chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL, MMR, PNC15, VARCEL
Symptoms: Pallor, Rash, Vomiting
Clinical narrative: On May 28th 2025, my infant   was scheduled to receive a vaccines at office. We arrived at 1:50 PM for the appointment. The vaccines were administered at 2:40 PM by clinic staff. At the time of the incident, three vaccines were administered during the  visit. Two of those vaccines  Varicella and Pneumococcal Conjugate been given previously to my baby without any prior reactions.This was the first time the third vaccine MMR had been administered and Shortly after the injection with in minutes, my child began to show signs of a severe allergic reaction.  At 2:47 PM, my baby started vomiting, became lethargic, and developed nasal congestion. I immediately informed the clinic staff of these symptoms. Despite the urgency of the situation and visible distress, no emergency action was taken by the clinic. No epinephrine was administered, and 911 was never called.  As our child s condition worsened, my husband and I made the decision to leave the clinic and transport our baby ourselves to the Emergency Room.  Upon arrival, ER staff immediately administered epinephrine, monitored our child, and stabilized the reaction. It is our firm belief that the delayed response by the clinic endangered our child s life and represents a serious breach of medical responsibility.
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Gait disturbance, Injection site pain, Weight bearing difficulty
Clinical narrative: Patient was previously active and ambulating without any difficulties. He was admitted to hospital for evaluation for re-listing for cardiac transplantation and PICC line placement from 5/5-5/8/2025. PCV20 vaccine was administered IM in the left thigh on the evening of 5/7/2025. The next morning when patient woke up he was complaining of significant left leg/thigh pain and refusing to bear weight due to pain. There was no obvious erythema or swelling noted at that time. He has continued to complain of left thigh pain and refused to bear weight on that leg since that time. At home (5/8- 5/14) patient required use of a wheelchair or had to be carried. He was readmitted to hospital on 5/14 for management of cardiac failure symptoms. During this hospitalization he has continued to experience pain in the left thigh area and was noted to have tenderness to palpation and swelling of the thigh for which the work-up below was conducted. Swelling improved with application of a compression wrap. In the past 24-48 hours he has begun putting some weight on the left leg but still experiences discomfort. An evaluation was completed to rule out other conditions on the differential diagnosis e.g. hematoma/bleed, pyomyositis/bacterial infection, DVT, fracture etc which were negative.
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Cardiac failure, Injection site oedema, Injection site pain, Injection site swelling, Limb discomfort
Clinical narrative: Patient was previously active and ambulating without any difficulties. He was admitted to hospital for evaluation for re-listing for cardiac transplantation and PICC line placement from 5/5-5/8/2025. PCV20 vaccine was administered IM in the left thigh on the evening of 5/7/2025. The next morning when patient woke up he was complaining of significant left leg/thigh pain and refusing to bear weight due to pain. There was no obvious erythema or swelling noted at that time. He has continued to complain of left thigh pain and refused to bear weight on that leg since that time. At home (5/8- 5/14) patient required use of a wheelchair or had to be carried. He was readmitted to hospital on 5/14 for management of cardiac failure symptoms. During this hospitalization he has continued to experience pain in the left thigh area and was noted to have tenderness to palpation and swelling of the thigh for which the work-up below was conducted. Swelling improved with application of a compression wrap. In the past 24-48 hours he has begun putting some weight on the left leg but still experiences discomfort. An evaluation was completed to rule out other conditions on the differential diagnosis e.g. hematoma/bleed, pyomyositis/bacterial infection, DVT, fracture etc which were negative.
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Limb ultrasound, Localised oedema, Oedema peripheral, Pain in extremity, Ultrasound joint normal
Clinical narrative: Patient was previously active and ambulating without any difficulties. He was admitted to hospital for evaluation for re-listing for cardiac transplantation and PICC line placement from 5/5-5/8/2025. PCV20 vaccine was administered IM in the left thigh on the evening of 5/7/2025. The next morning when patient woke up he was complaining of significant left leg/thigh pain and refusing to bear weight due to pain. There was no obvious erythema or swelling noted at that time. He has continued to complain of left thigh pain and refused to bear weight on that leg since that time. At home (5/8- 5/14) patient required use of a wheelchair or had to be carried. He was readmitted to hospital on 5/14 for management of cardiac failure symptoms. During this hospitalization he has continued to experience pain in the left thigh area and was noted to have tenderness to palpation and swelling of the thigh for which the work-up below was conducted. Swelling improved with application of a compression wrap. In the past 24-48 hours he has begun putting some weight on the left leg but still experiences discomfort. An evaluation was completed to rule out other conditions on the differential diagnosis e.g. hematoma/bleed, pyomyositis/bacterial infection, DVT, fracture etc which were negative.
Age: 8.0
Sex: M
Vaccine: PNC20, PNC20
Symptoms: Ultrasound scan abnormal, Weight bearing difficulty, Wheelchair user, X-ray limb normal
Clinical narrative: Patient was previously active and ambulating without any difficulties. He was admitted to hospital for evaluation for re-listing for cardiac transplantation and PICC line placement from 5/5-5/8/2025. PCV20 vaccine was administered IM in the left thigh on the evening of 5/7/2025. The next morning when patient woke up he was complaining of significant left leg/thigh pain and refusing to bear weight due to pain. There was no obvious erythema or swelling noted at that time. He has continued to complain of left thigh pain and refused to bear weight on that leg since that time. At home (5/8- 5/14) patient required use of a wheelchair or had to be carried. He was readmitted to hospital on 5/14 for management of cardiac failure symptoms. During this hospitalization he has continued to experience pain in the left thigh area and was noted to have tenderness to palpation and swelling of the thigh for which the work-up below was conducted. Swelling improved with application of a compression wrap. In the past 24-48 hours he has begun putting some weight on the left leg but still experiences discomfort. An evaluation was completed to rule out other conditions on the differential diagnosis e.g. hematoma/bleed, pyomyositis/bacterial infection, DVT, fracture etc which were negative.
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; they inadvertently gave VAQTA to a 6 month and 15 day old today on 23May2025. The baby is not having any problem and the physician not worried; This spontaneous report was received from a consumer or other non-health professional and refers to a 6-month-old patient (reported as 6-month and 15-day-old) of unknown gender (it was stated that the reporter believed that was a male patient but was not sure)  The patient's medical history, concurrent conditions, concomitant therapies, previous drugs reactions and allergies were not reported.   On 23-May-2025, the patient was inadvertently vaccinated with a dose of Hepatitis A Vaccine, Inactivated (VAQTA), 0.5 mL (two dose series) administered as prophylaxis (strength, Lot number, expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided) (product administered to patient of inappropriate age). It was stated that the patient was not having any problem. No additional adverse event was reported (no adverse event).
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered ACTHIB but they did not use the provided diluent, instead, they used sterile water with no reported adverse event; Initial information received on 27-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1-year-old male patient who was administered with HIB (PRP/T) vaccine [ACT-HIB] but they did not use the provided diluent, instead, they used sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, mumps vaccine, rubella vaccine (MMR); Varicella zoster vaccine (varicella vaccine); and Hepatitis A vaccine (Hepatitis A) all for Immunisation.  On 12-May-2025, the patient received a 0.5ml dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength (lot UK03611) (expiry date-unknown) via intramuscular route in the right thigh for Immunization but they did not use the provided diluent, instead, they used sterile water with no reported adverse event (product preparation error) (latency-same day).  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.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL, MMR, PNC15, VARCEL
Symptoms: Hypersensitivity, Lethargy, Nasal congestion, Vomiting
Clinical narrative: Patient received vaccines at 2:30 pm roughly. Within 10 minutes of vaccine administration patient vomited a large amount. Was alert, moving well with no other symptoms but did look slightly pale in color. Within 10 minutes when the provider re entered the room the patient was laying on the father, still alert but not as active, still with pale color but also now had a small rash to the side of is right eye.  Provider offered to administer Zyrtec to patient but parents declined and took him straight to he ER. A dose of 2.5 mg of Claritin and 0.1 mg IM epinephrine was administered at the ER visit. Patient arrived to ER at 3:36 pm. Per notes 40 mins after EPi color normal and rash resolved.
Age: 1.0
Sex: M
Vaccine: MMR, PPV, VARCEL, MMR, PNC15, VARCEL
Symptoms: Pallor, Rash, Vomiting
Clinical narrative: Patient received vaccines at 2:30 pm roughly. Within 10 minutes of vaccine administration patient vomited a large amount. Was alert, moving well with no other symptoms but did look slightly pale in color. Within 10 minutes when the provider re entered the room the patient was laying on the father, still alert but not as active, still with pale color but also now had a small rash to the side of is right eye.  Provider offered to administer Zyrtec to patient but parents declined and took him straight to he ER. A dose of 2.5 mg of Claritin and 0.1 mg IM epinephrine was administered at the ER visit. Patient arrived to ER at 3:36 pm. Per notes 40 mins after EPi color normal and rash resolved.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chest pain, Full blood count, Injection site erythema, Injection site pain
Clinical narrative: pain at and around injection site, redness and swelling at injection site, pain down right arm and into R chest.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Metabolic function test, Pain in extremity, Troponin
Clinical narrative: pain at and around injection site, redness and swelling at injection site, pain down right arm and into R chest.
Sex: F
Vaccine: VARZOS
Symptoms: Immune thrombocytopenia, Inappropriate schedule of product administration
Clinical narrative: I stopped getting the vaccine because I was diagnosed with ITP; This serious case was reported by a consumer via call center representative and described the occurrence of idiopathic thrombocytopenic purpura in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2021, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced idiopathic thrombocytopenic purpura (Verbatim: I stopped getting the vaccine because I was diagnosed with ITP) (serious criteria GSK medically significant). The outcome of the idiopathic thrombocytopenic purpura was not reported.   It was unknown if the reporter considered the idiopathic thrombocytopenic purpura to be related to Shingrix.     The company considered the idiopathic thrombocytopenic purpura to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2025 The reporter was the patient.  The patient received the 1st dose of Shingrix at a local pharmacy in October 2021.  The vaccine was administered in the left arm.  The patient reported due to medical reasons she was unable to get the 2nd dose 2 to 6 months after; and received the 2nd dose at her doctor's office in April 2025 in the left arm. The patient reported that recently in the past 3 years he stopped getting the vaccine because he was diagnosed with ITP The customer denied demographics, and the agent was unable to obtain any additional information.; Sender's Comments: Immune thrombocytopenia is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the 2 part injection but still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (have had shingles 7 times all on the back left side). Concurrent medical conditions included nerve pain (nerve pain was still going on in back now but did might be 12 to 15 months pain free now pain was back and seems like could not get any relief ).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the 2 part injection but still got the 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the 2 part injection but still got the shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles-7 times, insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; still got shingles; had three shingles shots; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles) and extra dose administered (Verbatim: had three shingles shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter wife (patient) had three Shingles shots and still got shingles and was down for a week. The reporter stated that the shot did not work. The patient received 3 doses of Shingles vaccine, which led to an extra dose administered. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and Dose 3).
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; now have 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: now have shingles). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. Consumer reported that he/she got both Shingle shots and now had a shingles. Reporter mentioned shots were only lesson the systems. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming 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 time to onset and laboratory confirmation of shingles) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had all the shots, just recently 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: had all the shots, just recently 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: 24-MAY-2025 This case was reported by a patient via interactive digital media. Patient had all the shots, just recently got shingles. Patient thought he/she was safe from getting them, not true. 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 Shingles vaccine.
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported PROQUAD administered after temperature excursion.  No additional information provided.  No additional AE/PQC reported.    ?    Names of vaccines involved (including lot/exp) PROQUAD  Y015355  3/10/2026        ?    Temperature -14C; This spontaneous report was received from an Other health professional and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 08-May-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection, (lot #Y015355, expiration date: 10-Mar-2026) at a dose of 0.5 mL administered by Subcutaneous route for prophylaxis. It was reported that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was administered after temperature excursion of -14 Celsius degrees (C) for the timeframe of 15 minutes (Product storage error). No additional information was provided. No additional AE/PQC was reported (No adverse event).
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Inappropriate schedule of product administration, Smear cervix abnormal
Clinical narrative: pap smear came back "abnormal"; Patient received one dose of GARDASIL in AUG 2007, one dose of GARDASIL in AUG 2008, and one dose of GARDASIL in AUG 2009; Patient received one dose of GARDASIL in AUG 2007, one dose of GARDASIL in AUG 2008, and one dose of GARDASIL in AUG 2009; This spontaneous report was received from a Nurse and referring to a 27-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   The patient received one dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) (strength, route, lot # and expiration date were not reported) in August 2007, one dose in August 2008 (Inappropriate schedule of product administration) and one dose in August 2009 (Inappropriate schedule of product administration).   On an unknown date (reported as recently), when patient came in for routine appointment, pap smear came back "abnormal". No treatment was given. At the reporting time, the outcome of the event was unknown. The action taken with Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was not applicable.   The causal relationship between the event of pap smear came back "abnormal" and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown.
Vaccine: RSV
Symptoms: Lung hyperinflation, Pulmonary thrombosis
Clinical narrative: blood clot in both lungs; This serious case was reported by a consumer via interactive digital media and described the occurrence of pulmonary thrombosis in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, less than a week after receiving Arexvy, the patient experienced pulmonary thrombosis (Verbatim: blood clot in both lungs) (serious criteria GSK medically significant). The outcome of the pulmonary thrombosis was not reported.   It was unknown if the reporter considered the pulmonary thrombosis to be related to Arexvy.     The company considered the pulmonary thrombosis to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 26-MAY-2025 Patient took RSV shot and developed blood clots in both lungs and an unspecified enlargment within a week.; Sender's Comments: Pulmonary thrombosis  is an unlisted event which is considered unrelated to GSK vaccine Arexvy
Vaccine: RVX
Symptoms: Asthenia, Balance disorder, Metapneumovirus infection
Clinical narrative: left me weak; no balance; think I had it; HMPV; This serious case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced weakness (Verbatim: left me weak) (serious criteria hospitalization), balance disorder (Verbatim: no balance) (serious criteria hospitalization), pneumonia (Verbatim: think I had it) (serious criteria hospitalization and GSK medically significant) and metapneumovirus infection (Verbatim: HMPV) (serious criteria hospitalization). The outcome of the weakness and balance disorder were not resolved and the outcome of the pneumonia and metapneumovirus infection were not reported.   It was unknown if the reporter considered the weakness, balance disorder, pneumonia and metapneumovirus infection to be related to RSV vaccine.     The company considered the weakness, balance disorder and metapneumovirus infection to be unrelated to RSV vaccine. It was unknown if the company considered the pneumonia to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. The reporter got RSV shot but a month ago the reporter got a virus related to this. It was a new respiratory virus that was no treatment for it nor vaccine. The reporter ended up in hospital for 3 days ,it was left reporter weak have no balance now after 3 weeks. The reporter doctor did put reporter on antibiotics after coming home. It was called HMPV it was really bad could go into pneumonia which think the reporter had. It was the worst thing the reporter had ever had, did not know where the reporter got the germ for did not go out much. The reporter get all vaccines.; Sender's Comments: Asthenia, Balance Disorder, Pneumonia and Metapneumovirus infection are unlisted events which are considered unrelated to GSK RSV vaccine.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth, Skin warm
Clinical narrative: Rash on her right arm; Itchy on her right arm; warmness on her right arm; soreness on her right arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-MAY-2025, the patient received Shingrix (right arm). In MAY-2025, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash on her right arm), itchy upper limbs (Verbatim: Itchy on her right arm), skin warm (Verbatim: warmness on her right arm) and pain in arm (Verbatim: soreness on her right arm). The outcome of the rash was resolving and the outcome of the itchy upper limbs was not resolved and the outcome of the skin warm and pain in arm were resolved.   It was unknown if the reporter considered the rash, itchy upper limbs, skin warm and pain in arm to be related to Shingrix.     It was unknown if the company considered the rash, itchy upper limbs, skin warm and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2025 The patient self-reported this case for herself. The patient received her first dose of Shingrix, she had soreness, a rash, itchiness, and warmness on her right arm where she received the vaccine.  The soreness and warmness went away but the rash and itchiness was still present.  The rash was about 3 inches long but was fading.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Rash
Clinical narrative: Rash on chest; 48 year old patient received shingles vaccine; This non-serious case was reported by a consumer and described the occurrence of rash in a 48-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24-MAY-2025, the patient received Shingles vaccine. On 24-MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced inappropriate age at vaccine administration (Verbatim: 48 year old patient received shingles vaccine). On 25-MAY-2025, the patient experienced rash (Verbatim: Rash on chest). The outcome of the rash was not resolved and the outcome of the inappropriate age at vaccine administration was not applicable.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAY-2025 The reporter reported that she had experience rash on chest. 48 year old patient received shingles vaccine which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: TDAP
Symptoms: Accidental exposure to product, Syringe issue
Clinical narrative: Accidental exposure to product/the vaccine, spilled onto the HCP's pant; Accidental exposure to product; The plunger from one BOOSTRIX slipped out of the syringe; product complaint; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number KR75K) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: Accidental exposure to product/the vaccine, spilled onto the HCP's pant), exposure via skin contact (Verbatim: Accidental exposure to product), syringe issue (Verbatim: The plunger from one BOOSTRIX slipped out of the syringe) and pharmaceutical product complaint (Verbatim: product complaint). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, syringe issue and pharmaceutical product complaint were not applicable.   It was unknown if the reporter considered the syringe issue to be related to Boostrix.     It was unknown if the company considered the syringe issue to be related to Boostrix.   Additional Information: GSK Receipt Date: 27-MAY-2025 The nurse reported that the plunger from one Boostrix slipped out of the syringe during preparation for administration.  Because of this the vaccine, spilled onto the healthcare professional's pants. The defect was discovered during preparation for administration, while the needle was being attached to the syringe, the suspect syringe was the first syringe removed from the multipack. The rod was very slick; there was no stopping point for it.  The stopper did not appear to be screwed all the way, was wobbly.  There did not appear to be any damage or other defects to the syringe.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had them last year; 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: Had them last year). 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-MAY-2025 The case was received from the patient via interactive digital media. The reporter had them last year. The reporter stated that shingles shot caused worse problems. The reporter was not a antivaxxer but that shot was not good. 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.; 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 Shingles vaccine.
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-MAY-2025 This case was reported by a patient via interactive digital media. The patient got the shingles jab because the physician recommended it to because of age. The patient never had shingles until he/she got the shot for it.  About a month later had to go to the hospital because of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; 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 Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; took the vaccine and still got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: took the vaccine and still got the 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-MAY-2025 This case was reported by a patient via interactive digital media. The patient took the vaccine and still got the shingles. This patient's case was quite severe. The patient suffered from the after effects in arm for about one year. The patient needed to go to different neurologists for treatment. 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 primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles 3 times since then; 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: had shingles 3 times since then). 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: 26-MAY-2025 The case was received from the patient via interactive digital media. The reporter had the vaccine and had shingles 3 times since then. 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.; 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.
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: my arm hurt bad for 2.5 days/ sore arm; 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.   In MAY-2025, the patient received the 1st dose of Shingles vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: my arm hurt bad for 2.5 days/ sore arm). The outcome of the pain in arm was 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-MAY-2025 This case was reported by a patient via interactive digital media. The patient got his/her first shot of Shingles vaccine in reporting week however sore arm but not that bad for 2.5 days.
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Have shingles at this time; 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: Have shingles at this time). 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-MAY-2025 The case was received from the patient via interactive digital media. The patient had shingles at this time and he/she was miserable.  Second time and this time was worse.  The patient stated that might would be worse if he/she was not vaccinated. No fun. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: shingles vaccine made me pretty 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 (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 vaccine and 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, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: shingles vaccine made me pretty sick). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2025AMR065532   Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that everybody reacts differently to drugs and vaccines.  Covid vaccines did not make him/her felt a thing but both doses of the shingles vaccine made him/her pretty sick for 2 to 3 days after.  It was still worth it because shingles could be really terrible and last a long time (like a year for some people).; Sender's Comments:  US-GSK-US2025AMR065532:
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; died from shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria death and GSK medically significant) and shingles (Verbatim: died from shingles) (serious criteria death). The outcome of the vaccination failure was not reported. The reported cause of death was herpes zoster.   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 :27-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that his/her mom got the shot and died from shingles. 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. Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.; Reported Cause(s) of Death: Herpes zoster
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It 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 : 26-MAY-2025 This case was reported by a patient via interactive digital media. Patient had just received first dose of the vaccine.  It hurt, but he/she guessed that shingles would have been worse.