chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Patient came to pharmacy asking to get mmr vaccine due to recent out break. Patient takes medication (Actemra) for arthritis. The medication lowers the immune systems response. This was accidently over looked and the vaccine was administered. Patient had a rash that popped up later that evening into the the next morning on her arms and back. The patient was advised to go get checked out by ER or family dr at the least. The patient decided that she would go get checked if the condition worsened. She said at the time she was not in pain and was only curious if having the rash was normal after receiving the mmr vaccine. Patient does not fill the Actemra at this pharmacy and was advised to reach out to the pharmacy that fills the Actemra for a second opinion and additional info about possible side effects with the medicine and the live vaccine. She was also advised to ask her rheumatologist  when to stop or continue with the next dose of her Actemra. Pharmacist did call once each day for 3 days following the identification of the event to check on patient and reiterate importance of checking with rheumatologist, other pharmacy and ER or family dr of second opinions about Actemra and possible other side effects.
Age: 63.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Arthralgia, Loss of personal independence in daily activities, Pain, Pain in extremity, Sleep disorder
Clinical narrative: My (R) arm and shoulder started hurting and aching that night making it extremely hard to sleep.  I have to sleep on my left side with a pillow propped under my right arm to stop the arm from throbbing and aching.  Movements such as moving my arm forward or back or to the side cause excruciating pain!  I am very limited in my everyday chores and if I accidentally move it in a certain way, it is very jarring and takes me to my knees. It is even difficult to get dressed and undressed every day.  I saw Dr., PA-C on 01/14/2024 and informed her of my situation and the pain I was experiencing since having the Flu and Pneumonia shot on 12/18/2024.  She then ordered the x-ray and prescribed me Naproxen 500mg Naproxen 500mg for the pain and put in an order for me to go to  Physical Therapy.  I have not scheduled any physical therapy because I currently am without health insurance.
Age: 63.0
Sex: F
Vaccine: UNK, UNK
Symptoms: X-ray limb
Clinical narrative: My (R) arm and shoulder started hurting and aching that night making it extremely hard to sleep.  I have to sleep on my left side with a pillow propped under my right arm to stop the arm from throbbing and aching.  Movements such as moving my arm forward or back or to the side cause excruciating pain!  I am very limited in my everyday chores and if I accidentally move it in a certain way, it is very jarring and takes me to my knees. It is even difficult to get dressed and undressed every day.  I saw Dr., PA-C on 01/14/2024 and informed her of my situation and the pain I was experiencing since having the Flu and Pneumonia shot on 12/18/2024.  She then ordered the x-ray and prescribed me Naproxen 500mg Naproxen 500mg for the pain and put in an order for me to go to  Physical Therapy.  I have not scheduled any physical therapy because I currently am without health insurance.
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Vaccine was in the freezer, pulled vaccine and did not check date. Gave client vaccine without checking expiration date. Noticed vaccine was expired when I put it into the chart for documentation.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was due for Dtap/Tdap/TD according to system which is a outside immunization data base for patients that have received immunizations outside of state. The medical assistant pulled and administered Dtap for the child however since the child 10 years old and the Dtap immunization is recommended for children less than 7 years of age, this particular child should have received the Tdap immunization instead. The parents were notified of the adverse event and are aware that the patient's school may require the child to receive the Tdap immunization in the fall if they do not accept the Dtap immunization. The medical assistant was re-educated on Immunization administration as well as assigned additional learning modules and new safeguards were placed to prevent future adverse events.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered past expiration date.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC20
Symptoms: No adverse event
Clinical narrative: No known adverse event
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, heat at injection site that extended to elbow. Diagnosed with cellulitis via telemedicine visit. Treated with Amoxicillin BID X 10 days.
Age: 23.0
Sex: F
Vaccine: CHIK, TYP, YF
Symptoms: Antinuclear antibody, Antinuclear antibody negative, Antinuclear antibody positive, Arthralgia, C-reactive protein
Clinical narrative: Experienced high fever (103) with chills that were not relieved much by ibuprofen for 7 days. After around 3-5 days fever-free, joint pain in the knees, ankles, wrists, and PIP joints similar to the symptoms of chikungunya persisted. Acute joint pain is still being experienced 5 months later. Leading theory from rheumatologist is that the vaccine predisposed the patient (me) to an autoimmune condition. Patient has been on and off prednisone, and is now seeking treatment using methotrexate and hydroxychloroquine to find relief.
Age: 23.0
Sex: F
Vaccine: CHIK, TYP, YF
Symptoms: Chills, Complement factor C3, Complement factor C4, Differential white blood cell count normal, Double stranded DNA antibody
Clinical narrative: Experienced high fever (103) with chills that were not relieved much by ibuprofen for 7 days. After around 3-5 days fever-free, joint pain in the knees, ankles, wrists, and PIP joints similar to the symptoms of chikungunya persisted. Acute joint pain is still being experienced 5 months later. Leading theory from rheumatologist is that the vaccine predisposed the patient (me) to an autoimmune condition. Patient has been on and off prednisone, and is now seeking treatment using methotrexate and hydroxychloroquine to find relief.
Age: 23.0
Sex: F
Vaccine: CHIK, TYP, YF
Symptoms: Full blood count normal, Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Experienced high fever (103) with chills that were not relieved much by ibuprofen for 7 days. After around 3-5 days fever-free, joint pain in the knees, ankles, wrists, and PIP joints similar to the symptoms of chikungunya persisted. Acute joint pain is still being experienced 5 months later. Leading theory from rheumatologist is that the vaccine predisposed the patient (me) to an autoimmune condition. Patient has been on and off prednisone, and is now seeking treatment using methotrexate and hydroxychloroquine to find relief.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: N/A - PATIENT RECIEVED HEPLISAV-B ON 1/2/25 AND RECIEVED ENGERIX-B ADULT AS A SECOND DOSE INSTEAD OF RECIEVING HEPLISAV-B
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Anti-aquaporin-4 antibody negative, Antinuclear antibody increased, Antinuclear antibody positive, Blood test normal, CSF myelin basic protein increased
Clinical narrative: Bilateral Optic Neuritis following Td Vaccination  no significant medical history or concomitant medications. No personal or family history of autoimmune disease.   January 19, 2025: Received Td vaccine (Td Adult, absorbed, PMC, Lot U83003A4) from provider:   Around 2 weeks later noted some pain around right temporal area at night which was worse when sleeping on his side and required sleeping on his back.  February 19 noted blurred vision especially in lower visual field of right eye. Progressed to inability to make out any details with right eye and severe blurred vision of left eye over the following days with headache.  February 24: Seen in the emergency room and bilateral optic nerve swelling was observed.  Cerebral MRI with and without contrast showed findings consistent with bilateral optic neuritis but no vascular or parenchymal abnormalities. CSF and blood panels show elevation of myelin basic protein consistent with optic neuritis. Aquaporin-4 receptor antibody negative.  Spine cervical MRI with and without contrast negative for white matter lesions. Spine thoracic MRI with and without contrast negative for white matter lesions. Admitted to the hospital overnight and discharged on February 25 Received 5 days of intravenous steroids from February 24 through March 1. Experienced headache and some neck pain intermittently. March 3: Visited neurologist. Evaluation negative for multiple sclerosis. Gradual improvement of vision but right eye continues impaired as of March 19, 2025.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Headache, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal, Neck pain, Optic neuritis
Clinical narrative: Bilateral Optic Neuritis following Td Vaccination  no significant medical history or concomitant medications. No personal or family history of autoimmune disease.   January 19, 2025: Received Td vaccine (Td Adult, absorbed, PMC, Lot U83003A4) from provider:   Around 2 weeks later noted some pain around right temporal area at night which was worse when sleeping on his side and required sleeping on his back.  February 19 noted blurred vision especially in lower visual field of right eye. Progressed to inability to make out any details with right eye and severe blurred vision of left eye over the following days with headache.  February 24: Seen in the emergency room and bilateral optic nerve swelling was observed.  Cerebral MRI with and without contrast showed findings consistent with bilateral optic neuritis but no vascular or parenchymal abnormalities. CSF and blood panels show elevation of myelin basic protein consistent with optic neuritis. Aquaporin-4 receptor antibody negative.  Spine cervical MRI with and without contrast negative for white matter lesions. Spine thoracic MRI with and without contrast negative for white matter lesions. Admitted to the hospital overnight and discharged on February 25 Received 5 days of intravenous steroids from February 24 through March 1. Experienced headache and some neck pain intermittently. March 3: Visited neurologist. Evaluation negative for multiple sclerosis. Gradual improvement of vision but right eye continues impaired as of March 19, 2025.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Scan with contrast abnormal, Sleep disorder, Vision blurred, Visual impairment
Clinical narrative: Bilateral Optic Neuritis following Td Vaccination  no significant medical history or concomitant medications. No personal or family history of autoimmune disease.   January 19, 2025: Received Td vaccine (Td Adult, absorbed, PMC, Lot U83003A4) from provider:   Around 2 weeks later noted some pain around right temporal area at night which was worse when sleeping on his side and required sleeping on his back.  February 19 noted blurred vision especially in lower visual field of right eye. Progressed to inability to make out any details with right eye and severe blurred vision of left eye over the following days with headache.  February 24: Seen in the emergency room and bilateral optic nerve swelling was observed.  Cerebral MRI with and without contrast showed findings consistent with bilateral optic neuritis but no vascular or parenchymal abnormalities. CSF and blood panels show elevation of myelin basic protein consistent with optic neuritis. Aquaporin-4 receptor antibody negative.  Spine cervical MRI with and without contrast negative for white matter lesions. Spine thoracic MRI with and without contrast negative for white matter lesions. Admitted to the hospital overnight and discharged on February 25 Received 5 days of intravenous steroids from February 24 through March 1. Experienced headache and some neck pain intermittently. March 3: Visited neurologist. Evaluation negative for multiple sclerosis. Gradual improvement of vision but right eye continues impaired as of March 19, 2025.
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Dysgeusia, Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Funny taste in mouth (metallic) immediately following vaccine administration. Encouraged to wait in building for 30 minutes. No further problems noted. Encouraged patient to call 911 or visit ER for signs/symptoms of anaphylaxis. Patient reported back to health department on 3/19/2025 with complaints of further issues. 3/13/25 left arm was sore and began to swell a little on 3/14/2025. Swelling lasted a few days and went down. Redness spread down arm the past couple of days. It also itches a little. Encouraged topical anti-inflammatory cream for itching  and to follow up with primary physician.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Cough, Fatigue, Influenza B virus test positive, Nasal congestion, Oropharyngeal pain
Clinical narrative: developed a fever, body aches, sore throat and nasal congestion starting the day after her TDaP and MenQuadFi Vaccines . Parents suspected this was related to the vaccines .  She fainted x 1.  My suspicion is that she developed a viral infection coinciding with the vaccines.  She ultimately tested positive for Influenza B.   She remained febrile for around 4 days and then at the time of this report still has fatigue and cough.
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Pyrexia, Syncope
Clinical narrative: developed a fever, body aches, sore throat and nasal congestion starting the day after her TDaP and MenQuadFi Vaccines . Parents suspected this was related to the vaccines .  She fainted x 1.  My suspicion is that she developed a viral infection coinciding with the vaccines.  She ultimately tested positive for Influenza B.   She remained febrile for around 4 days and then at the time of this report still has fatigue and cough.
Age: 70.0
Sex: F
Vaccine: PNC21
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Patient experienced red, itchy rashes all over her body, including the inside of her throat.  Patient has experienced similar reactions from multiple flu vaccinations as well as the shingles vaccination
Age: 1.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 0.5
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Pruritus, Throat irritation
Clinical narrative: Pt. received Sanofi Pasteur Quadracel, Merck ProQuad and Sequirus Flucelvax at his routine 4 year well. Within minutes of receiving the vaccine, he described throat itching. His skin became itchy but he did not develop hives. The physician was immediately notified and assessed the patient. He did not develop any respiratory distress. He was given oral Diphenhydramine and oral Dexamethasone and observed in the office until all his symptoms had resolved. Physician followed up by phone later in the day and the patient had no further symptoms.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling abnormal, Syncope
Clinical narrative: Per patient, he verbalized after receiving vaccination it was time to pick up his kid from school.  Patient was asked to wait up to 15mins before exiting center.  Patient left after 5 min stating that he needed to get to his son school on time.  Patient arrived to work this morning to report that he fainted while getting of the train. Patient verbalize that right before his train was to arrive at his destination he felt off and dizzy. He got up and once he exit train he fainted. He stated that he woke up to a lot of strangers standing over him in concerns and disbelief. Patient did not sustain any injury to head nor body upon passing out. No bruising or cuts upon nursing assessment. Vitals were stable.  At this time no other issues or concern per Patient.  Patient was advice to report any changes to staff. Also to seek out further evaluation if he ever finds himself at home feeling dizzy.  Patient understood and will follow up with any changes.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered past expiration date. No adverse effects reported by pt or parents.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Agitation, Erythema, Fatigue, Hyperhidrosis, Retching
Clinical narrative: About 10-15 minutes post vaccines, patient developed hives, somewhat diaphoretic and pretty agitated. Facial swelling.  He was pretty red overall, EXCEPT  at the injection sites.  He was given 12.5 mg of Benadryl and observed.  O2 sat about 93-94% and quite tired. He did have a bit of gagging, but never vomited.   He was observed for about 1 hour.  By the time he left, he was very chatty, though he was still a bit red.   Mom cautioned that if there is any return of sx, she should go to the closest ER for further evaluation.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Swelling face, Urticaria
Clinical narrative: About 10-15 minutes post vaccines, patient developed hives, somewhat diaphoretic and pretty agitated. Facial swelling.  He was pretty red overall, EXCEPT  at the injection sites.  He was given 12.5 mg of Benadryl and observed.  O2 sat about 93-94% and quite tired. He did have a bit of gagging, but never vomited.   He was observed for about 1 hour.  By the time he left, he was very chatty, though he was still a bit red.   Mom cautioned that if there is any return of sx, she should go to the closest ER for further evaluation.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Chills, Feeding disorder
Clinical narrative: Was very sick after first vaccine shot. After second shot, was even sicker and had chest pain/pressure from pericarditis/myocarditis. After 3rd shot, even sicker for longer. Chills, fever, aches & pains and chest pain.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis, Pain, Pericarditis, Pyrexia
Clinical narrative: Was very sick after first vaccine shot. After second shot, was even sicker and had chest pain/pressure from pericarditis/myocarditis. After 3rd shot, even sicker for longer. Chills, fever, aches & pains and chest pain.
Age: 7.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to a patient outside of age range
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Amnesia, Asthenia, Blood glucose normal, Blood test, Cheilitis
Clinical narrative: Developed redness, pain, inflammation and warmth at the injection site which is still present as of 1pm 3/19/205.  On 3/18/2025 around 7:15, 13 hours after administration of the vaccine, I experienced lightheadedness and weakness upon getting up from bed. I went back to bed for about 35-40 minutes. I then got up to get ready for the day; I checked my blood sugar (98), brushed teeth and walked to the kitchen.  Around 8:05AM, I was standing and started experiencing lightheadedness, weakness, blurred vision and went to seat. I called my husband who stated I was paled. He helped me to walk to the soda but I fainted and fell to the carpet hitting my head and bitting my lip. I do not remember any of that but my lip is still hurting and inflamed. He gave me a glass of water which I drank. He took my blood pressure but the machine didn?t register any reading the first two times he tried. He tried it on him to make sure the machine was working correctly and it was. On the third attempt @8:16  BP:65/44, HR:46    @8:22 BP:85/46,  HR:55   @8:28 BP:99/50, HR:57   @9:38 BP:91/48, HR:63
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Dizziness, Electrocardiogram normal, Fall, Head injury, Injection site erythema
Clinical narrative: Developed redness, pain, inflammation and warmth at the injection site which is still present as of 1pm 3/19/205.  On 3/18/2025 around 7:15, 13 hours after administration of the vaccine, I experienced lightheadedness and weakness upon getting up from bed. I went back to bed for about 35-40 minutes. I then got up to get ready for the day; I checked my blood sugar (98), brushed teeth and walked to the kitchen.  Around 8:05AM, I was standing and started experiencing lightheadedness, weakness, blurred vision and went to seat. I called my husband who stated I was paled. He helped me to walk to the soda but I fainted and fell to the carpet hitting my head and bitting my lip. I do not remember any of that but my lip is still hurting and inflamed. He gave me a glass of water which I drank. He took my blood pressure but the machine didn?t register any reading the first two times he tried. He tried it on him to make sure the machine was working correctly and it was. On the third attempt @8:16  BP:65/44, HR:46    @8:22 BP:85/46,  HR:55   @8:28 BP:99/50, HR:57   @9:38 BP:91/48, HR:63
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site inflammation, Injection site pain, Injection site warmth, Lip injury, Lip pain
Clinical narrative: Developed redness, pain, inflammation and warmth at the injection site which is still present as of 1pm 3/19/205.  On 3/18/2025 around 7:15, 13 hours after administration of the vaccine, I experienced lightheadedness and weakness upon getting up from bed. I went back to bed for about 35-40 minutes. I then got up to get ready for the day; I checked my blood sugar (98), brushed teeth and walked to the kitchen.  Around 8:05AM, I was standing and started experiencing lightheadedness, weakness, blurred vision and went to seat. I called my husband who stated I was paled. He helped me to walk to the soda but I fainted and fell to the carpet hitting my head and bitting my lip. I do not remember any of that but my lip is still hurting and inflamed. He gave me a glass of water which I drank. He took my blood pressure but the machine didn?t register any reading the first two times he tried. He tried it on him to make sure the machine was working correctly and it was. On the third attempt @8:16  BP:65/44, HR:46    @8:22 BP:85/46,  HR:55   @8:28 BP:99/50, HR:57   @9:38 BP:91/48, HR:63
Age: 63.0
Sex: F
Vaccine: PNC21
Symptoms: Pallor, Syncope, Vision blurred
Clinical narrative: Developed redness, pain, inflammation and warmth at the injection site which is still present as of 1pm 3/19/205.  On 3/18/2025 around 7:15, 13 hours after administration of the vaccine, I experienced lightheadedness and weakness upon getting up from bed. I went back to bed for about 35-40 minutes. I then got up to get ready for the day; I checked my blood sugar (98), brushed teeth and walked to the kitchen.  Around 8:05AM, I was standing and started experiencing lightheadedness, weakness, blurred vision and went to seat. I called my husband who stated I was paled. He helped me to walk to the soda but I fainted and fell to the carpet hitting my head and bitting my lip. I do not remember any of that but my lip is still hurting and inflamed. He gave me a glass of water which I drank. He took my blood pressure but the machine didn?t register any reading the first two times he tried. He tried it on him to make sure the machine was working correctly and it was. On the third attempt @8:16  BP:65/44, HR:46    @8:22 BP:85/46,  HR:55   @8:28 BP:99/50, HR:57   @9:38 BP:91/48, HR:63
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursitis, Injected limb mobility decreased, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Patient reported having a 101 degree temperature for over 7 days, severe reaction at the injection site to include redness and swelling extending to the elbow, three weeks post administration still unable to rotate right shoulder  and has been diagnosed with bursitis treated with tramadol and ibuprofen
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported having a 101 degree temperature for over 7 days, severe reaction at the injection site to include redness and swelling extending to the elbow, three weeks post administration still unable to rotate right shoulder  and has been diagnosed with bursitis treated with tramadol and ibuprofen
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given 3rd dose approximately 10 weeks after 2nd dose. Per ACIP guidelines the recommendation is to give the 3rd dose at least 12 weeks after the 2nd dose.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Foot deformity, Gait disturbance, Pain
Clinical narrative: She?s having trouble walking normal , her toes are pointed  inward as she walks, it was hurting her bad to walk, she needed help walking after the vaccines, she?s walking better now, walking on her own , but her feet are still pointed sideways inward  and she walks on her heels now !
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Head injury, Loss of consciousness, Pallor, Visual impairment
Clinical narrative: After giving 2 injections (HPV & Tdap) to patient, IM left deltoid. Patient turned pale and stated she was seeing white spots, within 30 sec-one minute, patient passed out and hit her head on the table. Within 20-30 seconds patient came to and sat up.  She did indicate that she has a history of passing out but did not inform before vaccines given.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA, HIBV, VARCEL
Symptoms: Induration
Clinical narrative: dime sized induration palpable
Age: 5.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: staring spell about 20 min after receiving the immunizations: pt had  episode outside clinic building of sitting awake  but unresponsive for several  minutes before spontaneously returning to baseline.  They did not seek care for the episode and no recurrence or further associated  event  ensued.
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Patient had swollen post cervical lymph node noticed 3/18/2025. Rash that started 3/18/2025 on torso, back, and face.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient inadvertently received Kinrix (DTaP-IPV), which is not approved for his age/dose, instead of DTaP. The patient did not have any adverse reaction to the vaccine and does not require treatment. The patient's parents have been notified of the administration error and report that the patient has not any adverse reactions. The dose does appear to count in the Registry towards the patient's DTaP and IPV series.
Age: 0.25
Sex: M
Vaccine: DTPPVHBHPB, PNC15, RV1
Symptoms: Crying, Infant irritability, Vomiting projectile
Clinical narrative: Mother of client contacted clinic around 3:00 EST. Mom states that ever since arriving home this morning patient has been fussy (around 10 EST). Mom attempted to give a bottle at 12:00 PM and patient projectile vomited. A 1.25 ml dose of infants tylenol was given around 12:30pm. According to mom, around 1 PM, patient began to cry inconsolably. Nothing she tried seemed to help. Mom informed APRN that patient seemed to have an episode where he stopped breathing for approx. 20 seconds. Mom states child is now resting and seems to be okay. Reassurance given and adivsed mom if any further issues or if baby has difficulty breathing, to contact emergency services.
Age: 74.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the vaccine too soon since last dose. Received first dose on 08/30/2024 and a second dose on 03/18/2025
Age: 68.0
Sex: F
Vaccine: PNC15
Symptoms: Dermatitis, Erythema, Pain
Clinical narrative: pain and redness including subcutaneous inflammation that started 7 days after vaccin
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hallucination, visual, Syncope
Clinical narrative: VERBALIZES SEEING COLORS, DIZZINESS AND SYNCOPE
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient, 27 years old, 32 weeks and 4 days pregnant, was given a high-dose fluzone vaccination. Patient as of now states no symptoms or allergic reactions. No symptoms as of this writing.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Client vaccinated at an in-school event on 3/18/2025 partnered between the local school system and local health department. VIIS record was checked and was incomplete as the client was from another state.  The client also only consented to receive the Tdap vaccine. Client received both Tdap and MenACWY but, upon post administration review of out-of-state records 3/19/2025 given to the school prior, the client had already received MenACWY. On 3/19/2025 the parent was called and notified of the medication error. The client was assessed by the school nurse and was found to not have any adverse signs or symptoms. School nurse educated the client on self monitoring for adverse vaccine reactions.
Age: 16.0
Sex: F
Vaccine: FLU3, MENB, MNQ
Symptoms: Oedema peripheral, Tenderness
Clinical narrative: Left arm- 3cm edema and tenderness.
Age: 50.0
Sex: M
Vaccine: COVID19, FLU3, PNC21, TDAP, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Vaccines discussed with client, and client elected to receive Covid, Pneumococcal, Shingles, and Tdap vaccines. RN discussed each vaccine with client, and he verbalized understanding. RN then mistakenly asked which flu shot the client would prefer between Fluzone and Flublok, and he elected to get Flublok. RN administered Flublok, Covid, Shingrix, and Tdap.  Then when documenting on the Vaccine System to give client, RN noticed the mistakenly given Flu shot instead of Pneumococcal and immediately talked with client about it. He said it's totally fine, and it won't hurt him, and he still wanted the Pneumoccocal vaccine. So, RN administered the PCV-21. Client tolerated all vaccines well, and without complaint. No adverse reactions were observed or reported. RN informed her direct supervisor, MSN, RN of the situation.
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash, Thirst
Clinical narrative: I woke up thirsty but i didn't drink anything because i didn't have any room temp water, then that morning when i got up around 8 o'clock i was itching on my hand. The itching went up my right forearm and i was just scratching and it was turning into a rash like thing. It just itched so bad. I did rub it with alcohol but it went to my right knee and it was itching all around my knee. I called my doctor who gave me the vaccine, and the MA called me back late that afternoon and told me to take some Benadryl. It helped stop the itching but it keeps coming back. I even came back today. It will stop one day and then it will come back. I have had to take the Benadryl for multiple days.
Age: 1.5
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Chills, Crying, Cyanosis, Fatigue, Feeling cold
Clinical narrative: Patient had a weird reaction this evening, about 5 hours after vaccines today.  This was post-bath time and very alarming & out of character: Floppy body/inability or unwillingness to stand herself up or hold anything. Goosebumps, shivering, screaming/crying, purple lips/mouth/skin and feeling cold to the touch. It was resolved after about 10 minutes. She?s exhausted, whiny, feverish, and sleepless. She was awake until about 4:30am.
Age: 1.5
Sex: F
Vaccine: COVID19, HEPA
Symptoms: Hypotonia, Irritability, Pyrexia, Screaming, Somnolence
Clinical narrative: Patient had a weird reaction this evening, about 5 hours after vaccines today.  This was post-bath time and very alarming & out of character: Floppy body/inability or unwillingness to stand herself up or hold anything. Goosebumps, shivering, screaming/crying, purple lips/mouth/skin and feeling cold to the touch. It was resolved after about 10 minutes. She?s exhausted, whiny, feverish, and sleepless. She was awake until about 4:30am.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3, PNC20, RSV, COVID19, FLU3, PNC20, RSV
Symptoms: Dysgraphia, Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: pt reports all 4 vaccines given in right arm, but vaccine reporting system shows discrepancies, pts daughter states all vaccines given in right arm(4 vaccines), unknown type of RSV vaccine per Vaccine reporting system, pt notes continued pain, numbness and tingling  in 4th and 5th fingers with right hand weakness, pt is right hand dominant and now hard to write
Age: 76.0
Sex: F
Vaccine: COVID19, FLU3, PNC20, RSV, COVID19, FLU3, PNC20, RSV
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: pt reports all 4 vaccines given in right arm, but vaccine reporting system shows discrepancies, pts daughter states all vaccines given in right arm(4 vaccines), unknown type of RSV vaccine per Vaccine reporting system, pt notes continued pain, numbness and tingling  in 4th and 5th fingers with right hand weakness, pt is right hand dominant and now hard to write
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Irritability, Sleep deficit, Tinnitus
Clinical narrative: he is losing sleep; has become very irritable with his family and coworkers; Ringing in ears; This spontaneous case was reported by a patient and describes the occurrence of SLEEP DEFICIT (he is losing sleep), IRRITABILITY (has become very irritable with his family and coworkers) and TINNITUS (Ringing in ears) in a 72-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced SLEEP DEFICIT (he is losing sleep), IRRITABILITY (has become very irritable with his family and coworkers) and TINNITUS (Ringing in ears). At the time of the report, SLEEP DEFICIT (he is losing sleep), IRRITABILITY (has become very irritable with his family and coworkers) and TINNITUS (Ringing in ears) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported.  The customer works 60 hours a week in security to make ends meet for his family. The customer stated that for the past 4 months, as he tried to get some sleep, he kept hearing a whooshing sound in his ears, kind of like a steady wind sound or ringing, he was losing sleep, had become very irritable with his family and coworkers, and will have to go for costly treatments very soon. The customer stated that before he contacted his attorneys, he wanted to contact Moderna directly and ask for some sort of settlement, somewhere in the neighborhood of $75,000.00 or an amount of their choosing. The customer stated that going through an attorney will cost much more and will cost more legal time, that's why he wanted to contact office directly. The customer requested to consider his plea and contact him for some sort of settlement very soon. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-783378 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2025: Live follow up received in which no new information was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-783378:Same reporter/different patient (Other people)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I did test COVID two years back after vaccination; I did test COVID two years back after vaccination; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 38-year-old male patient 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I did test COVID two years back after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: two years back; after vaccination. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient and his wife took Pfizer vaccines. Saturday (29Jun2024), patient's wife got diagnosed with COVID. On 03Jul2024, patient was told to have tested positive and picking up the same Paxlovid for COVID-19. Patient tested COVID two years back after vaccination and complained that Paxlovid was never this expensive then.
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Bipolar I disorder, Cardiac disorder, Craniocerebral injury, Mental impairment
Clinical narrative: CHI (Life threatening illness); schizophrenia; bipolar one; mental fog; My heart, my hair fell out; My heart, my hair fell out; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 17Mar2025, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications within 2 weeks prior to the event onset. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: CRANIOCEREBRAL INJURY (life threatening), outcome "unknown", described as "CHI (Life threatening illness)"; SCHIZOPHRENIA (medically significant), outcome "unknown"; BIPOLAR I DISORDER (medically significant), outcome "unknown", described as "bipolar one"; MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "mental fog"; ALOPECIA (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "My heart, my hair fell out". The patient had post vaccination problems. Therapeutic measures were taken as a result of craniocerebral injury. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Schizophrenia
Clinical narrative: CHI (Life threatening illness); schizophrenia; bipolar one; mental fog; My heart, my hair fell out; My heart, my hair fell out; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on 17Mar2025, this case now contains all required information to be considered valid.   This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 56-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications within 2 weeks prior to the event onset. Vaccination history included: Covid-19 vaccine (DOSE 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, manufacturer unknown), for COVID-19 immunization. The following information was reported: CRANIOCEREBRAL INJURY (life threatening), outcome "unknown", described as "CHI (Life threatening illness)"; SCHIZOPHRENIA (medically significant), outcome "unknown"; BIPOLAR I DISORDER (medically significant), outcome "unknown", described as "bipolar one"; MENTAL IMPAIRMENT (medically significant), outcome "unknown", described as "mental fog"; ALOPECIA (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "My heart, my hair fell out". The patient had post vaccination problems. Therapeutic measures were taken as a result of craniocerebral injury. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 48-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2024, outcome "unknown" and all described as "tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2024) Positive; (Jul2024) Positive. During an inbound call for financial assistance, the caller explained that they tested positive for COVID-19 and are staying at their parents' house. All three of them tested positive after doing two tests each. The caller's mother had attended a gathering with her three sisters, and they all got infected. The mother felt very ill the previous night, so the caller tested her, themselves, and their father in the morning, and all three tested positive. The caller's parents are 82 and 85 years old, and they don't want to take them for re-testing. Although they are quite sick, the symptoms have been lingering since the service they attended a week ago. The father started feeling unwell on Thursday, the mother felt worse on Friday, and the caller's symptoms worsened on Friday as well. Fortunately, they have all been vaccinated with Pfizer, including the latest available dose. They have been taking the vaccines at the withheld location. The caller is wondering if they should contact their parents' doctors from withheld to get a prescription for them. Later, the caller mentioned that both parents take several medications. The caller is very concerned about their parents due to their age. They believe it's fortunate they got infected now since they have been vaccinated. They have been taking the Pfizer vaccine from the beginning and are up to date, with the last vaccination being three or four months ago. They have received all the shots, including the third or fourth kind. Whenever Pfizer released a new vaccine for a new strain, they got it. This has helped them manage the symptoms. The caller's aunt mentioned that she and her husband took Paxlovid, and now the caller is trying to figure out how to get it for their parents and themselves as quickly as possible.; Sender's Comments: Linked Report(s): US-PFIZER INC-202500058182 same reporter/product/event, different patient.; US-PFIZER INC-202500058181 same reporter/product/event, different patient.;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19 shot didn't work good on me; Covid-19 shot didn't work good on me; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19 shot didn't work good on me".  Clinical course: During an inbound call for financial assistance, the patient said, "COVID-19 shot didn't work good on me." When asked to repeat, the caller said, "The COVID-19 shot didn't work too good on me".
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that; she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "she got diagnosed with COVID. She is also vaccinated like me with Pfizer vaccines and all that". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500031663 same reporter/product/event, different patient;
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "diagnosed with COVID". Clinical course: During an inbound call for assistance with a rejection, the reporter advised, "I'm trying to get Paxlovid. I was diagnosed on Tuesday with COVID. I got all the Pfizer shots for COVID back in Mar2021, Apr2021, Nov2021, Apr2022 and the last one at Dec2022. I got them all at the (Clinic name) at (withheld). So I don't know where I picked this up at I think I got it from a store, where the guy went to (withheld) for to weeks, that's the only place that I can think of where I might've picked something like this up because I don't know anybody that's got it." "Yeah, I don't feel good."