chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective
Clinical narrative: Covid/had it once before/taken Paxlovid; Covid/had it once before/taken Paxlovid; got Covid again/was prescribed Paxlovid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid/had it once before/taken Paxlovid"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "got Covid again/was prescribed Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical course: It was reported that the patient received 8 Pfizer COVID-19 vaccine shots, had COVID, had it once before and taken Paxlovid. The patient got COVID again and was prescribed Paxlovid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Infertility female
Clinical narrative: infertile/daughter became infertile after receiving the Pfizer COVID-19 vaccine three times.; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY FEMALE (non-serious), outcome "unknown", described as "infertile/daughter became infertile after receiving the Pfizer COVID-19 vaccine three times.".  Additional information: The reporter claimed that her daughter became infertile after receiving the Pfizer COVID-19 vaccine three times.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer recurrent
Clinical narrative: recurrent Breast Cancer; This is a spontaneous report received from a Consumer or other non HCP.  A 76-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure / PACS" (unspecified if ongoing); "Blood pressure / PACS" (unspecified if ongoing); "Preventive cholesterol" (unspecified if ongoing); "Breast cancer", start date: 25Feb1997 (ongoing); "pulmonary nodule", start date: 2017 (unspecified if ongoing), notes: MRI indicated 2 pulmonary nodules which necessitated a CT scan. The 2 nodules were in the right side. The 2nd in the lingula which had grown from 6 mm - 10 mm since 2017. Concomitant medication(s) included: DILTIAZEM taken for blood pressure abnormal, supraventricular extrasystoles; LOSARTAN; VALSARTAN; HCTZ; ROSUVASTATIN taken for blood cholesterol abnormal; ANASTROZOLE. Vaccination history included: moderna COVID-19 vaccine (DOSE 1, SINGLE), administration date: 12Feb2021, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 2, SINGLE), administration date: 12Mar2021, for Covid-19 immunization; moderna COVID-19 vaccine (DOSE 3 (BOOSTER), SINGLE), administration date: 22Oct2021, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE), administration date: 30Mar2022, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE), administration date: 09Sep2022, for Covid-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 6 (BOOSTER), SINGLE), administration date: 16Jun2023, for Covid-19 immunization. The following information was reported: BREAST CANCER RECURRENT (medically significant) with onset 28Aug2024, outcome "unknown", described as "recurrent Breast Cancer". Clinical course: Patient have received 8 covid shots and received vaccinations from 2021-2025. The vaccination date for the 7th dose was also reported as 18Sep2023/23May2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: doesn't always prevent covid; doesn't always prevent covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 58-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "doesn't always prevent covid".  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Ear disorder, Macular degeneration, Osteomyelitis
Clinical narrative: macular degeneration to go bad; suddenly she couldn't see; tibia was infected; fluid in her ear; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000329006 (Genentech).  An 85-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "knee replacement" (unspecified if ongoing); "cataract surgery" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]. The following information was reported: MACULAR DEGENERATION (medically significant), outcome "unknown", described as "macular degeneration to go bad"; BLINDNESS (medically significant), outcome "unknown", described as "suddenly she couldn't see"; OSTEOMYELITIS (medically significant), outcome "unknown", described as "tibia was infected"; EAR DISORDER (non-serious), outcome "unknown", described as "fluid in her ear".  Clinical course: On unknown date, patient started therapy with BioNTech Covid-19 Vaccine for unknown indication. On unknown date, it was reported that patient experienced: macular degeneration to go bad, suddenly she couldn't see. Tibia was infected, and fluid in her ear.  Batch/lot number is not provided, and it cannot be obtained.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Blood glucose, Presyncope, Tremor
Clinical narrative: Vasovagal reaction with tremor (seizure) -checked glucose, snack, monitored blood pressure
Age: 68.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received 2nd vaccine in series on day 27 instead of day 28 or later.  Pt stated side effects are normal as with 1st dose (arm soreness, feeling tired after)
Age: 76.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient reported she developed a severe fever, injection site swelling and redness later in the day after being administered Shingrix and Capvaxive on 7/6/25 . Patient reported she was treated in emergency department on 7/6/25, since then most of her symptoms have resolved.  She returned to pharmacy on 7/7/25  to report reaction, with leftover redness and swelling in injection site.
Age: 61.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Arthralgia, Headache, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pain at injection site for Prevnar, spread to whole left shoulder and still neck by the next morning, bad headache.  Neck and shoulder still very stiff and painful 4 days later
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Injection site haemorrhage
Clinical narrative: PATIENT CAME IN FOR FIRST SHOT OF SHINGRIX ON 7/7/25 AT APPROXIMATELY 9:30AM. RECONSTITUTION WAS UNREMARKABLE, HOWEVER, IN THE PROCESS OF ADMINISTERING THE VACCINE TO HER LEFT ARM, THE PATIENT JERKED TO THE RIGHT-- THUS REMOVING THE SHOT AFTER IT WAS INSERTED AND THE SUBSEQUENT VACCINE SQUIRTED ON HER LEFT ARM. IT APPEARS THAT AN UNDETERMINATED AMOUNT OF VACCINE ENTERED THE PATIENT'S ARM.  IT CAN BE CONFIRMED THAT THE NEEDLE FROM THE SYRINGE DID BREAK SKIN AS THERE WAS A DROP OF BLOOD AT THE SITE OF INJECTION. I SUBSEQUENTLY GAVE THE PATIENT A 2ND SHOT FROM THE SAME VACCINE LOT TO THE RIGHT ARM. THIS SHOT WAS SUCCESSFUL WITH NO ISSUES.
Age: 50.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Induration, Skin warm, Vomiting
Clinical narrative: Patient states arm is warm to the touch and hard. She reports vomiting today. I instructed her to take some APAP and monitor arm to see if it seems to be getting better or not.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Limb discomfort, Pain in extremity, Pruritus, Rash
Clinical narrative: At the advice of my PCP, I decided to get an updated Shingles Vaccine injection.  (previous injection was greater than 15 years ago). June 19, 2025 received Shingrix injection @ ~1:00pm in the left arm June 20-23, left arm felt heavy, sore but nothing bad June 24-25, the top of the right ear lobe became itchy but no rash June 25-29, a rash started on the inside of the left arm, near the elbow.  Very itchy.  Nothing seemed to work in relieving the itchiness.  Some internal achiness in the shoulder area.   Arm strength seems to be impacted. June 30th called Dermatologist to get an appointment.  Rash was spreading to front waistline area. July 3rd, went to Dermatologist, diagnosed as hives, likely as a result of an allergic reaction to the Shingrix injection.   Dermatologist prescribed medicine to alleviate the hives. July 3-7, rash spread to the right butt area, around the back side of the waist.  Other areas where itchiness has started including the upper chest, shoulders and back of the neck, as well as down the leg toward the knee area.   No issues below the knee. July 7, uncertain if getting better, still uncomfortable as hell.  The initial areas on the inside of the left arm appear to be waning away, rash still visible but smaller, not itching.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: At the advice of my PCP, I decided to get an updated Shingles Vaccine injection.  (previous injection was greater than 15 years ago). June 19, 2025 received Shingrix injection @ ~1:00pm in the left arm June 20-23, left arm felt heavy, sore but nothing bad June 24-25, the top of the right ear lobe became itchy but no rash June 25-29, a rash started on the inside of the left arm, near the elbow.  Very itchy.  Nothing seemed to work in relieving the itchiness.  Some internal achiness in the shoulder area.   Arm strength seems to be impacted. June 30th called Dermatologist to get an appointment.  Rash was spreading to front waistline area. July 3rd, went to Dermatologist, diagnosed as hives, likely as a result of an allergic reaction to the Shingrix injection.   Dermatologist prescribed medicine to alleviate the hives. July 3-7, rash spread to the right butt area, around the back side of the waist.  Other areas where itchiness has started including the upper chest, shoulders and back of the neck, as well as down the leg toward the knee area.   No issues below the knee. July 7, uncertain if getting better, still uncomfortable as hell.  The initial areas on the inside of the left arm appear to be waning away, rash still visible but smaller, not itching.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Hemiparesis, Immediate post-injection reaction, Pain
Clinical narrative: Customer was administered first dose of Shingrix vaccine in left arm on 6/11/25. Reported immediate soreness. Customer stated she felt some weakness begin in left arm about two days after vaccination. She states this has progressed to include her right arm at times as well as her legs. These symptoms were not reported to pharmacy until 7/7/25. She denies seeking medical treatment for complaints. Pharmacist notified PCP via phone regarding symptoms with customer's permission and advised the customer to seek medical treatment same day. Customer was observed walking around store / pharmacy on 7/7/25 in person. At that time customer still had not sought medical treatment from doctor.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives all over my body, I now break out in hives 2 to 3 x a year.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest discomfort, Fear, Pericarditis
Clinical narrative: 2 pericarditis events, one in November 2022 and the other in June 2023. Continue to feel unable to do max effort physical activity for fear of trigger more events. ER visit in June 2024 with recurrence scare. June 2025 chest heat and heart aching during physical activity
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test negative
Clinical narrative: After receiving the vaccine with two doses, I was given my treatment for MS, which is Ocrevus. Dr (name withheld) checked my titers after the second dose of the vaccine, and it was clear that I had immunity. Titers looked good. I then took my dose of Ocrevus. One week later, Dr. (name withheld) checked my titers again for the COVID-19 vaccine, and they were no longer detectable.  We suspect that Ocrevus, which is used to deplete B-cells, is also depleting the vaccine. I reported this to (withheld) in June of 2020.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Back pain, Fall, Gait disturbance, Headache, Peripheral swelling
Clinical narrative: Pt broke out into hives, bilateral feet and hand swelling, and proceeded to the ED at 11:21 PM arrival time on 7/2/25. Pt given Benadryl, Famotidine, Motrin, Decadron and Zyrtec in the ED.   Pt seen in ED again on 7/3/2025 at a different ED for bilat feet/hand swelling, headache, back ache, stumbling around and falling. Vomited on the way to the ED.  Pt was given more Zyrtec and Pepcid,  Prednisone and Zofran
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Urticaria, Vomiting
Clinical narrative: Pt broke out into hives, bilateral feet and hand swelling, and proceeded to the ED at 11:21 PM arrival time on 7/2/25. Pt given Benadryl, Famotidine, Motrin, Decadron and Zyrtec in the ED.   Pt seen in ED again on 7/3/2025 at a different ED for bilat feet/hand swelling, headache, back ache, stumbling around and falling. Vomited on the way to the ED.  Pt was given more Zyrtec and Pepcid,  Prednisone and Zofran
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, Pyrexia, Stomatitis
Clinical narrative: Sore mouth, (bumps under tongue) sore tongue, elevated temperature/mild fever, headache, nauseous
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient had a large reddened raised rash distal from insertion site. Insertion site Right Deltoid Muscle.
Age: 53.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chest X-ray, Chest pain, Electrocardiogram, Herpes zoster, Malaise
Clinical narrative: Proceeded to get sick, pain in my chest severe, finally told I had Shingles left chest breast area around to my back 11/1/24 @ E.R. after I spent past 10+ days trying to get help from (withheld) medical and then E.R. all these months later I am still trying to recover still today
Age: 18.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was given an adult dose of Hep A, instead of pediatric dose as indicated by manufacturer. No adverse reactions noted.
Age: 50.0
Sex: F
Vaccine: PNC21
Symptoms: Infection, Product administered at inappropriate site
Clinical narrative: the adverse event was not due to the vaccine itself but due to administration error. The pharmacist on duty administered the vaccine lower than the deltoid, near the tricep area. Patient came in the following week on antibiotic for  infection due to the administration of the vaccine
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: pain at site, red bump, itching since vaccination - using heat/ice/benadryl. still with itch at site
Age: 1.75
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: A wrong vaccine was given at time of office visit.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Allergy to chemicals, Extra dose administered
Clinical narrative: Patient received dose of MenQuadfi given by APRN when this was not indicated, as patient had already received appropriate booster dose at age 16 on 1/13/2020 per submitted immunization records that would meet college health entry requirements. Therefore, patient was given unnecessary dose of a Meningococcal ACWY vaccine.  This was discovered on routine chart audit of health records.
Age: 26.0
Sex: F
Vaccine: CHIK
Symptoms: No adverse event, Wrong product administered
Clinical narrative: PATIENT WAS SUPPOSED TO GET JAPANESE ENCEPHALITIS BUT IXCHIQ WAS ADMINISTERD BY MISTAKE.  CALLED AND TALKED TO PATIENT WHEN ERROR WAS IDENTIFIED ON 07/07/25. PATIENT REPORTED NOT ADVERSE EFFECT.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: Client presents with mother and family members for childhood immunizations. VIS provided. Questionnaire/consent obtained/reviewed. Injections given without difficulty, bandaids applied.  Returned to lobby. Per family, went to sit on chair and lost consciousness, family member was able to keep her in chair. RN observed her slumped over in chair. Other RNs were able to move her to the ground and elevate her legs using the chair. Vitals were obtained once she was positioned to her back on the ground. Initially, systolic was in 90's, diastolic was in 40's and pulse rate was 48 beats per minute using finger probe. Carotid pulse was slow but strong to palpation. Fan and cool rags were used to help stablize client. Client started to regain consciousness by opening her eyes. BP and pulse were rechecked, improved: 112/72 and pulse rate 70 bpm. Once client was able, staff assisted her to a sitting position and then helped her the chair and elevated her legs. Client had not ate or drank anything. Client was given a sugary snack to suck on once more alert and water provided. Family and staff remained at her side for 30 minutes until he was stable enough to walk to vehicle assisted by staff and family. Reassured family that this is a possible response to receiving injections. Will make a note on chart for when client returns for 2nd hpv immunization. Plan to recline client with legs elevated next visit and encouraged eating a snack or meal before injections.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Pruritus, Rash, Swelling of eyelid
Clinical narrative: whole upper body rash, itchiness starting that night. Next morning with eyelid swelling. Starting to self-resolve, prescribed Benadryl.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Influenza virus test negative, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative
Clinical narrative: Fever of 103.7, headache
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Mobility decreased, Tenderness
Clinical narrative: Patient with persistent shoulder pain 6 days following men B vaccine. Slightly limited ROM of shoulder and tenderness in the deltoid muscle about 2-3 cm below top of the shoulder. Symptomatic care recommended.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: INCORRECTLY ADMINISTERED A THIRD DOSE OF SHINGRIX TO THIS PATIENT - RECIEVED FIRST DOSE 2/16/2022 AND SECOND DOSE 3/27/2023
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Mobility decreased, Pain in extremity
Clinical narrative: Patient reported that her R arm got really swollen and was very painful, stated she could not lift her arm. This started Friday night.  Friday night she also woke up with stomach cramping and ended up vomiting through out the day. Also had cold chills & diarrhea. This subsided on Sunday 7/6, about 3 days s/p vaccine was given.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Vomiting
Clinical narrative: Patient reported that her R arm got really swollen and was very painful, stated she could not lift her arm. This started Friday night.  Friday night she also woke up with stomach cramping and ended up vomiting through out the day. Also had cold chills & diarrhea. This subsided on Sunday 7/6, about 3 days s/p vaccine was given.
Age: 18.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Both vaccines were given at pharmacy in (withheld).   Pt has had two events of Hospitilization for Myocarditis with no prior medical conditions.  Once on 2/08/2024 and 01/28/2025.   Provider feels that they are related to COVID Vaccines.
Age: 13.0
Sex: F
Vaccine: DTAP, HPV9, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given a Dtap vaccine when she should have been given a Tdap vaccine. No abnormal reaction.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: We are not aware of any side effects from giving the wrong vaccine to the child. She was given an adult version of Hepatitis B vaccine instead of the pediatric version.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Cold sweat, Dizziness, Pallor, Vision blurred
Clinical narrative: At 10:28 am after recieving MENV and BEX pt skin appeared pale and was visibly weak/lightheaded. Skin was clammy to touch. parent reported pt had not had anything to eat this morning. pt stated vision had become blurry. Assisted by the RN. Vitals taken at 10:28 BP-106/66 02-96% P-78, 10:31 BP-110/76 02-96% P-68, 10:36 BP-101/64 02-96% P-70. pt was able to stand and ambulate as normal. pt no longer presented with pale or clammy skin and stated that he feels much better and no longer c/o blurry vision, lightheadedness, weakness. family was accompanied to facility parking lot. pt left with parent
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: 2nd day past vaccine I had hives on my face. I've had hives in 2012 so I knew what it was. I did take a photo if it needs to be seen. They were gone the next day.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Blood test normal, Chills, Dizziness, Eye disorder
Clinical narrative: I had serious flu-like symptoms for two weeks. Chills, body and muscle aches, inflammation in my knee joints, a high ringing in my ears, and extreme dizziness. My doctor started me on Prednisone 40 mg and slowly tapered. As the taper began, I developed an itchy rash along my right arm and on the right side of my trunk, and my ears began ringing again, with dizziness accompanying it, only alleviated by lying down. Since the rash developed, I?ve begun taking 40 mg of Benadryl daily, plus I have applied hydrocortisone cream 1% to the rash site, as well as triamcinilone cream. None of it has affected the itching.    In the middle,of all this, on June 18th around 4:00 pm, I was driving home and had a sudden impairment of my eyesight. As far as the retinal specialist can tell, I had a sizeable amount of tissue break off inside my right eye, creating a number of floaters in my eye. They have not gone away since then.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia, Pain, Rash, Rash pruritic
Clinical narrative: I had serious flu-like symptoms for two weeks. Chills, body and muscle aches, inflammation in my knee joints, a high ringing in my ears, and extreme dizziness. My doctor started me on Prednisone 40 mg and slowly tapered. As the taper began, I developed an itchy rash along my right arm and on the right side of my trunk, and my ears began ringing again, with dizziness accompanying it, only alleviated by lying down. Since the rash developed, I?ve begun taking 40 mg of Benadryl daily, plus I have applied hydrocortisone cream 1% to the rash site, as well as triamcinilone cream. None of it has affected the itching.    In the middle,of all this, on June 18th around 4:00 pm, I was driving home and had a sudden impairment of my eyesight. As far as the retinal specialist can tell, I had a sizeable amount of tissue break off inside my right eye, creating a number of floaters in my eye. They have not gone away since then.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Visual impairment, Vitreous floaters
Clinical narrative: I had serious flu-like symptoms for two weeks. Chills, body and muscle aches, inflammation in my knee joints, a high ringing in my ears, and extreme dizziness. My doctor started me on Prednisone 40 mg and slowly tapered. As the taper began, I developed an itchy rash along my right arm and on the right side of my trunk, and my ears began ringing again, with dizziness accompanying it, only alleviated by lying down. Since the rash developed, I?ve begun taking 40 mg of Benadryl daily, plus I have applied hydrocortisone cream 1% to the rash site, as well as triamcinilone cream. None of it has affected the itching.    In the middle,of all this, on June 18th around 4:00 pm, I was driving home and had a sudden impairment of my eyesight. As far as the retinal specialist can tell, I had a sizeable amount of tissue break off inside my right eye, creating a number of floaters in my eye. They have not gone away since then.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Arthralgia, Back pain, Computerised tomogram neck, Computerised tomogram normal, Injected limb mobility decreased
Clinical narrative: I received a Tdap vaccine in my left shoulder on April 16th, 2024. Within hours I began experiencing persistent shoulder and neck pain that did not improve with time. The pain limited my ability to lift my arm, turn my head, sleep comfortably, and perform daily activities.  I returned to the same provider multiple times over the next three months. A CT scan was performed within the first two months, but no clear diagnosis was made and I was not offered further treatment or imaging like MRI or ultrasound.  The pain continued for over 15 months, radiating into my neck , upper back and shoulders. I later sought care from a sports medicine physician, received a cortisone injection and was prescribed oral steroids. An X-ray showed arthritis, but my symptoms began immediately after the injection and had never occurred prior.  At the time of this report, symptoms have recently improved slightly, but I continue to seek evaluation for a possible vaccine related shoulder injury. No soft tissue imaging has been performed yet.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Neck pain, Osteoarthritis, Pain
Clinical narrative: I received a Tdap vaccine in my left shoulder on April 16th, 2024. Within hours I began experiencing persistent shoulder and neck pain that did not improve with time. The pain limited my ability to lift my arm, turn my head, sleep comfortably, and perform daily activities.  I returned to the same provider multiple times over the next three months. A CT scan was performed within the first two months, but no clear diagnosis was made and I was not offered further treatment or imaging like MRI or ultrasound.  The pain continued for over 15 months, radiating into my neck , upper back and shoulders. I later sought care from a sports medicine physician, received a cortisone injection and was prescribed oral steroids. An X-ray showed arthritis, but my symptoms began immediately after the injection and had never occurred prior.  At the time of this report, symptoms have recently improved slightly, but I continue to seek evaluation for a possible vaccine related shoulder injury. No soft tissue imaging has been performed yet.
Age: 36.0
Sex: M
Vaccine: DTAP
Symptoms: Sleep disorder, X-ray limb abnormal
Clinical narrative: I received a Tdap vaccine in my left shoulder on April 16th, 2024. Within hours I began experiencing persistent shoulder and neck pain that did not improve with time. The pain limited my ability to lift my arm, turn my head, sleep comfortably, and perform daily activities.  I returned to the same provider multiple times over the next three months. A CT scan was performed within the first two months, but no clear diagnosis was made and I was not offered further treatment or imaging like MRI or ultrasound.  The pain continued for over 15 months, radiating into my neck , upper back and shoulders. I later sought care from a sports medicine physician, received a cortisone injection and was prescribed oral steroids. An X-ray showed arthritis, but my symptoms began immediately after the injection and had never occurred prior.  At the time of this report, symptoms have recently improved slightly, but I continue to seek evaluation for a possible vaccine related shoulder injury. No soft tissue imaging has been performed yet.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Rash, Skin warm, Urticaria
Clinical narrative: R Arm: Hives, redness, soreness, warm to the touch. Face: rash
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: R arm progressively became more swollen, hard, warm  over the 24 hours after injection. Itchy at the sire of injection. Improved on it's own after several days.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Brain fog, COVID-19, Disorientation, Fatigue
Clinical narrative: Pt states he had fatigue the next day after vaccine. The following Monday he was disoriented that continued Tuesday so he took a home covid test that was positive. His PCP started him on Paxlovid. He took another covid test about a week later and it was negative. He thinks he misread the covid test that it wasn't positive because he was so disoriented. He has brain fog and get confused like he lost his perception to detail to what he is trying to see and read.  It was scary since he has never experienced anything like this before. These symptoms seem to be a little better today. Temperature was slightly elevated first couple of days but is back to normal.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Pt states he had fatigue the next day after vaccine. The following Monday he was disoriented that continued Tuesday so he took a home covid test that was positive. His PCP started him on Paxlovid. He took another covid test about a week later and it was negative. He thinks he misread the covid test that it wasn't positive because he was so disoriented. He has brain fog and get confused like he lost his perception to detail to what he is trying to see and read.  It was scary since he has never experienced anything like this before. These symptoms seem to be a little better today. Temperature was slightly elevated first couple of days but is back to normal.
Age: 1.92
Sex: M
Vaccine: DTPPVHBHPB, MMR
Symptoms: Gait disturbance, Injection site pain, Pyrexia
Clinical narrative: Leg pain causing toddler to not want to bear his own weight on right leg. Fever (to be expected) after 24 hours leg pain still present, Tylenol helped pain but limping still occurring. This is not a normal reaction.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, MMRV, MNQ, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Inadvertently gave MMRV to client instead of administering separately an MMR vaccine and a Varicella  vaccine. Client was verbally informed of the error and instructed to return to the health clinic in one month to receive the two requested vaccines (MMR & VAR). Client was observed and showed no adverse effects. Client was provided a current vaccine record which listed the administration of the combination vaccine (MMRV).
Age: 75.0
Sex: F
Vaccine: COVID19, IPV
Symptoms: Agitation, Balance disorder, Blood test, Chest discomfort, Dizziness
Clinical narrative: Weird weighty feeling in chest, mild deminished breathing, bad headache, R inner ear hurting, severe dizziness and difficulty with balance more than usual, nausea and mental agitation.  Went to (withheld name) Hospital ER to see if vertigo or stroke...given morphine for headache, given MRI with and w/o contrast.  Dr. felt not vertigo and not stroke.  R arm had begun itching and turning red so put Cortisone on it and relieved itch. Sent home and took 3-4 days to begin recovery....fatigue still and take Rx for nausea which is better.
Age: 75.0
Sex: F
Vaccine: COVID19, IPV
Symptoms: Ear pain, Electrocardiogram, Erythema, Fatigue, Headache
Clinical narrative: Weird weighty feeling in chest, mild deminished breathing, bad headache, R inner ear hurting, severe dizziness and difficulty with balance more than usual, nausea and mental agitation.  Went to (withheld name) Hospital ER to see if vertigo or stroke...given morphine for headache, given MRI with and w/o contrast.  Dr. felt not vertigo and not stroke.  R arm had begun itching and turning red so put Cortisone on it and relieved itch. Sent home and took 3-4 days to begin recovery....fatigue still and take Rx for nausea which is better.
Age: 75.0
Sex: F
Vaccine: COVID19, IPV
Symptoms: Magnetic resonance imaging, Nausea, Pruritus, Respiratory rate decreased, Scan with contrast
Clinical narrative: Weird weighty feeling in chest, mild deminished breathing, bad headache, R inner ear hurting, severe dizziness and difficulty with balance more than usual, nausea and mental agitation.  Went to (withheld name) Hospital ER to see if vertigo or stroke...given morphine for headache, given MRI with and w/o contrast.  Dr. felt not vertigo and not stroke.  R arm had begun itching and turning red so put Cortisone on it and relieved itch. Sent home and took 3-4 days to begin recovery....fatigue still and take Rx for nausea which is better.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Chronic fatigue syndrome, Depression
Clinical narrative: Anxiety, depression, and chronic fatigue syndrome- years of medication, therapy, TMS therapy
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased
Clinical narrative: Patient called stating hours after he received the vaccine, he was unable to move his left arm.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Blister
Clinical narrative: I woke this morning from after getting it and i broke out with blisters all over my hands and some on my legs also on my feet. I am homeless so i live in my vehicle. I have a doctors appoint July 16th to get it checked out.
Age: 69.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema
Clinical narrative: Pt reported redness around the injection site this morning.  Or was contacting md
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: PATIENT RECEIVED A SECOND DOSE OF RSV VACCINE ONCE SHE REQUESTED ON IMMUNIZATION CONSENT FORM.  RPH FAILED TO VERIFY IN WEBSITE IF SHE HAD ALREADY RECEIVED IT.  ONCE THIS ERROR WAS REPORTED FROM PHARMACY CUSTOMER EXPERIENCE TO THE PHARMACY 2 DAYS AFTER, WE HAD CONTACTED PATIENT. SHE WAS ASKED ABOUT A POSSIBLE SIDE EFFECTS SUCH AS FEVER, FATIGUE, OR INJECTION SITE PAIN. PATIENT DID NOT EXPERIENCED ANY OF THEM AND CONFIRMED THAT SHE HAD REQUESTED AND SIGNED ADMINISTRATION OF RSV
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and minor swelling around the injection site. No pain or heat.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose received after 6 months (longer than recommended); 2nd dose received on 21st days; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient received the 3rd dose of Twinrix and the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 3rd dose received after 6 months (longer than recommended)) and drug dose administration interval too short (Verbatim: 2nd dose received on 21st days). The outcome of the drug dose administration interval too long and drug dose administration interval too short were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-JUN-2025 The reporter was a female adult patient. The patient was also a HCP (Pharmacist). The patient received Twinrix in 2013 or 2014. The patient received Twinrix at 0 month, 21 days, and 6-month schedule. The patient received 3rd dose of Twinrix,?later than the recommended interval, which led to lengthening of vaccinations schedule. The patient received 2nd dose of Twinrix,?earlier than the recommended interval, which led to shortening of vaccinations schedule. This case is linked with US2025081319 reported by same reporter.; Sender's Comments:  US-GSK-US2025081319:Same reporter,Different patient
Age: 67.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Inappropriate schedule of product administration, Skin warm
Clinical narrative: arm was warmer; received the second dose 1 month ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin warm in a 67-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis.   Previously administered products included Shingrix (received the first dose of shingrix in 2019). Concurrent medical conditions included diabetes (Diabetes).   In MAY-2025, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received Influenza vaccine. In MAY-2025, an unknown time after receiving Shingles vaccine and Influenza vaccine, the patient experienced drug dose administration interval too long (Verbatim: received the second dose 1 month ago). On an unknown date, the patient experienced skin warm (Verbatim: arm was warmer). The outcome of the skin warm was unknown and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the skin warm to be related to Shingles vaccine and Influenza vaccine.     It was unknown if the company considered the skin warm to be related to Shingles vaccine and Influenza vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2025 The patient's arm was warmer for the second shot of Shingrix than when he got the flu vaccine. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. This case was linked with US2025AMR083726, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2025AMR083726:husband case
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: He has not yet had the second dose which was due between 24 Dec 2024 and 24 Apr 2025, but will receive it today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 24-OCT-2024, the patient received 1st dose).   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: He has not yet had the second dose which was due between 24 Dec 2024 and 24 Apr 2025, but will receive it today). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-JUL-2025 This report was submitted via the online direct entry reporting system. The Pharmacy technician reported that the patient received his first dose on 24 Oct 2024. The patient not yet had the second dose which was due between 24-Dec-2024 and 24-Apr-2025 but would receive it on the day of reporting. Till the time of reporting the patients did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first dose of Shingrix a year ago. 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 adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year ago).   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: received her first dose of Shingrix a year ago. She never received her second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 03-JUL-2025 The patient self-reported this case. The patient received her first dose of Shingrix a year ago and never received her second dose Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: RSV
Symptoms: Migraine
Clinical narrative: migraine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of migraine in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced migraine (Verbatim: migraine). The outcome of the migraine was not reported.   It was unknown if the reporter considered the migraine to be related to Arexvy.     It was unknown if the company considered the migraine to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a patient via interactive digital media. Patient stated that after receiving Arexvy vaccine they get migraines often.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had a dose of Shingrix 5 years ago, had another dose yesterday; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 5 years ago).   On 28-JUN-2025, the patient received the 2nd dose of Shingrix. On 28-JUN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: had a dose of Shingrix 5 years ago, had another dose yesterday). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 29-JUN-2025 The patient received 2nd dose at longer interval than recommended which led lengthening of vaccination schedule. The reporter asked did he/she need a third dose in 2 to 4 months.
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site
Clinical narrative: i have taken first dose of Shingrix at buttock; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of vaccine administered at inappropriate site in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: i have taken first dose of Shingrix at buttock). The outcome of the vaccine administered at inappropriate site was not applicable.   Additional Information: GSK Receipt Date: 28-JUN-2025 This case was reported by a patient via interactive digital media. The reporter reported that have taken first dose of Shingrix at buttock which led to vaccine administered at inappropriate site. The reporter asked was it ok.
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, 4 months 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: 02-JUL-2025 This case was reported by a patient via interactive digital media. The patient mentioned he/she got the shot of Shingles vaccine and then got the shingles four months after the vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule 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 and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-day-old female patient who received HBV (Engerix B) (batch number 92DJ3, expiry date 03-MAY-2025) for prophylaxis.   On 18-JUN-2025, the patient received Engerix B. On 18-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 License practice nurse called to report that a 5 days old female patient received an expired dose of Engerix-B. The vaccine was expired since 5/3/2025 and the patient received it today on 6/18/2025. The reporter asked do we have to revaccinate the patient.