chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: Shingles). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-APR-2025 This case was reported by a patient via interactive digital media. The patient had vaccine and still got shingles. The patient was so done with the vaccine. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the 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, Immediate post-injection reaction
Clinical narrative: after the second shot I immediately contracted shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a 61-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: after the second shot I immediately contracted shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 22-APR-2025 The patient had both shingles shots and after the second shot immediately contracted shingles internally. The patient would not get another shot and hope did not get them again.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23-APR-2025, the patient received the 2nd dose of Shingles vaccine. On 23-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm a little sore). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient got the second shot and arm was little sore, there was no other problem.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; received the shingle shot and still got 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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: received the shingle shot and still got shingles). 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 to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-APR-2025 This case was reported via interactive digital media. The people who received the shingle shot, still got the shingles. The people were playing with their immune system. 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: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: The shot does hurt; 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.   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: The shot does hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 23-APR-2025 This case was reported by a patient via interactive digital media. Reporter reported that the shot did hurt.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Engerix-B administration in a pregnant woman; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received HBV (Engerix B adult) (batch number T5D73, expiry date 10-APR-2027) for prophylaxis.   On 19-FEB-2025, the patient received the 1st dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced vaccine exposure during pregnancy (Verbatim: Engerix-B administration in a pregnant woman). The outcome of the vaccine exposure during pregnancy was not applicable.   Pregnancy exposure: Pregnancy Exposure (Engerix B adult): To mother in second trimester Pregnancy Outcome: Pregnancy was ongoing   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-APR-2025, 23-APR-2025 Nurse wanted to know if it was okay to administer a second dose of Engerix-B to a 20-years-old pregnant patient and what would be the administration schedule for someone with that age.  Also, mentioned that she received the first dose being already pregnant with 14 weeks and 5 days on 19-FEB-2025, which led to vaccine exposure during pregnancy.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received only the adjuvant portion of Shingrix; received only the adjuvant portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number J32PB, expiry date 31-MAR-2027) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 22-APR-2025 On 22 April 2025, a medical supervisor called to report that they accidentally administered only the adjuvant portion of Shingrix to a female patient. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter enquired if we had any safety recommendations.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: A 13 years old female patient received an expired dose of Engerix-B; 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 13-year-old female patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis.   On 22-APR-2025, the patient received Engerix B. On 22-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: A 13 years old female patient received an expired dose of Engerix-B). 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: 23-APR-2025 The medical assistant report that a patient received an expired dose of Engerix-B which led to, expired vaccine used. The reporter had a questioned did they need to revaccinate the patient.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Maladministration of Shingrix after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number 47N3Y, expiry date 20-MAR-2027) for prophylaxis.   On 22-APR-2025, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Maladministration of Shingrix after a temperature excursion). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 24-APR-2025 The Shingrix was exposed to -8C for 6 hours on 22nd April 2025. After this temperature excursion, Shingrix was administered to a patient, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidental administration of Boostrix instead of Infanrix; accidental administration of Boostrix; accidental administration of Boostrix to 2 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number l5229, expiry date 19-APR-2027) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   Previously administered products included Dtap vaccine  (received 3 doses of Dtap series on an unknown date).   On 24-APR-2025, the patient received Boostrix. On an unknown date, the patient received Infanrix. On 24-APR-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: accidental administration of Boostrix instead of Infanrix), accidental underdose (Verbatim: accidental administration of Boostrix) and inappropriate age at vaccine administration (Verbatim: accidental administration of Boostrix to 2 year old). The outcome of the wrong vaccine administered, accidental underdose and inappropriate age at vaccine administration 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: 24-APR-2025 A registered nurse called in to request data about the accidental administration of Boostrix instead of Infanrix as the fourth dose in the Dtap series for a patient, which led to wrong vaccine administered, accidental underdose and inappropriate age at vaccine administration. First the requested safety data and then they requested recommendations.  The vaccine administration facility was the same as primary reporter.
Age: 110.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 year-old female patient that on 4/17/2025 received 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 10-year-old female patient who received DTPa-IPV (Kinrix) (batch number 34mf9, expiry date 13-FEB-2026) for prophylaxis.   Concomitant products included Proquad and Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 17-APR-2025, the patient received Kinrix. On 17-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 year-old female patient that on 4/17/2025 received Kinrix). 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: 25-APR-2025 Medical Assistant had a 10 year-old patient that received Kinrix , which led to inappropriate age at vaccine administration. The patient also received Proquad and Engerix-B. There was no vaccination records. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Maladministration of pediatric dose on adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a adult patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced adult use of a child product (Verbatim: Maladministration of pediatric dose on adult patient) and accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient). The outcome of the adult use of a child product and accidental underdose 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: 25-APR-2025 The vaccine service center transfers a pharmacy technician that calls to asked about dosage/schedule for ten adult's patients that were maladministered with pediatric doses of the Havrix vaccine. The reporter reported that the adult patient received pediatric dose which led to, adult use of a child product and accidental underdose.  The reporter had a questioned was there any guidance/advice on this situation or no vaccination date, vaccine detail or patient demographics detail was provided from the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose of Twinrix was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received HAB (Twinrix) (batch number P2443, expiry date 18-SEP-2027) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose on 12-JUL-2024).   On 25-APR-2025, the patient received the 2nd dose of Twinrix. On 25-APR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: late second dose of Twinrix was administered). The outcome of the drug dose administration interval too long 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: 25-APR-2025 Pharmacist reported that a late second dose of Twinrix was administered to a patient.  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Vaccine: RSV
Symptoms: Needle issue
Clinical narrative: The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off; The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE ISSUE (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "The Act-o-vial, they had a problem with it being really hard to push down; The needle also separate from that; Needle breaking off".  Causality for "the act-o-vial, they had a problem with it being really hard to push down; the needle also separate from that; needle breaking off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 13.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was given on 4/17/25, but medication expired on 4/7/25. Member/guardian was informed of expired vaccine administration. No adverse reactions were reported. Member will be re-vaccinated with new vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Burning sensation, Influenza like illness, Malaise, Paraesthesia
Clinical narrative: On evening of vaccination, started to feel very sick with strong joint pain. This felt like a very strong case of the flu; it persisted for 2 days. Since receiving the shot, I also feel a painful tingle around half of my left ankle (where the foot folds toward the lower leg; not on the heel side). It's a disagreeable, localized, but not very strong pain, best described as a burning or needling, that is most pronounced at bedtime and in the morning when I get up. There is no rash associated with it. The skin is not dry or otherwise impacted. I do not use any ointment or lidocain cream on the area, as pain is bearable and does not prevent me from falling asleep.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Muscle oedema, Skin warm
Clinical narrative: Erythema, edema and increased warmth in right deltoid area.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Arthralgia, Balance disorder, Inflammation, Lymphadenopathy, Musculoskeletal discomfort
Clinical narrative: Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; then last night her neck was bothering her even more, then she noticed her glands were swollen and her lower jaw was feeling "sensitive".; She also mentioned having a "dot" on her neck that looks like a "bug bite" in the area of her swollen glands on her skin.; She also mentioned having achey joints in her fingers.; This spontaneous report was received from a consumer and refers to herself, a 61-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included type I diabetes. She did not have a spleen and was sensitive to SULFA drugs, mold and cat dander. Concomitant medications included long and short term insulin, and two hormone replacement medications: estrogen and progesterone .  On 02-Apr-2025 at 02:00 PM, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #, expiration date, route of administration, exact dose and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. On an unspecified date, she was also vaccinated with shingrix.  On 02-Apr-2025 (on the day of the shot), the patient's neck felt tight, then last night her neck was bothering her even more, then she noticed her glands were swollen and her lower jaw was feeling sensitive (lymphadenopathy). On an unspecified date in April 2025, she also mentioned having a dot on her neck that looks like a bug bite in the area of her swollen glands on her skin (skin lesion). She also mentioned having achy joints in her fingers (arthralgia). On an unspecified date, she also mentioned having inflammation from the shingrix vaccine, affecting her balance (inflammation; balance disorder). No additional adverse event (AE) or product quality complaint (PQC) was reported. The outcome of the adverse events was reported as not recovered.  The causal relationship between the adverse events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported. The causal relationship between the adverse events and Shingrix was not reported, with the exception of inflammation for which it was considered related.  Lot # is being requested and will be submitted if received.
Age: 61.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Skin discolouration
Clinical narrative: Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; Caller also mentioned having inflammation from the SHINGRIX vaccine, affecting her balance.; then last night her neck was bothering her even more, then she noticed her glands were swollen and her lower jaw was feeling "sensitive".; She also mentioned having a "dot" on her neck that looks like a "bug bite" in the area of her swollen glands on her skin.; She also mentioned having achey joints in her fingers.; This spontaneous report was received from a consumer and refers to herself, a 61-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions included type I diabetes. She did not have a spleen and was sensitive to SULFA drugs, mold and cat dander. Concomitant medications included long and short term insulin, and two hormone replacement medications: estrogen and progesterone .  On 02-Apr-2025 at 02:00 PM, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot #, expiration date, route of administration, exact dose and vaccination site were not reported) administered for prophylaxis. The vaccine was reconstituted with sterile diluent, solution for injection. On an unspecified date, she was also vaccinated with shingrix.  On 02-Apr-2025 (on the day of the shot), the patient's neck felt tight, then last night her neck was bothering her even more, then she noticed her glands were swollen and her lower jaw was feeling sensitive (lymphadenopathy). On an unspecified date in April 2025, she also mentioned having a dot on her neck that looks like a bug bite in the area of her swollen glands on her skin (skin lesion). She also mentioned having achy joints in her fingers (arthralgia). On an unspecified date, she also mentioned having inflammation from the shingrix vaccine, affecting her balance (inflammation; balance disorder). No additional adverse event (AE) or product quality complaint (PQC) was reported. The outcome of the adverse events was reported as not recovered.  The causal relationship between the adverse events and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was not reported. The causal relationship between the adverse events and Shingrix was not reported, with the exception of inflammation for which it was considered related.  Lot # is being requested and will be submitted if received.
Age: 17.0
Sex: F
Vaccine: HPV9, HPV9, HPV9, HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects were reported; the second extra dose (dose number 5) was on 3/4/2025; The first extra dose (dose number 4) was on 6/2/2023; This spontaneous report was received from a nurse concerning a 20-year-old female patient.   The patient's medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported.   On an unspecified date in approximately 2020, when she was 17-year-old, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) dose number 1, 1 dosage form (route of administration, anatomical location, lot # and expiration date were not reported). On unspecified dates, she received the doses 2 and 3 of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form each (route of administration, anatomical location, lot # and expiration date were not reported), completing the vaccination series. Then, on 06-Feb-2023, the patient was administered a 4th dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 1 dosage form (route of administration, anatomical location, lot # and expiration date were not reported) (extra dose administered). Additionally, on 04-Mar-2025, the patient received another dose of Human Papillomavirus 9-valent Vaccine, Recombinant, lot #Y018398, expiration date: 04-Nov-2026, dose number 5, 0.5 mL administered by a health professional (route of administration and anatomical location were not reported) (extra dose administered). All vaccine doses were administered as prophylaxis.  It was also reported that patient did not recall her administration history, when she consented to the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) series again on 06-Feb-2023. No adverse effects were reported (no adverse event.)  Additional lot #s are being requested and will be submitted if received.
Sex: F
Vaccine: HPV9
Symptoms: Lymphadenopathy
Clinical narrative: patient complained of enlarged lymph node after receiving GARDASIL 9.; This spontaneous report was received from a/an Consumer or other non health professional (Field-Based Employee [FBE]) and refers to a female patient of unknown age.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Suspension for injection (exact dose, dose number, anatomical location, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unspecified day in January 2025 (reported as about 3 months ago), the patient experienced enlarged lymph node after receiving suspect vaccine. At the reporting time, the outcome of enlarged lymph node was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) regarding the event was assessed as not applicable.   The causal relationship between the event of enlarged lymph node and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Arthralgia, Lymphadenopathy
Clinical narrative: Nurse reported the day after the last dose experiencing pain in her right clavicle; Nurse reported the day after the last dose experienced enlarged lymph nodes; This spontaneous report was received from a nurse and refers to herself, a female patient of an unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient was vaccinated with the first, second and third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) administered for prophylaxis (strength, exact quantity volume, lot #, expiration date, route and anatomical site of administration were not reported).  On an unknown date, the day after the last dose, the patient experiencing pain in her right clavicle (Pain) and enlarged lymph nodes. The patient also reported that her daughter also received this vaccine and did not experience any symptoms. At the reporting time, the patient recovered from the events.   The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant was not provided.
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE.; third dose of  ROTATEQ past the recommended age.; This spontaneous report was received from a health care professional referring to a 9-months-old patient, gender not reported.  Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On 29-APR-2025, at the age of 9 months, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent Oral solution (ROTATEQ) liquid, (valid lot number 2091232, with an expiration date on 17-APR-2026) administered orally for prophylaxis. (Product administered to patient of inappropriate age).
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: sores on body; sores that itch; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin ulcer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced skin ulcer (Verbatim: sores on body) and pruritus (Verbatim: sores that itch). The outcome of the skin ulcer and pruritus were not resolved.   It was unknown if the reporter considered the skin ulcer and pruritus to be related to Shingrix.     It was unknown if the company considered the skin ulcer and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-APR-2025 The case was self reported by patient. She was vaccinated with her first dose of Shingrix a few weeks back and about a week after vaccination she has sores on her body and the sores are itchy.   The sores are located on her legs and her back near her neck.   The consumer declined to provide any demographic information or information pertaining to vaccination.   No further information was provided/obtained.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pain and redness at injection site that is still worsening after two days; Pain and redness at injection site that is still worsening after two days; This non-serious case was reported by a consumer and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypothyroidism and blood cholesterol increased. Concomitant products included atorvastatin calcium (Atorvastatin) and levothyroxine sodium (Levothyroxine).   On 25-APR-2025, the patient received Shingrix .5 ml. On 25-APR-2025, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: Pain and redness at injection site that is still worsening after two days) and injection site pain (Verbatim: Pain and redness at injection site that is still worsening after two days). The outcome of the injection site erythema and injection site pain were not resolved.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site erythema and injection site pain to be related to Shingrix.   Additional Information: GSK receipt date: 27-APR-2025 The patient experienced pain and redness at injection site that was still worsening after two days. These symptoms were not treated.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; a bout of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: a bout of shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-APR-2025 The reporter states that she saw that female patient had received the Shingrix vaccine and subsequently experienced a bout of shingles.  The reporter does not know any further information about the patient or the event.  The reporter had no further information on this report. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This case was linked with US2025AMR051346, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingrix US-GSK-US2025AMR051346:Same reportr/Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: experienced arm soreness after his first dose of SHINGRIX; This non-serious case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 71-year-old male 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 pain in arm (Verbatim: experienced arm soreness after his first dose of SHINGRIX). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-APR-2025 The nurse reported that a patient experienced arm soreness after his first dose of Shingrix.; Sender's Comments:  US-GSK-US2025051113:SAME REPORTER US-GSK-US2025051111:SAME REPORTER
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: soreness on her left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included hydrochlorothiazide.   On 24-JAN-2025, the patient received the 1st dose of Shingrix. On 25-JAN-2025, 1 days after receiving Shingrix, the patient experienced pain in arm (Verbatim: soreness on her left arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 28-APR-2025 The patient reported that she experiencing soreness on her left arm after receiving the first dose of Shingrix vaccine. The batch number and expiry date was unknown.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Sleep disorder, Vaccination failure
Clinical narrative: Suspected vaccination failure; got a small episode of Shingles; I could not sleep; 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got a small episode of Shingles) and difficulty sleeping (Verbatim: I could not sleep). The outcome of the vaccination failure, shingles and difficulty sleeping were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and difficulty sleeping to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and difficulty sleeping to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-APR-2025 This case was reported by a patient via interactive digital media. Patient stated that he/she got the vaccine. Then several years after patient got the vaccine, got a small episode of Shingles. Patient indicated that it was painful and he/she could not sleep. Also stated it would have been horrible if he/she had not been vaccinated. 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: 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 vaccine Shingles vaccine. US-GSK-US2025AMR016049:same patient differen suspect
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 21-APR-2025 The reporter stated that she saw that two women had received the Shingrix vaccine and subsequently experienced a bout of shingles. The reporter does not know any further information about the patients or the events. Reporter had no further information on this report. 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. This case is linked with US2025051090 reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about  completion of primary vaccination schedule,  time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix. US-GSK-US2025051090:Same reportr/Different patient
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shingles vaccine Does hurt; 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.   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: Shingles vaccine Does hurt ). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-APR-2025 This case was reported by a patient via interactive digital media. The Shingles vaccine did hurt but having Shingles vaccine hurts worse than running through a under a wire fence.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: made me sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: made me sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK receipt date: 28-APR-2025 This case was reported by a consumer via interactive digital media. The reporter reported that after a Shingrix vaccination patient experienced sickness.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had a shingles shot 5 years ago do i need to restart again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received Shingles shot 5 years ago on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: had a shingles shot 5 years ago do i need to restart again). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 27-APR-2025 This case was reported by a patient via (Shingrix Chatbot) interactive digital media. Consumer reported that he/she had a Shingles shot 5 years ago and want to ask do he/she need to restart again. Till the time of reporting, the patient did not receive 2nd dose of Shingles shot, which led to an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: My mom got shingles each time she got the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: My mom got shingles each time she got the vaccine). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2021AMR184987   Additional Information: GSK Receipt Date : 24-APR-2025 The patient got shingles each time she got the vaccine which tells me not to get the vaccine.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR184987:same reporter, case created  for 1st dose
Sex: F
Vaccine: MNQ
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received any other doses since; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received a first dose on 20-JUL-2021, lot no AMXA517A).   On an unknown date, the patient did not receive the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incomplete course of vaccination (Verbatim: hasn't received any other doses since). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 23-APR-2025 The pharmacist reported that a patient received a first dose of Menveo 4 years ago and hasn't received any other doses since. The pharmacist mentioned patient required now to complete the Menveo schedule due to a soliris infusion. Till the time of reporting, the patient did not receive 2nd dose of Menveo, which led to incomplete course of vaccination.
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Maladministration of pediatric dose on adult patient; Adult use of child product; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: Maladministration of pediatric dose on adult patient) and adult use of a child product (Verbatim: Adult use of child product). The outcome of the accidental underdose 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: 25-APR-2025 The vaccine service center transferred a pharmacy technician who called to ask about the dosage/schedule for ten adult patients who were maladministered pediatric doses of the Havrix vaccine. The reporter stated that the adult patients had received pediatric doses, which led to the adult use of a child product and accidental underdose. The reporter asked if there was any guidance/advice on this situation, but no vaccination date, vaccine details, or patient demographic details were provided by the pharmacy technician. No further information was provided. This was 1 of 10 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2025050560:same reporter/different patient US-GSK-US2025050566:same reporter/different patient US-GSK-US2025050558:same reporter/different patient US-GSK-US2025050556:same reporter/different patient