chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Polyarthritis, Pyrexia, Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative
Clinical narrative: nausea and Fever 103.2 for 2 days, polyarthritis 2 weeks later for 5 days
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Customer called and reported that her adult son received VARIVAX as a child, but he recently had a titer which showed no immunity. The customer reports that he is going to receive a booster dose of VARIVAX. She asks if he should receive 1 or 2 doses; This spontaneous report was received from a consumer or other non health professional and refers to a adult male patient.   The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   On an unknown date (when patient was a child), he was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) as prophylaxis, reconstituted with a sterile diluent (MERCK STERILE DILUENT) (dose, indication, expiration date, and lot # were not reported).  On an unknown date (reported as recently), the patient had a titer which showed no immunity (antibody test negative). In addition, it was informed that he was going to receive a booster dose of the suspect vaccine and asked if he should receive 1 or 2 doses. At the reporting time, the patient had not recovered from the event.  The causal relationship between the event and the suspect vaccine was not provided.   Additional information is not expected.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE.; HCP calling to report patient inadvertently received expired dose of VAQTA; This spontaneous report was received from a health care professional and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant medications were unknown by the reporter.  On 24-JUN-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated Suspension for injection, as a dose of 0.5 ml (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number X025342, with an expiration date of 12-MAY-2025) administered for prophylaxis (Expired product administered). No additional adverse event was reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Cardiac monitoring abnormal, Carditis, Chest pain, Confusional state
Clinical narrative: Exhaustion, feeling like I was going to collapse, chest pain, feeling faint, confusion, fluttering in chest, shortness of breath
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Laboratory test normal, Supraventricular tachycardia
Clinical narrative: Exhaustion, feeling like I was going to collapse, chest pain, feeling faint, confusion, fluttering in chest, shortness of breath
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Exhaustion, feeling like I was going to collapse, chest pain, feeling faint, confusion, fluttering in chest, shortness of breath
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Confirmed no  symptomatic adverse events reported; Caller states that a vaccine was activated by attaching a syringe on 6-JUN-2025 but ended up not being used and was immediately placed back in the fridge. The dose was then administered to a patient on 9-JUN-2025.; This spontaneous report was received from a medical assistant on 13-Jun-2025, referring to a 37-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 09-Jun-2025, the patient was vaccinated with human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), lot #Y012865, expiration date: 10-Oct-2026, 0.5 mL / once, for prophylaxis (dose form, route of administration and anatomical site were not provided).   The reporter stated that a vaccine was activated by attaching a syringe on 6-JUN-2025 but ended up not being used and was immediately placed back in the fridge. The dose was then administered to the patient on 09-JUN-2025 (Product storage error). No symptomatic adverse events reported.
Age: 60.0
Sex: F
Vaccine: PNC21
Symptoms: Back pain, Breast pain, Vertigo
Clinical narrative: She also reported having mild vertigo starting 6/21/2025.; started experiencing moderate breast and back pain on 6/15/2025 on the same side that she received the vaccine.; started experiencing moderate breast and back pain on 6/15/2025 on the same side that she received the vaccine.; This spontaneous report was received from physician and refers to a 60-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 13-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) administered by intramuscular route for immunization (dose, lot #, expiration date and anatomical site of injection were not reported). On 15-Jun-2025, the patient experienced moderate breast and back pain on the same side where the vaccine was administered. On 21-Jun-2025, she experienced mild vertigo. At the reporting time, the patient was recovering from the events of breast pain, back pain and vertigo. The patient was treated with Celebrex. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine was not provided.  No additional information was provided.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I've got the vaccine 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 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've got the vaccine and still got 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.     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: 19-JUN-2025 This case was reported by a patient via interactive digital media. Patient got the vaccine and still got Shingles.  Patient was 70 years old and this was so painful.  This Sunday was going to be 3 weeks. 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.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I had a very severe case of Shingles requiring 5 days of hospitalization and treatment over many months affecting left back, buttock, and left lower front of torso with severe pain requiring Morphine and Oxycodone this first case was  in 2016 post cancer tx to for NHL.  I had the Shingrix Vaccine both doses in 2017. Since the vaccine I?ve had 2 Breakthrough reoccurrences of Shingles after having the Shingrix vaccine.  First breakthrough shingles  case was in 2021, moderate on my right shoulder, treated with valacyclovir 1 gram 3x day for. Week. Second shingles case was on 6/22/25 affected area was left hip annd buttock  and crease where thigh meets torso. Treatment is the same and ongoing. Pain has been moderate with both cases.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Rash vesicular, Scab
Clinical narrative: Vesicular, pruritic  rash 2 wks following varicella vaccination. Lesions have since crusted over.
Age: 27.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Angioedema, Corneal cyst, Impaired work ability, Peripheral swelling, Pruritus
Clinical narrative: After stopping zyrtec abruptly in summer of 2020, I developed intense itching as well as idopathic hives and angioedema. This caused me to restart the medication with each episode. The itching occurred every day that I did not take zyrtec. The hive and angioedema occurred weekly to biweekly unless taking 10 mg of zyrtec twice daily along with pepcid. I had to see an allergist later that year. Allergy testing was negative for any allergens for my symptoms. I also had several vaccinations prior to the start of the hives, including covid initial vaccine and booster, and the first two vaccines for gardasil. I did not have any know infections with Covid-19 that year or any other noteworthy illness. The swelling and itching impacted my ability to perform my job as a surgical physician assistant due to episodic swelling of my hands. I continue to have episodes of itching, hives and angioedema if I do not take zyrtec daily. While taking zyrtec twice daily to treat my hives, I developed a corneal inclusion cyst in my right eye. I eventually started treatment for the hives with xolair which improved the symptoms. I became pregnant in 2024 and stopped the xolair. During my pregnancy I tried to stop zyrtec again, with recurrence of my symptoms (itching, hives, angioedema). I ultimately had to restart zyrtec during my pregnancy and continue it daily to prevent my symptoms. The only time I have been able to stop zyrtec without significant symptoms is while on xolair.
Age: 27.0
Sex: F
Vaccine: COVID19, HPV9
Symptoms: Swelling, Urticaria
Clinical narrative: After stopping zyrtec abruptly in summer of 2020, I developed intense itching as well as idopathic hives and angioedema. This caused me to restart the medication with each episode. The itching occurred every day that I did not take zyrtec. The hive and angioedema occurred weekly to biweekly unless taking 10 mg of zyrtec twice daily along with pepcid. I had to see an allergist later that year. Allergy testing was negative for any allergens for my symptoms. I also had several vaccinations prior to the start of the hives, including covid initial vaccine and booster, and the first two vaccines for gardasil. I did not have any know infections with Covid-19 that year or any other noteworthy illness. The swelling and itching impacted my ability to perform my job as a surgical physician assistant due to episodic swelling of my hands. I continue to have episodes of itching, hives and angioedema if I do not take zyrtec daily. While taking zyrtec twice daily to treat my hives, I developed a corneal inclusion cyst in my right eye. I eventually started treatment for the hives with xolair which improved the symptoms. I became pregnant in 2024 and stopped the xolair. During my pregnancy I tried to stop zyrtec again, with recurrence of my symptoms (itching, hives, angioedema). I ultimately had to restart zyrtec during my pregnancy and continue it daily to prevent my symptoms. The only time I have been able to stop zyrtec without significant symptoms is while on xolair.
Age: 42.0
Sex: F
Vaccine: HEP, PNC21
Symptoms: Arthralgia, Computerised tomogram normal, Fatigue, Joint swelling, Lethargy
Clinical narrative: I received the capvaxive pneumonia vaccine on Monday 6/16 at about 11am. Tuesday 6/17 felt fatigued, at 10:30PM my supraclavicular lymph node was the size of a large grape and visible. Messaged the Dr saw Dr 9:30 6/18 and said yes it's probably from the vaccine and should go away, call if symptoms worsen. Injection was in text book location and no signs of infection. 6/19 woke up with my entire Right shoulder and neck in pain and swelling. Messaged Dr office. As the day went on my throat started to hurt and swallowing became painful. Called Dr office and they advised urgent care. I went to Urgent care and they were concerned about how enlarged my lymph's were and my throat being sore so they sent me to the emergency room. ER did blood work and CT found no underlying reason for the enlarged lymph nodes. Sent me home and said call us if you are struggling to breathe. 6/10 throat still hurts, very lethargic, lymph nodes still enlarged to the point it hurts to move my neck and I can not raise my hand above my clavical. Injection was given with Hep B in right deltoid.
Age: 42.0
Sex: F
Vaccine: HEP, PNC21
Symptoms: Lymphadenopathy, Mobility decreased, Neck pain, Odynophagia, Oropharyngeal pain
Clinical narrative: I received the capvaxive pneumonia vaccine on Monday 6/16 at about 11am. Tuesday 6/17 felt fatigued, at 10:30PM my supraclavicular lymph node was the size of a large grape and visible. Messaged the Dr saw Dr 9:30 6/18 and said yes it's probably from the vaccine and should go away, call if symptoms worsen. Injection was in text book location and no signs of infection. 6/19 woke up with my entire Right shoulder and neck in pain and swelling. Messaged Dr office. As the day went on my throat started to hurt and swallowing became painful. Called Dr office and they advised urgent care. I went to Urgent care and they were concerned about how enlarged my lymph's were and my throat being sore so they sent me to the emergency room. ER did blood work and CT found no underlying reason for the enlarged lymph nodes. Sent me home and said call us if you are struggling to breathe. 6/10 throat still hurts, very lethargic, lymph nodes still enlarged to the point it hurts to move my neck and I can not raise my hand above my clavical. Injection was given with Hep B in right deltoid.
Age: 42.0
Sex: F
Vaccine: HEP, PNC21
Symptoms: Pain, Swelling
Clinical narrative: I received the capvaxive pneumonia vaccine on Monday 6/16 at about 11am. Tuesday 6/17 felt fatigued, at 10:30PM my supraclavicular lymph node was the size of a large grape and visible. Messaged the Dr saw Dr 9:30 6/18 and said yes it's probably from the vaccine and should go away, call if symptoms worsen. Injection was in text book location and no signs of infection. 6/19 woke up with my entire Right shoulder and neck in pain and swelling. Messaged Dr office. As the day went on my throat started to hurt and swallowing became painful. Called Dr office and they advised urgent care. I went to Urgent care and they were concerned about how enlarged my lymph's were and my throat being sore so they sent me to the emergency room. ER did blood work and CT found no underlying reason for the enlarged lymph nodes. Sent me home and said call us if you are struggling to breathe. 6/10 throat still hurts, very lethargic, lymph nodes still enlarged to the point it hurts to move my neck and I can not raise my hand above my clavical. Injection was given with Hep B in right deltoid.
Vaccine: RAB
Symptoms: Product contamination physical
Clinical narrative: patient needed a Rabavert injection in the ER. Med was sent to the ER and when the nurse opened the package, she noticed that there was a partical in the syringe. The drug and original package was sent back to pharmacy to inspect. Upon inspection, there was a piece of rubber in the syringe.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Ear discomfort, Hyperacusis
Clinical narrative: Had meningitis B vaccine on 5/22/25. Experiencing some related side effects including heightened hearing , ears clogging, right ears sensitive .
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Shingrix vaccine dose 1 received on Monday June 9th 2025 shot received on left arm Patient age 51. Female. BMI 23.5 By Wednesday pain in arm moved to pain in left airmmpit. Pain in left arm Pit continues.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Heavy menstrual bleeding
Clinical narrative: 48 yo woman on birth control. Immune compromised with persistent hypogammaglobulinemia following Rituxan exposure allowed me to get shingles vaxx. Received my second Shingrix vaccine on 5/17/25. 3 days later experienced unexpected off-cycle abrupt loss of uterine lining over course of 6 hours (heaviest chunkiest period of my life). Continued "normal" period-type bleeding for 1 week. Have had intermittent bleeding for 4 total weeks to date. My birth control is continuous monophasic, so I normally don't have a period at all. I did have some mild spotting after initial COVID vaccine boosters. I know Shingrix only recently cleared for those under 55, figure its impact on menstruation may not be well studied and my data point may help.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrointestinal pain, Headache
Clinical narrative: Pharmacy administered Shingrix vaccine first dose May 27. I am 69 year old male in good health, no diseases or treated conditions. No maintenance drugs. I am 10 days since shot and still gastrointestinal ache (3) level and daily light headache.
Sex: M
Vaccine: MMRV, MMRV, MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptoms reported at the time of the call; extradose adminsitered; This spontaneous report was received from a health care professional on 23-Jun-2025 and refers to a 5-year-old male patient.  The patient's medical history, and concurrent conditions were not reported.  Historical vaccines included Measles, mumps, and rubella virus vaccine live (M-M-R II), and (Varicella zoster vaccine live (Oka/Merck)) (VARIVAX), administered on 15-Jun-2021. Concomitant therapies were not reported.   On 02-Oct-2024, the patient was vaccinated with a second dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)injection, dose: 0.5 mL (route of administration, anatomical location, lot # and expiration date were not reported) with sterile diluent, dose: 0.5 mL (route of administration, anatomical location, lot # and expiration date were not reported), on the same date for prophylaxis.   On 29-May-2025, the patient was vaccinated with a third dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection,dose: 0.5 mL (route of administration, anatomical location, lot # and expiration date were not reported) with sterile diluent, dose: 0.5 mL (route of administration, anatomical location, lot # and expiration date were not reported), on the same date for prophylaxis (Extra dose administered).  No symptoms reported at the time of the call.
Vaccine: PNC21
Symptoms: No adverse event, Product storage error
Clinical narrative: no patient symptoms have been reported; 1 dose of CAPVAXIVE involved in a temperature excursion was administered to a patient; This spontaneous report was received from a pharmacy intern (also reported as medical student) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 23-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z002626, expiration date: 04-Sep-2026, strength and route were unknown), 1 dosage form for prophylaxis (Product storage error). No patient symptoms have been reported (No adverse event).  Administered dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) experienced the temperature excursion below 15.8degree Celsius [C] for 8 Hours 0 Minutes 0 Seconds. No previous temperature excursions reported.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Pharmacist called and reported that a consumer with Rheumatoid Arthritis had titers drawn for MMR-II and had no levels.; Information has been received from a pharmacist and referred to a female patient of unknown age. The patient's concurrent condition included rheumatoid arthritis. Concomitant medication included tofacitinib citrate (XELJANZ). The patient's medical history was not reported.  On an unknown date, the patient vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT).   On an unknown date, the patient had titers drawn for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and had no levels (Antibody test negative). The concomitant medication tofacitinib citrate (XELJANZ) was withheld by the physician so the patient could receive a booster dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II). The patient had sought medical attention. At the reporting time, the patient had not recovered from the event.   The causal relationship between the event and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), sterile diluent (MERCK STERILE DILUENT) was not provided.   Lot# is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: she was diagnosed with cancer after receiving the first Shingrix vaccine; This serious case was reported by a consumer via call center representative and described the occurrence of cancer in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included lisinopril and amlodipine.   In FEB-2025, the patient received the 1st dose of Shingrix. In FEB-2025, less than a month after receiving Shingrix, the patient experienced cancer (Verbatim: she was diagnosed with cancer after receiving the first Shingrix vaccine) (serious criteria GSK medically significant). The outcome of the cancer was unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.     The company considered the cancer to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 18-JUN-2025 Customer reported that she was diagnosed with cancer after receiving first dose of Shingrix vaccine.; Sender's Comments: Neoplasm malignant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Vaccine: VARZOS
Symptoms: Erectile dysfunction
Clinical narrative: Penis won't get hard now; This serious case was reported by a consumer via interactive digital media and described the occurrence of erectile dysfunction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19-JUN-2025, the patient received the 1st dose of Shingles vaccine. On 19-JUN-2025, less than a day after receiving Shingles vaccine, the patient experienced erectile dysfunction (Verbatim: Penis won't get hard now) (serious criteria GSK medically significant). The outcome of the erectile dysfunction was not resolved.   It was unknown if the reporter considered the erectile dysfunction to be related to Shingles vaccine.     The company considered the erectile dysfunction to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2025 This case was reported by a patient via (Chatbot) interactive digital media. The patient got the first shot today now tonight the patient's penis will not get hard. The patient wanted to know when it would work again.; Sender's Comments: Erectile dysfunction is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Sore arm could not put shirt on missed day of work; Sore arm could not put shirt on missed day of work; This non-serious case was reported by a nurse via sales rep and described the occurrence of pain in arm 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 pain in arm (Verbatim: Sore arm could not put shirt on missed day of work) and activities of daily living impaired (Verbatim: Sore arm could not put shirt on missed day of work). The outcome of the pain in arm and activities of daily living impaired were resolved.   The reporter considered the pain in arm and activities of daily living impaired to be related to Shingles vaccine.     The company considered the pain in arm and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-JUN-2025 The patient had Shingles vaccine first dose. The patient had sore arm, could not put shirt on missed day of work. The reporter would like to provide additional information about this report as said it had some years ago.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she never received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 06-JAN-2024).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she never received her second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 16-JUN-2025 The patient reported that she received her first dose of Shingrix on 6th January 2024. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Occupational exposure to product
Clinical narrative: nurses at the healthcare facility was drawing up a shingrix vaccine (after the antigen and adjuvant were mixed); Accidental exposure to product; drop sprayed in her eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 16-JUN-2025, an unknown time after receiving Shingrix, the patient experienced occupational exposure while preparing product for administration (Verbatim: nurses at the healthcare facility was drawing up a shingrix vaccine (after the antigen and adjuvant were mixed)), inadvertent exposure to vaccine (Verbatim: Accidental exposure to product) and exposure via eye contact (Verbatim: drop sprayed in her eye). The outcome of the occupational exposure while preparing product for administration, inadvertent exposure to vaccine and exposure via eye contact were not applicable.   Additional Information: GSK Receipt Date: 16-JUN-2025 Pharmacist reported that one of the nurses at the healthcare facility was drawing up a Shingrix vaccine (after the antigen and adjuvant were mixed) and a drop sprayed in her eye which led to inadvertent exposure to vaccine (Adverse event -Accidental Exposure).
Vaccine: VARZOS
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Vaccine preparation error; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in product usage process in a patient who received Herpes zoster (Shingrix) (batch number 594G2) for prophylaxis.   On 23-JUN-2025, the patient received Shingrix. On 23-JUN-2025, an unknown time after receiving Shingrix, the patient experienced wrong technique in product usage process (Verbatim: Vaccine preparation error). The action taken with Shingrix was unknown. The outcome of the wrong technique in product usage process was not applicable.   Additional Information: GSK receipt date: 23-JUN-2025 HCP was the reporter.  States when drawing up the final reconstituted solution of Shingrix the needle was not securely tightened to the syringe and medication leaked out of the syringe (preparation error.), which led to Wrong technique in product usage process. The patient received a dose of Shingrix using a different antigen/adjuvant of Shingrix. No further information was obtained/provided.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles/pain; 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, 6 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles/pain). 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: 17-JUN-2025 This case was reported by a patient via interactive digital media. Patient got both of those shots and still got shingles 6 years later.  Also stated that their pain at the time reporting was a nine at best, and patient was on three different medications. This case was considered as suspected vaccination failure as details regarding 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: MMR
Symptoms: Incorrect dose administered
Clinical narrative: some patients who did not receive a full dose of Priorix; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete dose administered in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incomplete dose administered (Verbatim: some patients who did not receive a full dose of Priorix). The outcome of the incomplete dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 16-JUN-2025 This case was reported by a patient via interactive digital media. The reporter had some patients who did not receive a full dose of Priorix vaccine which led to Incomplete dose administered.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was inadvertently given DTaP when he was due for Td due to age of 7 years old. He was given TDaP last on 12/18/24.  He displayed no adverse reaction to the DTaP vaccine.
Age: 9.0
Sex: F
Vaccine: IPV, IPV, TDAP, TDAP
Symptoms: Headache, Loss of consciousness, Seizure like phenomena
Clinical narrative: Child received Tdap and polio and approximately 5 minutes after vaccination mother and child walked to checkout, and child passed out briefly but also noticed seizure like activity. Sister was also present at time of event and also verified patient did not hit head. Patient fell on chair and slid down wall to floor. Also, patient stated when aroused she had a headache prior to passing out. Parent was encouraged to take child to PCP after appointment for follow up. Patient was stable leaving with mother and no longer had a headache.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Resident passed away
Vaccine: COVID19, FLUX, RVX
Symptoms: Influenza, Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; RSV; Flu; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   Previously administered products included Covid-19 vaccine (received 8 doses on an unknown date).   On an unknown date, the patient received RSV vaccine, Influenza vaccine and the 9th dose of COVID-19 vaccine. On an unknown date, an unknown time after receiving RSV vaccine, Influenza vaccine and COVID-19 vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: RSV) and influenza (Verbatim: Flu). The outcome of the vaccination failure, respiratory syncytial virus infection and influenza were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and influenza to be related to RSV vaccine, Influenza vaccine and COVID-19 vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection and influenza to be related to RSV vaccine, Influenza vaccine and COVID-19 vaccine. It was unknown if the company considered the vaccination failure to be related to Influenza vaccine and COVID-19 vaccine.   Additional Information: GSK Receipt Date: 19-JUN-2025 This case was reported by a patient via interactive digital media. The patient had a flu shot, an RSV shot, and 9th Covid shot in last fall but still got the Flu and respiratory syncytial virus before February.  The patient spent some time in the hospital and then they brought nurses to saws the patient in the house for another few days four times a day.  If patient not had insurance he/she would have been billed for over 16,000 dollars. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.; 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 RSV vaccine.
Age: 50.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Boostrix vaccine was administered outside of CDC guidelines. No adverse event was reported.
Age: 70.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: gave im instead of sq no reaction
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Feeling cold, Hallucination
Clinical narrative: I woke up the next morning and i was light headed and tired i was having hallucination. I was having trouble breathing like i was having an asthma attack. I was really cold i had to keep the heat up in the house. I had a lack of appetite and my memory is bad.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Memory impairment
Clinical narrative: I woke up the next morning and i was light headed and tired i was having hallucination. I was having trouble breathing like i was having an asthma attack. I was really cold i had to keep the heat up in the house. I had a lack of appetite and my memory is bad.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Anxiety, Arthralgia, Balance disorder, Blood test
Clinical narrative: I woke up at 230 am on Dec 15 with ringing in my ears. As the weeks went on I developed muscle and joint pain, pins and needles, hearing sensitivity, light sensitivity, electrical currents going through my body, Insomnia, Brain fog, Anxiety, TMJ, Vertigo, Dizziness, off balance, weight and muscle loss. I could no longer function. Having conversations with people was hard. Memory loss and the list goes on, I saw at least 12 Western Medicine specialist and none of them would say it was from the Vaccine except one. So no one treated me for a Vaccine injury. I saw two Long Haul Covid Clinics. The outcome is I am still fighting to get my life back. I still have symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain fog, Cognitive disorder, Computerised tomogram, Dizziness, Electric shock sensation
Clinical narrative: I woke up at 230 am on Dec 15 with ringing in my ears. As the weeks went on I developed muscle and joint pain, pins and needles, hearing sensitivity, light sensitivity, electrical currents going through my body, Insomnia, Brain fog, Anxiety, TMJ, Vertigo, Dizziness, off balance, weight and muscle loss. I could no longer function. Having conversations with people was hard. Memory loss and the list goes on, I saw at least 12 Western Medicine specialist and none of them would say it was from the Vaccine except one. So no one treated me for a Vaccine injury. I saw two Long Haul Covid Clinics. The outcome is I am still fighting to get my life back. I still have symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperacusis, Insomnia, Loss of personal independence in daily activities, Magnetic resonance imaging, Muscle atrophy
Clinical narrative: I woke up at 230 am on Dec 15 with ringing in my ears. As the weeks went on I developed muscle and joint pain, pins and needles, hearing sensitivity, light sensitivity, electrical currents going through my body, Insomnia, Brain fog, Anxiety, TMJ, Vertigo, Dizziness, off balance, weight and muscle loss. I could no longer function. Having conversations with people was hard. Memory loss and the list goes on, I saw at least 12 Western Medicine specialist and none of them would say it was from the Vaccine except one. So no one treated me for a Vaccine injury. I saw two Long Haul Covid Clinics. The outcome is I am still fighting to get my life back. I still have symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Paraesthesia, Photophobia, Temporomandibular pain and dysfunction syndrome, Tinnitus
Clinical narrative: I woke up at 230 am on Dec 15 with ringing in my ears. As the weeks went on I developed muscle and joint pain, pins and needles, hearing sensitivity, light sensitivity, electrical currents going through my body, Insomnia, Brain fog, Anxiety, TMJ, Vertigo, Dizziness, off balance, weight and muscle loss. I could no longer function. Having conversations with people was hard. Memory loss and the list goes on, I saw at least 12 Western Medicine specialist and none of them would say it was from the Vaccine except one. So no one treated me for a Vaccine injury. I saw two Long Haul Covid Clinics. The outcome is I am still fighting to get my life back. I still have symptoms.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Weight decreased
Clinical narrative: I woke up at 230 am on Dec 15 with ringing in my ears. As the weeks went on I developed muscle and joint pain, pins and needles, hearing sensitivity, light sensitivity, electrical currents going through my body, Insomnia, Brain fog, Anxiety, TMJ, Vertigo, Dizziness, off balance, weight and muscle loss. I could no longer function. Having conversations with people was hard. Memory loss and the list goes on, I saw at least 12 Western Medicine specialist and none of them would say it was from the Vaccine except one. So no one treated me for a Vaccine injury. I saw two Long Haul Covid Clinics. The outcome is I am still fighting to get my life back. I still have symptoms.
Age: 37.0
Sex: M
Vaccine: HEP, MNQ
Symptoms: Wrong product administered
Clinical narrative: Hep B given instead of Hep A.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac monitoring, Cardiac stress test, Catheterisation cardiac
Clinical narrative: Got a blood clot in my left hand, ring finger and this required a couple of days in the hospital and missing lots of work. Was put on Eliquis 2 x a day and aspirin daily. On Dec 2021 I had to have a Heart Ablation done because I was also AFIB. I wear a couple of different heart monitors that then required me to get a Loop Monitor put into my chest in Oct 2022. In around Oct 2023 I had a Watchman Device put into my heart. I have several health issues these last 4 years and its been tough. I have so many follow up visits and scans, missing lots of work unpaid. Not being able to do the things I use to do before all this happened. Nothing good came out of getting this Vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Echocardiogram, Electrocardiogram, Impaired work ability, Implantable cardiac monitor insertion
Clinical narrative: Got a blood clot in my left hand, ring finger and this required a couple of days in the hospital and missing lots of work. Was put on Eliquis 2 x a day and aspirin daily. On Dec 2021 I had to have a Heart Ablation done because I was also AFIB. I wear a couple of different heart monitors that then required me to get a Loop Monitor put into my chest in Oct 2022. In around Oct 2023 I had a Watchman Device put into my heart. I have several health issues these last 4 years and its been tough. I have so many follow up visits and scans, missing lots of work unpaid. Not being able to do the things I use to do before all this happened. Nothing good came out of getting this Vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Left atrial appendage closure implant, Loss of personal independence in daily activities, Thrombosis
Clinical narrative: Got a blood clot in my left hand, ring finger and this required a couple of days in the hospital and missing lots of work. Was put on Eliquis 2 x a day and aspirin daily. On Dec 2021 I had to have a Heart Ablation done because I was also AFIB. I wear a couple of different heart monitors that then required me to get a Loop Monitor put into my chest in Oct 2022. In around Oct 2023 I had a Watchman Device put into my heart. I have several health issues these last 4 years and its been tough. I have so many follow up visits and scans, missing lots of work unpaid. Not being able to do the things I use to do before all this happened. Nothing good came out of getting this Vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthma, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Extreme exhaustion feeling like is have the flu, headaches, nausea, cognitive looseness-spacey, temperature steady at 99.1, chills, sensitive to sounds and light, nauseated. These all started on Sunday June 21st and still are all present to date .
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyperacusis, Influenza like illness, Nausea, Photophobia
Clinical narrative: Extreme exhaustion feeling like is have the flu, headaches, nausea, cognitive looseness-spacey, temperature steady at 99.1, chills, sensitive to sounds and light, nauseated. These all started on Sunday June 21st and still are all present to date .
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphonia, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: Extreme exhaustion feeling like is have the flu, headaches, nausea, cognitive looseness-spacey, temperature steady at 99.1, chills, sensitive to sounds and light, nauseated. These all started on Sunday June 21st and still are all present to date .
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hyperacusis, Impaired work ability, Influenza, Mental disorder
Clinical narrative: Extreme exhaustion feeling like is have the flu, headaches, nausea, cognitive looseness-spacey, temperature steady at 99.1, chills, sensitive to sounds and light, nauseated. These all started on Sunday June 21st and still are all present to date .
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Photophobia, Pyrexia
Clinical narrative: Extreme exhaustion feeling like is have the flu, headaches, nausea, cognitive looseness-spacey, temperature steady at 99.1, chills, sensitive to sounds and light, nauseated. These all started on Sunday June 21st and still are all present to date .
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Limb mass, Pain in extremity
Clinical narrative: pt reported sore arm with knot. pt states she took tylenol, pharmacist recommended ibuprofen and see primary or urgent care provider
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: erythema and swelling of the leg that worsened significantly 2 days later. Started to improve on Day 3 and is now doing well.
Age: 0.75
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Gave extra dose of flu. No adverse symptoms as of now
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC20, RV5
Symptoms: Malaise, Pyrexia
Clinical narrative: FEVER, GENERAL MALAISE
Age: 50.0
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient said her arm was red and swollen and it was itchy
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had their 1st dose a year a ago or two years ago; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first and a year ago or two years ago.).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had their 1st dose a year a ago or two years ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 16-JUN-2025 The pharmacist reported some patients come in and had their 1st dose a year a ago or two years ago, what are the guidelines.  The pharmacist reported they come and ask.  When pharmacist was asked to clarify scenario and confirm if this occurred, pharmacist said, possibly but the number of patients is unknown.  She states this is just a general question. Till the time of reporting, the patients did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 87.0
Sex: M
Vaccine: HEPAB, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient received a 2nd dose of Prevnar 20 on 6/24/2025 despite receiving a dose of the same on 2/3/2023. This 2nd dose was determined to be clinically inappropriate as current guidelines indicate patient should receive only one dose of Prevnar 20.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Hypotonia
Clinical narrative: NOT SURE MOM AND GRANDMA had different version, mom said it was normal, Grandma said baby was limp for few seconds, did not turn blue or stopped breathing