chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: On  4/3/25, I made an inadvertent error in administering a COVID-19 vaccine dose to a 17-year-old patient. This occurred while I was experiencing flu-like symptoms, including brain fog, which contributed to my lapse in focus. I deeply regret the mistake and wish to offer a detailed explanation of the circumstances that led to the error.  Background and Circumstances: That day, I had already encountered confusion due to the handling of different vaccine lot numbers, which was compounded by the fact that I was also managing the administration for a different provider. While this situation should not have influenced my ability to properly assess the patient's eligibility, it led to a series of mental lapses that caused the mistake.  I had been dealing with Flu A symptoms and brain fog, but I recognize this does not serve as an excuse for the oversight. It is important to note that at the time of administering the vaccine, I was operating on autopilot, which led to an error in selecting the appropriate vaccine dosage for the patient. The dose administered was intended for a different age group (6 months to 11 years), which does not align with the recommended dosage for a 17-year-old.  Immediate Actions Taken: As soon as I became aware of the mistake, I immediately reported the adverse event according to the protocol. I take full responsibility for the oversight and acted quickly to ensure that the situation was handled appropriately.  I deeply regret the error and the potential implications it may have had on the patient's health and wellbeing. I am committed to improving my processes to ensure such an oversight does not occur again in the future. This includes taking additional steps to review vaccine guidelines and ensuring greater focus on patient eligibility criteria, especially during periods when I am unwell.  Moving Forward: I will take steps to reinforce the importance of accuracy and vigilance in vaccine administration, especially during times of personal health challenges. I understand the gravity of this incident and am actively working to minimize any future risks to patients.  I would like to reassure all involved parties that this event was promptly reported and fully acknowledged, and I am committed to ensuring the safety and well-being of those I serve.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Injection site rash, Rash pruritic
Clinical narrative: Covid arm: itchy rash at injection site manifested 3 days after jab
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Patient received only the diluent without the active virus, after talking to patient, no adverse  reaction for patient
Age: 43.0
Sex: F
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pain
Clinical narrative: +tenderness induration erythema right posterior arm  +painful ROM of right shoulder Ice Pack to affected area, Rest of right arm
Age: 43.0
Sex: F
Vaccine: SMALLMNK, SMALLMNK
Symptoms: Arthralgia, Electrocardiogram normal, Erythema, Pain
Clinical narrative: +tenderness induration erythema right posterior arm  +painful ROM of right shoulder Ice Pack to affected area, Rest of right arm
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site macule, Injection site pain, Injection site warmth
Clinical narrative: The patient developed two warm, erythematous, tender, indurated macules around the injection sites of his Tdap and meningitis vaccines on his right arm.  He did not run a fever.  The patient went to stay with his father shortly after receiving his vaccines, so mom did not note the cutaneous reaction until patient can back to her house on 4/6/25.  She is not sure how long before that the reaction was present.  As of today, 4/8/25, the patient is starting to feel better with Tylenol and ibuprofen.  The erythematous areas are shrinking per mom.  I suspect a local reaction.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Mood altered, Screaming
Clinical narrative: screaming uncontrollably, not happy for 8 weeks, quit laughing
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Aphasia, Decreased activity, Decreased appetite, Decreased eye contact, Screaming
Clinical narrative: screaming uncontrollably, lost all vocabulary, quit talking, quit eating, started stemming, quit making eye contact, quit playing, quit engaging in other kids
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Rash
Clinical narrative: Patient reported rash on arm and red spot around injection site that has gotten better. She had itching that started shortly after injection on her back neck stomach and chest. Her provider had her take benadryl and now she picked up sarna to help with the itching. It is getting better after 1 week of benadryl but did not go away fully.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: The patient reported that her arm has been sore ever since she received her flu vaccine. She noticed it 1-2 days after getting the vaccine. It has continued for around 1 month. The patient reported she might seek medical attention, but hasn't yet.
Age: 1.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Rash, Urticaria
Clinical narrative: REPORTED TO THIS WRITER BY MOM: ~24 hrs post vaccination developed rash on trunk which then spread to extremities and progressed to "hives." Lasted 3 days per mom.
Age: 62.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness to L arm measuring 5cm x 5cm. Warm to touch. Per patient it is very itchy.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left arm treated with Cephalexin 500 mg every 8 hours X 5 days
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Lip swelling, Vomiting
Clinical narrative: lip swelling, shivering, vomiting
Age: 4.0
Sex: F
Vaccine: DTPPVHBHPB, MMRV
Symptoms: Extra dose administered
Clinical narrative: Accidently gave additional dose of Hep B and Hib due to grabbing the wrong vaccine. Should have given Kinrix (DTap and Polio) instead of Vaxelis (DTaP, Polio, Hib, and Hep B)
Age: 76.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema, Rash erythematous, Rash pruritic
Clinical narrative: Notice in the morning I had a rash on the upper body. It itch's very badly. It is also red and my face is red.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID 19 vaccination for ages 6 months - 4 years that was expired due to time in refrigerator exceeding 70 days (10 weeks) . Expiration date 1/30/25.  No adverse events noted for patient following vaccination; issue noted upon records review. Labeling on product reviewed by pharmacist prior to dispense rather than shortened date on box due to refrigeration.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on arms, legs, and chest
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cardiac monitoring abnormal, Cardiac pacemaker insertion, Cold sweat, Dizziness, Dyspnoea
Clinical narrative: I was VERY DIZZY AND OUT BREATH FAINTING AND ABOUT TO FAINT MANY TIMES AND  C0LD SWEATS. DOCTORS FINALY  REALIZED TESTING ME AND ON LOOP IMPLANTED HEART  MONITOR  IN 2022 THAT MY HEART STOPS FEW S3C AT THE TIME .PACEMAKER WAZ THE NEXT SURGERY IN 2023
Age: 63.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Extrasystoles
Clinical narrative: I was VERY DIZZY AND OUT BREATH FAINTING AND ABOUT TO FAINT MANY TIMES AND  C0LD SWEATS. DOCTORS FINALY  REALIZED TESTING ME AND ON LOOP IMPLANTED HEART  MONITOR  IN 2022 THAT MY HEART STOPS FEW S3C AT THE TIME .PACEMAKER WAZ THE NEXT SURGERY IN 2023
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccination that expired on 1/30/25;  pharmacist reviewed expiration date on individual vial which indicated 1/31/2026. No ADEs identified, the incident was noted upon records review which is why there is delayed reporting of error. VERP report also submitted related to incident.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: pt at the time while inside the clinic did not have any symptoms
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccination that had expired. Pharmacist reviewed expiration date on vial of 1/31/2026 rather than shortened expiration date notated on vaccine box (1/30/25). VERP report also submitted related to this incident
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: MMR PRIORIX given subQ to right arm. Pt started complaining of itching at injection site at 15 minutes. Site assessment includes redness at injection site that spread upward towards shoulder and shoulder blade. The patient was given Benadryl 50mg by mouth, cold compress applied and monitored for further symptoms. After 30 minutes, the area of redness had decreased, the employee denies itching of swelling to face or throat, shortness of breath, or difficulty breathing.  The employee was released with instructions to go to ED or UC.  1 hour later, called employee to follow up. The employee reported she was currently at the urgent care due to the redness and itching had traveled upward to her neck and ears.  04/08/2025- called to follow up, employee reported she was given  Pepcid and Prednisone while in the UC and was given a Medrol dose pack for 5 days.
Age: 12.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: erythematous reticular rash on LUE > RUE a/w calor, mild pruritus
Age: 64.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Areflexia, CSF red blood cell count positive, CSF white blood cell count negative, Gait inability, Guillain-Barre syndrome
Clinical narrative: Guillain Barre syndrome, onset 4/3/25
Age: 64.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Guillain Barre syndrome, onset 4/3/25
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine given
Age: 1.5
Sex: M
Vaccine: DTAPHEPBIP, HEP, HEPA, PNC20, RV1
Symptoms: Extra dose administered, No adverse event
Clinical narrative: EXTRA DOSE OF ROTARIX GIVEN NO NONE ADVERSE EFFECTS
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: EXTRA DOSE GIVEN, NO ADVERSE EVENT
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: The patient reported an abnormally elevated blood pressure after the vaccination. Prior to the vaccine, her physician had discontinued her blood pressure medication because her blood pressure has been within normal limits for multiple months. After the vaccination, the BP was 170/107. Patient denies chest pain, palpitations and other symptoms. She proceeded to restart her BP med, metoprolol, and her blood pressure has been coming down very slowly. Currently, it is 150/89. Patient is encouraged to report this to her physician.
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Gingival pain, Pain, Pyrexia, Rash morbilliform
Clinical narrative: Pt called office on 04/07/2025 complaining of symptoms since 3/31 after MMR vaccination. MMR vaccination on 3/20/25. Per pt she became very achy and had a fever up to 102. States her sinuses were aching and gum line became sore. Pt had decreased appetite. Full body "measles-like" rash started on Saturday 04/05/2025. Pt states she is doing well now but wanted to make us aware as she was to get a second booster and isn't sure that is the best idea. Dr. made aware. Pt declined care at this time as states symptoms are mostly gone. First booster administered in series after negative titer on 03/06/2025. Pt unsure if/when any prior MMR vaccination took place.
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Sinus pain
Clinical narrative: Pt called office on 04/07/2025 complaining of symptoms since 3/31 after MMR vaccination. MMR vaccination on 3/20/25. Per pt she became very achy and had a fever up to 102. States her sinuses were aching and gum line became sore. Pt had decreased appetite. Full body "measles-like" rash started on Saturday 04/05/2025. Pt states she is doing well now but wanted to make us aware as she was to get a second booster and isn't sure that is the best idea. Dr. made aware. Pt declined care at this time as states symptoms are mostly gone. First booster administered in series after negative titer on 03/06/2025. Pt unsure if/when any prior MMR vaccination took place.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Cold sweat, Dizziness, Headache
Clinical narrative: about an hour after the vaccination he developed a headache, had some dizziness.  He went home and felt chills and clammy.  Encouraged fluid and rest, please call back if needed, if develop allergic reaction symptoms (hives, difficulty breathing, swelling of face and throat) call 911.  No further signs or symptoms noted, recovered, returned to work next day.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient reported tinnitus.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Soreness post vaccination for 2 days. Rebound injection site soreness at day 7, along with injection site warm to touch and swelling. Pt will follow up with provider and report back to pharmacy for outcome.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head titubation, Tremor
Clinical narrative: The patient received the immunization without an issue. While the patient was waiting  afterwards, the patient fell onto the ground for a brief period. There was some shaking noted in the arm and head. Per RN on the scene, there was no evidence of head trauma. After the event, the patient denied any complaints. The patient was positioned in a place of comfort and given water. 911 was called, the EMS responded and arrive on the scene. After talking with the paramedics, the parent decided to take the patient to a urgent care rather than being transported by ambulance to the ED.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt was administered Hep A and Varicella 3/4 and again on 4/5. Unclear if they are having symptoms. We have not been able to reach them.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Circular erythematous raised lesion at the site of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling warmth at injection spot on day 4
Age: 70.0
Sex: M
Vaccine: PNC21, TDAP, VARZOS
Symptoms: Lip swelling
Clinical narrative: Patient's wife said they experienced upper lip swelling later in the evening of the day they received vaccines.  They said the swelling went away with 2 doses of benadryl and did not return.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia
Clinical narrative: I received a Tetanus shot while in the ER on Mar. 23 for a deep cut on my knee.  My shoulder started hurting the day after and then pain escalated to a deep tissue pain in my shoulder during the following week and the pain still persists even today (Apr. 8).
Age: 42.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: On 4-7-25 patient contacted County Health Department regarding third dose of HPV vaccine needed. While discussing the vaccine patient reported a vaccine reaction following the HPV vaccine given on 11-26-24. Patient reported hives one week after vaccine received, around 12/3/24. She described the hives like welts and very itchy. The hives were located on her neck, chest, stomach, armpits, and back. She reported taking Benadryl and Allegra every night for five days and applying Calamine lotion. Hives cleared up after 2-3 weeks. Patient reported no trouble breathing and no other symptoms. Patient then added that after the first dose of HPV vaccine on 10/2024 a week later she noticed a few spots on her stomach (4-5) on the side the vaccine was given. She reported the spots as hives and they cleared up in 2 weeks with no medication. I explained to patient that as a nurse I do not feel comfortable administering the 3rd dose of HPV vaccine due to the reaction from her last HPV vaccine. Also the reaction worsened from the first to 2nd dose and we do not know how she will react to the 3rd dose. Also I added that the the hives were near her airway.  I referred patient to her medical provider to discuss the 3rd dose of HPV based on risk/benefit and if her provider recommended the 3rd dose, I recommneded her medical provider administer the vaccine.
Age: 7.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Dizziness, Pallor
Clinical narrative: After receiving vaccines while at the check out, child became dizzy. Dad lowered child to floor. Child was coherent, but pale. BP checked @ 10:31 am- 83/50 and P-85. Child had not eaten anything this morning. Offered coke and peanut butter crackers but dad wanted child to only have water.  BP checked again @ 10:36 am - 97/66 P-80. Child was able to sit up and stated that he felt better. Advised dad to wait in lobby an additional 15 mins before they leave the building. Dad voiced understanding.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abdominal X-ray, Central venous catheterisation, Haematochezia, Necrotising colitis, Pain
Clinical narrative: Recurring bloody stools on 3/14/2025. PO feeds stopped 3/15. Signs of pain noted 3/14so went to ED around 9 pm. Tx was GI rest, antibiotics, IV fluids, and monitor Pneumatosis. Slowly introduce oral/ng feeds of Alimentum..
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Pneumatosis
Clinical narrative: Recurring bloody stools on 3/14/2025. PO feeds stopped 3/15. Signs of pain noted 3/14so went to ED around 9 pm. Tx was GI rest, antibiotics, IV fluids, and monitor Pneumatosis. Slowly introduce oral/ng feeds of Alimentum..
Age: 26.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Syncope
Clinical narrative: Syncope when standing at checkout after vaccination. (5-15 min after vaccination)
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-ganglioside antibody positive, Dysarthria, Miller Fisher syndrome, Tremor
Clinical narrative: Patient states he experiences increased hand tremors, dysarthria,  elevated gd1b gq1b test results, patient states he has miller fisher syndrome
Vaccine: FLU3, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse event; Wrong solution used in drug reconstitution; Information has been received from a medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 05-Mar-2025, the patient vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX  REFRIGERATOR STABLE) (lot #Y009955, expiration date: 28-May-2026, dose, strength, frequency, route were unknown) for prophylaxis. The vaccine was reconstituted with fluconazole (FLUZONE) due to a human error, instead of sterile diluent (MERCK STERILE DILUENT) (Wrong solution used in drug reconstitution). No other adverse event was reported.  At the reporting time, the outcome of the events was unknown.
Age: 86.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling
Clinical narrative: "arm swollen a little bit"
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Patient had rash on face and redness
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy
Clinical narrative: Patient 32 weeks pregnant at time of administration
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Evening of vaccine developed redness and fever, following day worsened redness swelling and fever, in ER treated for Lt thigh (at site of DTap) cellulitis with antibiotic course, and symptoms improved.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Implantable defibrillator insertion, Ventricular tachycardia
Clinical narrative: Sustained Ventricular tachycardia which led to hospitalization and icd implantation
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: DONOR CALLED TO REPORT THAT HIS RT.ARM IS STILL SORE FROM RECEIVING THE TETANUS  IMMUNIZATION ON 2/10/25.  DONOR STATED THAT HIS ARM HAS BEEN SORE EVER SINCE THE IMMUNIZATION BUT IS JUST NOW REPORTING IT.  DONOR DENIES ANY REDNESS, WARMTH OR SWELLING AT THE SITE. DONOR CAN STILL DO HIS JOB AS A PAINTER AND INSTALLING FLOORING. COUNSELED DONOR TO SEEK MEDICAL ATTENTION WITH HIS FAMILY PHYSICIAN. DONOR HAS NOT SOUGHT ANY MEDICAL ATTENTION SINCE RECEIVING THE IMMUNIZATION.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No reported adverse reaction.  It was learned after administration that this was 3rd dose in a series that should only be two doses.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, chills, body aches, headache, fatigue starting about 12 hours after vaccine and lasting 24 hours. Additionally, swelling and pain at the injection site that became red and hot, and is persisting 48+ hours after the shot.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache, fatigue starting about 12 hours after vaccine and lasting 24 hours. Additionally, swelling and pain at the injection site that became red and hot, and is persisting 48+ hours after the shot.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Autonomic nervous system imbalance, Back pain, Brain fog, Chest pain
Clinical narrative: 4/6 by 4:00 pm had noise intolerance, tinnitus, heartburn, by that night had a foggy head and left side body and head nerve irritation. 4/7 stuffy nose, stomach upset, headache, traps hurt. Mid and upper back pain start. More nerve pain and spasms start. Pelvic pain and pressure. 4/9 woke up with fast heart rate, 119 bpm, hot and sweaty, palpitations and shortness of breath along with previous symptoms. Back pain becomes more intense by 4/12. Within 2 weeks dysautonomia/ POTS symptoms begin with previous symptoms still remaining along with chest pains. As of 4/8/25 the majority of symptoms still remain, especially dysautonomia/ POTS which I was officially diagnosed with and the cause stated to be the vaccine. Treatments have been things to try and relieve symptoms. Outcome is that I have all of the above symptoms and dysautonomia/ POTS. I am disabled and wheelchair bound outside of the house. The vaccine destroyed my life.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspepsia, Dyspnoea, Feeling hot, Headache
Clinical narrative: 4/6 by 4:00 pm had noise intolerance, tinnitus, heartburn, by that night had a foggy head and left side body and head nerve irritation. 4/7 stuffy nose, stomach upset, headache, traps hurt. Mid and upper back pain start. More nerve pain and spasms start. Pelvic pain and pressure. 4/9 woke up with fast heart rate, 119 bpm, hot and sweaty, palpitations and shortness of breath along with previous symptoms. Back pain becomes more intense by 4/12. Within 2 weeks dysautonomia/ POTS symptoms begin with previous symptoms still remaining along with chest pains. As of 4/8/25 the majority of symptoms still remain, especially dysautonomia/ POTS which I was officially diagnosed with and the cause stated to be the vaccine. Treatments have been things to try and relieve symptoms. Outcome is that I have all of the above symptoms and dysautonomia/ POTS. I am disabled and wheelchair bound outside of the house. The vaccine destroyed my life.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hyperacusis, Hyperhidrosis, Laboratory test, Muscle spasms
Clinical narrative: 4/6 by 4:00 pm had noise intolerance, tinnitus, heartburn, by that night had a foggy head and left side body and head nerve irritation. 4/7 stuffy nose, stomach upset, headache, traps hurt. Mid and upper back pain start. More nerve pain and spasms start. Pelvic pain and pressure. 4/9 woke up with fast heart rate, 119 bpm, hot and sweaty, palpitations and shortness of breath along with previous symptoms. Back pain becomes more intense by 4/12. Within 2 weeks dysautonomia/ POTS symptoms begin with previous symptoms still remaining along with chest pains. As of 4/8/25 the majority of symptoms still remain, especially dysautonomia/ POTS which I was officially diagnosed with and the cause stated to be the vaccine. Treatments have been things to try and relieve symptoms. Outcome is that I have all of the above symptoms and dysautonomia/ POTS. I am disabled and wheelchair bound outside of the house. The vaccine destroyed my life.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Neuralgia, Palpitations, Pelvic pain
Clinical narrative: 4/6 by 4:00 pm had noise intolerance, tinnitus, heartburn, by that night had a foggy head and left side body and head nerve irritation. 4/7 stuffy nose, stomach upset, headache, traps hurt. Mid and upper back pain start. More nerve pain and spasms start. Pelvic pain and pressure. 4/9 woke up with fast heart rate, 119 bpm, hot and sweaty, palpitations and shortness of breath along with previous symptoms. Back pain becomes more intense by 4/12. Within 2 weeks dysautonomia/ POTS symptoms begin with previous symptoms still remaining along with chest pains. As of 4/8/25 the majority of symptoms still remain, especially dysautonomia/ POTS which I was officially diagnosed with and the cause stated to be the vaccine. Treatments have been things to try and relieve symptoms. Outcome is that I have all of the above symptoms and dysautonomia/ POTS. I am disabled and wheelchair bound outside of the house. The vaccine destroyed my life.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Tinnitus, Wheelchair user
Clinical narrative: 4/6 by 4:00 pm had noise intolerance, tinnitus, heartburn, by that night had a foggy head and left side body and head nerve irritation. 4/7 stuffy nose, stomach upset, headache, traps hurt. Mid and upper back pain start. More nerve pain and spasms start. Pelvic pain and pressure. 4/9 woke up with fast heart rate, 119 bpm, hot and sweaty, palpitations and shortness of breath along with previous symptoms. Back pain becomes more intense by 4/12. Within 2 weeks dysautonomia/ POTS symptoms begin with previous symptoms still remaining along with chest pains. As of 4/8/25 the majority of symptoms still remain, especially dysautonomia/ POTS which I was officially diagnosed with and the cause stated to be the vaccine. Treatments have been things to try and relieve symptoms. Outcome is that I have all of the above symptoms and dysautonomia/ POTS. I am disabled and wheelchair bound outside of the house. The vaccine destroyed my life.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient received initial vaccine 4/8/2024. patient received second vaccine 4/7/2025.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Decreased appetite, Fatigue, Headache, Laboratory test
Clinical narrative: Within a day developed a fever and left arm hurts bad and when she opens her mouth. Jaw continues to hurt a few days. Headaches begin. Loss of appetite. Nausea. Legs are hurting by 8/21 and has been very tired. Headaches and fatigue continue. Developed POTS/dysautonomia symptoms within a few weeks. Treatment has been trying to ease symptoms. Outcomes is diagnosis of headaches and POTS/dysautonomia by cardiology and neurology stemming from the vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pain in jaw, Postural orthostatic tachycardia syndrome
Clinical narrative: Within a day developed a fever and left arm hurts bad and when she opens her mouth. Jaw continues to hurt a few days. Headaches begin. Loss of appetite. Nausea. Legs are hurting by 8/21 and has been very tired. Headaches and fatigue continue. Developed POTS/dysautonomia symptoms within a few weeks. Treatment has been trying to ease symptoms. Outcomes is diagnosis of headaches and POTS/dysautonomia by cardiology and neurology stemming from the vaccine.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Within a day developed a fever and left arm hurts bad and when she opens her mouth. Jaw continues to hurt a few days. Headaches begin. Loss of appetite. Nausea. Legs are hurting by 8/21 and has been very tired. Headaches and fatigue continue. Developed POTS/dysautonomia symptoms within a few weeks. Treatment has been trying to ease symptoms. Outcomes is diagnosis of headaches and POTS/dysautonomia by cardiology and neurology stemming from the vaccine.
Age: 59.0
Sex: M
Vaccine: PNC21, VARZOS
Symptoms: Decreased appetite, Headache, Pyrexia
Clinical narrative: Fever, headache and loss of appetite
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Immunisation reaction, Injection site discolouration, Injection site erythema, Injection site pallor
Clinical narrative: Immediate egg yolk size bump and entire upper arm turned red and hot. Reported it at the time and was asked to follow up for a few months via phone and text app. Was told it was  Covid arm.   Bump never went away but the redness did. In the last few days the bump has grown and changed shape. Upper arm surrounding bump is reddish purple and discolored. Warm to the touch. Skin over the bump area is pale and not warm.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Immediate egg yolk size bump and entire upper arm turned red and hot. Reported it at the time and was asked to follow up for a few months via phone and text app. Was told it was  Covid arm.   Bump never went away but the redness did. In the last few days the bump has grown and changed shape. Upper arm surrounding bump is reddish purple and discolored. Warm to the touch. Skin over the bump area is pale and not warm.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Skin irritation
Clinical narrative: Me and my child both had 5 does of the pfizer vaccine and we are experiencing irritation, skin crawling on face and scalp. I think we had one too many shots and it is urgent that this unusual side effects of the vaccine is reported. On the other hand I have experiencing identity fraud here in (state name redacted) so someone had one of covid vaccinations erased off my record. I am looking into that currently. Also called a lawyer, thank you
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PPV, RV5
Symptoms: Cyanosis, Full blood count, Injection site reaction, Petechiae, Platelet count normal
Clinical narrative: About 15min after vax. parents noted both lower extremities were cyanotic. They undressed her, brought her back in the office. Color returned in a few minutes but left w/petechial rash R>L legs. Parents don't think the lower extremity cyanosis was positional and at any rate the petechiae were and changes were within an hour of vaccination. Otherwise the baby was fine. Call back on 4/4/25 baby is fine w/ no new lesions.
Sex: F
Vaccine: COVID19
Symptoms: Death, Lymphadenopathy, Renal failure
Clinical narrative: kidney failure; lymphadenopathy; death; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, 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: DEATH (death, medically significant) with onset 26May2021, outcome "fatal"; RENAL FAILURE (medically significant), outcome "unknown", described as "kidney failure"; LYMPHADENOPATHY (non-serious), outcome "unknown". The patient date of death was 26May2021. The reported cause of death was unknown. It was not reported if an autopsy was performed. Clinical course: As reported, her death resulted from complications of the Pfizer COVID-19 vaccine, which caused lymphadenopathy leading to kidney failure due to medical negligence. Claimed she had cancer without evidence and misrepresented her death as cancer related. The vaccine caused continuous replication of spike proteins in her bone marrow, leading to lymphadenopathy that mimicked cancer. Her kidneys were overwhelmed due to medical neglect, further worsening her condition withheld repeatedly pressured me to sign a Do Not Resuscitate (DNR) order, despite my mother's explicit wishes for 13 years to be resuscitated, which she also verbally confirmed to withheld staff. This pressure for resuscitation was intensified for me and my mother after we witnessed the wrongful deaths of her mother, withheld at withheld due to DNR and the death of my dad, withheld, who I watched suffer under similar DNR circumstances. As my dad was coerced into a DNR by withheld and withheld who is an end-of-life nurse. withheld took him the day he was released from the hospital while suffering from confusion to sign his DNR, later suffocating to death in front of me and his granddaughter withheld as the DNR ensured his head turned blue from lack of oxygen to his brain. This case involves violations of due process, medical malpractice, and wrongful death, with withheld and its staff engaging in fraudulent medical practices, coercion, and obstruction of justice to conceal the true cause of my mother's death which was the Pfizer Covid-19 shot she received in 2021 before she left for vacation in March 2021 and her surprising death on 26May2021.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Reported Cause(s) of Death: unknown cause of death
Vaccine: COVID19
Symptoms: Bell's palsy, Deafness unilateral
Clinical narrative: Bells Palsy; loss of hearing in left ear; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: BELL'S PALSY (medically significant), outcome "unknown", described as "Bells Palsy"; DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "loss of hearing in left ear".  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Breakthrough COVID-19 infection; Breakthrough COVID-19 infection; This is a spontaneous report received from a Physician.  A 40-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 24Sep2024 as dose 1, single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "B12 deficiency" (unspecified if ongoing). The patient did not receive other vaccine on the same date. The patient did not receive other vaccine in fours weeks. Concomitant medication(s) included: LEVOTHYROXINE; ORAL CONTRACEPTIVE NOS. Past drug history included: Dilantin, reaction(s): "Known allergies: Dilantin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Apr2025, outcome "not recovered" and all described as "Breakthrough COVID-19 infection". Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omicron (kp.2) in this patient cannot be completely excluded.,Linked Report(s) : US-PFIZER INC-202400264844 same patient/dose, different events;
Age: 11.0
Sex: M
Vaccine: UNK, UNK, FLUX, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; administered improperly stored GARDASIL 9; This spontaneous report was received from a reporter and refers to a 12-year-old male patient.   The patient's medical history was not reported. His concurrent conditions included ADHD and autism. Concomitant therapies were not reported.   On 23-Oct-2024, at a private doctor's or hospital, the patient was vaccinated with an improperly stored dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot number reported as X023113, which has been verified as valid, expiration date reported and validated as 10-MAY-2026) administered by intramuscular route for prophylaxis; and with a flu vaccine. It was reported that the fridge dropped below freezing while office was closed over the weekend (Product storage error). No additional adverse events were reported. No symptoms were reported. No additional adverse event (AE) details reported. No additional AE or product quality complaint (PQC).; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-03-13 , number : , number : , number : , number :  , Central date : 2025-03-10 , Classification : , Attachment description : Post Marketing Basic , Safety case number :
Age: 65.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Injection site pain
Clinical narrative: Pain injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-MAR-2025, the patient received Arexvy. In MAR-2025, less than 2 weeks after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain injection site). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-MAR-2025 and 27-MAR-2025 The reporter reported that she received a dose of AREXVY on 13 MAR 2025. Consumer stated she did not experience injection site pain at the onset of the injection, however, states that later she began to feel injection site pain and it was persisting (onset of injection site pain unknown.) One had the side effects that she was having so that she just gave a three. Consumer stated she received the vaccination. Consumer declined to provide any additional information. Consumer stated she reported this adverse event to and to the pharmacy. No further information was obtained/provided.
Age: 13.0
Sex: M
Vaccine: UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Product storage error; This spontaneous report was received from a vaccine provider and refers to a(n) 13-year-old male patient.   The patient's medical history was not reported. The patient's concurrent conditions included ADHD. Concomitant medications included Meningococcal vaccine B .  On 24-OCT-2024, the patient was vaccinated with an improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), ((lot #X025115, expiration date reported as 12-MAY-2026, but upon internal validation established as 19-MAY-2026) for Prophylaxis (Product storage error). The fridge had felt below freezing over the weekend while the office was closed. The temperature was 25 F for 1 hour.  No adverse event was reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had COVID, I was all - I had to admit to the ICU; I had COVID, I was all - I had to admit to the ICU; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: COVID-19 (life threatening), DRUG INEFFECTIVE (life threatening), outcome "unknown" and all described as "I had COVID, I was all - I had to admit to the ICU". Clinical course: The caller said, "last time when I had COVID, I was all - I had to admit to the ICU because it went really serious. That was the time when COVID first came, and I had only the first shot. So, when the COVID came, right. The first time, so it was two shots, I only got one shot. And before I got my second shot, I got infected. And I had to be in ICU for like a week. And so, I react very badly with COVID"   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500065985 Same patient and suspect product different dose/AE;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had COVID, I was all - I had to admit to the ICU; I had COVID, I was all - I had to admit to the ICU; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 70-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: COVID-19 (life threatening), DRUG INEFFECTIVE (life threatening), outcome "unknown" and all described as "I had COVID, I was all - I had to admit to the ICU". Clinical course: The caller said, "last time when I had COVID, I was all - I had to admit to the ICU because it went really serious. That was the time when COVID first came, and I had only the first shot. So, when the COVID came, right. The first time, so it was two shots, I only got one shot. And before I got my second shot, I got infected. And I had to be in ICU for like a week. And so, I react very badly with COVID"   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500065985 Same patient and suspect product different dose/AE;
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: No additional AE; report administration of VARIVAX and PROQUAD today; This spontaneous report was received from a medical assistant (MA) and refers to a(n) 1-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Apr-2025 (reported as today), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y007176, expiration date was reported as 26-Apr-2026 but was established as 04-Apr-2026 upon internal validation (strength, dose, route of administration and anatomical location were not provided) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y012076, expiration date was reported as 26-Jan-2026 but was established as 05-Jan-2026 upon internal validation (strength, dose, route of administration and anatomical location were not provided), administered for prophylaxis (Inappropriate schedule of vaccine administered). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot#, expiry date and dosage information were not provided). Patient was not experiencing any symptoms. Confirmed no additional information. No additional AE (No adverse event).
Age: 1.0
Sex: M
Vaccine: MMRV, MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; report administration of VARIVAX and PROQUAD today; This spontaneous report was received from a medical assistant (MA) and refers to a(n) 1-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Apr-2025 (reported as today), the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y007176, expiration date was reported as 26-Apr-2026 but was established as 04-Apr-2026 upon internal validation (strength, dose, route of administration and anatomical location were not provided) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), lot #Y012076, expiration date was reported as 26-Jan-2026 but was established as 05-Jan-2026 upon internal validation (strength, dose, route of administration and anatomical location were not provided), administered for prophylaxis (Inappropriate schedule of vaccine administered). The vaccines were reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot#, expiry date and dosage information were not provided). Patient was not experiencing any symptoms. Confirmed no additional information. No additional AE (No adverse event).
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No symptomatic events were reported.; administered to a patient after suffering Temperature excursion; This spontaneous report was received from registered nurse (RN) concerning a patient of unspecified age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On unspecified date, doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) underwent a temperature excursion at a temperature of 70 (units not provided) during a time frame of 72 hours, 0 minutes, and 0 seconds. Previous temperature excursions were reported as not applicable (N/A.)  On 21-FEB-2025, the patient was vaccinated with improperly stored doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Injection, lot #X026404, expiration date: 08-NOV-2025) 0.5 mL (0.5mL/series) (dosage regimen, anatomical location and route of administration were not provided), and Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), Injection, lot #Y014182, expiration date: 20-AUG-2026, 0.5 mL (0.5mL/series) (dosage regimen, anatomical location and route of administration were not provided), both administered a prophylaxis (product storage error) which were reconstituted with an unknown sterile diluent (manufacturer unknown) injection (dose, indication, expiration date, and lot # were not reported.)  No symptomatic events were reported (no adverse event). No additional information was provided.   Lot # is being requested and will be submitted if received.   Follow-up information has been received from RN on 31-MAR-2025 concerning 4-years-old male patient. The patient's medical historu included "NKA" and allantonic cyst. His concurrent conditions included gross motor development delay and cow's milk intolerance. Concomitant vaccine included dtap  polio vaccine (QUADRACEL). All suspect vaccines were administered by subcutaneous route. Lot # #X026404 and lot #Y014182 has been established as valid.