chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: no side effects reported; She said she was given the VARIVAX vaccine when she was unaware that she was pregnant.; This prospective spontaneous report was received from patient refering to herself as a 32-year-old female pregnant.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 27-DEC-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (dose, vaccination scheme, injection site, strength, lot #, expiration date, and route of administration were not provided). It was reported that when she was given the she was unaware that she was pregnant (exposure during pregnancy); at the time of reporting she was 7 weeks of gestation. No side effects were reported. The pregnancy and fetal outcomes were unknown.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still got them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Still got them). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JAN-2025 This case was reported by the patient via interactive digital media. The patient had the vaccine and still got them (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Blood grouping, Lethargy, Mobility decreased
Clinical narrative: couldn't move for almost a year; lethargic in the chair; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-781503 (Moderna).  A 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: MOBILITY DECREASED (medically significant), outcome "unknown", described as "couldn't move for almost a year"; LETHARGY (non-serious), outcome "unknown", described as "lethargic in the chair". The patient was lethargic in the chair and couldn't move for almost a year, but had the "Pfizer. Believes the effects are because of "blood type" O negative,  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 1.5
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Hypophagia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had redness and swelling at the site the next day.. Three days after he had fevers to 103 which have persistent to day 6. He has diarrhea and decrease oral intake. In the office his vitals were normal 4 hours after tylenol, was more playful to mom and eating better. Red outline was still there but redness fading. Nontender
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PATIENT RECEIVED PREVNAR 20 ON 1/28/25. SHE EXPERIENCED REDNESS AND ITCHING FOR FEW DAYS. SHE STILL HAS SOME REDNESS AROUND THE INJECTION SITE. I PROVIDED AN ICE PACK AND ADVISED HER TO TAKE BENADRYL FOR ITCHING IF NECESSARY
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event
Clinical narrative: no adverse effects noted
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received another dose of Boostrix in less than a 1-year time frame. The patient does not have any symptoms or side effects. She got a vaccine in June of 2024 and again yesterday, 2/4/25.
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Duplicate administration. Previously administered 11/2023. No reported ADR. Reported to patient who denies knowledge of previous administration.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: No ADR. Duplicate vaccine. Previously administered in 11/2023. Pt denied knowledge of previous vaccination.
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Blister, Blister rupture, Hypersensitivity, Injection site pain, Pruritus
Clinical narrative: Patient called the pharmacy 2 days post vaccine of Capvaxive. Patient was inquiring about possible side effects. Patient explained that she was itching all over with swelling of the face. Patient also stated she had blisters arise on her hands and legs that have since ruptured due to itching. Patient stated she had a low grade fever with injection site pain. Patient clarified she DID NOT have any difficulty breathing at the moment. RPH on staff explained that what she was experiencing describes an allergic reaction and directed her to take benadryl (diphenhydramine). Pharmacist emphasized to seek emergency help if difficulty breathing or altered mental state occurs. Patient verified understanding.
Age: 54.0
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia, Swelling face
Clinical narrative: Patient called the pharmacy 2 days post vaccine of Capvaxive. Patient was inquiring about possible side effects. Patient explained that she was itching all over with swelling of the face. Patient also stated she had blisters arise on her hands and legs that have since ruptured due to itching. Patient stated she had a low grade fever with injection site pain. Patient clarified she DID NOT have any difficulty breathing at the moment. RPH on staff explained that what she was experiencing describes an allergic reaction and directed her to take benadryl (diphenhydramine). Pharmacist emphasized to seek emergency help if difficulty breathing or altered mental state occurs. Patient verified understanding.
Age: 78.0
Sex: F
Vaccine: PNC20
Symptoms: Rash
Clinical narrative: PT STATED SHE HAD A LOCAL RASH (NOT RAISED) and rash on her torso, inner upper right thigh.  pt said it was not itchy.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of RSV (Arexvy) vaccine. Patient stated no side effects.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Ear discomfort, Impaired work ability, Myalgia, Nasal congestion
Clinical narrative: Arm pain 2 days, muscle aches, nasal congestion, ears plugged, weakness and pain after exercising 5 days and still running.  Missed work.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm pain 2 days, muscle aches, nasal congestion, ears plugged, weakness and pain after exercising 5 days and still running.  Missed work.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second dose of RSV (Arexvy); had previously received in 2023. Patient stated no side effects.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Patient received shingrix shot Monday Feb 3 and woke up Tuesday Feb 4 to swollen hand on the same side she received vaccine.  No swelling in arm or at injection site, just swollen hand.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Erythema, Inflammation, Myalgia, Pyrexia
Clinical narrative: Arm was red from my shoulder to my elbow, and was inflamed. I had incredible muscle aches, fever, and was sick to my stomach for 5 -7 days
Sex: F
Vaccine: COVID19, FLUX, RVX
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Pruritus
Clinical narrative: sore arm; chills, especially at night; muscle aches; headache; some itching on the lop of her head; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 71-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Influenza vaccine for prophylaxis and COVID-19 vaccine for prophylaxis.   Concomitant products included modafinil, cetirizine hydrochloride (Zyrtec), trazodone hydrochloride (Trazodone Hcl), clonazepam, fluoxetine hydrochloride (Prozac), ascorbic acid (Vitamin C), colecalciferol (Vitamin D3) and calcium.   On an unknown date, the patient received RSV vaccine, Influenza vaccine and COVID-19 vaccine. On 16-DEC-2024, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm), chills (Verbatim: chills, especially at night), muscle pain (Verbatim: muscle aches), headache (Verbatim: headache) and pruritus (Verbatim: some itching on the lop of her head). The outcome of the pain in arm, chills, muscle pain, headache and pruritus were unknown.   It was unknown if the reporter considered the pain in arm, chills, muscle pain, headache and pruritus to be related to RSV vaccine.     It was unknown if the company considered the pain in arm, chills, muscle pain, headache and pruritus to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 28-JAN-2025 The reporter reported that a 71 years old female patient who had sore arms, chills, especially at night, muscle aches. headache and some itching on the lop of her head after receiving RSV vaccine, Covid 19 vaccine and Influenza vaccine.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Red spots diagnosed as Pityriasis rosea; This serious case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 10-JAN-2025, 8 days after receiving Shingrix, the patient experienced pityriasis rosea (Verbatim: Red spots diagnosed as Pityriasis rosea) (serious criteria GSK medically significant). The outcome of the pityriasis rosea was unknown.   It was unknown if the reporter considered the pityriasis rosea to be related to Shingrix.     The company considered the pityriasis rosea to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 30-JAN-2025 The patient stated that he received his dose of Shingrix. On 6th January 2025, the patient had an appointment with his dermatologist for a full body scan and he did not present with any spots or lesions.  On 10th January 2025, the patient had a single red spot on his chest.  Then on 16th January 2025 he reported numerous red spots on his torso (front and back) and his sides.  On 28th January 2025, the patient was examined by his dermatologist and the primary care physician diagnosed his condition as pityriasis rosea.  The patient was informed by the dermatologist that the antigen caused a secondary latent condition related to certain herpes virus exposures and presented as a singular red spot known as herald patch. The spots were termed daughters. The condition was known as pityriasis rosea. The herald patch was a single oval one-inch lesion.  The patient was undergoing treatment for this condition that lasted for six to ten weeks.  No further information was provided, including treatment of the condition.; Sender's Comments: Pityriasis rosea is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pityriasis rosea, Skin lesion
Clinical narrative: Red spots diagnosed as Pityriasis rosea; This serious case was reported by a consumer via call center representative and described the occurrence of pityriasis rosea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-JAN-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 10-JAN-2025, 8 days after receiving Shingrix, the patient experienced pityriasis rosea (Verbatim: Red spots diagnosed as Pityriasis rosea) (serious criteria GSK medically significant). The outcome of the pityriasis rosea was unknown.   It was unknown if the reporter considered the pityriasis rosea to be related to Shingrix.     The company considered the pityriasis rosea to be unrelated to Shingrix.   Additional Information: GSK Receipt Date: 30-JAN-2025 The patient stated that he received his dose of Shingrix. On 6th January 2025, the patient had an appointment with his dermatologist for a full body scan and he did not present with any spots or lesions.  On 10th January 2025, the patient had a single red spot on his chest.  Then on 16th January 2025 he reported numerous red spots on his torso (front and back) and his sides.  On 28th January 2025, the patient was examined by his dermatologist and the primary care physician diagnosed his condition as pityriasis rosea.  The patient was informed by the dermatologist that the antigen caused a secondary latent condition related to certain herpes virus exposures and presented as a singular red spot known as herald patch. The spots were termed daughters. The condition was known as pityriasis rosea. The herald patch was a single oval one-inch lesion.  The patient was undergoing treatment for this condition that lasted for six to ten weeks.  No further information was provided, including treatment of the condition.; Sender's Comments: Pityriasis rosea is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: RSV
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: got GB; Unknown cause of death; This serious case was reported by a physician via sales rep and described the occurrence of unknown cause of death in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced unknown cause of death (Verbatim: Unknown cause of death) (serious criteria death and GSK medically significant) and guillain barre syndrome (Verbatim: got GB) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not reported. The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death and guillain barre syndrome to be related to Arexvy.     The company considered the unknown cause of death and guillain barre syndrome to be unrelated to Arexvy.   Additional Information: GSK Receipt Date: 30-JAN-2025 The physician just stated that one of his patients received a RSV (Arexvy) vaccine and got GB (Guillain Barre syndrome), was admitted to the hospital and died. The GSK representative was not sure about the outcome of death or the patient demographics.; Sender's Comments: Death and Guillain-Barre syndrome are unlisted events which are considered unrelated to GSK vaccine Arexvy.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: large knot left after vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mass in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced mass (Verbatim: large knot left after vaccination). The outcome of the mass was not reported.   It was unknown if the reporter considered the mass to be related to Shingrix.     It was unknown if the company considered the mass to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JAN-2025 The case was received from the patient via interactive digital media. The reporter reported that what if you had large knot left after vaccination it's had been since Tuesday.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Cough, Eyelid cyst, Injection site erythema, Injection site infection, Injection site pain
Clinical narrative: redness - injection site; swelling - injection site; pain - injection site; infection - injection site; eyelid cyst; lung pain; cough; stuffy nose; runny nose; sneezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included pregabalin (Lyrica).   On 09-DEC-2024, the patient received Arexvy (intramuscular, unknown deltoid). In DEC-2024, less than a month after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness - injection site), injection site swelling (Verbatim: swelling - injection site), injection site pain (Verbatim: pain - injection site) and injection site infection (Verbatim: infection - injection site). On an unknown date, the patient experienced eyelid cyst (Verbatim: eyelid cyst), pulmonary pain (Verbatim: lung pain), cough (Verbatim: cough), nasal stuffiness (Verbatim: stuffy nose), runny nose (Verbatim: runny nose) and sneezing (Verbatim: sneezing). In DEC-2024, the outcome of the injection site erythema, injection site swelling, injection site pain and injection site infection were not resolved. The outcome of the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The reporter considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The company considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that a patient received Arexvy on 9th December 2024.  About two weeks later the vaccination, she developed injection site redness, swelling and pain.  The area was about the size of a fifty cent piece.  She believed the injection site was infected but not diagnosed by Healthcare professional.  The local or injection site effects had not resolved.  About three weeks after the vaccine, she developed sneezing, runny nose, stuffy nose, cough, and lung pain.  At first, she thought the sneezing, runny nose, stuffy nose, cough and lung pain were due to environmental allergies.  After reading about the potential side effects of Arexvy, she believed all these effects were due to the vaccine.  She saw her physician a day before reporting.  The physician prescribed an unknown topical treatment for the cyst on her eyelid.  The patient would see a dermatologist in two weeks regarding the injection site effects.  Nothing else was reported.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Nasal congestion, Pulmonary pain, Rhinorrhoea, Sneezing
Clinical narrative: redness - injection site; swelling - injection site; pain - injection site; infection - injection site; eyelid cyst; lung pain; cough; stuffy nose; runny nose; sneezing; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included pregabalin (Lyrica).   On 09-DEC-2024, the patient received Arexvy (intramuscular, unknown deltoid). In DEC-2024, less than a month after receiving Arexvy, the patient experienced injection site erythema (Verbatim: redness - injection site), injection site swelling (Verbatim: swelling - injection site), injection site pain (Verbatim: pain - injection site) and injection site infection (Verbatim: infection - injection site). On an unknown date, the patient experienced eyelid cyst (Verbatim: eyelid cyst), pulmonary pain (Verbatim: lung pain), cough (Verbatim: cough), nasal stuffiness (Verbatim: stuffy nose), runny nose (Verbatim: runny nose) and sneezing (Verbatim: sneezing). In DEC-2024, the outcome of the injection site erythema, injection site swelling, injection site pain and injection site infection were not resolved. The outcome of the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing were not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The reporter considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy.     It was unknown if the company considered the injection site erythema, injection site swelling, injection site pain and injection site infection to be related to Arexvy. The company considered the eyelid cyst, pulmonary pain, cough, nasal stuffiness, runny nose and sneezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that a patient received Arexvy on 9th December 2024.  About two weeks later the vaccination, she developed injection site redness, swelling and pain.  The area was about the size of a fifty cent piece.  She believed the injection site was infected but not diagnosed by Healthcare professional.  The local or injection site effects had not resolved.  About three weeks after the vaccine, she developed sneezing, runny nose, stuffy nose, cough, and lung pain.  At first, she thought the sneezing, runny nose, stuffy nose, cough and lung pain were due to environmental allergies.  After reading about the potential side effects of Arexvy, she believed all these effects were due to the vaccine.  She saw her physician a day before reporting.  The physician prescribed an unknown topical treatment for the cyst on her eyelid.  The patient would see a dermatologist in two weeks regarding the injection site effects.  Nothing else was reported.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: patient is describing tender, burning, and redness that is spreading to elbow after an inject of Prevnar 20
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Dyspnoea, Heart sounds abnormal, Malaise, Wheezing
Clinical narrative: I received the COVID shot from Pfizer and ever since I have been having trouble catching my breath. I also nearly "Died Suddenly" when my heart started hurting out of no where and made a thud.
Sex: F
Vaccine: RV5
Symptoms: Developmental regression
Clinical narrative: After baby received first dose of rotavirus vaccine she stopped being able to roll front to back even though she was consistently able to do so prior. She also had a significant decrease in her babbling and cooing. We thought it was just a coincidence so opted to still get the second dose. She slowly regained her ability to roll again over that time period and also started rolling back to front. The babbling and cooing remained decreased but she did still do it. After the second dose of rotavirus on 1/20/25 she again stopped rolling. When doing tummy time she no longer rolled or even push up on her arms even though she consistently did so beforehand and very frequently. She would barely lift her head off the ground. She stopped reaching forward to grab toys and play while on her tummy. Arms would remain by her side like she couldn't lift them. She also completely stopped babbling and cooing. A week later and now she has started to roll both ways again but it seems more difficult for her like she's learning all over. The babbling and cooing has not returned.
Sex: F
Vaccine: FLUX
Symptoms: Axillary mass, Swelling, Tenderness
Clinical narrative: A tender, large lump appeared under my left armpit after getting the flu vaccination in my left arm. It's no longer tender and the swelling went down a couple days later. I just don't know if it's completely gone.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Infection, Pain, Rash, Skin exfoliation, Skin laceration
Clinical narrative: patient reported 6 recent infections and was hospitalized for staph infection in january. rheumatologist has referred her to infectious disease department. patient broke out in peeling skin on hands, got better in hospital, but the skin tears are back. patient has upcoming appointment with md, but there are no plans stop cosentyx because she has crippling pain without it. md discontinued prolia because she had 3 utis after starting prolia. patient reports she had flu and covid vaccines on 12/18/24; the rash started the next day. rash was so severe that she went to hospital, where they told her that she had staph infection. patient using triamcinolone. exact dates and length of stay of hospitalization unknown.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Staphylococcal infection
Clinical narrative: patient reported 6 recent infections and was hospitalized for staph infection in january. rheumatologist has referred her to infectious disease department. patient broke out in peeling skin on hands, got better in hospital, but the skin tears are back. patient has upcoming appointment with md, but there are no plans stop cosentyx because she has crippling pain without it. md discontinued prolia because she had 3 utis after starting prolia. patient reports she had flu and covid vaccines on 12/18/24; the rash started the next day. rash was so severe that she went to hospital, where they told her that she had staph infection. patient using triamcinolone. exact dates and length of stay of hospitalization unknown.
Age: 0.75
Sex: M
Vaccine: FLU3, HEP
Symptoms: Urticaria
Clinical narrative: Hives < 48hrs after receiving Hepatitis B and Influenza vaccine.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Patient had a reaction on the injection site---redness , swelling and soreness were visible  when patient came in to report on 2/4/25
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging spinal, Nerve conduction studies, Small fibre neuropathy
Clinical narrative: Small fiber Neuropathy developed . Treatment steroid with relief but relapse after stopping. Unable to tolerate Dulexetine. And higher doses of pregabalin. Taking Pregabalin 75 mg bid . Persistent symptoms. Developed Left Facial nerve palsy
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I accidentally gave patient the adult HEP A Vaccine instead of the children's HEP A Vaccine
Age: 76.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Acne, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient states injection site turned red, warm to the touch, itching,  and a white pimple formed.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: ActHIB was given without the diluent it was given with sterile diluent. Patient had no reaction.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Muscular weakness, Paraesthesia
Clinical narrative: Pain and rash at injection site. Weakness in left hand and tingling in 4th and 5th fingers of left hand.
Age: 9.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Pallor
Clinical narrative: @1650: mom called us into the room and said patient had fainted. Upon entering the room patient was sitting up, pale, answering questions appropriately. I asked mom if she had hit anything like her head or anything else and mom said no. We laid her down and elevated her feet and color returned to her cheeks. Lying VS: 77 HR, 98% O2 on RA, 90/56 blood pressure. When she sat up HR went up to 110 but quickly went down to <100bpm and O2 remained at 98%. We also gave her some apple juice. Within 5 minutes she said "I feel all better" and was alert, in no acute distress, respirations nonlabored, skin color normal for ethnicity. She hopped up got ready to leave and safely exited the clinic. Mom stated that Mom faints with vaccines as well. I did not clarify if she fully lost consciousness. I tried to call mom afterward and LMOM for her to call back. I will try to call her later this week to clarify this. Per the nurse she was clenching up during vaccine administration due to nerves and after the nurse left the room, mom called out and said "I need help in here, my daughter just passed out."  2/4/25 @1710: Mom called me immediately back and said patient fell, mom caught her and patient fully lost consciousness for about 30 seconds and then was coherent again.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient given immunization too soon after first dose (1 month instead of 6 months)
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of RSV vaccine. Previous dose was on 9/14/2023.
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis acneiform
Clinical narrative: Pimple like rash noticed aprox 8 days post injection of varicella and MMR. Nurse discussed this may be a reaction to the varicella vaccine and to avoid immunocompromised individuals.  Pt was to monitor and call back with no improvement, new/worsening sxs or questions/concerns.
Age: 1.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Dose given was reconstituted the previous day, so out of the 12 hour range. Dose may not be fully effective. No adverse effects to patient. Mother of patient notified.
Age: 0.75
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Dose given was reconstituted the previous day. So outside of the 12 hour manufacturer guideline. No adverse effects to patient. Recommended that patient be re-dosed.  Mother of patient notified.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Gardasil vaccine was given to patient, patient has not reported any adverse events or side effects.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Electrocardiogram normal, Electroencephalogram normal, Fall, Fear
Clinical narrative: Extreme anxiety and fear not previously observed, seizures that became so common that he began having on a daily basis, and tingling of the left arm prior to these episodes.  Currently on SSRI (celexa) and 3 seizure meds (Clobazam, Keppra, Oxcarbazepine).   Also has frequent episodes of complete mental and body "freezing" where he will fall over.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Magnetoencephalography, Paraesthesia, Scan with contrast normal, Seizure
Clinical narrative: Extreme anxiety and fear not previously observed, seizures that became so common that he began having on a daily basis, and tingling of the left arm prior to these episodes.  Currently on SSRI (celexa) and 3 seizure meds (Clobazam, Keppra, Oxcarbazepine).   Also has frequent episodes of complete mental and body "freezing" where he will fall over.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis atopic, Skin disorder
Clinical narrative: According to my dermatologist and primary care physician, something within the vaccine caused my skin barrier to break down. I have a type of super atopic dermatitis from head to toe that has not completely cleared since 5/20/21. I still have to manage it and will have to for the rest of my life by taking multiple bleach baths per week, using 3 to 5 cream/lotions, giving myself 4 shots per month of Nemluvio.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Erythema, Skin lesion
Clinical narrative: Cellulitis after Quadracel: Left thigh has erythematous raised lesion measuring 4.5 in by 4 inch Cellulitis after Proqrad: Right thigh has erythematous raised lesion measuring 2.5 in by 2.5 in  Worsening after 3 days and started of cephalexin
Age: 60.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: HPV given to patient over age of 45.  Should have been given  Prevnar 20.  Patient notified at time of visit with no adverse effects notified.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood test abnormal, Chest pain, Computerised tomogram thorax abnormal, Echocardiogram abnormal
Clinical narrative: About 10 days after receiving the vaccine, I developed chest pains, especially lying down.  About 14 days later I was admitted to the ER and then to the  IC with arterial fibrillation (which I had never had been diagnosed in yearly exams) and diagnosed also with pericarditis and pleural effusion.  I was in out of the the hospital for a week, on oxygen for over a month,  24hrs a day, at home.  I had in home nurse visitse for 3 months, physical therapy and am on blood thinners for the rest of my life, according my cardiologist and my primary care physician..
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Pericarditis, Pleural effusion
Clinical narrative: About 10 days after receiving the vaccine, I developed chest pains, especially lying down.  About 14 days later I was admitted to the ER and then to the  IC with arterial fibrillation (which I had never had been diagnosed in yearly exams) and diagnosed also with pericarditis and pleural effusion.  I was in out of the the hospital for a week, on oxygen for over a month,  24hrs a day, at home.  I had in home nurse visitse for 3 months, physical therapy and am on blood thinners for the rest of my life, according my cardiologist and my primary care physician..
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine past beyond use date
Age: 60.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Expired product administered
Clinical narrative: Administered vaccine past beyond use date
Age: 47.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient was incorrectly given Fluad instead of Afluria given age <65 years without immunocompromising condition.  She received Fluad in addition to a moderna covid-19 booster vaccination.   After 24 hours, patient experiencing a typical immune response with no adverse reactions.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Dermatitis, Eye inflammation, Inflammation, Injection site inflammation, Pyrexia
Clinical narrative: ON 02-01-25 PATIENT WAS VACCINATED , AND AFTER ARRIVING HOME EXPERIENCED A LIKE ANA ALLERGIC REACTION BUT AT THE TIME WASN'T TOO SERIUS, SHE HAD THE AREA OF THE VACCINATION INFLAMED A LITTLE BIT. THE NEXT DAY THE PATIENT WAS FEELING  WORST THE NEXT DAY WITH INFLAMED EYES, INFLAMED ARMS AND FEVER. aSHE WENT TO TEH DOCTOR ON 02/04/25 AND HE PRESCRIPBED ANTIBIOTICS ( LEVOFLOXACIN ) AND TODAY 02/05/25 HE SEND TOBRADEX. PATIENT FELT MUCH BETTER TODAY AFTER ANTIBIOTICS PRESCRIBED YESTERDAY AND PHYSICIAN SAID THE POSSIBLE MAS A DERMATITIS.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: PATIENT RECEIVED THE SECOND DOSE OF THE VACCINE ON THE 25TH DAY INSTEAD OF THE REGULAR 30 DAYS AFTER FIRST DOSE. PATIENT HAS NO SYMPTOMS AND PATIENT CLAIMS TO BE IN PERFECT CONDITION
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: The patient came in asking for a flu vaccine. We told them we did not have the high dose vaccine in stock we only had the regular dose. The patient asked when we would be getting more in, I told her we wouldn't be as the flu vaccine giving is ending. She said fine I will take the regular dose. She then came back in a few hours later saying she forgot she already had a flu vaccine, when I looked back she did receive the high dose flu vaccine (fluzone HD).
Age: 40.0
Sex: M
Vaccine: ANTH, IPV, MMR, TYP
Symptoms: Dysgeusia
Clinical narrative: Patient complaint of change in taste in palette shortly after receiving Polio, Anthrax, Typhoid  and MMR
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered Covid 12+ to patient who is 10 years old
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Patient stated that she started getting pain on vaccine site a week after she had gotten the vaccine. The pain comes and goes. Pain just comes, nothing that she does different causes the pain.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Eye pain, Pain
Clinical narrative: Pain in right eye, worse with movement of eye.  Attempted to treat with ibuprofen, not effective.  Ongoing pain, 21 hours thus far.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm on administration site was painful,  swollen, red, and hot from shoulder to elbow. Started on 1/31/25 evening and continued to spread further down arm past elbow through 2/4/25. Saw HCP on 2/4/25 afternoon.  Prescriptions for  cefelexin 500mg  and benedryl. diagnosis of Cellulitis.  Improvement noted with minimal redness still visible by 2/5/25
Age: 0.33
Sex: M
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: influenza vaccine administered to infant 4 months of age
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose given at 15 weeks 1 day of age
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered varicella vaccine too soon from previous administration due to wrong documentation of first administration
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warm to touch around injection site and down to elbow of left arm
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Patient stated on 2/5/25 he experienced injection site reaction of redness, swelling and had a sore arm. Stated he felt bad for several days and tested positive with covid with a home test. Patient's vaccine was part of a temperature excursion as well.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, SARS-CoV-2 test positive
Clinical narrative: Patient stated on 2/5/25 he experienced injection site reaction of redness, swelling and had a sore arm. Stated he felt bad for several days and tested positive with covid with a home test. Patient's vaccine was part of a temperature excursion as well.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Lethargy, No adverse event, Pyrexia, Vomiting projectile
Clinical narrative: Pt received pediarix, hib, and rota at his 2 month well check on 11/20/24. Within 24 hours pt experienced high fever.  Pt was given a Prevnar vaccine on 12/27/24 and did not have any adverse reaction.  On 2/4/25 Pt was given Hib and Prevnar vaccines and within 8-12 hours had a high fever (102.0), lethargy, and projectile vomiting.
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Physician ordered Menveo 1-vial formulation for 2-year old patient in preparation for upcoming travel out of the country. Vaccine administered by LVN as ordered.  Menveo 1-vial formulation is FDA-approved for ages 10-55 years. The prescribing information states "Safety and effectiveness of the one-vial presentation of MENVEO in children aged younger than 10 years have not been established. For children 2 months through 9 years of age, only the two-vial presentation is approved for use." The order in EMR reads "Meningococcal MCV40 (MENVEO) - 1 vial (10-55yr)". The vial states "10 years through 55 Years of Age".
Age: 0.75
Sex: F
Vaccine: FLU3
Symptoms: Acne, Crying, Erythema, Pruritus
Clinical narrative: After we return from her visit I realized she wasn't herself. She was crying so I put her to bed. In the night some minutes to 12, I realized she is itching. I switched the over head lights on and her entire body had pimples all over even her face and her eyes had red streaks in it like blood shots. I raised the concern to a friend and I called the doctor but was unable to get in contact, so I took pictures to show the doctor on her next visit. This is when the doctor advised me to contact VAERS and make a report.
Age: 0.67
Sex: M
Vaccine: MNQ
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Physician ordered Menveo 1-vial formulation for 2-year old patient in preparation for upcoming travel out of the country. Vaccine administered by LVN as ordered.  Menveo 1-vial formulation is FDA-approved for ages 10-55 years. The prescribing information states "Safety and effectiveness of the one-vial presentation of MENVEO in children aged younger than 10 years have not been established. For children 2 months through 9 years of age, only the two-vial presentation is approved for use." The order in record reads "Meningococcal MCV40 (MENVEO) - 1 vial (10-55yr)". The vial states "10 years through 55 Years of Age".
Age: 0.25
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Rotarix dose 1 was given at 17 weeks 1 day of age.  Should be given before 14 weeks and 6 days.
Age: 27.0
Sex: M
Vaccine: HEP, IPV, MMR
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: 3:05 PM pt stated he felt dizzy, he looked pale, got diaphoretic, and felt nauseous. Treatment initiated right away by placing an ice pack on the back of his neck, smelling an alcohol pad, and fanning him with a fan. At 15:15 BP read 110/70, HR 64, Temperature 97.4.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood test normal, Condition aggravated, Decreased appetite, Drug screen positive, Insomnia
Clinical narrative: After injection on 01/04/2025 I did not have any major symptoms, where my family also got vaccinated that day they were recovering as if from a flu for a day but I did not have the same reaction. Instead on 01/06/2025 I began feeling manic, unable to sleep that night. By the next day (tues) I was having to stay home from normal activities. Wednesday things got worse and I was speaking rapidly, unable to stop moving. Still not sleeping. Thursday and friday I stopped eating and barely drinking. On Saturday morning my husband dragged me to the ER where I had to be restrained and sedated until I spent the next 3 weeks at hospital.
Age: 39.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Loss of personal independence in daily activities, Mania, Patient restraint, Pressure of speech, Psychomotor hyperactivity
Clinical narrative: After injection on 01/04/2025 I did not have any major symptoms, where my family also got vaccinated that day they were recovering as if from a flu for a day but I did not have the same reaction. Instead on 01/06/2025 I began feeling manic, unable to sleep that night. By the next day (tues) I was having to stay home from normal activities. Wednesday things got worse and I was speaking rapidly, unable to stop moving. Still not sleeping. Thursday and friday I stopped eating and barely drinking. On Saturday morning my husband dragged me to the ER where I had to be restrained and sedated until I spent the next 3 weeks at hospital.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort
Clinical narrative: The Injection was more painful then I have ever received and I have been receiving injections for 82 years. That evening about 6 hours later I started having pain in my left arm (injection arm). Pain was very painful I was thinking I am having a heart attack. Now 3 weeks later I am still having discomfort in my left arm.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Back pain, Burning sensation, Rash, Rash erythematous, Scab
Clinical narrative: Presenting for a rash/burning and pain that has been present over the right side over her lower abdomen/hip for the past 5 days. States that the burning is quite severe. States that the lesions for showed up in her right upper inguinal region but she also had/has pain in her low back on the right side as well. States that they showed up as red bumps and have turned into scab like lesions at this point but still are quite painful.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Presenting for a rash/burning and pain that has been present over the right side over her lower abdomen/hip for the past 5 days. States that the burning is quite severe. States that the lesions for showed up in her right upper inguinal region but she also had/has pain in her low back on the right side as well. States that they showed up as red bumps and have turned into scab like lesions at this point but still are quite painful.
Age: 20.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Reported to Dr. no concerns, monitoring for possible fever
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blister rupture, Vaccination site vesicles
Clinical narrative: A blister formed within 24 hrs at his vaccination site.  Ruptured on it's own and is now healing
Age: 87.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: patient received the arexvy vaccine twice, once on 10/27/23 and once on 2/4/25
Age: 66.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Patient stated that she has burning pain in her arm
Age: 2.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: Rash
Age: 1.33
Sex: M
Vaccine: HIBV, HIBV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where PEDVAXHIB was administered to one patient. No signs or symptoms reported. No additional AE/No PQC.  PEDVAX HIB: X020942 EXP: 03/07/2026 35.2F for 0 HOURS 50 MINUTES 0 SECONDS - CURRENT  35.8f for 0 HOURS 37 MINUTES 30 SE; This spontaneous report was received from an other healthcare professional referring to a 16-month-old male patient. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date in 2025, the patient was vaccinated with haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection (0.5 ml, lot#: X020942, expiration date: 07-MAR-2026; strength and route of administration were not reported) for prophylaxis. The administered vaccine experienced temperature excursion (TE) on 31-JAN-2025: 35.2F for 50 minutes (product storage error). The vaccine experienced TE at 35.8 F for 37 minutes previously.  No additional adverse event occurred.