my doctor that I felt like the vaccine was placed too high when I was given it. Symptoms improved for a couple of months and then returned severely around the end of January 2025. Returned to the orthopedist for follow up care and was sent for imaging. Followed up with Orthopedic PA shoulder specialist and surgery was recommended.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Magnetic resonance imaging abnormal, Mobility decreased, Pain, Tendon disorder
Clinical narrative: Severe pain beginning the next day (9/13/2024) and continuing to present. Limited mobility especially in raising arm overhead. Pain with sitting if elbow not supported. I saw my orthopedist on 10/29/2024 and was given an injection for pain. We discussed the possibility of SIRVA as there had been no trauma or pain in my LEFT shoulder until receiving this vaccine. I shared with my doctor that I felt like the vaccine was placed too high when I was given it. Symptoms improved for a couple of months and then returned severely around the end of January 2025. Returned to the orthopedist for follow up care and was sent for imaging. Followed up with Orthopedic PA shoulder specialist and surgery was recommended.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tendon rupture
Clinical narrative: Severe pain beginning the next day (9/13/2024) and continuing to present. Limited mobility especially in raising arm overhead. Pain with sitting if elbow not supported. I saw my orthopedist on 10/29/2024 and was given an injection for pain. We discussed the possibility of SIRVA as there had been no trauma or pain in my LEFT shoulder until receiving this vaccine. I shared with my doctor that I felt like the vaccine was placed too high when I was given it. Symptoms improved for a couple of months and then returned severely around the end of January 2025. Returned to the orthopedist for follow up care and was sent for imaging. Followed up with Orthopedic PA shoulder specialist and surgery was recommended.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: a pregnant female patient that received first 2 doses of a 3 dose series of Gardasil 9 while pregnant. The patient did not know she was pregnant a; This spontaneous report was received from a nurse Practitioner referring to an early 30s female patient.   The patient's medical history included History of abnormal paps. The patient's concurrent conditions, Concomitant therapies, and drug reactions/allergies were not reported.   On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 1, (indication, expiration date, and lot # were not reported).  On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose number 2, (indication, expiration date, and lot # were not reported). The patient was pregnant while receiving the first 2 doses of a 3-dose series of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (Vaccine exposure during pregnancy). The patient did not know she was pregnant at the time. The outcome of the event was unknown.  The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as drug withdrawn.
Sex: F
Vaccine: VARZOS
Symptoms: Limb mass, Pain
Clinical narrative: the lump from the second shot was as big as an egg/lump in arm; painful; This non-serious case was reported by a consumer and described the occurrence of local swelling in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (recived 1st dose on 30-OCT-2024). Concurrent medical conditions included diabetes. Concomitant products included tirzepatide (Mounjaro) and empagliflozin (Jardiance).   On 06-FEB-2025, the patient received the 2nd dose of Shingles vaccine. On 06-FEB-2025, less than a day after receiving Shingles vaccine, the patient experienced local swelling (Verbatim: the lump from the second shot was as big as an egg/lump in arm) and pain (Verbatim: painful). The outcome of the local swelling was resolving and the outcome of the pain was not reported.   It was unknown if the reporter considered the local swelling and pain to be related to Shingles vaccine.     It was unknown if the company considered the local swelling and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2025 The patient reported that she had recived 2nd dose of Shingrix vaccine and experienced lump in arm. The reporter mentioned that lump from the second shot was as big as an egg and very painful. It was a smaller now, but it was lasted a month. The expiry date of Shingles vaccine was unknown.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis.   On 07-MAR-2025, the patient received Kinrix (intramuscular) .5 ml. On 07-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 07-MAR-2025 The reporter stated that she vaccinated an 11-year-old with a dose of Kinrix ,which led to inappropriate age at vaccine administration. No further information was provided/obtained.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue
Clinical narrative: had diarrhea, an upset stomach, and just feeling tired out; This non-serious case was reported by a consumer and described the occurrence of diarrhea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-MAR-2025, the patient received Shingrix (intramuscular) .5 ml. In MAR-2025, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: had diarrhea, an upset stomach, and just feeling tired out). The outcome of the diarrhea was not reported.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     It was unknown if the company considered the diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2025 The patient reported that after getting the shot yesterday, they have had diarrhea, an upset stomach, and just feeling tired out.  No further information provided.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Getting the shingles vaccines didn't help at all.; 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: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Getting the shingles vaccines didn't help at all.). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2025 This case was reported by a patient via interactive digital media. The reporter reported that, getting the shingles vaccines did not help at all. 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.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got the vaccine and still got them but a milder case; 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: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got the vaccine and still got them but a milder case). The outcome of the vaccination failure was not reported 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.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and still got them but a milder case that didn't surface on the skin and remained interior.  The physician told the patient that it happens and still felt them sometimes after 9 months ago This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine. Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: administred 4th dose of Pediarix; 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 4-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 34MF9, expiry date 13-FEB-2026) for prophylaxis.   Previously administered products included Pediarix (At 2 months of age: 1st Pediarix dose), Pediarix (At 4 months of age: 2nd Pediarix dose) and Pediarix (At 6 months of age: 3rd Pediarix dose).   On 27-SEP-2024, the patient received the 4th dose of Pediarix. On 27-SEP-2024, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: administred 4th dose of Pediarix). The outcome of the extra dose administered was not applicable.   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: 27-FEB-2025 The reporter reported that a 4 years old male patient received the vaccines fourth dose of Pediarix which led to Extra dose administered. At 4 years of age also received first Kinrix dose on 25 Feb 2025 with lot number 34MF9, expiry date 13 Feb 2026.
Sex: F
Vaccine: DTAP
Symptoms: Underdose, Wrong product administered
Clinical narrative: Infanrix dose administered to an adult instead of Boostrix; patient that received a dose of Infanrix instead of Boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old female patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 05-MAR-2025, the patient received Infanrix. On an unknown date, the patient received Boostrix. On 05-MAR-2025, immediately after receiving Infanrix and not applicable after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix dose administered to an adult instead of Boostrix) and adult use of a child product (Verbatim: patient that received a dose of Infanrix instead of Boostrix). The outcome of the wrong vaccine administered and adult use of a child product were not applicable.   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: 06-MAR-2025 Pharmacist called on behalf of a medical assistant to ask if a patient that received a dose of Infanrix instead of Boostrix could receive the latter, which led to wrong vaccine administered and adult use of a child product. The reporter consented to follow up.
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Arm swollen after 1st dose of Shingles vaccine; Arm red after 1st dose of Shingles vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: Arm swollen after 1st dose of Shingles vaccine) and erythema of extremities (Verbatim: Arm red after 1st dose of Shingles vaccine). The outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.     It was unknown if the company considered the swelling arm and erythema of extremities to be related to Shingrix.   Additional Information: GSK receipt date: 06-MAR-2025 the reporter asked if she should get the 2nd dose of shingles vaccine or not.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administration of Havrix expired dose 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 2YS34, expiry date 02-MAR-2025) for prophylaxis.   On 05-MAR-2025, the patient received Havrix. On 05-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administration of Havrix expired dose to a patient). The outcome of the expired vaccine used was not applicable.   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: 07-MAR-2025 The medical assistant reported the administration of Havrix expired dose to a patient, which led to an expired vaccine used. The HCP (health care professional) requested guidance on this situation.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 15 months old male patient received a dose of Boostrix.; 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 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number XN575, expiry date 22-MAR-2027) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 15 months old male patient received a dose of Boostrix.). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 07-MAR-2025 A nurse practitioner called to report that a 15 months old patient received by error Boostrix, which led to an inappropriate age at vaccine administration. The reporter wanted to know if there was anything to be concerned of.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received HAV (Havrix) (batch number 24534, expiry date 02-MAR-2025) for prophylaxis.   On 07-MAR-2025, the patient received Havrix. On 07-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was not applicable.   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: 10-MAR-2025 RN (registered nurse) reported the administration of an expired dose of Havrix to a patient, which led to an expired vaccine used.
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered the Engerix-B adult dose to a 13 years old patient by accident; administered the Engerix-B adult dose to a 13 years old patient by accident; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 13-year-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: administered the Engerix-B adult dose to a 13 years old patient by accident) and adult product administered to child (Verbatim: administered the Engerix-B adult dose to a 13 years old patient by accident). The outcome of the accidental overdose and adult product administered to child were not applicable.   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:10-MAR-2025 The reporter reported that one of his/her providers administered the Engerix-B adult dose to a 13 years old patient by accident (6 months ago) and asked if there were there any adverse effects or concerned for the child, which led to accidental overdose and adult product administered to child. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received an extra dose today; 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 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a complete schedule on an unknown date).   On 11-MAR-2025, the patient received the 3rd dose of Shingrix. On 11-MAR-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received an extra dose today). The outcome of the extra dose administered was not applicable.   Additional Information: GSK Receipt Date: 11-MAR-2025 The medical assistant called to report a patient that received a complete schedule for Shingrix and received an extra dose today (on the day of reporting), which led to an extra dose administered. Medical assistant wanted guidance on this topic. No vaccine detail (lot number and expiration date) nor patient demographics were provided from the medical assistant's end. No further information was obtained or provided from the medical assistant's end in this call.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient can take the second dose approximately 13 months after the first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 98-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in March 2024).   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: patient can take the second dose approximately 13 months after the first dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 11-MAR-2025 Registered nurse wanted to know if a 98-year-old patient can take the second dose approximately 13 months after the first dose or if she had to restart the administration scheme. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: intramuscular administration of Priorix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 67-year-old female patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 08-MAR-2025, the patient received Priorix (intramuscular). On 08-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-MAR-2025 The reporter reported that the intramuscular administration of Priorix to patient , which led to subcutaneous injection formulation administered by other route. This was 1 of 3 linked cases , reported by the same reporter. ; Sender's Comments:  US-GSK-US2025029891:Same reporter/Different patient US-GSK-US2025029889:Same reporter/Different patient
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: Developed dermatographia 2 weeks later; This spontaneous case was reported by a patient and describes the occurrence of MECHANICAL URTICARIA (Developed dermatographia 2 weeks later) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 14-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MECHANICAL URTICARIA (Developed dermatographia 2 weeks later). At the time of the report, MECHANICAL URTICARIA (Developed dermatographia 2 weeks later) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no risk factor.   No concomitant medication was reported.  It was reported that post Moderna Covid booster vaccination patient was developed symptom of dermatographia 2 weeks later.   She was experienced whole body intense itchy, and patent was reported that when she scratches the red marks appeared and then disappeared approximately 30 minutes later.   It was reported that the patient can write words on the skin that used to disappear.   This symptom was lasted for about 1.5-2 years for patient.   It had gotten better over time for patient but still the symptom showed the red marks when she scratched the skin.   The patient did not experience any additional symptoms/events.   There were no lab data/results available.  No treatment medication was reported.  Reporter causality was not reported.
Age: 46.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: administration of expired typhim VI vaccine with no reported adverse event; Initial information received on 11-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves 46 years old female patient who received expired typhoid VI polysaccharide vaccine  [typhim VI] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Mar-2025, the patient received an expired unknown dose of suspect typhoid VI polysaccharide vaccine, Solution for injection (lot W1A441M  and expiry date: 07-Mar-2025) (Frequency: once and strength: standard) via intramuscular route in the left deltoid for immunization with no reported adverse event (expired product administered) (Latency: same day).  Reportedly, Patient tried to contact the HCP  (health care professional) who gave the vaccine to confirm if it was a typographical error, but they haven't responded to her. She wanted to know if the expiration date is correct based on the lot number. She refused to provide address. MIS (Management Information System) advised to contact healthcare provider to confirm the information. Patient advised that she needs the information (with regards to the expiration date) urgently as she will be travelling, and that the HCP cannot be reached.  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.