chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site erythema
Clinical narrative: this is my arm after the Tdap in 2019; Adacel administered via Subcutaneous route; Initial information received on 07-Dec-2024 regarding an unsolicited valid non-serious case received from a Consumer/ Non-Healthcare Professional.  This case involves Adult female patient to whom diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] administered via subcutaneous route and experienced (vaccination site erythema) this is my arm after the tdap in 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On unknown date In 2019, the patient received unknown dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection (lot number, expiry date, strength; unknown) via subcutaneous route in unknown administration site for Prophylactic vaccination (incorrect route of product administration) (unknown latency).  Information on batch number and expiry date corresponding to the one at time of event occurrence was requested.  On unknown date In 2019 the patient reported this is my arm after the tdap in 2019 (vaccination site erythema) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event, Product storage error
Clinical narrative: Temperature excursion involve ADACEL, Someone did not close the refrigerator correctly, Max/low temperature reached 85.5F maximum and 34.4F minimum for around 18 hours with no reported Adverse event; ADACEL administered after temperature excursion with no reported Adverse event; 34 weeks and 4 days pregnant women administered with ADACEL with no reported Adverse event; Initial information received on 11-Dec-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 28 years old pregnant female patient who was exposed to Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] in context of temperature excursion involve adacel, someone did not close the refrigerator correctly, max/low temperature reached 85.5f maximum and 34.4f minimum for around 18 hours and administered after temperature excursion with no reported adverse event.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy.   On an unknown date, the pregnant female patient received a 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine Suspension for injection (strength: unknown, expiry date: 31-Aug-2026 and lot U8264AA via unknown route in unknown administration site as immunization (poor quality product administered) (exposure during pregnancy) (latency: same day), someone did not close the refrigerator correctly, max/low temperature reached 85.5f maximum and 34.4f minimum for around 18 hours with no reported adverse event (product storage error) (unknown latency)  Additionally, at time of reporting, the outcome of the pregnancy is unknown.  Reportedly: " Human error: YES, the extended stability data cover the excursion: NO, the product administered to a patient: YES."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 16.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm
Clinical narrative: 13 X 10 cm Redness & swelling. warm to touch on Rt Arm (PPV23) Dx with cellulitis Treatment: Cephalexin 500mg tab
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Condition aggravated, Headache
Clinical narrative: I had two vaccinations in a short time period and because they were so close together I developed a severe headache and my blood pressure spiked much higher than normal. On Saturday, December 7 2024, I was given a flu vaccine and then on the next day (December 8, 2024) I was given the Moderna COVID vaccine booster shot. Both shots were given at the clinic.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Skin exfoliation
Clinical narrative: Had a Covid vaccine booster Rt arm. Had pain at site then noticed severe bruising, inderated, sloughing of skin at site and periphery. Striated markings across site. Purpura? Necrotizing? Appointment to see wound care
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV1
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Patient received Beyfortus, Pediarix, PedVaxHib, Prevnar20, and Rotarix on 12/09/2024. Second round of vaccinations. Started with a maculopapular rash on abdomen that spread to arms/back/face/head within a few hours of vaccine. No SOB, vomiting, wheezing, cough, swelling
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Tremor
Clinical narrative: 14 hours after having Arexvy (.5ml) for RSV, I experienced severe shaking/shivering throughout my entire body. This lasted for 1.3 hours. I have never had any reaction like this before. It is not listed on possible side effects.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope, Tremor
Clinical narrative: Writhin 10 minutes of receiving the Gardisil vaccine my 17 year old daughter fainted and jolted until regaining consciousness about 1 minute later.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Joint swelling, Nausea, Peripheral swelling
Clinical narrative: 2 days later, (L) arm swollen.  swollen ankles and knees, (+) erythema Dizziness Nausea, itchiness, (+) Hives
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: 2 days later, (L) arm swollen.  swollen ankles and knees, (+) erythema Dizziness Nausea, itchiness, (+) Hives
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash 7-10 days after vaccine (Both silbings had some response)
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19-2, COVID19-2
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Alopecia - Areata autoimmune disorder. It started with small circular bald spots three years ago. The first vaccines were given in January 2021. In March, I noticed unusual amount of loose hair in my brush. At the visit to visits to my cosmetologist, she insisted I see a medical doctor. The first medical visit; the doctor was very rude and extremely hostile! He informed that "old lose their hair", (at the date I was 83 years old). Visits with other doctors were non productive. They were polite, seemed of the same mindset. Was prescribed clobetasol propionate 50ml. It gave limited results the first year. Three or four weeks after each injection more and larger bald spots developed. Luckly, my hair was full enough to cover those spots. Also noticed that the amount of loose hair in my hair brush would be less about 10-11 months AFTER the last injection. The last Covid-19 injection was September 17, 2024. October 24, 2024 my cosmetologist cried because the size and number of the bald spots. By early November almost the entire left side of my scalp was bald, plus other huge bald areas. When I demanded answers from the medical personal, I was referred a dermatologist, where the condition was given a name - Alopecia and prescribed a course of treatment. Did my immune system became over activate from the vaccinations? I am "sort of" thankful that this autoimmune disorder resulted in alopecia and not some of the other horrible disorders.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall
Clinical narrative: getting up @ 7Am I had no leg & arm  could not get up off floor where I went  down tried to crawl - then called EM
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm
Clinical narrative: redness to (L) arm 5 x 4 cm warm to touch
Age: 13.0
Sex: M
Vaccine: FLU3, HPV9, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Was given Men B instead of Menveo. No reactions documented.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Nervous system disorder
Clinical narrative: Neuromuscular system is adversely affected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging, Mobility decreased, Shoulder injury related to vaccine administration
Clinical narrative: Client verbalized- within hours of injection, developed discomfort and increasing immobility of left arm, which continued to increase over next several days.  Reported to PCP- , - post Covid reaction.  Over the next month, discomfort diminished, but immobility continued.  12/9 - MRI obtained.  12/12/2024- per Dr- Dx of SIRVA-  ( Shoulder Injury Related to Vaccine Administration.)
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Started with a sore throat and then now I?m having a stuffed up nose
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Discomfort, Immediate post-injection reaction, Mobility decreased, Pain
Clinical narrative: Right shoulder pain - Range of motion is also decreased. Feels tugging/pulling when she tries to raise her arm. Sometimes if stretches feels a pain in the upper arm. Started immediately after vaccine administration, not improved as of 12/17/2024  No pain in the joint area, pain in upper arm near deltoid,  However no erythema, edema, ecchymoses, etc. Will trial NSAIDs and muscle relaxer- ortho if no improvement.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Right shoulder pain - Range of motion is also decreased. Feels tugging/pulling when she tries to raise her arm. Sometimes if stretches feels a pain in the upper arm. Started immediately after vaccine administration, not improved as of 12/17/2024  No pain in the joint area, pain in upper arm near deltoid,  However no erythema, edema, ecchymoses, etc. Will trial NSAIDs and muscle relaxer- ortho if no improvement.
Age: 45.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Oligomenorrhoea
Clinical narrative: Monthly Menstrual period started as expected on 11/16 but lasted 3 weeks!? 11/16-12/05!?
Age: 70.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia
Clinical narrative: Patient received initial Prevar 20 on 1/13/2023. She was given a second Prevnar 20 dose on 11/1/2024.  Doing well 1 month ago, had Prevnar 20 vaccine with pharmacy. No issues/concerns after shot immediately. 3-4 weeks after the vaccine developed numbness radiating down her right arm (no pain). Extends to all 5 fingers. No weakness. Symptoms have been static, not getting worse or better. Never had similar problems before. No neck pain. Starts at shoulder (deltoid) and radiates down to finger tips. TTP on right arm at prior vaccine site.  Has existing neuropathy (pins and needles) in hands and feet from breast cancer chemo. This is different - has never had numbness.  H/o carpal tunnel s/p release surgery b/l. Has b/l lymphedema from breast surgery
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Patient states she is having shoulder pain for approximately one month after receiving the vaccine.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Neck pain, Nervousness
Clinical narrative: pt says that her arm was very sore and the pain went up into her neck. The next day she woke up not feeling well and was shaky. She had an overall feeling of weakness, she was very tired and shaky all day the next day. She feels some better but is not comepletly well yet and her arm and neck are still sore.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pt says that her arm was very sore and the pain went up into her neck. The next day she woke up not feeling well and was shaky. She had an overall feeling of weakness, she was very tired and shaky all day the next day. She feels some better but is not comepletly well yet and her arm and neck are still sore.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction. Extra dose given than recommended.
Age: 70.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gait inability, Guillain-Barre syndrome
Clinical narrative: PATIENT REPORTED THAT AFTER GETTING VACCINE HE DEVELOPED GUILLAIN-BARRE SYNDROME SYMPTOMS ON THE NIGHT OF THE VACCINATION. HE WAS NOT ABLE TO WALK FOR 2-3 HOURS BUT DIDN'T SEEK MEDICAL ATTENTION AND RECOVERED ON ITS OWN.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event. Extra dose given
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Pain, SARS-CoV-2 test
Clinical narrative: Chills, fatigue, bodyaches
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Erythema, Headache, Hypoaesthesia
Clinical narrative: First day (Monday 12/9/24) was just a sore left shoulder. Second day was fever, aches/pains all over, and an occasional headache. As well as a small red area on my left arm where I got the vaccination, maybe 2x2 inches. Third day was fever, aches/pains all over, headache more often, diarrhea and cramps. The red area grew about 30% on my left shoulder. Fourth day had all the same symptoms. The red area had grown another 30%, I think up to 3x4 inches then and had a slight itch. The skin on top of my left thigh started to become numb when I was sleeping or laying down as well. I went to the doctor that day and he thought it was an infection. So he prescribed cephalexin and a strong steroid cream. I started using them that day. The fifth day, I had an itchy spot on the red area but the rash had not grown since the day before. I'm still on antibiotics until this weekend. The rash is mostly gone but has left a slight red mark on my skin. The skin on top of my left thigh is now numb almost all day. And the skin on top of my right thigh is partially numb as well. This was my second dose of Shingrix. The first dose had no effects, other than a sore shoulder. But I also had a covid booster, flu shot and tdap at the same time as the first dose of Shingrix.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Infection, Injection site erythema, Injection site pruritus, Muscle spasms, Pain
Clinical narrative: First day (Monday 12/9/24) was just a sore left shoulder. Second day was fever, aches/pains all over, and an occasional headache. As well as a small red area on my left arm where I got the vaccination, maybe 2x2 inches. Third day was fever, aches/pains all over, headache more often, diarrhea and cramps. The red area grew about 30% on my left shoulder. Fourth day had all the same symptoms. The red area had grown another 30%, I think up to 3x4 inches then and had a slight itch. The skin on top of my left thigh started to become numb when I was sleeping or laying down as well. I went to the doctor that day and he thought it was an infection. So he prescribed cephalexin and a strong steroid cream. I started using them that day. The fifth day, I had an itchy spot on the red area but the rash had not grown since the day before. I'm still on antibiotics until this weekend. The rash is mostly gone but has left a slight red mark on my skin. The skin on top of my left thigh is now numb almost all day. And the skin on top of my right thigh is partially numb as well. This was my second dose of Shingrix. The first dose had no effects, other than a sore shoulder. But I also had a covid booster, flu shot and tdap at the same time as the first dose of Shingrix.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Rash
Clinical narrative: First day (Monday 12/9/24) was just a sore left shoulder. Second day was fever, aches/pains all over, and an occasional headache. As well as a small red area on my left arm where I got the vaccination, maybe 2x2 inches. Third day was fever, aches/pains all over, headache more often, diarrhea and cramps. The red area grew about 30% on my left shoulder. Fourth day had all the same symptoms. The red area had grown another 30%, I think up to 3x4 inches then and had a slight itch. The skin on top of my left thigh started to become numb when I was sleeping or laying down as well. I went to the doctor that day and he thought it was an infection. So he prescribed cephalexin and a strong steroid cream. I started using them that day. The fifth day, I had an itchy spot on the red area but the rash had not grown since the day before. I'm still on antibiotics until this weekend. The rash is mostly gone but has left a slight red mark on my skin. The skin on top of my left thigh is now numb almost all day. And the skin on top of my right thigh is partially numb as well. This was my second dose of Shingrix. The first dose had no effects, other than a sore shoulder. But I also had a covid booster, flu shot and tdap at the same time as the first dose of Shingrix.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Chills, Nausea, Pyrexia, Vertigo
Clinical narrative: chills, fever, nausea for first 36 hours then (now) vertigo.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: red swollen patches down toward the elbow, not at injection site, warm to the touch
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administration error.  Dose for age group 6month to 11years inadvertently administered per documentation instead of the recommended dose for age group 12 years and over.  No known adverse reactions noted.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: After receiving vaccination. Student fell out of chair at 11:53 AM and lost consciousness for less than 1 minute. Nurses provided emergency care. EMS called. Student stable. EMS evaluated. Parent on scene. Transported by EMS.
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Back pain, Hypertension, Tremor
Clinical narrative: After shot, walked 50 feet to waiting room chairs and sat down with extensive lower back pain. She was shaking and complaining of pain so we called EMS. Waiting for EMT she started feeling better. They evaluated her and took her BP. Her BP was high but she felt better and declined further help and left with her husband.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5-11 year old COVID vaccine given to 4 year old
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Injection site pain, Magnetic resonance imaging joint, Pain
Clinical narrative: Patient began experiencing pain to touch at injection site within 48 hrs of vaccination. Since then, she has experienced ongoing lateral internal and external rotation pain/weakness.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Sore arm and minor flu like symptoms for 2 days after vaccine. One week ago  I came down with a bad head cold, my symptoms now are related to that cold.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Measles, Pyrexia, Urticaria
Clinical narrative: One week later developed high fever of 103, turned into what was thought to be severe hives over entire body 8 days after vaccine given. Pediatrician feels it?s a mild case of measles from the live virus, 11 days after vaccine was given.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Swollen tongue
Clinical narrative: 1 Week after vaccination patient reported buring sensation in mouth and swollen tongue that lasted for months
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Product administered to patient of inappropriate age
Clinical narrative: Pt was given the adult covid vaccine instead of the pediatric dose.  This was reviewed with Mom afterward.  I do not think this should cause a problem given his size, but I did alert Mom to watch for any concerns.  I apologized for the mistake.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: wanted to notify you that I had a reaction to the influenza vaccine that I received on Friday, October 25th at doctor office. This includes 6 weeks of extreme muscle soreness on the right arm around the injection site and radiating up and down the arm, and several weeks of intense systemic joint pain.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Paraesthesia, Swelling
Clinical narrative: Extreme left shoulder pain, limited range of motion, numbness, tingling,  swelling
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Administered vaccine into patient's right arm. After administering patient said that she felt lightheaded and that this isn't unusual and happens to her. Later she specified that it happens after getting blood drawn but hasn't happened with a vaccine before. Opened the door to let the air circulation and brought her a water bottle. She said leaning forward helped. Tried to give her ice packs to put on the back of her neck but they didn't get cold, so the patient didn't use. Patient said she was feeling better after about 20 minutes. I suggested she move from the immunization room to the pharmacy waiting area to make sure she was feeling alright and better air circulation closer to the door. She said ok and that she was feeling ok and we gave her a juice as she was walking but then she left the store. Called the patient 45 minutes after and she said she was feeling good, no lightheadedness and thanked me for calling.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Extra dose given
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Extra dose given
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No symptoms, the vaccine administrated was + 12 yo, she was 10 yo.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Rash erythematous, Rash pruritic, Respiratory disorder
Clinical narrative: Red, itchy rash; brief "breathing issue"
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Acoustic stimulation tests, Aphasia, Dysphagia, Echocardiogram, Laboratory test
Clinical narrative: Patient received Varicella and PCV (pneumo) on 5/2/08 and approximately 36-48 hours later she stopped speaking and couldn't swallow. Seen by pediatrician and HE REFUSED TO ACKLOWLEDGED THIS WAS A VACCINE INJURY.  Pushing me to continue vaccine series, I felt pressured to continue vaccines. Since she had PCV before, the dr insisted and recommended on PCV 8/28/08. She was released from the office since I was hesitant to continue vaccines WHILE SHE WAS IN CRISIS and moved her care to Hospital. She was at Hospital for over 15 years seeing Immunology, ENT, Nutrition, Hearing, GI specialist, Neurology, Balance therapy, etc.  Because I'm a physician, had her reports sent to Clinic Immunology morning report and Hospital Immunology morning report- Called by Immunology department- "yes, she had a vaccine injury" believe approximately in 2 years she may improve from Varicella. Child slowly healing but neurological events continue, delay speech, leg pain neurological shocks
Age: 1.33
Sex: F
Vaccine: VARCEL
Symptoms: Nerve stimulation test, Neurogenic shock, Pain in extremity, Speech disorder developmental, Swallow study
Clinical narrative: Patient received Varicella and PCV (pneumo) on 5/2/08 and approximately 36-48 hours later she stopped speaking and couldn't swallow. Seen by pediatrician and HE REFUSED TO ACKLOWLEDGED THIS WAS A VACCINE INJURY.  Pushing me to continue vaccine series, I felt pressured to continue vaccines. Since she had PCV before, the dr insisted and recommended on PCV 8/28/08. She was released from the office since I was hesitant to continue vaccines WHILE SHE WAS IN CRISIS and moved her care to Hospital. She was at Hospital for over 15 years seeing Immunology, ENT, Nutrition, Hearing, GI specialist, Neurology, Balance therapy, etc.  Because I'm a physician, had her reports sent to Clinic Immunology morning report and Hospital Immunology morning report- Called by Immunology department- "yes, she had a vaccine injury" believe approximately in 2 years she may improve from Varicella. Child slowly healing but neurological events continue, delay speech, leg pain neurological shocks
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Hypoaesthesia, Palpitations
Clinical narrative: 12/6/24 6:00pm started having heart palpitations and heat rate of 110 bpm, intermittently occurred for a couple of days. 12/8/24 began to experience intermittent chest tightness. 12/11/24 started experiencing intermittent chest and upper abdominal pain. 12/15/2024 started experiencing intermittent numbness and tingling bilaterally in arms with chest pain and burning sensation in chest.
Age: 28.0
Sex: F
Vaccine: COVID19, FLU3, TDAP
Symptoms: Paraesthesia
Clinical narrative: 12/6/24 6:00pm started having heart palpitations and heat rate of 110 bpm, intermittently occurred for a couple of days. 12/8/24 began to experience intermittent chest tightness. 12/11/24 started experiencing intermittent chest and upper abdominal pain. 12/15/2024 started experiencing intermittent numbness and tingling bilaterally in arms with chest pain and burning sensation in chest.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 24 hrs after vaccine she developed numbness tingling of right cheek, chin, involving facial nerve buccal, mandibular and zygomatic branch.   Persisted for 4 days now without resolution.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Rash, Rash papular
Clinical narrative: I had a slight fever, muscle ache, and tiredness the next day, which is typical for me after a Covid shot. However, this time a couple days later I have (and still have two weeks later) itchy raised skin on my legs, arms and collarbone, as well as a slight fever.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: I had a slight fever, muscle ache, and tiredness the next day, which is typical for me after a Covid shot. However, this time a couple days later I have (and still have two weeks later) itchy raised skin on my legs, arms and collarbone, as well as a slight fever.
Age: 0.25
Sex: F
Vaccine: UNK
Symptoms: Deafness bilateral, Pruritus, Unresponsive to stimuli
Clinical narrative: Itching, deaf  in ears , advoc,  can't react to emotional 1st response, children adverse response withdrawal from family unit ,
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Injection site pain
Clinical narrative: Varicella was administered to a 17 year old pregnant patient.  Live-Attenuated vaccine typically are not administer during pregnancy.  Not treatment or further testing required. Patient only developed a sore arm on local area of vaccine administered.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Hallucination, Paraesthesia, Syncope
Clinical narrative: Pt had hallucinations at night following vaccination along with a "pins and needles" feeling. The following day she fainted and decided to consult a MD who checked all her vitals and did bloodwork--nothing abnormal was detected. The MD decided that the pt's immune system "went into overdrive" to cause these events.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Biopsy bladder normal, Bladder catheterisation, Bladder dysfunction, Blood pressure increased
Clinical narrative: Timeline of Events: 1. **COVID-19 Vaccination Requirement:** - Due to the COVID-19 pandemic and a scheduled work-related attendance at the onference, patient was required to receive a COVID-19 vaccine for travel and event entry. - On **July 22, 2021**, patient received a single-dose Johnson & Johnson vaccine at Pharmacy. Prior to administration, he signed documentation releasing Johnson & Johnson from liability. 2. **Immediate Adverse Effects:** - Upon arrival, patient experienced **elevated blood pressure, dizziness, and profound weakness**, limiting his ability to attend scheduled meetings. - He returned to home state, and sought rest, intending to recover. Lost of muscle mass and  weight loss. 3. **Subsequent Medical Findings:** - During a routine eye exam the following day, his optometrist detected burst blood vessels in his eyes, indicating dangerously high blood pressure. - Patient was referred to the hospital, where his **blood pressure was recorded at 178/117**. His kidneys were found to be failing, necessitating **dialysis for four hours**. - He experienced significant difficulty urinating, requiring the placement of a catheter. Over time, he has relied on **intermittent catheterization (2-3 times daily)** due to persistent bladder dysfunction.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy abnormal, Cystitis noninfective, Cystoscopy abnormal, Dialysis
Clinical narrative: Timeline of Events: 1. **COVID-19 Vaccination Requirement:** - Due to the COVID-19 pandemic and a scheduled work-related attendance at the onference, patient was required to receive a COVID-19 vaccine for travel and event entry. - On **July 22, 2021**, patient received a single-dose Johnson & Johnson vaccine at Pharmacy. Prior to administration, he signed documentation releasing Johnson & Johnson from liability. 2. **Immediate Adverse Effects:** - Upon arrival, patient experienced **elevated blood pressure, dizziness, and profound weakness**, limiting his ability to attend scheduled meetings. - He returned to home state, and sought rest, intending to recover. Lost of muscle mass and  weight loss. 3. **Subsequent Medical Findings:** - During a routine eye exam the following day, his optometrist detected burst blood vessels in his eyes, indicating dangerously high blood pressure. - Patient was referred to the hospital, where his **blood pressure was recorded at 178/117**. His kidneys were found to be failing, necessitating **dialysis for four hours**. - He experienced significant difficulty urinating, requiring the placement of a catheter. Over time, he has relied on **intermittent catheterization (2-3 times daily)** due to persistent bladder dysfunction.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysuria, Eye haemorrhage, Impaired work ability, Large intestinal polypectomy
Clinical narrative: Timeline of Events: 1. **COVID-19 Vaccination Requirement:** - Due to the COVID-19 pandemic and a scheduled work-related attendance at the onference, patient was required to receive a COVID-19 vaccine for travel and event entry. - On **July 22, 2021**, patient received a single-dose Johnson & Johnson vaccine at Pharmacy. Prior to administration, he signed documentation releasing Johnson & Johnson from liability. 2. **Immediate Adverse Effects:** - Upon arrival, patient experienced **elevated blood pressure, dizziness, and profound weakness**, limiting his ability to attend scheduled meetings. - He returned to home state, and sought rest, intending to recover. Lost of muscle mass and  weight loss. 3. **Subsequent Medical Findings:** - During a routine eye exam the following day, his optometrist detected burst blood vessels in his eyes, indicating dangerously high blood pressure. - Patient was referred to the hospital, where his **blood pressure was recorded at 178/117**. His kidneys were found to be failing, necessitating **dialysis for four hours**. - He experienced significant difficulty urinating, requiring the placement of a catheter. Over time, he has relied on **intermittent catheterization (2-3 times daily)** due to persistent bladder dysfunction.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Large intestine polyp, Muscle atrophy, Renal failure, Urinary retention, Weight decreased
Clinical narrative: Timeline of Events: 1. **COVID-19 Vaccination Requirement:** - Due to the COVID-19 pandemic and a scheduled work-related attendance at the onference, patient was required to receive a COVID-19 vaccine for travel and event entry. - On **July 22, 2021**, patient received a single-dose Johnson & Johnson vaccine at Pharmacy. Prior to administration, he signed documentation releasing Johnson & Johnson from liability. 2. **Immediate Adverse Effects:** - Upon arrival, patient experienced **elevated blood pressure, dizziness, and profound weakness**, limiting his ability to attend scheduled meetings. - He returned to home state, and sought rest, intending to recover. Lost of muscle mass and  weight loss. 3. **Subsequent Medical Findings:** - During a routine eye exam the following day, his optometrist detected burst blood vessels in his eyes, indicating dangerously high blood pressure. - Patient was referred to the hospital, where his **blood pressure was recorded at 178/117**. His kidneys were found to be failing, necessitating **dialysis for four hours**. - He experienced significant difficulty urinating, requiring the placement of a catheter. Over time, he has relied on **intermittent catheterization (2-3 times daily)** due to persistent bladder dysfunction.
Age: 71.0
Sex: M
Vaccine: COVID19, FLU3, PPV, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Medical assistant administered an expired Pneumo 23 vaccine to a patient.  The patient did not experience any adverse reactions from this vaccine.  The vaccine expired on 11/22/2024 and was administered to the patient on 12/17/2024.
Age: 68.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received duplicate Prevnar 20 vaccine. No adverse side effects noted.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Death
Clinical narrative: Routine vaccinations above given on 11/29/2024 at well child check up. Patient was found deceased in his crib on the morning of 12/10/2024 at home by parents.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMRV, PNC20, VARCEL
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Vaccine error was made. Medical assistant giving shots drew up and gave MMRV and Varivax instead of MMR and Varivax. Error was discovered later that day. Doctor made aware. MA called mom and let her know. Advised to watch for any side effects and contact us with any questions or concerns. No adverse reaction at this time.
Age: 0.5
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was seen for their 6 month well child check. At the patient's appointment, Hepatitis B (Engerix) was ordered. The Medical Assistant removed the vaccine from the refrigerator and verified that it was the correct vaccine with another Medical Assistant. Correct vaccine was verified but double check of expiration date was overlooked.  No reactions at time administration and no adverse reactions reported at this time.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Joint range of motion decreased, Pain, Sleep disorder
Clinical narrative: Seven hours after receiving the vaccination she awakened from sleep with extreme pain in the right shoulder making sleep difficult and making moving the right shoulder extremely painful.  Came to my clinic the next day for treatment.  Was given 30mg Ketorolac IM and 60mg liquid fexofenadine.  Instructed her to apply 30 minutes of heat or ice 2-3 times daily, continue the fexofenadine daily until symptoms resolve, and Tylenol prn for pain.   3-4 days she reported improvement, but pain and limited movement still present.  Today (23 days later) she still has mild pain and minimal limited ROM of her right shoulder.  She was instructed to continue the heating pad to her shoulder as needed.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: Patient inadvertently received a high dose influenza vaccine despite history of Guillain-Barre' and patient request for receipt of a COVID-19 vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-GAD antibody positive, Glycosylated haemoglobin increased, Hyperglycaemia
Clinical narrative: 3/4/2024 Moderna Covid-19 monovalent vaccine was administered.  The patient's HgbA1C increased from 5% to 6.2%. He was again vaccinated on 9/9/2024 with Pfizer Omicron KP2 XBB 1.5. Developed over hyperglycemia on 11/18/2024. HgbA1C was up to 10.9%. Further evaluation revealed positive GAD-65 AB.
Age: 13.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Fall, Head injury, Skin laceration
Clinical narrative: Patient received vaccines and didnt want to see his little brother get vaccines. Patient stood up and looked at the door. While giving vaccine the patient's sibling a vaccine, their other brother yelled and the patient hit his head against the door and before he hit the floor his brother caught him and helped him to the floor. Before they got to the floor the patient was already alert. He had a red mark on his forehead and a small laceration on the bridge of his nose. Patient was checked out by our RN and Physician on site and was cleared of any serious injury or concussion. The patient stayed in the room for observation for 20 minutes after this event and was discharged home after demonstrating that he could stand and walk without any dizziness.
Age: 63.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Burning sensation, Injected limb mobility decreased, Injection site reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported to my clinic today 12/17/24 with injection site reaction since receiving flu and RSV vaccines 11/19/24. She reports she was given vaccines in the same arm and injector (at local pharmacy) administered in the same site, in the lower L deltoid. Her arm has been burning, itching, painful, swollen and discolored without current signs of infection. She has limitations in range of motion due to pain. She has used ice and heat without relief. I have started her on steroids short-term, antihistamine and hydrocortisone ointment daily. She reports she has had flu vaccines in the past without reactions.
Age: 63.0
Sex: F
Vaccine: RSV, UNK
Symptoms: Pruritus, Skin discolouration
Clinical narrative: Patient reported to my clinic today 12/17/24 with injection site reaction since receiving flu and RSV vaccines 11/19/24. She reports she was given vaccines in the same arm and injector (at local pharmacy) administered in the same site, in the lower L deltoid. Her arm has been burning, itching, painful, swollen and discolored without current signs of infection. She has limitations in range of motion due to pain. She has used ice and heat without relief. I have started her on steroids short-term, antihistamine and hydrocortisone ointment daily. She reports she has had flu vaccines in the past without reactions.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, FLU3, PNC20
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12/17/24- assessed pt for allergies, medical conditions, or adverse reactions to past vaccines. Mom denied all and agreed to vaccines given. vis given for all vaccines given.  fluzone trivalent vaccine given at age 4mo and 22 days into L thigh IM. Vaxelis administer L thigh IM. Prevnar administered R thigh IM.  Administration error of Fluzone vaccine intended for ages 6 mo and older realized after mom left clinic. Notified Dr. of error and he notified me to contact parent and make aware of error and adverse reactions to be alert for. Call place to parent twice with no answer utilizing language line interpreter for language speaking mother. Left msg via interpreter to call clinic back as soon as possible.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: dfhdfhdfh
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Cardiac monitoring, Cardiac pacemaker insertion, Feeling abnormal, Ventricular extrasystoles
Clinical narrative: About 2 hours after vaccine, patient felt wired and anxious like he had consumed a whole pot of coffee.  That went away in the evening.  The next morning he had PVC's, which continued and got progressively worse over the next month.  Saw pcp in October, and was referred to cardiologist 5 days later.   Patient was put on heart monitor on 11/11/24 and on 12/12/24 he had to have a pacemaker put in.
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash to torso
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: None, patient did not reported any side effects or s/s that resulted from the inj.
Age: 19.0
Sex: F
Vaccine: COVID19, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Headache, Mass, Pruritus, Swelling
Clinical narrative: Symptoms reported at approximately 11:40 a.m., included headache and itchiness all over along with redness of the face and arms as well as palpable subcutaneous bumps/swelling along the back. Patient took two 25mg Diphenhydramine tablets by mouth and was observed with vital sign monitoring for 27 minutes. The patient declined to stay the recommended 30 minutes because she had an interview and was feeling much better. Patient departed the clinic at approximately 12:10 p.m. via independent ambulation with no additional concerns noted or reported.
Age: 53.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Vision blurred
Clinical narrative: Rapid Heart beat, dizziness, headache, nausea, blurred vision
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Dose was given outside of approved age range15 year old boy.; No additional AE; This spontaneous report was received from a consumer via company representative referring to a 15-year-old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.   On 06-DEC-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection administered 1 injection for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were not provided) (Product administered to patient of inappropriate age). No treatment was given. No adverse side effects at time but the reporter wanted to report the error. No additional adverse events (AEs) or product quality complaint (PQC) were reported.
Sex: F
Vaccine: HIBV
Symptoms: Bacterial test positive, Haemophilus test positive, Malaise, Pneumonia bacterial, Pneumonia haemophilus
Clinical narrative: tested positive for Haemophilus B and pneumonia; multiple other bacteria/pneumonia; This spontaneous report was received from a nurse and refers to a 2-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 an unknown date, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection administered for prophylaxis (strength, dose, units, frequency, lot #, expiry date, and route of administration were not provided). It was reported that the patient was fully vaccinated.  On an unknown date in 2024 (reported as about a month ago), the patient began to become sick with runny nose and very high fever. She was given respiratory treatments (not specified), but once they stopped, she got sick again. She was at that point swabbed, and test came back positive for Haemophilus B, along with multiple other bacteria (unspecified) and pneumonia. The patient was additionally treated with paracetamol (TYLENOL), ibuprofen (MOTRIN), and amoxicillin (+) clavulanate potassium (AUGMENTIN). At the reporting time, the patient has not recovered from the events.  The causal relationship between the events of pneumonia haemophilus and pneumonia bacterial and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was not provided.  Upon internal review, the events of pneumonia haemophilus and pneumonia bacterial were determined to be medically significant.
Sex: F
Vaccine: HIBV
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: tested positive for Haemophilus B and pneumonia; multiple other bacteria/pneumonia; This spontaneous report was received from a nurse and refers to a 2-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 an unknown date, the patient started therapy with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection administered for prophylaxis (strength, dose, units, frequency, lot #, expiry date, and route of administration were not provided). It was reported that the patient was fully vaccinated.  On an unknown date in 2024 (reported as about a month ago), the patient began to become sick with runny nose and very high fever. She was given respiratory treatments (not specified), but once they stopped, she got sick again. She was at that point swabbed, and test came back positive for Haemophilus B, along with multiple other bacteria (unspecified) and pneumonia. The patient was additionally treated with paracetamol (TYLENOL), ibuprofen (MOTRIN), and amoxicillin (+) clavulanate potassium (AUGMENTIN). At the reporting time, the patient has not recovered from the events.  The causal relationship between the events of pneumonia haemophilus and pneumonia bacterial and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was not provided.  Upon internal review, the events of pneumonia haemophilus and pneumonia bacterial were determined to be medically significant.