chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: CHIK
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Fever, severe bone pain, muscle aches, severe headache (described as the worst she's had, skeletal in nature. Teeth throbbing, skull pain, etc), lethargy, chills. Symptoms started on day 7, still continuing on day 10 . Patient reported today that she is starting to feel better, but still has nausea, low grade fever, fatigue. OTC medications not helpful in managing symptoms.
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Rash, Rash erythematous
Clinical narrative: Rash up and down his arms and legs, on his back.   Pt also had rosy cheeks.  Pt's abdomen was clear.  Rash is smooth and red, not raised.  It is not itchy.  Mom gave him Benadryl and Tylenol.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Reported arm redness and swelling the evening after vaccination. Fever 101F noted 05/07/2025 morning
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Death, Dyspnoea, Pallor, Pulse absent
Clinical narrative: 5/6 evening  Resident gotten ready for bed with assist of 1 and when resident laid down on bed became SOB and had labored breathing and also became unresponsive. Skin color in face was ashen and purple around lips and nose. 911 was notified. Ambulance arrived and resident was gasping for air and pulse could not be felt. Resident passed away. No adverse events noted prior.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: 5/6 evening  Resident gotten ready for bed with assist of 1 and when resident laid down on bed became SOB and had labored breathing and also became unresponsive. Skin color in face was ashen and purple around lips and nose. 911 was notified. Ambulance arrived and resident was gasping for air and pulse could not be felt. Resident passed away. No adverse events noted prior.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills, aches, fever for 18 hours
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient had vaccines in several facilities per patient's mom. Patient is over vaccinated.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: rash
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Abdominal pain upper, Feeling hot, Headache, Hyperhidrosis, Nausea
Clinical narrative: Approximately 5 minutes after vaccination administration the patient began to voice complaints of being hot and sweaty, having a headache, stomach ache, nausea and had 2 vomitus episodes. Cool towelette was placed on the patient?s forehead and the patient was provided a receptacle to vomit. Vitals were assessed, and they were as follow: B/P 89/56, HR 67bpm and respirations 14bpm. After the vomitus episode the patient was taken to an examination room to lie down and states she felt better after vomiting, voiced she is hungry and was provided a pack of peanut butter crackers and water. The patient ate the crackers with no complications or issues noted. Patient was observed for approx. 15 minutes thereafter with no issues, signs of adverse reactions, anaphylaxis or complications noted prior to departure. Vital signs at departure: B/P 95/57, heart rate 64bpm, respirations 14bpm.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Approximately 5 minutes after vaccination administration the patient began to voice complaints of being hot and sweaty, having a headache, stomach ache, nausea and had 2 vomitus episodes. Cool towelette was placed on the patient?s forehead and the patient was provided a receptacle to vomit. Vitals were assessed, and they were as follow: B/P 89/56, HR 67bpm and respirations 14bpm. After the vomitus episode the patient was taken to an examination room to lie down and states she felt better after vomiting, voiced she is hungry and was provided a pack of peanut butter crackers and water. The patient ate the crackers with no complications or issues noted. Patient was observed for approx. 15 minutes thereafter with no issues, signs of adverse reactions, anaphylaxis or complications noted prior to departure. Vital signs at departure: B/P 95/57, heart rate 64bpm, respirations 14bpm.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Administration of Havrix adult dose to a 17 year-old patient; received the adult dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 17-year-old female patient who received HAV (Havrix adult) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult use of a child product (Verbatim: Administration of Havrix adult dose to a 17 year-old patient) and overdose (Verbatim: received the adult dose of Havrix). The outcome of the adult use of a child product and overdose were not applicable.   Additional Information: GSK Receipt Date: 28-APR-2025 The pharmacist reported that a month ago on March 2025, a 17 year-old patient received the adult dose of Havrix as a first dose, which led to adult use of a child product and overdose. Patient was going to the military so she had been taking all vaccination again, such as IPV, Varicella, etc. The Healthcare professional advised her doctor about this procedure.  No adverse effects had been reported to date.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 57.0
Sex: F
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: The patient was administered the incorrect vaccine (Menveo). The member should have received the Men-B (Bexsero) on 4/29/2025. The member did receive the correct vaccine on 5/2/2025 (Men-B (Bexsero)--Lot#52N4S/NDC#58160-976-02, exp date 11/30/2027) at facility.
Age: 77.0
Sex: F
Vaccine: HEPAB
Symptoms: Lymphadenopathy
Clinical narrative: 2 days after receiving vaccine, the lymph nodes in the neck on the left side (side vaccine was administered) started swelling and being sore. This lasted for another 2-3 days then resolved.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain, Swelling
Clinical narrative: pain, redness, size of a softball swelling immediately after injection
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: Pt developed redness at the site of injection. 24 hours later, He had generalized hives and a rash. No SOB or other respiratory symptoms. He has prior h/o allergies.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: approximately a softball size circular red and warm area around injection site with fatigue
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Discomfort, Haematochezia, Intussusception
Clinical narrative: Several currant-jelly bloody stools 18-24 hours after vaccine, transient discomfort. Suspect self-resolved intussusception.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Severe neck pain approximately 3 days after neck pain lasting 3 days, pt went to hospital to treat pain, was given prednisone and that seemed to alleviate the pain
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: MOC states Pt. is having weakness, fever and dizziness. Ondansetron was given as treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Impaired healing, Injection site pain
Clinical narrative: pt says her right arm has a sore around the injection site that never healed. She has been to several doctors since then and they have never been able to help her with it. The last doctor that she saw has ordered her some blood work to help diagnose the issue with her arm not healing. She is waiting on her results to come back.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pallor, Syncope
Clinical narrative: Patient had syncopal episode after receiving vaccines. Patient was seated in office room chair in clinic room.  HPV and Medquadfi were administered first in left arm and then Trumenba was administered in right arm and patient had the episode. Episode lasted approximately 5 seconds; head slouched down and eyes closed. Immediately patient sat up startled and opened eyes. Patient did not fall from chair.  Patient was pale, but alert. Provider notified and patient observed for additional 15 minutes. Patient was given water. Patient was okay and ambulated.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Hypersomnia, Mood altered
Clinical narrative: hypersomnolence, headache, mood changes
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient developed redness and warmth below the injection site 4 days after administration
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: pt came for well check up and was accidentally given 12 and up Covid age vaccine instead of 4- 11 years
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: When discussing vaccines to be given, this RN noted in the Registry that rotavirus was not listed in the recommended vaccines. The note at the bottom of the recommendation list states, "please do not rely soley on the Recommender to forecast immunizations." Upon looking at the number of days old listed in Epic, this RN noted "(85 day old)" and attempted to calculate age based on days old. Based on 85 day old status, pt would be 12 weeks old. Discussed with CPNP-PC and PA-C if there would be an indication of why a pt wouldn't be able to receive the vaccine at approx 12 weeks with recommendation starting prior to 15 weeks old. None noted when asked. Looked up and printed off CDC recommendation for rotavirus, highlighted 15 week limit, printed off Rotavirus VIS report for MOC and highlighted 15 week limit. Discussed with Dr., PA-C, and CPNP-PC age less than 15 weeks and okay for pt to receive rotavirus. Dr. in agreement and verbally gave order to be put into Epic for rotavirus. This RN charted giving rotavirus prior to going into room and sent vaccine to Registry to verify okay to receive and that the immunization would not be flagged as inappropriate prior to administration. Upon refreshing registry, valid first dose documented. When entering room to administer vaccines, relayed all vaccines to be given and gave VIS printout of all vaccines to be given. Discussed time frame and age with MOC, relayed no pressure to receive rotavirus if not comfortable. MOC verbalized okay to give, this RN showed vaccine, manufacturer, expiration date and administered rotavirus along with other vaccines ordered. After finished charting, this RN rechecked date given and birth date to realize that pt is 17 weeks old based on birth date. RN reported to Dr. and Director of Nursing.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash, Serum sickness
Clinical narrative: Received MMMR & Varicella on 4/24/25, developed serum sickness like reaction 9 days later on 5/3/25. No exposure to suggest other trigger - like no medications, no infectious symptoms prior to onset of reaction. Rash consistent with serum sickness, not a typical MMR rash.
Age: 65.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Nurse did not reconstitute and gave only the diluent.  She realized before the patient left.  Acquired additional diluent, reconstituted correctly and gave the vaccine.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient woke up in the middle of the night with soreness in the arm. In the morning, he noticed arm is red, warm, tender, and slightly swollen with a "little ball" at the injection site. He's been extremely fatigued throughout the day.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain in extremity, Sleep disorder
Clinical narrative: Patient woke up in the middle of the night with soreness in the arm. In the morning, he noticed arm is red, warm, tender, and slightly swollen with a "little ball" at the injection site. He's been extremely fatigued throughout the day.
Age: 51.0
Sex: F
Vaccine: PNC20
Symptoms: Gait disturbance, Nervous system disorder
Clinical narrative: I am having neurological issues, my legs have became weak and it is hard to walk.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Joint stiffness, Lymph node pain
Clinical narrative: Taken from patient's message sent to MD:       Starting Monday 4/21 I woke up feeling sick with painful and enlarged lymphs around my ears, throat, neck and back of the head. Symptoms continued all week with  slight fever and fatigue. Started feeling better on Sat 4/26, then Tues 4/29 started having extremely stiff and painful joints in my wrist and hands. Very bad numbness at night, been waking up all night with extreme pain and numbness in my hands (especially Left). This morning 5/2 started to feel stiffness and pain in my ankles and feet. While still having the hand issues.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Malaise, Musculoskeletal stiffness, Pain in extremity, Pyrexia
Clinical narrative: Taken from patient's message sent to MD:       Starting Monday 4/21 I woke up feeling sick with painful and enlarged lymphs around my ears, throat, neck and back of the head. Symptoms continued all week with  slight fever and fatigue. Started feeling better on Sat 4/26, then Tues 4/29 started having extremely stiff and painful joints in my wrist and hands. Very bad numbness at night, been waking up all night with extreme pain and numbness in my hands (especially Left). This morning 5/2 started to feel stiffness and pain in my ankles and feet. While still having the hand issues.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Sleep disorder
Clinical narrative: Taken from patient's message sent to MD:       Starting Monday 4/21 I woke up feeling sick with painful and enlarged lymphs around my ears, throat, neck and back of the head. Symptoms continued all week with  slight fever and fatigue. Started feeling better on Sat 4/26, then Tues 4/29 started having extremely stiff and painful joints in my wrist and hands. Very bad numbness at night, been waking up all night with extreme pain and numbness in my hands (especially Left). This morning 5/2 started to feel stiffness and pain in my ankles and feet. While still having the hand issues.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC15, VARCEL
Symptoms: Pyrexia
Clinical narrative: DEVELOPED HIGH FEVERS OF 105
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: pt was given comirnaty on 4/30/25 expiration date was 4/26/25.  Pt has had no adverse reactions or problems.  She has been contacted to return to clinic to have another vaccination.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Dyskinesia, Eye movement disorder, Hypoacusis, Hypotonia
Clinical narrative: Patient received meningococcal group B vaccine and within a couple minutes, patient turned pale and slumped to the left side sitting in the chair. Patient began making abnormal movements with arms and trunk of body along with head. Mouth was open and eyes were rolling back. Mother stated patient's name and patient was able to respond. This lasted 15 to 30 seconds. Provider notified immediately and came into the room to examine patient. Patient became nauseous but did not vomit. Patient reported tingling in their hands, blurry vision and muffled hearing. Patient also complained of being tired and dizzy. Patient declined any chest pain or headache. Patient's symptoms improved within 5 to 10 minutes. Blood pressures were taken in 5 minute increments while patient was being monitored from incident. Patient was then able to tolerate drinking sips of apple juice and was able to eat a graham cracker. Patient was able to stand up without feeling dizzy or having any pain. Provider re-examined patient and discharged patient from the clinic. All questions and concerns from Mother were answered by provider. Mother instructed to contact provider if any other questions or concerns come up.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pallor, Paraesthesia, Vision blurred
Clinical narrative: Patient received meningococcal group B vaccine and within a couple minutes, patient turned pale and slumped to the left side sitting in the chair. Patient began making abnormal movements with arms and trunk of body along with head. Mouth was open and eyes were rolling back. Mother stated patient's name and patient was able to respond. This lasted 15 to 30 seconds. Provider notified immediately and came into the room to examine patient. Patient became nauseous but did not vomit. Patient reported tingling in their hands, blurry vision and muffled hearing. Patient also complained of being tired and dizzy. Patient declined any chest pain or headache. Patient's symptoms improved within 5 to 10 minutes. Blood pressures were taken in 5 minute increments while patient was being monitored from incident. Patient was then able to tolerate drinking sips of apple juice and was able to eat a graham cracker. Patient was able to stand up without feeling dizzy or having any pain. Provider re-examined patient and discharged patient from the clinic. All questions and concerns from Mother were answered by provider. Mother instructed to contact provider if any other questions or concerns come up.
Age: 15.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Lethargy, Loss of consciousness
Clinical narrative: 5 MINUTES AFTER RECEEIVING VACCINE THAT I DENIED, MY DAUGHTER PASS OUT FOR  A MINUTE AND WAS BEING A BIT LOTHARGIC, IM ACTUALLY VERY DISSAPOINTED WITH FACILITY, MY DAUGHTER NEVER RECEIVED FIRST DOSAGE
Age: 1.75
Sex: M
Vaccine: FLU3, HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event. Incorrect dosage given (12 year & older)
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Scratch, Underdose
Clinical narrative: Child was receiving 2nd dose of Hep A. When medical assistant went to administer, parent did not have efficient hold on childs leg-needle pulled out and scratched patients' right thigh. Most of the Hep A vaccine spilled onto father leg. Less than half of the Hep A was injected to the patient. Patient was wiped clean. No reactions to actual vaccine.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Skin abrasion, Syringe issue, Underdose
Clinical narrative: Child was receiving 2nd dose of Hep A. When medical assistant went to administer, parent did not have efficient hold on childs leg-needle pulled out and scratched patients' right thigh. Most of the Hep A vaccine spilled onto father leg. Less than half of the Hep A was injected to the patient. Patient was wiped clean. No reactions to actual vaccine.
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered
Clinical narrative: Patient spoke another language and we resorted to using a translator to help her fill out her questionnaire. During this process we accidently pulled the immunization history for her husband who has a very similar name. Her husband did need and rsv vaccine but she had already gotten one in February of this year so she did not need the dose we gave her today on 5/7/25. This mistake occurred due to a language barrier and a breakdown in our system. Patient was fine after receiving the vaccine.
Age: 82.0
Sex: M
Vaccine: TD
Symptoms: No adverse event
Clinical narrative: N/A no adverse symptoms, no change in treatment.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: Administered Expired vaccine .contacted parents and vaccine will be readministered.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness of RT arm near injection site all throughout the day (05/07/25).
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Aphasia, Dizziness, Paraesthesia
Clinical narrative: Patient was ordered PCV 21 vaccine after physical visit by provider. PCV 21 vaccine administered by nurse per order in patient's left upper arm. Patient was fasting at the time for blood work. Patient tolerated immunization well, walked to check out within clinic. At check out patient reports 10 minutes after vaccination that she felt suddlenly light headed and that it was hard to talk, noting she might faint. Sat down in the lobby and asked for help. RN came out to assess and assist patient, she brought patient back to exam room. Patient BP 132/82, HR 74 at 11:34. Patient laid on exam table with multiple blankes and hot packs complaining of shaking and chills with continued light headed ness. 12:08 patient BP 132/82, HR 75, O2 saturation 100% on room air. Patient complains of feeling tingly all over the exterior of her body. Denies chills or shaking at this time. Light headedness comes and goes. Denies itching, no swelling or rash, or changes in breathing. 12:45 Patient's blood pressure 115/74 HR 72. Provider advised patient to take home dose of PRN xanax once spouse at chair side. Patient ate crackers and states she is feeling much better. Moved to sitting position and responding with spouse. At 1:20 patient got up without assistance to bathroom, stable when walking, no complaint of light headed or dizziness. Patient departed clinic unassisted. All symptoms resolved.
Age: 51.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea, Pruritus
Clinical narrative: Patient received her PCV-20 and Heplisav-B vaccines on 4/30/25; both immunizations administered to right deltoid per patient request. No reactions during post-vaccine 15-minute monitoring.  Patient has no allergies, and confirmed that she had no prior known reactions to vaccines. Patient returned on 5/7/25 for another previously scheduled appointment, and reported that she had some redness/swelling at the injection site starting on 4/30/25 until Saturday, 5/3/25. Patient also reported having rash, itchiness, tiredness, and nausea (without vomiting) during this time period. Patient stated that she took Claritin, which helped her symptoms. Injection site still appeared a little red on 5/7/25. Reaction reported to the patient's PCP. Per MD, patient can continue to take Claritin as needed, with no other interventions needed at this time. Patient will be following up with PCP on 5/21/25; provider will discuss vaccine reactions with patient prior to ordering any additional doses of Heplisav-B, as it is unknown whether patient reaction to Heplisav-B vaccine, PCV-20 vaccine, or both.
Age: 51.0
Sex: F
Vaccine: HEP, PNC20
Symptoms: Rash
Clinical narrative: Patient received her PCV-20 and Heplisav-B vaccines on 4/30/25; both immunizations administered to right deltoid per patient request. No reactions during post-vaccine 15-minute monitoring.  Patient has no allergies, and confirmed that she had no prior known reactions to vaccines. Patient returned on 5/7/25 for another previously scheduled appointment, and reported that she had some redness/swelling at the injection site starting on 4/30/25 until Saturday, 5/3/25. Patient also reported having rash, itchiness, tiredness, and nausea (without vomiting) during this time period. Patient stated that she took Claritin, which helped her symptoms. Injection site still appeared a little red on 5/7/25. Reaction reported to the patient's PCP. Per MD, patient can continue to take Claritin as needed, with no other interventions needed at this time. Patient will be following up with PCP on 5/21/25; provider will discuss vaccine reactions with patient prior to ordering any additional doses of Heplisav-B, as it is unknown whether patient reaction to Heplisav-B vaccine, PCV-20 vaccine, or both.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Hyperhidrosis, Pallor, Syncope, Visual impairment
Clinical narrative: Patient left immediately after vaccine administration and felt faint while checking out. Patient sat down in chart prior to fainting d/t black spots in vision. She became diaphoretic, pale, and had a drop in her blood pressure.
Age: 59.0
Sex: F
Vaccine: COVID19, PNC20, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope
Age: 16.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Left arm redness, warmth, swelling that started the evening of the injection, and persisted for 6 days, at which time she came in to the office.  She took Tylenol without improvement.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called on 5/7/25 at 1023am to report adverse effects from her second shingles vaccine (received on 5/5/25) at the localized injection site (left deltoid) of redness, swelling, and itchiness. She did report that scratching caused it to bleed. Apology was given and was told that we are required to report this incident and to reach out to Pharmacy manager if she has unresolved issues.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC15, VARCEL
Symptoms: Pallor, Rash, Rash maculo-papular
Clinical narrative: rash that started on the face and spread to the extremities and trunk, blanching erythematous maculopapular rash to face, trunk, extremities.
Age: 69.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Food allergy, Pruritus, Rash
Clinical narrative: Rash, redness and severe itching reported by patient after administration and continued until now.  Rash has subsided but not completely.  Patient also reported development of allergy to shrimp and salmon, which she had never had before.  I recommended Benadryl to patient in the meantime and advised her to contact her PCP if reaction continues.
Age: 0.5
Sex: F
Vaccine: COVID19, DTPPVHBHPB, PNC15, RV5
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach pain and diarrhea for 1.5 weeks; Stomach pain and diarrhea for 1.5 weeks; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain and diarrhea for 1.5 weeks) and DIARRHOEA (Stomach pain and diarrhea for 1.5 weeks) in a 6-month-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect products included non-company products Vaxelis for an unknown indication, Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) for an unknown indication and Rotavirus vaccine live reassort oral 5v (Rotateq) for an unknown indication.    Concurrent medical conditions included Cold.   On 12-Feb-2025, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form, dose of Vaxelis (unknown route) 1 dosage form, dose of Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) (unknown route) 1 dosage form and dose of Rotavirus vaccine live reassort oral 5v (Rotateq) (Oral use) 2 dosage form. On 14-Feb-2025, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain and diarrhea for 1.5 weeks) and DIARRHOEA (Stomach pain and diarrhea for 1.5 weeks). In February 2025, ABDOMINAL PAIN UPPER (Stomach pain and diarrhea for 1.5 weeks) and DIARRHOEA (Stomach pain and diarrhea for 1.5 weeks) had resolved.        The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown) was unknown.       Medications at the time of vaccination, history/ allergies were none.  No concomitant medication was reported.  Moderna, Vaxelis, Vaxneuvance was given via syringe at site LG and Rotateq via oral route at site MO.  On 12-Feb-2025, patient also received 1 dose of unknown vaccine via syringe at site LG.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type
Clinical narrative: at the end had Alzheimer's; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (at the end had Alzheimer's) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Food allergy (was allergic to corn).    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 DEMENTIA ALZHEIMER'S TYPE (at the end had Alzheimer's) (seriousness criterion medically significant). At the time of the report, DEMENTIA ALZHEIMER'S TYPE (at the end had Alzheimer's) had not resolved.            No concomitant medications were reported.  The patient did not experience any additional symptoms or events  No treatment medications were reported.  Company comment:  Very limited information provided in this case report precludes meaningful medical assessment. Temporal relationship was not provided, as well as the patient's age and medical history. Although there was lack of information at this point, until the date, there is no evidence to suggest that the suspect product can cause Alzheimer's disease and due to lack of biological plausibility, the causality is assessed as not related to the suspect product. The benefit-risk relationship of the product is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2025-785740 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2025: Live follow-up received contains non-significant information and added Reference ID. On 28-Apr-2025: Live follow-up received contains non-significant information and added Reference ID. On 29-Apr-2025: Live follow-up received contains non-significant information and added Reference ID.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785740:Master Case (Patient, Spikevax 2024-25 PFS)
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Type II hypersensitivity
Clinical narrative: I didn't really get much of a type 2 reaction, you know the big bump on your arm; I didn't really get much of a type 2 reaction, you know the big bump on your arm; This serious initial spontaneous safety report was received by Novavax on 29-Apr-2025 from an Other health professional via contact center (MI No. NOV25-00250).  A 42-year-old female was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report) on Nov-2023.  The following medical history was reported: HYPOGAMMAGLOBULINEMIA, AUTO-INFLAMMATORY CONDITION, YAO SYNDROME, LONG COVID, MCAS, POTS, SMALL FIBER NEUROPATHY FROM LONG COVID, SEVERE ASTHMA, VOCAL CORD DYSFUNCTION, METABOLIC SYNDROME, AUTONOMIC DYSFUNCTION, SEVERE GASTROPARESIS, GI DYSMOTILITY, LATEX ALLERGY, PENICILLIN ALLERGY, BEE ALLERGY, BEE'S WAX AND HONEY ALLERGY, METRONIDAZOLE ALLERGY, IODINE CONTRAST ALLERGY and IMMUNOCOMPROMISED.   The following concomitant medications were reported: MITOCHONDRIAL NRG(d-ribose), GAMMAGARD(immunoglobulin human normal), SULFADIAZINE(sulfadiazine), METFORMIN(metformin), MESTINON(pyridostigmine bromide), FAMOTIDINE(famotidine), LORATADINE(loratadine), ACETYSALICYLIC ACID(acetylsalicylic acid), CROMOLYN [CROMOGLICIC ACID](cromoglicic acid), DIGESTIVE ENZYMES [BETAINE HYDROCHLORIDE;BROMELAINS;CELLULASE;PANCREATIN;PAPAIN](betaine hydrochloride), MAGNESIUM(magnesium), NIACIN(nicotinic acid), MIRTAZAPINE(mirtazapine), NALTREXONE(naltrexone), SYMBICORT(formoterol fumarate), ALBUTEROL [SALBUTAMOL SULFATE](salbutamol sulfate), ATROVENT(ipratropium bromide), FLONASE [MOMETASONE FUROATE](mometasone furoate), BENADRYL [ACRIVASTINE](acrivastine), VYVANSE(lisdexamfetamine mesilate), METOPROLOL(metoprolol), CORLANOR(ivabradine hydrochloride), NATAZIA(estradiol valerate), SLYND(drospirenone) and ZYRTEC [LEVOCABASTINE HYDROCHLORIDE](levocabastine hydrochloride).  On unspecified dates after vaccination the patient experienced "I didn't really get much of a type 2 reaction, you know the big bump on your arm (Type II hypersensitivity) (Serious: Other Medically Important Condition)" and "I didn't really get much of a type 2 reaction, you know the big bump on your arm" (Injection site mass).  At the time of reporting, the outcomes of events Type II hypersensitivity and Injection site mass were Unknown.  Additional case number for this patient included: 2025-NVX-US-00307.; Sender's Comments: This 42-year-old female experienced Type II hypersensitivity and Injection site mass after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula).  The event Type II hypersensitivity was reported as serious.  The event Injection site mass was reported as non-serious.   Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Type II hypersensitivity and Injection site mass is considered Possible.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse reaction noted.   Called pt.'s mother .Spoke with mother Per mother pt. is stable no side effects noted.  Reviewed side effects of HPV Vaccine Soreness,redness or swelling Health Provider ordered Prevnar 20 . Pt Received HPV.    4/21/25 5 pm Called pt's mother  Spoke with mother and was informed Pt. Received HPV instead of Prevnar.20. Reviewed side effects of HPV Soreness,redness or swelling where vaccines was administered. Pt was given Er precautions if severe allergic reaction (hives swelling of the face and throat difficulty breathing call 911 and take pt to nearest hospital. Mother verbalized understanding.  4/22/25 9 20 amCalled pt.'s mother .Spoke with mother Per mother pt. is stable no side effects noted.  Reviewed side effects of HPV Vaccine Soreness,redness or swelling where vaccines was administered. Pt was given ER precautions if severe allergic reaction (hives swelling of the face and throat difficulty breathing call 911 and take pt to nearest hospital. Mother verbalized understanding. Pt. Mother requested Immunization card to be mail. Printed and mailed to address on file.   04/23/25 1:15 pmCalled pt.'s mother .Spoke with mother Per mother pt.  is stable no side effects noted.  Reviewed side effects of HPV Vaccine Soreness,redness or swelling where vaccines was administered. Pt was given ER precautions if severe allergic reaction (hives swelling of the face and throat difficulty breathing call 911 and take pt to nearest hospital. Mother verbalized understanding
Age: 55.0
Sex: F
Vaccine: COVID19, PNC21, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt claims day after vaccination she experienced redness around injection site on both arms. Then the right arm redness extended down to elbow, the next  day the opposite arm did the same thing and while the right arm went back to normal. Overall redness, warmth, pain alternated between the arms.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC15, RV5
Symptoms: Brief resolved unexplained event
Clinical narrative: BRUE
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Crying, Fear, Headache, Nausea, Syncope
Clinical narrative: Pt fainted approximately 2 minutes after HPV vaccine given. She was seated on the exam table and laid herself back as she fainted.  Mom assisted as she was almost horizontal on the exam table. No injury occurred.  Pt woke up on her own after approximately 15 seconds.  She cried immediately and was very scared about episode that just occurred.  She asked "what happened?"  I explained to her that she fainted after her vaccine and that this can happen with the HPV or any vaccine/blood draw, etc.  Dr. came to room to evaluate patient.   Patient reported that has a headache and is nauseous but otherwise feeling better about 10 minutes after episode.  Both parents, Dr., and this RN in the room when patient was advised after 15 minutes she could slowly stand up if she was ready.  She was able to stand up with standby assist and reported she feels ok to leave the office.  Emesis bag provided to pt in case of vomiting after leaving office.  Father did assist her out of the office with his arm around her arm in the event dizziness/fainting reoccurred.  Pt discharged with both parents and all belongings.   All questions/concerns addressed before discharge.                                                                                                                                                                                         BP at start of visit 115/74  HR - 100.     5 minutes after syncopal episode BP 132/84  HR - 100,    15 minutes after episode BP 121/78 HR - 100
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness the next morning
Age: 75.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Atrial fibrillation, Feeling abnormal, Paraesthesia
Clinical narrative: The patient reported feeling bad that evening and worse the next day.  She said she felt like needles were poking her all over.  The following day she went to the ER where they found her to be in A fib.  She followed up with her primary care and they also referred her to also follow up with her cardiac specialist.    She has been in A fib before but they feel like the shingles shot made her have another episode.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Patient described a raised bump at the site of injection , patient reported no issues day of injection but stated the morning after she woke she felt sore in her arm and the areas was red and inflamed the size of a "ping pong ball", patient did not know if caused specifically by vaccine , but was in process to see a acute care clinic.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: starting 5/6 patient had sore arm but then woke up 5/7 with total body tingling and was sore from head to toe(this is 5 days after shot)
Age: 82.0
Sex: M
Vaccine: PNC20
Symptoms: No adverse event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain, Pemphigoid
Clinical narrative: Patient claims after 3 weeks the vaccine cause "Bullous pemphigoid" on her hands and feet. There are multiple blisters on hands/feet that are "opening" and excepetionally painful.
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Brain fog, Chest discomfort, Disorientation, Dizziness, Eye pain
Clinical narrative: Disorientation, fogginess of the brain, severe headache back of head,  severe pain in back of eyes, dizziness, heavy chest, heavy head, severe neck pain, sneezing and runny nose for the first nine days. Thought if he went to sleep, he wouldn't wake up. Still having dizziness and disorientation.
Age: 62.0
Sex: M
Vaccine: PNC20
Symptoms: Head discomfort, Headache, Neck pain, Rhinorrhoea, Sneezing
Clinical narrative: Disorientation, fogginess of the brain, severe headache back of head,  severe pain in back of eyes, dizziness, heavy chest, heavy head, severe neck pain, sneezing and runny nose for the first nine days. Thought if he went to sleep, he wouldn't wake up. Still having dizziness and disorientation.
Age: 58.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presents to the pharmacy counter 3 days after receiving first dose of Shingrix vaccine in her right arm and Capvaxive in her left arm. No adverse reactions to the Capvaxive vaccine but patient has injection site reaction to the Shingrix vaccine which includes large area of redness and swelling on her upper arm. She states that it began as a small area but grew to a cover a much larger area. Patient was given recommendations for how to treat reaction at home including taking OTC pain relievers such as Ibuprofen and placing an ice pack on the area to reduce swelling. She stated that she would follow those recommendations and follow up if not improved after a few days.
Age: 24.0
Sex: F
Vaccine: MENB, TDAP
Symptoms: Arthralgia, Inflammation, Peripheral swelling, Urticaria
Clinical narrative: 24-48hrs after started to hives on bilateral shoulder expanding to rest of body  (side abdomen, thighs/legs, back). Put hydrocortisone and  Calamine lotion.   Side effect really itchy thus the medication and ice cold baths.   Then started to get water retention (swollen feet, ankles). After a day of swollen feet it started to hurt when standing. The swelling progressed behind knees and at elbows. Didn't resolved until two weeks ago. Started using the ibuprofen 2-3days after realizing the swelling was  not going away. It relieved a little bit but didn't remove the inflammation completely still felt stiff. Maybe the lymph nodes are    clogged told by another person. Tried oiling body and doing "Gah-sha" (chinese remedy?). Was extreme sore 3 days after this. Slowly was    getting better. The "Gah-sha" treatment started after most recent telephone call from provider on 4/24 when she explained the symptoms multiple joint pain and hives. Prescribed naproxen for suspected reactive arthritis on 4/25. Swelling joint pain 4 days after    the "Gah-sha" started to improve. Not completely resolved about 75% relieved today (5/7). Have to take breaks from arts and crafts.   Noticed red eyes about 2-3wks ago. Denies chest pain, palpitations, coughing, wheezing, abdominal pain, N/V,  diarrhea, constipation. +dyspnea (only when walk) after initial hives getting little better     Didn't seek ED care, because naturally gets hives during the summer. Was somewhere on 4/12-13 which was very sunny and hot.  Didn't notice any bug bites in the area. Hives happened about 2-3 other times in the past years. In the past the hives  would last 1-2 days and goes away with calamine and hydrocortisone. If didn't then would take allegra. didn't take the allergra this time around.    Swelling on bottom of feet started the day after initial visit followed by joint  pain two days after. Joint pain started with ankles bilaterally but the moved up  to knees, then few days in wrists and elbows. Now every night how she sleeps will  feel the joint pain.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial thrombosis, Atrial fibrillation, Cerebral haemorrhage, Coronary arterial stent insertion
Clinical narrative: 18 months later went into AFIB, blood clots in right descending arterial. Went into surgery, received 2 stints. 4 days after found bleeding in lower cerebellum
Age: 72.0
Sex: F
Vaccine: FLU3, COVID19, FLU3
Symptoms: Injected limb mobility decreased, Rash
Clinical narrative: Patient states she has shoulder pain 16 days after vaccine and unable to use arm. Prompted visit to urgent care to get pain medications. Urgent care would not prescribe anything for her. I advised patient to try ibuprofen or APAP. She stated she needed something stronger. I told her she would need a prescription for anything stronger than what is available OTC. Patient stated she would be contacting an attorney if arm pain did not resolve and that vaccines such as the one she received should not be given.
Age: 72.0
Sex: F
Vaccine: FLU3, COVID19, FLU3
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient states she has shoulder pain 16 days after vaccine and unable to use arm. Prompted visit to urgent care to get pain medications. Urgent care would not prescribe anything for her. I advised patient to try ibuprofen or APAP. She stated she needed something stronger. I told her she would need a prescription for anything stronger than what is available OTC. Patient stated she would be contacting an attorney if arm pain did not resolve and that vaccines such as the one she received should not be given.
Age: 41.0
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pharmacist called to report that a 41 year old was supposed to receive both an MMR and VARICELLA vaccine but instead was administered PROQUAD. Caller provided the name and address he was calling from and stated it happened at one of their facilities; No patient symptoms had been reported; 41 year old received PROQUAD; This spontaneous report was received from a Pharmacist and refers to a 41-year-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #, expiration date, strength, route of administration, anatomical location not provided) as prophylaxis; instead of measles, mumps and rubella (MMR) and varicella vaccine as it was supposed to be received (wrong vaccine administered, inappropriate age at vaccine administration). It was stated that no symptoms had been reported.
Age: 1.0
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported, no further information provided; Field employee called to report a patient received an expired VAQTA.; This spontaneous report was received from a nurse and refers to a 1-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 16-Apr-2025, the patient was vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), (lot #X025482, expiration date: 12-Apr-2025) (1 dose) for prophylaxis. No additional adverse event was reported.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Autoimmune disorder, Biopsy skin abnormal, Pruritus, Skin hyperpigmentation, Vein discolouration
Clinical narrative: autoimmune response that generates lichen planus; she noted that her veins looked "darker and blue/One week after noticing the vein discoloration/hyperpigmentation showed up all throughout the body/lichen planus pigmentosus; This spontaneous report was received from a consumer, regarding herself, a 46-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Mar-2024, the patient was vaccinated with the first dose of human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), dose of 0.5 mL, intramuscularly administrated in the left deltoid (lot #1957407 which has been verified to be a valid number, expiration date reported and validated as 23-Jan-2026) as a prophylaxis.  On unspecified date in 2024 (reported as about 7 days later), the patient noted that her veins looked darker and blue. On unspecified date (reported as one week after noticing the vein discoloration) she started itching all over her body for a few days. She thought it was just a rash, but then a month later hyperpigmentation showed up all throughout the body. The patient sought medical attention calling the health care professional (HCP). On 03-Dec-2024, the patient went to see the dermatologist and a biopsy was taken from the left deltoid area, which confirmed that there was an induced autoimmune response (autoimmune disorder) that caused lichen planus pigmentosus. The patient was placed on treatment which had been unsuccessful. At the reporting time, the patient had not recovered from the events.  The action taken with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was reported as therapy discontinued.    The causal relationship between the events with human papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not provided.   Upon internal review, the event of autoimmune disorder was determined to be medically significant.