chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A Pediarix was given to an 18 month old in place of an Infanrix. During the double check process, the 1st clinical staff was questioned that this was the incorrect vaccine but assured the 2nd clinical staff that they were correct. The incorrect vaccine was administered.  PCP and Clinical staff have been updated and educated. Messages have been left with parents of the patient to get an update on the patient and also let them know the situation.
Age: 26.0
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea and fatigue through the rest of the day
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Computerised tomogram head normal, Full blood count normal, Impaired work ability, Metabolic function test normal
Clinical narrative: On 5/9/2024 received Hepatitis B vaccination left deltoid and 15 minutes later developed itch, red rash right inner forearm, states 'looked like a welt'. Shortly after, employee developed muscle aches, joint pain and 'blurred' vision. On 5/10/2024 employee was seen in Employee Health and then sent to the ED for evaluation. CT scan of the head and labwork was normal and employee was discharged that evening. She then floowed up with an ophthalmologist on 5/15/2024, where she had vision tests doe. She failed visual field test. Has a follow-up appointment on 5/29/2024. Blurred vision persists with 10 % improvement. On 5/18/2024 had follow-up telephone appointment, still complaining of blurry vision. The ophthalmologist told the patient that they have seen blurry vision occur post-vaccination and it normally resolves. Patient remains out of work. Advised patient to follow up with neurologist for further evaluation.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia, Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: On 5/9/2024 received Hepatitis B vaccination left deltoid and 15 minutes later developed itch, red rash right inner forearm, states 'looked like a welt'. Shortly after, employee developed muscle aches, joint pain and 'blurred' vision. On 5/10/2024 employee was seen in Employee Health and then sent to the ED for evaluation. CT scan of the head and labwork was normal and employee was discharged that evening. She then floowed up with an ophthalmologist on 5/15/2024, where she had vision tests doe. She failed visual field test. Has a follow-up appointment on 5/29/2024. Blurred vision persists with 10 % improvement. On 5/18/2024 had follow-up telephone appointment, still complaining of blurry vision. The ophthalmologist told the patient that they have seen blurry vision occur post-vaccination and it normally resolves. Patient remains out of work. Advised patient to follow up with neurologist for further evaluation.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred, Visual field tests abnormal
Clinical narrative: On 5/9/2024 received Hepatitis B vaccination left deltoid and 15 minutes later developed itch, red rash right inner forearm, states 'looked like a welt'. Shortly after, employee developed muscle aches, joint pain and 'blurred' vision. On 5/10/2024 employee was seen in Employee Health and then sent to the ED for evaluation. CT scan of the head and labwork was normal and employee was discharged that evening. She then floowed up with an ophthalmologist on 5/15/2024, where she had vision tests doe. She failed visual field test. Has a follow-up appointment on 5/29/2024. Blurred vision persists with 10 % improvement. On 5/18/2024 had follow-up telephone appointment, still complaining of blurry vision. The ophthalmologist told the patient that they have seen blurry vision occur post-vaccination and it normally resolves. Patient remains out of work. Advised patient to follow up with neurologist for further evaluation.
Age: 33.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Abdominal pain, Feeling hot, Pain, Vomiting
Clinical narrative: Patient received vaccine Friday 5/10/24 and states she felt fine Saturday 5/11/24, Sunday 5/12/24 and Monday 5/13/24. Patient states she went for a challenging run on Saturday. Patient reports when she woke Tuesday 5/14/24 she was experiencing abdominal pain, felt feverish (did not check temp with a thermometer) and had body aches. After she got up she vomited 2x. When she left the message on my phone she stated she "feels pretty rough". Called and spoke to patient who reports she did not see a medical provider but did take Zofran at 11:30 am  on 5/14/24. Patient reports she slept and rested for most of that day. When I spoke to her Wednesday 5/15/24, she reports she was feeling better but not quite 100%.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Skin discolouration, Swelling
Clinical narrative: Pt mother presented with child. Visit discussed with use of interpreter. Reports Child having reaction to vaccine given at last visit. Upon assessment, skin on left ventrogluteal darker and noticeably swollen compared to surrounding tissue. Report they went to UC but unable to relay if child received treatment. Denies difficulty breathing. Advised can give benadryl to help with swelling and can go to ER for reported pain, itching, and swelling to area.
Age: 66.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HEPLISAV-B given as second dose for a patient that received RECOMBIVAX HB as their first dose.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Induration, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: mother states child woke up on Sunday morning the 5/19/2024 and mentioned to mother that her left arm was hot and swollen and hard. mother than rushed child to  Urgent care for left arm pain. provider at Urgent care recommended warm compresses to the area.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Auditory nerve disorder, Deafness, Deafness unilateral, Dizziness, Magnetic resonance imaging head abnormal
Clinical narrative: Within 24 hours there was a ringing in my right ear. By Tuesday I suffered severe dizziness and hearing loss and ended up in a hospital out of town due to work. I had gone completely deaf in my right ear and 30-40% loss in my left ear.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis, Tinnitus
Clinical narrative: Within 24 hours there was a ringing in my right ear. By Tuesday I suffered severe dizziness and hearing loss and ended up in a hospital out of town due to work. I had gone completely deaf in my right ear and 30-40% loss in my left ear.
Age: 69.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea exertional, Echocardiogram normal
Clinical narrative: Client reports new onset shortness of breath with exertion, like when climbing stairs or a hill. Reports that 1-2 days before vaccine he walked 18 holes of golf without shortness of breath. He has been seen by his cardiologist, had an echocardiogram which patient reports was clear. He is awaiting a stress test.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered
Clinical narrative: Patient received Comirnaty 2023-2024 dose on 10/2/2023. She returned on 4/29/24 and filled out paperwork for a covid booster dose and was given another dose of Comirnaty 2023-2024 even though she is only 60 years old and marked no to immune system problems. Based on current recommendations, she did not qualify for a booster dose at that time. This was discovered on 5/21/24 when her husband, age 59, was inquiring about a booster covid dose and was told he did not qualify at this time.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient came in for her 2nd Hep B Vaccine of the 2nd Series and I gave her a Tdap Vaccine instead and realized I had given her a Tdap instead of the Hep B Vaccine. I went straight to the Provider and told her about it and we went in the exam room right away and told patient what had happened. Patient stated it was ok mistakes happen. Then I went and got the Hep B Vaccine and gave it to her.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia
Clinical narrative: PATIENT EXPERIENCED DOUBLE VISION APPROXIMATELY 1 HOUR AFTER VACCINATION. PATIENT DID NOT EXPERIENCE THIS WITH ANY PREVIOUS PFIZER VACCINE.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Areflexia, Asthenia, CSF protein increased, CSF white blood cell count negative, Hypoaesthesia
Clinical narrative: Progressive weakness, numbness, predominantly BLE over several days.  Absence of deep tendon reflexes on neurology exam.  Currently receiving IVIG.  Exam stable over multiple days, no respiratory depression or further ascension of nerve symptoms.
Age: 74.0
Sex: M
Vaccine: PNC20
Symptoms: Immunoglobulin therapy, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness, Neurological examination abnormal
Clinical narrative: Progressive weakness, numbness, predominantly BLE over several days.  Absence of deep tendon reflexes on neurology exam.  Currently receiving IVIG.  Exam stable over multiple days, no respiratory depression or further ascension of nerve symptoms.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: At a Jr. High School outreach clinic, the school nurse was looking up needed vaccines for the students. It was overlooked that this student already had a MCV4 vaccine and did not need it. However, this was not discovered until several days later.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Resident received 2nd dose too close to 1st dose.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Brain fog, Impaired work ability, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Since the vaccine on January 21, 2020  I have experience psychosis type symptoms.  I have been unable to work, I lost relationships, I lost my job, been unable to make a living for myself leaving me have my daughter take financial care of me.    Altered reality feeling, brain fog, no energy, difficult to complete daily tasks like I once could.  This went on for several months, I started to feel better and it came on again.  I am again starting to get better.  No doctor would take me seriously during those times as it was during the covid outbreak and they all would blame covid and not the true source of my injury.  I would also like to add that during my visit at the clinic on the day of my vaccine.... there were many red flags .. the MA that administrated the vaccine, even stated during the proceedure that the vaccine was very thick.... A man met her at the door with the vaccine, and the Dr that was seeing me that day would not leave the room until I received my vaccine.  I asked her why she was still in the room and she stated that she was going to make sure I didn't run out of the room.....  I was pressured into receiving this vaccine..   and that has changed the past 4 years of my life.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Psychotic symptom, X-ray
Clinical narrative: Since the vaccine on January 21, 2020  I have experience psychosis type symptoms.  I have been unable to work, I lost relationships, I lost my job, been unable to make a living for myself leaving me have my daughter take financial care of me.    Altered reality feeling, brain fog, no energy, difficult to complete daily tasks like I once could.  This went on for several months, I started to feel better and it came on again.  I am again starting to get better.  No doctor would take me seriously during those times as it was during the covid outbreak and they all would blame covid and not the true source of my injury.  I would also like to add that during my visit at the clinic on the day of my vaccine.... there were many red flags .. the MA that administrated the vaccine, even stated during the proceedure that the vaccine was very thick.... A man met her at the door with the vaccine, and the Dr that was seeing me that day would not leave the room until I received my vaccine.  I asked her why she was still in the room and she stated that she was going to make sure I didn't run out of the room.....  I was pressured into receiving this vaccine..   and that has changed the past 4 years of my life.
Age: 31.0
Sex: F
Vaccine: COVID19, HEP
Symptoms: Dyspnoea, Fatigue, Laboratory test normal, Migraine, Panic attack
Clinical narrative: Patient reported that she had a reaction to the Moderna COVID vaccine on 10/31/2023 at Occupational Health. She had gotten the Pfizer vaccine in previous years and had more mild reactions including some of the same symptoms, but never for a long period of time or severe.  She reports having gone to work just after getting the vaccine. Within a couple of hours, she started feeling shortness of breath and fatigue that escalated throughout her shift. After her shift she drove home and the SOB continued to worsen. She started tracking her heartrate and it was up to 170bpm. She went to the ED they ran tests.  She was given a diagnosis of panic attack. Thais reports that this event felt significantly different than panic attacks she has had in the past and that her therapist agreed it was probably not a panic attack. She was given Benadryl, lactated ringers, lorazepam, neutra-phos, and Imitrex for migraine that came on after hours of SOB.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Biopsy, Blood test, Bronchitis, Central venous catheterisation, Chemotherapy
Clinical narrative: She got her vaccine, and then started coughing.  It has escalated to the point of very severe coughing to the point that she could not complete a sentence.  She had a video APT on 2/1/24 and he was diagnosed then with Bronchitis, put on steroids and antibiotics, which did nothing for her at all.  On 3/1/24 she called her PCP, and he went in to see him, and he had imaging on 3/23/24.  On 3/27/24 she spoke with her PCP.  On 3/28/24 she had a CT scan at Hospital.  On 3/29/24 she saw her PCP again.  4/4/24 spoke with her PCP, 4/9/24 she was imaging.  She was then referred on 4/16/24 and on 4/24/24 she was in Hospital for a biopsy.  4/26/24 she saw Dr.s on 4/30/24 she had a FU.  On 5/1/24 she had a port inserted .  On 5/8/24 she talked to her PCP.  On 5/8 and 5/9/24 she had chemotherapy.  She was diagnosed Diffuse large B-cell lymphoma and on one spot 2B and 3B.  She had non-Hodgkin's lymphoma and treated with Ritaxm treatments in 2018 and 2019, and this was dorment, and wonders if this RSV vaccine awakened and escalated another type of lymphoma which is much more aggressive than her Non-Hodgkin's lymphoma.  She goes back for another chemo treatment on 5/30/24 for round 2, and will probably be getting treatments every 3-4 weeks for up to 6 rounds, and gets R-CHOP chemo.  She is also on Allopurinol for her BP.  Before she gets treatment, the day of treatment she taking Prednisone on M-W-F and when she goes back for treatment to take it that day and for 4 days after for the next cycle, 5 pills a day, each pill 20 mg.   She thinks if there are any other people are out there that have cancer or respiratory issues that if this is a common denominary that people should be warned about it.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram, Cough, Diffuse large B-cell lymphoma, Imaging procedure, Positron emission tomogram
Clinical narrative: She got her vaccine, and then started coughing.  It has escalated to the point of very severe coughing to the point that she could not complete a sentence.  She had a video APT on 2/1/24 and he was diagnosed then with Bronchitis, put on steroids and antibiotics, which did nothing for her at all.  On 3/1/24 she called her PCP, and he went in to see him, and he had imaging on 3/23/24.  On 3/27/24 she spoke with her PCP.  On 3/28/24 she had a CT scan at Hospital.  On 3/29/24 she saw her PCP again.  4/4/24 spoke with her PCP, 4/9/24 she was imaging.  She was then referred on 4/16/24 and on 4/24/24 she was in Hospital for a biopsy.  4/26/24 she saw Dr.s on 4/30/24 she had a FU.  On 5/1/24 she had a port inserted .  On 5/8/24 she talked to her PCP.  On 5/8 and 5/9/24 she had chemotherapy.  She was diagnosed Diffuse large B-cell lymphoma and on one spot 2B and 3B.  She had non-Hodgkin's lymphoma and treated with Ritaxm treatments in 2018 and 2019, and this was dorment, and wonders if this RSV vaccine awakened and escalated another type of lymphoma which is much more aggressive than her Non-Hodgkin's lymphoma.  She goes back for another chemo treatment on 5/30/24 for round 2, and will probably be getting treatments every 3-4 weeks for up to 6 rounds, and gets R-CHOP chemo.  She is also on Allopurinol for her BP.  Before she gets treatment, the day of treatment she taking Prednisone on M-W-F and when she goes back for treatment to take it that day and for 4 days after for the next cycle, 5 pills a day, each pill 20 mg.   She thinks if there are any other people are out there that have cancer or respiratory issues that if this is a common denominary that people should be warned about it.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Targeted cancer therapy, Therapeutic product ineffective, X-ray
Clinical narrative: She got her vaccine, and then started coughing.  It has escalated to the point of very severe coughing to the point that she could not complete a sentence.  She had a video APT on 2/1/24 and he was diagnosed then with Bronchitis, put on steroids and antibiotics, which did nothing for her at all.  On 3/1/24 she called her PCP, and he went in to see him, and he had imaging on 3/23/24.  On 3/27/24 she spoke with her PCP.  On 3/28/24 she had a CT scan at Hospital.  On 3/29/24 she saw her PCP again.  4/4/24 spoke with her PCP, 4/9/24 she was imaging.  She was then referred on 4/16/24 and on 4/24/24 she was in Hospital for a biopsy.  4/26/24 she saw Dr.s on 4/30/24 she had a FU.  On 5/1/24 she had a port inserted .  On 5/8/24 she talked to her PCP.  On 5/8 and 5/9/24 she had chemotherapy.  She was diagnosed Diffuse large B-cell lymphoma and on one spot 2B and 3B.  She had non-Hodgkin's lymphoma and treated with Ritaxm treatments in 2018 and 2019, and this was dorment, and wonders if this RSV vaccine awakened and escalated another type of lymphoma which is much more aggressive than her Non-Hodgkin's lymphoma.  She goes back for another chemo treatment on 5/30/24 for round 2, and will probably be getting treatments every 3-4 weeks for up to 6 rounds, and gets R-CHOP chemo.  She is also on Allopurinol for her BP.  Before she gets treatment, the day of treatment she taking Prednisone on M-W-F and when she goes back for treatment to take it that day and for 4 days after for the next cycle, 5 pills a day, each pill 20 mg.   She thinks if there are any other people are out there that have cancer or respiratory issues that if this is a common denominary that people should be warned about it.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Exposure during pregnancy
Clinical narrative: Patient felt dizzy after 15 minutes of administration. You are 28 weeks pregnant.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Immunoglobulin therapy, Laboratory test, Lumbar puncture
Clinical narrative: Patient initial presentation was that of tingling involving both hands and feet, presented to the emergency room with some complaints of blurry vision which improved, although the tingling and paresthesias continue.  Patient notice the symptoms after his 1st Pfizer COVID-19 vaccine, the symptoms were transient but worsened and became permanent after the booster vaccination leading to an emergency room visit on 05/14/2021.  Over time patient feels that the symptoms have worsened. Patient was diagnosed with CIPD on 1/4/2024. Patient started IVIG on 03/11/2024.  Had an initial loading dose 3/11/2024 - 3/15/2024 and has been getting IVIG  0.5 grams/kilogram every 2 weeks.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Paraesthesia, Vision blurred
Clinical narrative: Patient initial presentation was that of tingling involving both hands and feet, presented to the emergency room with some complaints of blurry vision which improved, although the tingling and paresthesias continue.  Patient notice the symptoms after his 1st Pfizer COVID-19 vaccine, the symptoms were transient but worsened and became permanent after the booster vaccination leading to an emergency room visit on 05/14/2021.  Over time patient feels that the symptoms have worsened. Patient was diagnosed with CIPD on 1/4/2024. Patient started IVIG on 03/11/2024.  Had an initial loading dose 3/11/2024 - 3/15/2024 and has been getting IVIG  0.5 grams/kilogram every 2 weeks.
Age: 82.0
Sex: M
Vaccine: UNK
Symptoms: Musculoskeletal disorder
Clinical narrative: Could not lift arm
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Administered MMRV, Varicella, Hep A and PCV15 that was in orders in computer, and there weren't hard stops in the computer, therefore patient received two doses of the Varicella.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Vaccine administered per EMR records when system not interacting with EMR. When system was active it pulled prior vaccine over.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass, Pain
Clinical narrative: PATIENT REPORTED A LARGE RED LUMP AND SHE WAS EXPERIENCING LOTS OF PAIN.
Age: 1.17
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt was given Proquad (MMRV) instead of MMR
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Rash pruritic, Skin abrasion
Clinical narrative: Pt received the vaccine around 10:30am. Around 1:30 pm same day, pt called to report body rash (mostly on the chest and arms). Per pt, no tongue swelling, no difficulties breathing and no lip swelling. We instructed patient to take 50mg of Benadryl. Per pt, she got the same vaccine a few years ago with no reaction. We checked back with patient around 8:30 pm same day. Patient reported no signs of compromising airway/anaphylaxis shock. In addition, the rashes were still there, and patient also had been doing errands run as well. We instructed patient to keep monitoring for next 2-3 days and use benadryl cream as needed for itching and report us any changes. We followed up with patient after 6 days. After 6 days, patient reported that itch has gone away but since the patient scratched herself a lot, then skin is healing. Per pt, she did not seek any medical treatment.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Myalgia, Neck pain, Syncope
Clinical narrative: Fainted as we were heading out of the office.  Was slow to awake.  Had very low pulse at time of event. Pulse eventually came back up and she still couldn?t open her eyes. Was given electrolytes at the office. One week later and still has head,neck and muscle pain.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Pallor, Pyrexia, Visual impairment
Clinical narrative: about 6 hours after meningitis B and meningitis A vaccines given at well child check, pt developed chills, subjective fever intermittently, then dizziness and pallor. she also reports about 24 hours after vaccines, having lightheadedness when standing, severe pallor and changes in vision, including visual fields appearing all white. improved after few minutes with lying down. sx gradually improved over the day.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Rash
Clinical narrative: Rash
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Syncope
Clinical narrative: Patient had a syncopial episode after vaccine.
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: none
Age: 4.0
Sex: F
Vaccine: PNC15
Symptoms: Extra dose administered
Clinical narrative: this does was not needed. no reactions noted. nurse did not follow protocol.
Age: 59.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient given Hib Conjugate dose instead of ordered vaccine, Tdap. No adverse side effects expected per PCP. Patient advised to return to clinic for Tdap.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 9 cm by 15 cm rash on left arm, slight warmth
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Fatigue, Full blood count normal, Metabolic function test normal
Clinical narrative: Extreme otherwise unexplained fatigue
Age: 38.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: RSV (Arexvy)   is for 60 years and older. Given to a patient 38 years .    No adverse effects noted by patient
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Limb discomfort, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: Patient received the vaccine on 4/15/24 and states that his arm was sore for a few days like he had experienced from other vaccines then it subsided. He then states after sort of a delay maybe 10 days prior to today (5/21) he started having an occasional tingling sensation in his left arm he explained it as "nothing to serious" at first. But today (5/21) it was bothering him and had restricted his ability to do certain activities due to numbness and tingling  He said he has self treated with two 500mg acetaminophen and two ibuprofens once a day and it works great. but today he forgot to take some and he was having some discomfort in his arm
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on forehead and cheeks, resolved within 5-10min but received benadryl 2.5mg of 12.5mg/5mL liquid childrens benadryl within 5min of rash starting
Age: 43.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Injection site pain, Sleep disorder
Clinical narrative: When I got the shot, it made a terrible bubbly 'splat' noise at the end of the shot. It hurt worse than most shots I have had, enough that I googled it and the general consensus was that there was no problem if there was air when it was shot into the muscle. I used my arm regularly as advised, although the injection spot had a mild burning sensation for about a week. Sometimes the burning would get worse at night and wake me up. After a week, my elbow started aching and my arm just had a dull ache near the injection site. The injection site is tender to the touch and my elbow is still currently aching.  I haven't changed my diet or exercise or vitamins that I'm taking. No falls or injury. My right arm is totally fine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The left arm was very painful and the patient was not able to move the arm very much.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Covid-19 Pfizer vaccination given to patient of 9 years old, but vaccine has only been approved for children 12+ years old on 05/20/2024 at roughly 6pm. Patient's parents have been contacted regarding the missfill and the only documented adverse effect at this time is arm pain.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema, Skin warm
Clinical narrative: erythematous patch 6x7cm, mild warmth to palpation
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blindness, Blindness unilateral
Clinical narrative: Blind in right eye.  Gradual loss of vision starting at the end of April.  Almost complete as it 5/21/24
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Sacral pain
Clinical narrative: Low back pain, sacral?worsens when sitting for extended periods, lessens with movement
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: he noted that where he got this it was red (about the size of a half dollar) , hot and sore.   advised that he take a Benadryl, draw a line around the red area so we can see if it gets bigger smaller, stays the same. He will call us in the am with an update
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: No adverse event
Clinical narrative: No adverse events or symptoms reported. Manufacture was contacted.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addtional AE; a dose of ROTATEQ was administered after its labeled expiration date.; This spontaneous report was received from an other Health Professional and referred to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 29-APR-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1933923, expiration date: 28-APR-2024, administered orally for prophylaxis (strength was not provided). The vaccine was administered after its labeled expiration date. Product had never undergone a temperature excursion. No additional AE.
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse calling to report female patient received a(ppropriately stored) dose of PNEUMOVAX 23 that expired on 5/6/2024.  No adverse effects reported.  No additional information provided.  No additional AE. No PQC.; Nurse calling to report female patient received a(ppropriately stored) dose of PNEUMOVAX 23 that expired on 5/6/2024.  No adverse effects reported.  No additional information provided.  No additional AE. No PQC.; This spontaneous report was received from a licensed visiting nurse regarding a female patient of unspecified age. Her medical history, historical drugs, known, allergies, concurrent conditions, and concomitant therapies were not reported.  On 14-MAY-2024, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) that upon review, was confirmed to be a vial, at a dose of 0.5 milliliter (ml), lot #W011148, that had expired on 06-MAY-2024, for prophylaxis (strength, anatomical location, and route of administration were not provided) (Expired vaccine used). However, this dose had been properly stored and no adverse effects were reported.
Sex: F
Vaccine: PPV
Symptoms: Multiple allergies
Clinical narrative: Allergic to everything; This spontaneous report was received from a physician and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On approximately 2017 (reported as about 7 years ago), the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for prophylaxis (strength, specific dosage, dose number, route of administration, anatomical site of application, lot number and expiration date were not provided) and tolerated it without any complications, also health care professional (HCP) was looking to possibly administer another dose.  On an unknown date, it was reported patient was "allergic to everything" (multiple allergies) (unable to confirm if she had any prior reactions to the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23)). The outcome of the event was not provided.   The causal relationship between the event and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.   Additional information was not expected.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported.; Nurse reported that a patient received an expired MMRII vaccine on 5/13/2024.; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 13-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, 1 dose, lot #W034592, expiration date: 10-MAY-2024, (strength, exact dose and route of administration were not provided) administered for prophylaxis (Expired product administered). Operator of device was reported as health professional. No additional adverse events were reported. No further information provided. No product quality complaint.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC.; administration of PROQUAD to a 15 year old patient.; This spontaneous report has been received from other health professional (nurse), referring a 15-year-old patient of an unknown gender.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 14-MAY-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, rHA, administered as prophylaxis (strength, dose, route  and anatomical location administration were not provided; lot # reported as Y003881, which is a valid lot # for this vaccine, expiration date provided and validated to be on 05-AUG-2025). It was highlighted that this vaccine was administered to a 15 year old patient (product administered to patient of inappropriate age). No additional adverse event (AE) or product quality complaint (PQC) reported (no adverse event).
Sex: U
Vaccine: SMALLMNK
Symptoms: Product label confusion
Clinical narrative: Jynneos expiration date in the system was not matching with the box expiration date from which a dose was administered; Jynneos expiration date in the system was not matching with the box expiration date from which a dose was administered; Case reference number US-BN-2024-001827 is a spontaneous case report initially received from nurse via Med Communication (reference number: USBAV24-0783) on 18-Apr-2024 and concerns a patient of unspecified demographics.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, patient was vaccinated with a dose of Jynneos vaccine (batch number: FDP00013), at unknown dose, route, or site of administration for unknown indication. It was reported that Jynneos expiration date in the system (24-Sep-2023) was not matching with the box expiration date (Sep-2024) from which a dose was administered (explicitly coded as 'product expiration date issue' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  Additional information received from Bavarian Nordic on 22-Apr-2024 included PQC reference number (QE-009756); Reporter's Comments: A patient of unspecified demographics was vaccinated with a dose of Jynneos vaccine for unknown indication. It was reported that Jynneos expiration date in the system (24-Sep-2023) was not matching with the box expiration date (Sep-2024) from which a dose was administered, which is considered as product expiration date issue and product administration error. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Product expiration date issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Product expiration date issue and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified demographics was vaccinated with a dose of Jynneos vaccine for unknown indication. It was reported that Jynneos expiration date in the system (24-Sep-2023) was not matching with the box expiration date (Sep-2024) from which a dose was administered, which is considered as product expiration date issue and product administration error. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Product expiration date issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Product expiration date issue and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: Jynneos vaccine was administered after the beyond use date; Case reference number US-BN-2024-001886 is a spontaneous case report initially received from a nurse practitioner via Med Communication (reference number: USBAV24-0968) on 08-May-2024 and concerns patient of unspecified age and gender.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient was vaccinated with dose of Jynneos vaccine (batch number: FDP0020), at unknown dose, route, or site of administration for unknown indication. As reported, the vaccine was thawed and provided beyond eight weeks (explicitly coded as 'expired vaccine used')  At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  No further information provided.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with a dose of Jynneos vaccine for unknown indication. As reported, the vaccine was thawed and provided beyond eight weeks, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Expired product administered is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with a dose of Jynneos vaccine for unknown indication. As reported, the vaccine was thawed and provided beyond eight weeks, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Expired product administered is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient inadvertently administered a pediatric dose of Engerix-B; adult patient inadvertently administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 21-year-old female patient who received HBV (Engerix B pediatric) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 15-MAY-2024, the patient received the 3rd dose of Engerix B pediatric. On 15-MAY-2024, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: adult patient inadvertently administered a pediatric dose of Engerix-B) and underdose (Verbatim: adult patient inadvertently administered a pediatric dose of Engerix-B). The outcome of the adult use of a child product and underdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-MAY-2024  A pharmacist reported that a patient was inadvertently administered a pediatric dose of Engerix-B on 15 May 2024 which led to Adult use of child product and Underdose. This was the patient's third series dose, the patient was still in the pharmacy at the time of reporting, no further doses had been administered.  The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered first dose of Shingrix on 03 May 2024 and the 2nd dose on 17 May 2024; This non-serious case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 17-MAY-2024, the patient received the 2nd dose of Shingrix. On 17-MAY-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Patient was administered first dose of Shingrix on 03 May 2024 and the 2nd dose on 17 May 2024). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 17-MAY-2024 A reporter reported that a patient administered 2 doses of Shingrix 1st dose on 03 May 2024 and 2nd dose on 17 May 2024, there were no side effects was reported but the account was concerned for possible side effects and they need additional information regarding whether a 3rd dose should be given at 2-6 months timeframe.  The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm/ arm hurt; body aches/ bit achy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox twice as a child) and pain in arm (patient's arm hurt like before).   On 07-MAY-2024, the patient received the 2nd dose of Shingles vaccine. In MAY-2024, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm/ arm hurt) and general body pain (Verbatim: body aches/ bit achy). In MAY-2024, the outcome of the pain in arm and general body pain were resolved (duration 24 hrs).   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2024 This case was reported by the patient via interactive digital media. The patient had his/her second dose this past Tuesday (from the day of reporting).  The patient's arm hurt like before and was a bit achy for about 24 hours, but the patient read that could indeed happened.  The patient said he/she would gladly take a sore arm and body aches for a day over shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: discovered shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 08-MAY-2024, the patient received Shingles vaccine. On 08-MAY-2024 22:00, less than a day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: discovered shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine on Wednesday morning (from the date of reporting) and by 10pm he/she discovered shingles, that was the reaction the patient had.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site haemorrhage, Myalgia
Clinical narrative: elbow pain/pain of her right elbow where it looks like a nodule; sensitive area; tiredness/tired; muscle aches/muscle aches, particularly her quads; injection site erythema/injection site (right arm) was erythematous/Site injection red; site was erythematous (red) with ecchymosis; elbow pain/pain of her right elbow where it looks like a nodule; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-MAY-2024, the patient received the 1st dose of Shingrix (right arm). On 09-MAY-2024, 2 days after receiving Shingrix, the patient experienced nodule on extremity (Verbatim: elbow pain/pain of her right elbow where it looks like a nodule) and sensitive skin (Verbatim: sensitive area). In MAY-2024, the patient experienced injection site erythema (Verbatim: injection site erythema/injection site (right arm) was erythematous/Site injection red), injection site ecchymosis (Verbatim: site was erythematous (red) with ecchymosis), pain in elbow (Verbatim: elbow pain/pain of her right elbow where it looks like a nodule), tiredness (Verbatim: tiredness/tired) and myalgia of lower extremities (Verbatim: muscle aches/muscle aches, particularly her quads). The outcome of the injection site erythema, pain in elbow, tiredness and myalgia of lower extremities were unknown and the outcome of the injection site ecchymosis, nodule on extremity and sensitive skin were not reported.   It was unknown if the reporter considered the injection site erythema, injection site ecchymosis, pain in elbow, nodule on extremity, tiredness, myalgia of lower extremities and sensitive skin to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site ecchymosis, pain in elbow, nodule on extremity, tiredness, myalgia of lower extremities and sensitive skin to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-MAY-2024 The patient self reported that she received first dose of Shignrix on Tuesday (07-MAY-2024) and her injection site was erythematous (red) with ecchymosis. She was tired and her muscles particularly aches in quads. Today morning ( day of reporting) she woke up in severe pain in her right elbow where it looked like a nodule which was not erythematous, but looked like she had 2 elbows. She also mentioned two days after the administration of Shingrix vaccine had a huge protrusion on elbow and sensitive area.