chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Patient presents with mother to the facility this date following a vaccine reaction given by Public Health on 06/25/2025. Mother reports onset of symptoms occurred last night, 06/26/2025 to include temperature of 100.1, erythema, and edema to the left upper extremity extending mid upper arm.  Examination unremarkable with the exception of a flat, reddened rash and mild- moderate edema localize to the left upper extremity, starting at superior aspect of extremity extending to mid upper extremity. Injection site raised, measuring approximately 10mm x 8mm with erythema, edema, warmth and tenderness to touch. Otherwise, general appearance normal. Patient/mother instructed to continue with children's Tylenol and ibuprofen as directed on packaging. To apply cold compress to affected area five times per day x 10 minutes as needed. May also use children's Benadryl as directed on packaging. Discussed red flag symptoms in which to present to nearest ER. Reassured mother of localized allergic reaction, who stated patient's left upper arm is already getting better, that this is likely a delayed onset reaction, not uncommon, and the fact that it is already improving is a good sign. Informed her vaccinate benefits still outweighs risk. Informed mother reaction site should continue getting better and be resolved within the next week or so. Otherwise, she is to return to either location of administration or the facility.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Myalgia, Pyrexia, Skin tightness
Clinical narrative: Patient presents with mother to the facility this date following a vaccine reaction given by Public Health on 06/25/2025. Mother reports onset of symptoms occurred last night, 06/26/2025 to include temperature of 100.1, erythema, and edema to the left upper extremity extending mid upper arm.  Examination unremarkable with the exception of a flat, reddened rash and mild- moderate edema localize to the left upper extremity, starting at superior aspect of extremity extending to mid upper extremity. Injection site raised, measuring approximately 10mm x 8mm with erythema, edema, warmth and tenderness to touch. Otherwise, general appearance normal. Patient/mother instructed to continue with children's Tylenol and ibuprofen as directed on packaging. To apply cold compress to affected area five times per day x 10 minutes as needed. May also use children's Benadryl as directed on packaging. Discussed red flag symptoms in which to present to nearest ER. Reassured mother of localized allergic reaction, who stated patient's left upper arm is already getting better, that this is likely a delayed onset reaction, not uncommon, and the fact that it is already improving is a good sign. Informed her vaccinate benefits still outweighs risk. Informed mother reaction site should continue getting better and be resolved within the next week or so. Otherwise, she is to return to either location of administration or the facility.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: Patient had reported that the next day she got hives, swelling and redness in a large area on her arm for 3 weeks.  She went to see MD the first week and her doctor said she is allergic to Prevnar 20.  It went away after 3 weeks, she is ok now but she wants to report it.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Pt has a red, swollen,  warm arm after her vaccination. I discussed she can use ice, tylenol, and ibuprofen
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in for 12 year well child appointment. She cancelled her 11 year well child and had not been seen since she was 9 years old. I gave her the 11/12 year old immunizations- they did not show previously given in her chart. Parent of child did not express that she had received her immunizations at 11 since she was not seen. I always double check with the parents the immunizations that are needed/given.  act(s) contributed to the incident? I checked her chart- which showed she had not had these immunizations. I did not check database because parent did not inform me that she may have had them, she was seen before and she was not from out of state. These are usually the reasons I double check database. Database is not always checked by back office because not all employees have a database log in. Because I informed the parent of the need of immunizations and they did not inform me of previous immunizations given. No adverse reactions have been reported over the past year.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Asthenia, Clumsiness, Dizziness
Clinical narrative: In serious pain on the shoulder all the way down to the wrists with bodyaches, had swelling in the armpit of the left arm where vaccine was given but swelling has gone down. Other things going on are feeling weak, unsteady, almost clumsy, dizziness, abd pain, headaches.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: In serious pain on the shoulder all the way down to the wrists with bodyaches, had swelling in the armpit of the left arm where vaccine was given but swelling has gone down. Other things going on are feeling weak, unsteady, almost clumsy, dizziness, abd pain, headaches.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Anxiety, Blood pressure abnormal, Nervousness, Pallor, Vomiting
Clinical narrative: When into pt room, verified correct pt, Verified with mom she read VIS, Pt mother stated he hadn't aten anything.  Pt was feeling nervous and anxious.  Gave pt vaccines pt was fine. Walked out the room, pt mother asked us for water, gave pt water and popsicle , Pt looked paled and wanted to throw up, grabbed vomiting bag, Pt started throwing up spit, pt looked pale, Other M.A. took blood pressure,  we repeated taking blood pressure till normal range, Doctor when in 2 times to check up on patient. Pt left after 30 minuets of observation
Age: 18.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I did not look at shot database. It has only been 7 years since last shot. Haven't been able to reach patient as of yet.
Age: 74.0
Sex: F
Vaccine: HEP, RSV
Symptoms: Extra dose administered
Clinical narrative: Vaccine was administered outside of ACIP guidelines.  (Patient received 1st dose 1/14/25)
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased
Clinical narrative: patient could not move left arm starting about 4:30pm, EMT was called and they stated it was not a reaction to the vaccine but may have hit a nerve. It is 75% better as stated by patient.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: none reported, spoke with parent at 7:45 pm about 1.5 hours after the vaccine was given and he stated there were no current adverse events
Age: 13.0
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: Pt. fainted / dizzy per mother.
Age: 11.0
Sex: M
Vaccine: MNP, TDAP
Symptoms: Rash, Rash erythematous, Rash macular
Clinical narrative: A red, splotchy rash developed on patient's left arm the day after Penbraya was administered into left arm.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reports RECOMBIVAX HB was inadvertently administered to a patient following a TE.; This spontaneous report was received from a consumer and refers to a female patient of unknown age.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 25-Jun-2025, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (lot #Unknown), dose number 1, (expiration date was not reported) for prophylaxis (product storage error). No adverse event was reported.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gestational diabetes, Maternal exposure before pregnancy, Neonatal disorder, Polyhydramnios
Clinical narrative: Patient was vaccinated three times for covid 19. Her last vaccine was in 2022.  She gave birth to her first child on 12/28/2024 who was discovered to have a congenital birth defect- severe coarctation of the aorta on 1/13/2025 when he presented to our office with tachypnea and retractions and grunting.   Maternal prenatal care was adequate.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Bell's palsy, Blood test, Cerebrovascular accident, Magnetic resonance imaging head abnormal, Scan
Clinical narrative: Bells Palsy on right side of face presenting itself on 6/10 and still prevalent. Evidence of stroke from MRI findings in emergency room. Bells Palsy is not believed to be stroke related.
Age: 1.67
Sex: F
Vaccine: VARCEL
Symptoms: Computerised tomogram head, Electroencephalogram, Injection site erythema, Injection site mass, Laboratory test
Clinical narrative: 5/1: redness, lump (delayed from when vaccine given on 4/20).  5/4: vomit 1x  5/7: 2 seizures
Age: 1.67
Sex: F
Vaccine: VARCEL
Symptoms: Seizure, Vomiting
Clinical narrative: 5/1: redness, lump (delayed from when vaccine given on 4/20).  5/4: vomit 1x  5/7: 2 seizures
Age: 26.0
Sex: M
Vaccine: CHIK, TYP
Symptoms: Arthritis, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Tuesday morning started feeling joint inflammation / stiffness / discomfort. Primarily knees, feet, ankles, and back. Continued on Wednesday. Thursday I felt really bad when I woke up. I was feverish with my head feeling warm and chills in my body. Join discomfort continued. And developed a moderate headache with full pain. I took some advil around 8am and that helped alleviate most symptoms. Also developed a sore throat that has lasted 3 days. It is now Saturday, June 28th and I still have joint discomfort, a headache, and feverish symptoms. This is significantly longer than the 2 day median in their informational pamphlet. I?ve never had a bad vaccine reaction before. I feel like I have the flu
Age: 26.0
Sex: M
Vaccine: CHIK, TYP
Symptoms: Joint stiffness, Musculoskeletal discomfort, Musculoskeletal stiffness, Oropharyngeal pain, Pain
Clinical narrative: Tuesday morning started feeling joint inflammation / stiffness / discomfort. Primarily knees, feet, ankles, and back. Continued on Wednesday. Thursday I felt really bad when I woke up. I was feverish with my head feeling warm and chills in my body. Join discomfort continued. And developed a moderate headache with full pain. I took some advil around 8am and that helped alleviate most symptoms. Also developed a sore throat that has lasted 3 days. It is now Saturday, June 28th and I still have joint discomfort, a headache, and feverish symptoms. This is significantly longer than the 2 day median in their informational pamphlet. I?ve never had a bad vaccine reaction before. I feel like I have the flu
Age: 26.0
Sex: M
Vaccine: CHIK, TYP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Tuesday morning started feeling joint inflammation / stiffness / discomfort. Primarily knees, feet, ankles, and back. Continued on Wednesday. Thursday I felt really bad when I woke up. I was feverish with my head feeling warm and chills in my body. Join discomfort continued. And developed a moderate headache with full pain. I took some advil around 8am and that helped alleviate most symptoms. Also developed a sore throat that has lasted 3 days. It is now Saturday, June 28th and I still have joint discomfort, a headache, and feverish symptoms. This is significantly longer than the 2 day median in their informational pamphlet. I?ve never had a bad vaccine reaction before. I feel like I have the flu
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Emotional distress, Eye pruritus, Injection site rash, Ocular hyperaemia
Clinical narrative: Within about 15 minutes of receiving the vaccine, as he was in the parking lot leaving clinic, the patient had an episode of vomiting, which was originally thought to be related to crying and emotional distress about the vaccinations. He then fell asleep in the car on the way home, which is very atypical for him. When he got home about 30 minutes later (45 minutes after receiving the vaccine) his parent noted scattered large areas of confluent erythematous rash involving the extremities, torso, and face. He also developed periorbital swelling, eye redness, and itchy eyes. A dose of Benadryl was given, and rash resolved. He was able to eat a normal dinner that night and slept well. In the morning he still had residual periorbital swelling and eyes were still injected. He never had any respiratory symptoms, and his physical exam at 10am the morning after the episode was notable only for periorbital swelling, conjunctival injection, and a few excoriations on the lower abdomen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Periorbital swelling, Rash, Rash erythematous, Skin irritation, Somnolence
Clinical narrative: Within about 15 minutes of receiving the vaccine, as he was in the parking lot leaving clinic, the patient had an episode of vomiting, which was originally thought to be related to crying and emotional distress about the vaccinations. He then fell asleep in the car on the way home, which is very atypical for him. When he got home about 30 minutes later (45 minutes after receiving the vaccine) his parent noted scattered large areas of confluent erythematous rash involving the extremities, torso, and face. He also developed periorbital swelling, eye redness, and itchy eyes. A dose of Benadryl was given, and rash resolved. He was able to eat a normal dinner that night and slept well. In the morning he still had residual periorbital swelling and eyes were still injected. He never had any respiratory symptoms, and his physical exam at 10am the morning after the episode was notable only for periorbital swelling, conjunctival injection, and a few excoriations on the lower abdomen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Within about 15 minutes of receiving the vaccine, as he was in the parking lot leaving clinic, the patient had an episode of vomiting, which was originally thought to be related to crying and emotional distress about the vaccinations. He then fell asleep in the car on the way home, which is very atypical for him. When he got home about 30 minutes later (45 minutes after receiving the vaccine) his parent noted scattered large areas of confluent erythematous rash involving the extremities, torso, and face. He also developed periorbital swelling, eye redness, and itchy eyes. A dose of Benadryl was given, and rash resolved. He was able to eat a normal dinner that night and slept well. In the morning he still had residual periorbital swelling and eyes were still injected. He never had any respiratory symptoms, and his physical exam at 10am the morning after the episode was notable only for periorbital swelling, conjunctival injection, and a few excoriations on the lower abdomen.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dehydration, Diarrhoea, Malaise, Vomiting
Clinical narrative: Patient states that 2 hours after 2ne shingles dose, she felt sick. She had vomiting and diarrhea which resulted in dehydration. Patient is 93 and frail. She ended up going to ER for dehydration. Patient is fine today. No further side effects reported. Patient does not seek any monetary damages. She reported incident to us 3 days ago(06/25/2025).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Eye pain, Gastric cancer, Headache, Visual impairment
Clinical narrative: I took the Moderna on 02/11/2021 2-4 days later I was getting headaches, small amount of lower vision of both eyes, and I put in my glaucoma eye drops to relieve the aching feeling. I took the second Moderna shot on 03/11/2021 at (redacted) Pharmacy and 3 or 4 days later, the symptoms came back, I thought maybe it?s my glasses. So I went to look at my prescriptions on my glasses to see if there was a problem. So I ordered new glasses on May 8th at (eye doctor), and asked for the doctor, I needed them to check my eyes and renew a prescription called (redacted). I had been diagnosed with cancer of the stomach and I had an operation date of May 13th 2021 I went to a cancer center in (redacted) for the operation and stayed in the hospital for several days. I was still complaining about my eyes at the time, and I was using three different eyedrops at the time. And they told me when I get released from the hospital to contact my eye doctor, which at the time was Dr. (redacted) at (redacted) and she checked my eyes and said I was going blind, I could not understand it, everything was going fine. My pressure was maintained and I was on eyedrops, my left eye had problems, but my right eye was 20/20 and was working fine, after being total discouraged with my Doctor. I changed to Dr. (redacted). And she performed several different operations. When i mentioned about the Moderna vaccine to Dr. (redacted), she discarded it, after all operations were complete, my left eye was totally blind and I can only see white clouds and blindness out of my right eye. And every time I mentioned anything about the vaccine, it was always discarded, no matter anyone I talk to, then I heard about some people having problems with their eyes after receiving the Moderna shot and I realized that I could be one of the individuals that could have been affected.
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Cellulitis, Decreased appetite, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: Swollen leg, red, fever 103, loss of appetite, fatigue,
Age: 2.0
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Swollen leg, red, fever 103, loss of appetite, fatigue,
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent tinnitus
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Biopsy skin abnormal, Condition aggravated, Diarrhoea, Drug hypersensitivity, Fatigue
Clinical narrative: Multiple Skin disorders, 6 SSQ skin cancers, Accelerated drug sensitivity, Accute IBS-D  - Treatments are ongoing for skin disorders and SSQ skin cancers. Daily issues and occasional Flares with intestinal flares. Additionally, Fatigue for past years since vaccine.
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Irritable bowel syndrome, Squamous cell carcinoma
Clinical narrative: Multiple Skin disorders, 6 SSQ skin cancers, Accelerated drug sensitivity, Accute IBS-D  - Treatments are ongoing for skin disorders and SSQ skin cancers. Daily issues and occasional Flares with intestinal flares. Additionally, Fatigue for past years since vaccine.
Age: 79.0
Sex: M
Vaccine: PNC21
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient received vaccine. Next day, wife stopped into the pharmacy to state that patient was stating his arm was "more sore" than usual and that it was painful to raise.  Suggested to ice the location, take some anti-inflammatories, and reach out to medical provider if not better in 3 days.
Age: 84.0
Sex: M
Vaccine: HEPAB
Symptoms: Injection site bruising, Injection site mass
Clinical narrative: Patient reported to the pharmacy on 6/28/25 stating a couple days after injection on  6/19/25 that patient developed a bruise and has only gotten worse , upon visual inspection there is a decent size bruise at the injection site with a purple center and yellowing around the outside, told patient that the yellowing bruise is signs of healing. patient also mentioned that there is a tiny bump at the injection side itself. patient mentioned if it does not get better this week he is going to the doctors office to get it looked at.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: swelling to left deltoid injection site with induration. induration approx 3mm thick, size of induration 30x20 oval shaped with redness surrounding the induration approx 5mm all around
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin abnormal, Malignant melanoma stage I, Skin neoplasm excision
Clinical narrative: I don't know if this is related to the COVID vaccine, but I wanted to report this.  I was diagnosed with Melanoma Stage 1 following a skin biopsy.  The cancer was removed via excision and the margins were clear.  There is no history of skin cancer in my family prior to me being diagnosed.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Product administered at inappropriate site
Clinical narrative: The patient reported to the pharmacy on 6/28 that his vaccine given by the pharmacist on duty on 5/29 was given too high up his shoulder resulting with shoulder pain lingering till today. He has had pain since the injection was given and it has not improved. I recommended the patient to take OTC pain relievers and contact his prescriber or doctor to check his shoulder for any damage. I recommended movement and possible physical therapy depending on his doctor's recommendation.
Age: 33.0
Sex: F
Vaccine: HEPAB, MMR
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Fatigue, diarrhea, headache
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Influenza like illness, Myalgia, Pyrexia, Somnolence
Clinical narrative: Within four hours I was having flu-like symptoms with chills, muscle aches, low fever, weakness, and sleepiness.  This continued for 36 hours.  All symptoms went away after 36 hours except weakness.  I am now on day 4 after the injection and am still feeing considerable weakness.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Calcinosis, Injection site haematoma, Injection site haemorrhage, Injection site pain, Injection site reaction
Clinical narrative: Bleeding post vaccine, followed by immense pain, and formation of small lump inside muscle, causing pain during activity. Pain caused patiwnt to withdraw from normal activity. Doctor assessed on June 23 that hematoma and calcium deposit had formed due to administration of vaccine.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Loss of personal independence in daily activities
Clinical narrative: Bleeding post vaccine, followed by immense pain, and formation of small lump inside muscle, causing pain during activity. Pain caused patiwnt to withdraw from normal activity. Doctor assessed on June 23 that hematoma and calcium deposit had formed due to administration of vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Vitiligo
Clinical narrative: Vitiligo was discovered under my armpits and spreading rapidly, I did multiple rounds of laser treatment with XTRACT laser.  Lifelong autoimmune condition with no cure.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Autophony, Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: Sudden hearing loss left ear on 5/22/25, ringing, echoing, oral steroids within 24 hours of symptom onset, steroid injections x 2 directly into the ear, low tone hearing loss.  We ironically have an acquaintance who had the same symptoms and treatment 2 weeks after her Pfizer vaccine and has also been left with significant hearing loss.  This is not something people in their 40's should be experiencing.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Sudden hearing loss left ear on 5/22/25, ringing, echoing, oral steroids within 24 hours of symptom onset, steroid injections x 2 directly into the ear, low tone hearing loss.  We ironically have an acquaintance who had the same symptoms and treatment 2 weeks after her Pfizer vaccine and has also been left with significant hearing loss.  This is not something people in their 40's should be experiencing.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Dizziness, Nausea
Clinical narrative: Nausea and dizziness; patient admitted after onset of symptoms to having not had anything to eat or drink yet that day. Pharmacy offered water and snack, patient declined both. Pharmacy purchased a Propel electrolyte beverage which patient did accept to drink. Pharmacist asked patient to remain seated until symptoms subsided but patient remained for approximately 15 minutes then cautiously left.  Pharmacist repeatedly asked him to please be very careful and to let the pharmacy know when he got home safely. Followed up with patient on next day AM and he said he is "completely fine" and felt better once he got home and ate the day prior.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Blood calcium normal, Blood folate normal, Blood thyroid stimulating hormone decreased, Calcium ionised normal, Electromyogram normal
Clinical narrative: Patient developed paresthesias of both feet, both hands, face and tongue over the course of 24 hours.  These have lasted until now.  Course of prednisone starting at 40 mg x 3 days and tapering down from there did not improve symptoms
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Magnetic resonance imaging neck normal, Paraesthesia, Paraesthesia oral, Vitamin B12 normal
Clinical narrative: Patient developed paresthesias of both feet, both hands, face and tongue over the course of 24 hours.  These have lasted until now.  Course of prednisone starting at 40 mg x 3 days and tapering down from there did not improve symptoms
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral disorder, Pain, Pain in jaw
Clinical narrative: Patient reported left sided jaw pain starting 2 hours after receiving Shingrex vaccine. She states she had Shingles infection in the same area including oral lesions 1 month prior to receiving the vaccine, and the pain after the vaccine was similar to the pain she had with the shingles infection.
Age: 31.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: Administered via intramuscular injection instead of subcutaneous.
Age: 74.0
Sex: F
Vaccine: COVID19, RSV, VARZOS
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Patient reported developing severe adverse reactions for 3 days following vaccinations.  Reported fever of 101, severe fatigue/acheness, and swelling around lymphnodes in armpit/breast area
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Laboratory test, Macular telangiectasia
Clinical narrative: 1st shot was 4/13/2021 & second shot was 5/11/2021;   Adverse effects: Two issues occurred after the shots:  1)   There were long term pain in both arms at site of each injection.  Treatment - no further COVID-19 shots and began to tak "Chela-Nox" to detox the effects of the shots. Outcome: pain is seldom felt anymore. 2)  MacTel, or macular telangiectasia: Within three months of the second dose, i began to experience issues with both eyes. (redacted) Eye Institute on 8/26/2021 diagnosed that i had developed MacTel, or macular telangiectasia.  Treatment - no further COVID-19 shots and began to take AREDS twice a day. Outcomes:  stabilized but not going away at this time.
Age: 51.0
Sex: M
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Dizziness, Hypersensitivity, Rash, Rash erythematous, Vision blurred
Clinical narrative: Pt is having a allergic reaction with red rash on face and neck. Pt also felt dizziness and blurred vision on 6/29/25 at 3 pm when he visited pharmacy
Age: 51.0
Sex: M
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Fatigue, Rash, Rash erythematous, Rash papular
Clinical narrative: Pt is having a allergic reaction with red rash on face and neck. Pt also felt dizziness and blurred vision on 6/29/25 at 3 pm when he visited pharmacy
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: PATIENT REPORTED RED RASH AROUND INJECTION SITE OF 5MM DIAMETER CAUSING ITCHING AND SWELLING
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given an extra dose of MenQuadfi instead of Bexero. No adverse effects or reactions observed or noted.Pt was requesting a Meningococcal B vaccine for college. Patient was consulted for the Mengicoccal B vaccine. I highlighted the Mengicoccal B space on the CIS and entered the date after patient received her vaccine in the Meningococcal B space on the CIS. I accidently wrote MenACWY  on the consent from and this resulted in the patient receiving the MenACWY. I notified the on-call provider about the patient receiving the extra dose of MenACWY. She advised that the patient would not have any adverse reactions to the extra dose and it would be safe if the patient came back and received the correct Meningococcal B vaccine. The patient was notified via phone call with no answer. The patient was then notified via text and she call me back. She gave verbal understanding about the incident and decided to come back and receive the correct vaccine. Pt did return and received the Meningococcal B vaccine. Pt was monitored and no noted reactions were observed. She received education regarding any adverse and urgent side effects and who to notify in case of an emergency. Pt gave verbal understanding.
Age: 55.0
Sex: F
Vaccine: PNC15
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: headache, fatigue, and red, swollen arm at the injection site. lasted several days
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule
Clinical narrative: Patient states they have had "knot" in arm since administration with no other symptoms.  Advised patient to keep watch if no improvement continues to follow-up with PCP.  Knot is not interfering with QOL currently
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Fatigue, Headache, Joint swelling
Clinical narrative: arthralgia, myalgia, chronic fatique, headaches, nausea, and very swollen and painful left middle finger knuckle. I could not lift anything with my left hand for several days due to the pain and driving was even painful. It has since gone away, however, I still feel mild pain in the knuckle. It has never felt the same since the vaccination. I really felt extremely unwell and had very little energy to do my exercise. It lasted about 6 weeks. I do feel better now.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Myalgia, Nausea, Pain
Clinical narrative: arthralgia, myalgia, chronic fatique, headaches, nausea, and very swollen and painful left middle finger knuckle. I could not lift anything with my left hand for several days due to the pain and driving was even painful. It has since gone away, however, I still feel mild pain in the knuckle. It has never felt the same since the vaccination. I really felt extremely unwell and had very little energy to do my exercise. It lasted about 6 weeks. I do feel better now.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: On 06/27/25, patient presented with mother at clinic due to concerns regarding Menquadfi injection reaction that was administered by clinic on 06/25/25. Left arm was red, swollen, taut and very warm to touch from armpit up to acromion process and spanning all across upper arm. Mother stated that patient has been complaining of extreme soreness at site of injection with fever and muscle aches. Mother stated  patient was given Tyenol for fever and pain on 06/26. She applied a Salonpas to help relieve pain. Referred them to get further evaluation completed by Doctor/Nurse Practitioner. Mother stated that they would be following up at another clinic.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site swelling, Rash macular
Clinical narrative: On 06/27/25, patient presented with mother at clinic due to concerns regarding Menquadfi injection reaction that was administered by clinic on 06/25/25. Left arm was red, swollen, taut and very warm to touch from armpit up to acromion process and spanning all across upper arm. Mother stated that patient has been complaining of extreme soreness at site of injection with fever and muscle aches. Mother stated  patient was given Tyenol for fever and pain on 06/26. She applied a Salonpas to help relieve pain. Referred them to get further evaluation completed by Doctor/Nurse Practitioner. Mother stated that they would be following up at another clinic.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: On 06/27/25, patient presented with mother at clinic due to concerns regarding Menquadfi injection reaction that was administered by clinic on 06/25/25. Left arm was red, swollen, taut and very warm to touch from armpit up to acromion process and spanning all across upper arm. Mother stated that patient has been complaining of extreme soreness at site of injection with fever and muscle aches. Mother stated  patient was given Tyenol for fever and pain on 06/26. She applied a Salonpas to help relieve pain. Referred them to get further evaluation completed by Doctor/Nurse Practitioner. Mother stated that they would be following up at another clinic.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Myalgia, Pyrexia, Skin tightness
Clinical narrative: On 06/27/25, patient presented with mother at clinic due to concerns regarding Menquadfi injection reaction that was administered by clinic on 06/25/25. Left arm was red, swollen, taut and very warm to touch from armpit up to acromion process and spanning all across upper arm. Mother stated that patient has been complaining of extreme soreness at site of injection with fever and muscle aches. Mother stated  patient was given Tyenol for fever and pain on 06/26. She applied a Salonpas to help relieve pain. Referred them to get further evaluation completed by Doctor/Nurse Practitioner. Mother stated that they would be following up at another clinic.
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP reported a lot of PROQUAD was administered on 23MAY2025 after the product experienced a temperature excursion on 19MAY2025.  No symptoms reported.  HCP consented to correspondence.  See related AE case 02817288.  No additional AEs/No PQC reported; No symptoms reported; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender.   The patient's medical history, historical drugs, known drug allergies, concurrent conditions, and concomitant therapies were not reported. On 19-May-2025, doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) solution for injection, underwent a temperature excursion of 10.5F for an hour (no previous excursions had occurred), and was later administered to the patient on 23-May-2025, lot #Y010930, expiration date 14-Dec-2025, reconstituted with sterile diluent (MERCK STERILE DILUENT) solution for injection (lot #1950636, expiration date: 22-Jan-2026), at a dose of 0.5 mL as prophylaxis by a health professional (route of administration and anatomical location were not reported) (Improper storage of product in use). However, no symptoms were reported.
Vaccine: PNC21
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP stated that no adverse reactions were experienced after the administered dose; CAPVAXIVE that was administered after TE on 06/26/2025; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) injection 168 mcg/ml (lot #Z004301, expiration date: 07-Sep-2026, 0.5 ml, route unknown) for prophylaxis after temperature excursions (product storage error). No adverse reactions were experienced after the administered dose.  Administered dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) experienced the temperature excursion below 10.1 degree Celsius for 0 hours, 30 minutes, 0 seconds. No prior excursions.
Sex: M
Vaccine: VARZOS
Symptoms: Labyrinthitis
Clinical narrative: Labyrinthitis; This non-serious case was reported by a physician via sales rep and described the occurrence of labyrinthitis in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2025, the patient received the 2nd dose of Shingrix. In MAY-2025, 2 days after receiving Shingrix, the patient experienced labyrinthitis (Verbatim: Labyrinthitis). The outcome of the labyrinthitis was resolved.   The reporter considered the labyrinthitis to be related to Shingrix.     The company considered the labyrinthitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JUN-2025 The physician reported that the patient got labyrinthitis 2 days after second dose and the symptoms resolved several weeks later and occurred within last month.
Sex: M
Vaccine: RVX, RVX
Symptoms: Gastroenteritis rotavirus, Vaccination failure
Clinical narrative: Suspected vaccination failure; rota virus infections/gastroenteritis; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 1-year-old male patient who received Rotavirus vaccine for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received the 2nd dose of Rotavirus vaccine and the 1st dose of Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine and Rotavirus vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and rotavirus gastroenteritis (Verbatim: rota virus infections/gastroenteritis) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the rotavirus gastroenteritis was not resolved.   The reporter considered the vaccination failure and rotavirus gastroenteritis to be related to Rotavirus vaccine, Rotarix Unspecified Oral Administation Device, Rotavirus vaccine and Rotarix Unspecified Oral Administation Device.     The company considered the vaccination failure and rotavirus gastroenteritis to be unrelated to Rotavirus vaccine, Rotarix Unspecified Oral Administation Device, Rotavirus vaccine and Rotarix Unspecified Oral Administation Device.   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: 14-JUN-2025 The case was received from the patient's parent via interactive digital media. The patient gotten Rotarix vaccine, unfortunately he had suffered from two times rota virus infections. The reporter wondered why the patient suffered from rota gastroenteritis although he vaccinated. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming rotavirus infection and gastroenteritis were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Rotarix (Dose 1 and Dose 2) and Rotarix UNSPECIFIED ORAL ADMINISTATION DEVICE
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; the rash during the outbreak to heal or minimize the discomfort/ rashes still keep coming; Discomfort; 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 (Herpes Zoster vaccine) for prophylaxis.   On an unknown date, the patient received Herpes Zoster vaccine. On an unknown date, an unknown time after receiving Herpes Zoster vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: the rash during the outbreak to heal or minimize the discomfort/ rashes still keep coming) and discomfort (Verbatim: Discomfort). The outcome of the vaccination failure, shingles and discomfort were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and discomfort to be related to Herpes Zoster vaccine.     The company considered the vaccination failure to be unrelated to Herpes Zoster vaccine. It was unknown if the company considered the shingles and discomfort to be related to Herpes Zoster vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via Interactive digital media. The patient mentioned that he/she had the Herpes Zoster vaccine but the rashes still keep coming. The patient enquired what they could do to the rash during the outbreak to heal or minimize the discomfort.  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 Herpes Zoster vaccine.
Vaccine: RSV
Symptoms: Influenza
Clinical narrative: have symptoms flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of flu symptoms in a 74-year-old 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 flu symptoms (Verbatim: have symptoms flu). The outcome of the flu symptoms was not reported.   It was unknown if the reporter considered the flu symptoms to be related to Arexvy.     It was unknown if the company considered the flu symptoms to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-JUN-2025 The patient self-reported that case. The patient had symptoms of flu, but patient had flu shot pneumonia shot
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administered only the adjuvant portion of Shingrix; administered only the adjuvant portion of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 31-MAR-2027) 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 inappropriate preparation of medication (Verbatim: administered only the adjuvant portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: administered only the adjuvant portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 Nurse called to report that they accidentally could have administered only the adjuvant portion of Shingrix to patient.  Also stated that this would be the first dose of Shingrix for the patient and asked is there any immunity screening or any titers test for Shingrix. Asked if they have to revaccinate the patient involved in this possible administration of the adjuvant only. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is one of the seven linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: got a dose of Menveo reconstituted with normal saline; got a dose of Menveo reconstituted with normal saline; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 18-JUN-2025, the patient received Menveo. On 18-JUN-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: got a dose of Menveo reconstituted with normal saline) and inappropriate dose of vaccine administered (Verbatim: got a dose of Menveo reconstituted with normal saline). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 18-JUN-2025 The healthcare professional had called to request data regarding the validity and need for revaccination of a patient who had received a dose of Menveo reconstituted with normal saline which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. They declined to provide information about the vaccine, patient, and event, and did not consent to follow-up. The vaccine administration facility was the same as the primary reporter.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of Pediarix in 2008; 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 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B163BC, expiry date 06-OCT-2008) for prophylaxis.   On 28-OCT-2008, the patient received Pediarix. On 28-OCT-2008, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of Pediarix in 2008). 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 A medical assistant reported that the patient received an expired dose of Pediarix in 2008 which led to expired vaccine used. The expiration date was 6th October 2008, and the vaccine was given on 28th October 2008. The medical assistant asked if this dose was considered valid. This case is linked with US2025076597, reported by same reporter for different (twin) patient.; Sender's Comments:  US-GSK-US2025076597:Same reporter/Diffrent patient