chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Transaminases increased
Clinical narrative: Admit date: 2/7/2024  Discharge date: 2/12/24  Admitting Physician: DO   Attending Physician at the Time of Discharge: DO  Primary Care Physician: NP  Summary HPI: "Patient is a 79 YO female with a past medical history of HTN, HLD, T2DM, glaucoma and cryptogenic CVA with chronic left sided deficits that presents to the ED via EMS with complaints of chest pain for the past 2 days. "  Please see admission H&P for further details.  Summary of Hospitalization: Patient is a 79- YO F with a PMHx of dementia who lives at AFC, CVA with left hemiplegia, DM2, HTN who presents with cough and chest pain.  Suspect secondary to COVID infection.  Symptom onset approximately 2/6 and will require isolation until 2/16.  Patient will not need isolation on 02/17.  Cardiology consulted for chest pain and as echo showed no wall motion abnormalities and chest pain resolved; no further workup planned.  Due to RUQ pain, extrahepatic dilation, elevated LFTs MRCP obtain and showed cholelithiasis and choledocholithiasis.  Due to COVID isolation status, ERCP planned for outpatient followed by outpatient cholecystectomy.  Appreciate GI and General surgery recommendations.  Cholelithiasis and choledocholithiasis CBD dilation, Elevated transaminases -GI consulted, ERCP planned for outpatient -Zosyn due to question of infection with fever, which is most likely due to respiratory status.  Antibiotics not continued and discharge after discussion with Gastroenterology  -general surgery consulted, plan for cholecystectomy as outpatient  AKI with high anion gap metabolic acidosis-resolved Almost certainly secondary to poor oral intake while NPO for MRCP Patient does have poor oral intake at baseline and nutritional supplements discussed with patient's son  COVID pneumonia Testing negative, but with exposure and symptoms will elect to remain in isolation. No evidence of superimposed bacterial pneumonia Isolation 2/6-16.  Patient is out of isolation 2/17. -treatment not indicated without hypoxia, supportive care Discharged to Home.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Moderna SpikeVax that was received by the clinic on 10/16/2023, and placed in a temperature monitored refrigerator, the beyond use date for this vaccine was 11/16/2024.  I did not know that Moderna had a 30 day BUD when removed from a feezer, and placed in a fridge as I am a new vaccine site coordinator. The patient received this vaccine on 1/26/2024. It was 72 days beyond use.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives starting at the injection site 2 day after vaccination, became full-body hives
Age: 6.0
Sex: M
Vaccine: HPV9, TDAP, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Tdap and HPV vaccines which are both not age appropriate. Patient is too young to receive them. Patient's mother was contacted on 2/15/24 and she reported the patient is doing well with no side effects.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC20, VARCEL
Symptoms: Crying, Injection site movement impairment
Clinical narrative: Patient started crying and refusing to walk a few hours after vaccines. Gave Tylenol and was better a few hours later.
Age: 82.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Light red/pink area tenderness ranging 4 inches in length  to 1 inch across top and bottom and 2  inches across in middle of area
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given. Patient advised. Manufacturer contacted. Will need revaccinated.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT VACCINATED AFTER VIABILITY DATE.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Differential white blood cell count, Full blood count, Headache, Injection site erythema, Injection site pain
Clinical narrative: The patient received evaluation after development of a headache and the area on the left arm at the injection site where he developed redness and pain at the ER on 2/10/94.  Patient also had a headache which resolved. Swelling, erythema, and warmth of the left arm with scabbing area occurred at the injection site.  There were some fluid-filled lesions noted around the area where the injection likely occurred with some scabbing. The patient was sent home in stable condition. It was recommended for patient to follow up with the primary care doctor and return to the ER if worse. The MD in the ED prescribed Benadryl and Keflex.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Injection site reaction, Injection site scab, Injection site swelling, Injection site warmth, Metabolic function test
Clinical narrative: The patient received evaluation after development of a headache and the area on the left arm at the injection site where he developed redness and pain at the ER on 2/10/94.  Patient also had a headache which resolved. Swelling, erythema, and warmth of the left arm with scabbing area occurred at the injection site.  There were some fluid-filled lesions noted around the area where the injection likely occurred with some scabbing. The patient was sent home in stable condition. It was recommended for patient to follow up with the primary care doctor and return to the ER if worse. The MD in the ED prescribed Benadryl and Keflex.
Age: 13.0
Sex: M
Vaccine: HEP
Symptoms: Skin lesion, Ultrasound scan normal
Clinical narrative: The patient received evaluation after development of a headache and the area on the left arm at the injection site where he developed redness and pain at the ER on 2/10/94.  Patient also had a headache which resolved. Swelling, erythema, and warmth of the left arm with scabbing area occurred at the injection site.  There were some fluid-filled lesions noted around the area where the injection likely occurred with some scabbing. The patient was sent home in stable condition. It was recommended for patient to follow up with the primary care doctor and return to the ER if worse. The MD in the ED prescribed Benadryl and Keflex.
Age: 1.0
Sex: M
Vaccine: COVID19, HEPA, MMR, VARCEL
Symptoms: Chills, Vomiting
Clinical narrative: Approx 1 hour after receiving vaccines, patient developed afebrile chills that lasted several minutes and then vomited x 1.
Age: 89.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Resident had a Pfizer Bivalent on 10/28/2023 and was given another on 11/15/2023 (Moderna) by mistake.  There was no adverse reaction
Age: 34.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Dysstasia, Gait disturbance, Nausea, Vomiting
Clinical narrative: After Vaccine I started to feel Nausea and vomiting. My body began to get weak and I had to be admitted to ER for fluids.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) RA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) RA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Aphasia, Blood test, Cerebrovascular accident, Communication disorder, Computerised tomogram
Clinical narrative: Stroke involving aphasia, memory confusion and severe communication problems
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Confusional state, Echocardiogram, Magnetic resonance imaging
Clinical narrative: Stroke involving aphasia, memory confusion and severe communication problems
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Chills, Cough, Dysphagia, Fatigue, Headache
Clinical narrative: swollen lymph nodes, facial swelling, difficulty swallowing, fever, chills, pins and needles all over body, cough , fatigue, headache
Age: 36.0
Sex: F
Vaccine: ANTH
Symptoms: Lymphadenopathy, Paraesthesia, Pyrexia, Swelling face
Clinical narrative: swollen lymph nodes, facial swelling, difficulty swallowing, fever, chills, pins and needles all over body, cough , fatigue, headache
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Angiocardiogram, Autonomic nervous system imbalance, Blood test, Cardiac monitoring, Cardiac stress test
Clinical narrative: Developed tachycardia,  fatigue, shortness of breath, lightheadedness 2/10/2021.  Saw pcp 2/11/2021.  Initial cardiac workup negative.  Symptoms continued.  Developed chest pain late July 2021.  Admitted to Hospital with diagnosis of pericarditis.  Never cleared to return to work as a physical therapist after that time.  Diagnosed with POTS/ dysautonomia by cardiologist 10/2021.   Continued tachycardia,  lightheadedness,  fatigue,  chest pain,  shortness of breath,  decreased exercise tolerance, and decreased activity tolerance since that time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Chest X-ray, Chest pain, Computerised tomogram thorax, Decreased activity
Clinical narrative: Developed tachycardia,  fatigue, shortness of breath, lightheadedness 2/10/2021.  Saw pcp 2/11/2021.  Initial cardiac workup negative.  Symptoms continued.  Developed chest pain late July 2021.  Admitted to Hospital with diagnosis of pericarditis.  Never cleared to return to work as a physical therapist after that time.  Diagnosed with POTS/ dysautonomia by cardiologist 10/2021.   Continued tachycardia,  lightheadedness,  fatigue,  chest pain,  shortness of breath,  decreased exercise tolerance, and decreased activity tolerance since that time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Exercise tolerance decreased, Fatigue
Clinical narrative: Developed tachycardia,  fatigue, shortness of breath, lightheadedness 2/10/2021.  Saw pcp 2/11/2021.  Initial cardiac workup negative.  Symptoms continued.  Developed chest pain late July 2021.  Admitted to Hospital with diagnosis of pericarditis.  Never cleared to return to work as a physical therapist after that time.  Diagnosed with POTS/ dysautonomia by cardiologist 10/2021.   Continued tachycardia,  lightheadedness,  fatigue,  chest pain,  shortness of breath,  decreased exercise tolerance, and decreased activity tolerance since that time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Laboratory test, Magnetic resonance imaging heart, Pericarditis, Positron emission tomogram
Clinical narrative: Developed tachycardia,  fatigue, shortness of breath, lightheadedness 2/10/2021.  Saw pcp 2/11/2021.  Initial cardiac workup negative.  Symptoms continued.  Developed chest pain late July 2021.  Admitted to Hospital with diagnosis of pericarditis.  Never cleared to return to work as a physical therapist after that time.  Diagnosed with POTS/ dysautonomia by cardiologist 10/2021.   Continued tachycardia,  lightheadedness,  fatigue,  chest pain,  shortness of breath,  decreased exercise tolerance, and decreased activity tolerance since that time.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postural orthostatic tachycardia syndrome, Tachycardia
Clinical narrative: Developed tachycardia,  fatigue, shortness of breath, lightheadedness 2/10/2021.  Saw pcp 2/11/2021.  Initial cardiac workup negative.  Symptoms continued.  Developed chest pain late July 2021.  Admitted to Hospital with diagnosis of pericarditis.  Never cleared to return to work as a physical therapist after that time.  Diagnosed with POTS/ dysautonomia by cardiologist 10/2021.   Continued tachycardia,  lightheadedness,  fatigue,  chest pain,  shortness of breath,  decreased exercise tolerance, and decreased activity tolerance since that time.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA for ages 5-11 (Lot: HE2391, BUD 11/30/23).
Age: 28.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Peripheral swelling
Clinical narrative: Received Pfizer booster, and Flu Shot. Later that day my fingers swelled up. Swelling stayed for about 3 hours and went away the next morning.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angioedema
Clinical narrative: Angioedema to the left side of the face
Age: 41.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Left shoulder and upper arm began feeling stiff and sore soon after vaccine was administered. However, the stiffness and soreness have only worsened over time. Range of motion and ease of motion are now impacted, as is ability to carry weight.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles, pain started February 4, rash started / noted February 5, diagnosed February 6, 2024.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal pain, Headache, Injection site rash, Malaise, Nausea
Clinical narrative: 17 year old male. He had Bexsero 2 days ago in the left arm im. He developed a rash at the injection site of this vaccine. He has had abdominal pain and nausea. Malaise and headache.
Age: 11.0
Sex: M
Vaccine: HEP, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented 1/15/24 for additional vaccines. At that time, they reported patient's right arm was still sore, red, and swollen.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: vaccine was given outside of ACIP/CDC recommended interval. Patient was notified after the and was educated on what could happen or what to expect. patient was not concerned and no side effects were reported
Age: 48.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Neck pain
Clinical narrative: Patient presented on 12/19/2023 stating they are having left shoulder and neck pain post vaccination. Patient also presented 1/4/2024 for same issue.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Decreased appetite, Hyperhidrosis, Panic attack
Clinical narrative: Several hours after taking first dose developed mild anxiety that was progressively worse.  He had intense feelings of doom, anxious.  He took a second dose 2 days later and almost immediately the anxiety worsened.  After the third dose 2 days later he had sweating and panic attack.  He has had no appetite over the ensuing 3 days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Influenza like illness, Wheezing
Clinical narrative: COVID-type symptoms/ flu-like symptoms with wheezing cough
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: No adverse effects from the second dose of Spike Vax
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event. Pt tolerated well. This was a valid dose but per protocol Proquad can only be given up to age 12 therefore VAERS is being completed.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Decreased appetite, Diarrhoea, Rash papular
Clinical narrative: Patient received vaccinations then developed decreased appetite. approximately 12 hours later he vomited. by 18 hours after vaccine administration, he had an episode of diarrhea and he had an erythematous, papular rash  sparing only the face (present on soles of hands and feet, genitals, trunk, extremities). No fevers or other sick contacts.
Age: 81.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff neck
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain, Diarrhoea, Hyperhidrosis, Throat tightness, Vomiting
Clinical narrative: within 30 minutes vomiting, sweating, throat closure, diarrhea and abdominal pain
Age: 50.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt Mis-stated date of birth.  Upon evaluation/entry into system it was discovered that pt was 10 years younger than they represented.  No adverse reactions noted or expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: On July 6th, 2023 I was diagnosed acute DVT in left leg.  DVT extends from left femoral vein and distally.   Diagnoses method was color and spectral doppler analysis.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Magnetic resonance imaging abnormal, Tendon disorder, X-ray limb normal
Clinical narrative: Pain in shoulder and unability to rotate, seen orthopedic received to 2 cortisone injections  - mid relief not permanent
Age: 77.0
Sex: M
Vaccine: COVID19, PNC20
Symptoms: Arthralgia, Asthenia, Back pain, Pain, Pain in extremity
Clinical narrative: On physical exam on 2/16/2024, acute pain of the right shoulder since receiving vaccines on 12/12/2023. Pain radiates to the arm and back. Associated symptoms include weakness.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product administration error, Wrong product administered
Clinical narrative: Vaccine administration error: Chart review indicated first dose of varicella was due, nurse administered MMR instead. Pt had no adverse reaction to vaccine. Error was discovered when nurse was recording patient's immunization history in database. Present writer notified supervisor, documented error in EMR and clinical incident form, notified patient's parent (as patient is minor), and is submitting this VAERS report.
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: Throat tightness, Urticaria
Clinical narrative: This is the first Moderna vaccine patient is receiving. Previous 3 vaccines were Pfizer. Around 24 hours after vaccine administration patient developed hives and a sensation of closing of throat, symptoms improved in ER after administration of epinephrine, rash resolved after another 24 hours.
Age: 46.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidently given when patient age does not match criteria of older then 65.
Age: 0.58
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Administration error- vaccine was given past the expiration date from the 30 days of being set from freezer to fridge
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: 4 vaccines were administered and within one minute of the last vaccine, patient had hives on his chest and arms. His provider was called into the patient's room. She requested one of the pediatricians come into the room to evaluate patient, she had requested 25 milligrams of Benadryl be given to patient. Benadryl was given as requested. Epi pen was brought into the room in case the patient's reaction became more severe. Within a few minutes the patient's hives went away. He was monitored for fifteen minutes with no further reaction.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Child was given Kinrix combo DTaP/IPV vaccine at age 8 years which is out of age range for this combined vaccine.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Nurse administered Proquad in lieu of MMR and also administered varicella. Proquad not appropriate for patient's age and considered double dose of varicella.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, RV5, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received 2nd dose of RSV / Beyfortus 1.0ml which was not indicated; pt did not have adverse reaction to injection.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given dose 2 of shingrix 12 days apart
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diagnostic aspiration, Injection site mass, Injection site reaction, Magnetic resonance imaging, Mass excision
Clinical narrative: Over the summer, noticed mass in Lt shoulder while applying sunscreen. Had  not noticed it before. Went to Dermatologist who felt NOT lipoma, referred me to Orthopedic Surgeon who did MRI (Signal enhancing mass, can not R/O malignancy) and referred to had needle biopsy (Myopericytoma) and later Excision
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myopericytoma
Clinical narrative: Over the summer, noticed mass in Lt shoulder while applying sunscreen. Had  not noticed it before. Went to Dermatologist who felt NOT lipoma, referred me to Orthopedic Surgeon who did MRI (Signal enhancing mass, can not R/O malignancy) and referred to had needle biopsy (Myopericytoma) and later Excision
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Condition aggravated, Cough, Dyspepsia, Dysphagia
Clinical narrative: Few days after the first injection, I started coughing whenever I walked bare foot in my house. It was unusual that I asked my work colleagues if they had similar reactions. Weeks later I started having numbness and cold sensation in the lateral side of my feet which progressed to sever numbness, tingling an burning sensation from toes to upper thigh.  Weeks from the vaccine my occasional stable heart burn markedly progressed and developed dysphagia for which I underwent upper GI endoscopy and diagnosed with sever (grade C) esophagitis and started in Omperazole 40 mg bid.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Endoscopy upper gastrointestinal tract abnormal, Feeling cold, Hypoaesthesia, Oesophagitis
Clinical narrative: Few days after the first injection, I started coughing whenever I walked bare foot in my house. It was unusual that I asked my work colleagues if they had similar reactions. Weeks later I started having numbness and cold sensation in the lateral side of my feet which progressed to sever numbness, tingling an burning sensation from toes to upper thigh.  Weeks from the vaccine my occasional stable heart burn markedly progressed and developed dysphagia for which I underwent upper GI endoscopy and diagnosed with sever (grade C) esophagitis and started in Omperazole 40 mg bid.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Few days after the first injection, I started coughing whenever I walked bare foot in my house. It was unusual that I asked my work colleagues if they had similar reactions. Weeks later I started having numbness and cold sensation in the lateral side of my feet which progressed to sever numbness, tingling an burning sensation from toes to upper thigh.  Weeks from the vaccine my occasional stable heart burn markedly progressed and developed dysphagia for which I underwent upper GI endoscopy and diagnosed with sever (grade C) esophagitis and started in Omperazole 40 mg bid.
Age: 22.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Arthralgia, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: A few hours post vaccination, a tingling, numbness, and painful sensation developed near where the vaccine was given. This spread through the left shoulder blade area, and has not changed since. Treatment has not been successful. I have tried heat, ice, ibuprofen, per doctor's requests, and none of it has helped. This has been a constant numbness with frequent tingling and stabbing sensations that only cease at rest.
Age: 22.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Paraesthesia
Clinical narrative: A few hours post vaccination, a tingling, numbness, and painful sensation developed near where the vaccine was given. This spread through the left shoulder blade area, and has not changed since. Treatment has not been successful. I have tried heat, ice, ibuprofen, per doctor's requests, and none of it has helped. This has been a constant numbness with frequent tingling and stabbing sensations that only cease at rest.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: COMIRNATY COVID VACCINE 12 YEARS AND OLDER WAS GIVEN TO PATIENT WHO IS 11 YEARS OLD. MOTHER OF CHILD WAS NOTIFED
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Spikevax administered to 11 year old
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eustachian tube dysfunction, Eye pain, Neck pain, Pharyngeal swelling
Clinical narrative: Ear ache in right side, swelling in throat on right side, neck pain on right side. Fexofenadine, acetaminophen, fluticasone nasal spray, and prednisone don't seem to alleviate any symptoms. Went to a primary care physician who said it was a eustachian tube dysfunction. Also saw my allergist, who thinks it might be a viral infection. Symptoms have so far lasted one week.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy
Clinical narrative: chills for 2 days, lethargy
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Completed suicide, Death, Depression
Clinical narrative: Patient was a previously healthy 15 year old male without diagnosis of depression. Patient died by suicide within 5 days of receiving vaccine
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site pain
Clinical narrative: pain during injection, heart rate increase which improved which improved 30 minutes within injection but still having pain at the injection site and now it's been over 1 month
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Immune system disorder, Respiratory tract congestion, Secretion discharge
Clinical narrative: After a few months of receiving my  third COVID shot, I started to get overly stuffy in my head and it never subsided. Every day I wake up with an abnormally amount of mucus and it has been every day since. No medicine prescribed or over the counter has worked. This booster has severely affected my immune system.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hypersensitivity, Lip swelling, Pruritus, Sleep disorder
Clinical narrative: She got her vaccine, was fine and then at 2:00 AM she was on fire, sweating, had to take all her clothes off in the middle of winter and had to sleep in her underwear.  She had large welts like she had never seen before.  The welts were on the top of her feet, on her calves, thighs on both sides, her abdomen, not the breasts but her chest, arms, and the scapula behind the right shoulder where she got the injection was like bubble wrapped.  She had hives on top of hives on top of hives.  Also on her back, back of her thighs.  Later in the morning when she got back up she called her doctor and he sent her a Medro dose pack.  She took it and started reading about the Moderna Spikevax and read that she could take the steroids and it said that once you stop the steroids the next day they will come back, which is what happened.  She is still getting the hives now, and that people with thyroid issues could get chronic urticaria which can last 1-5 years.  Last night she was sitting with her son and watching a show and had to go upstairs as her body was itching so bad that she had to get the back scratcher and scratch her back, take move Benadryl.  Her lips are also swelling up, also gets hives on her face, and sometimes it's just her top lip to the point that she looks like a duck.  Last night it was her bottom lip that looked like she had gotten a Botox injection.  It is still a little swollen right now.  She has been using Benadryl cream, has used multiple tubes and multiple capsules of the Benadryl.  She does have a follow up appointment with her doctor in a couple of weeks.  She is a retired RN, and pretty much knows how to treat the reaction.   All of her other COVID vaccines were Pfizer and she had never gotten any reaction with any of those.  Her entire body feels bloated and feels that her subcutaneous tissue has thickened.  It is starting to take a toll on her like she used to be able to put it out of her mind, and do her daily chores and getting to the point when she wakes up whether she should get up or not.  She is so tired of being in a state of an allergic reaction.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: She got her vaccine, was fine and then at 2:00 AM she was on fire, sweating, had to take all her clothes off in the middle of winter and had to sleep in her underwear.  She had large welts like she had never seen before.  The welts were on the top of her feet, on her calves, thighs on both sides, her abdomen, not the breasts but her chest, arms, and the scapula behind the right shoulder where she got the injection was like bubble wrapped.  She had hives on top of hives on top of hives.  Also on her back, back of her thighs.  Later in the morning when she got back up she called her doctor and he sent her a Medro dose pack.  She took it and started reading about the Moderna Spikevax and read that she could take the steroids and it said that once you stop the steroids the next day they will come back, which is what happened.  She is still getting the hives now, and that people with thyroid issues could get chronic urticaria which can last 1-5 years.  Last night she was sitting with her son and watching a show and had to go upstairs as her body was itching so bad that she had to get the back scratcher and scratch her back, take move Benadryl.  Her lips are also swelling up, also gets hives on her face, and sometimes it's just her top lip to the point that she looks like a duck.  Last night it was her bottom lip that looked like she had gotten a Botox injection.  It is still a little swollen right now.  She has been using Benadryl cream, has used multiple tubes and multiple capsules of the Benadryl.  She does have a follow up appointment with her doctor in a couple of weeks.  She is a retired RN, and pretty much knows how to treat the reaction.   All of her other COVID vaccines were Pfizer and she had never gotten any reaction with any of those.  Her entire body feels bloated and feels that her subcutaneous tissue has thickened.  It is starting to take a toll on her like she used to be able to put it out of her mind, and do her daily chores and getting to the point when she wakes up whether she should get up or not.  She is so tired of being in a state of an allergic reaction.
Age: 15.0
Sex: F
Vaccine: MMRV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 year old patient who was catching up on vaccines needed MMR and Varicella. A combination of MMR/Varicella (Proquad) was administered to patient. It is recommended for patients older than 12 years of age to be administered separated vaccines.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: hospitalized with COVID
Age: 76.0
Sex: F
Vaccine: RSV, TDAP
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: The next morning she woke up with a raised rash below the injection site. Itchy and slightly warm, she reports.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, VARCEL
Symptoms: Hyperhidrosis, Loss of consciousness
Clinical narrative: after last injection ,3rd vaccine given HPV9  ,  a few minutes  later head tilted down . remained sitting in chair however didn't lift head up  when asked ,  loss of consciousness  noticed,  diaphoresis notice to forehead and back of neck. with assistance client was placed on exam bed with feet elevated. responded  a few minutes later.   Walk out of clinic after 40 min, with  adult relative.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered Covid 19 vaccine 5-11 past 10 week refrigerator expiration date, vaccine was kept in fridge but expired 1.19.24,  and administered 2.9.24. no information on patient have left message for call back from parents.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Anxiety, Nausea, Vomiting
Clinical narrative: Patient endorsed feeling anxious and nauseous prior to receiving vaccine due to "feeling anxious".  Had vomiting x 3 after ~ 5-10min after vaccination
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling and redness at the injection site.  Started day after, and one week later, is still red/purple (measures approx 6 inches by 6 inches)
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: Deep Itching all over the patients' body, lasting hours.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; administration of expired dose of MMRII; This spontaneous report was received from a healthcare business professional, referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions and allergies were not reported.  On 03-JAN-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) injection, (lot #W009106 which has been confirmed as a valid lot, expiry date was not provided but upon internal validation was verified as: 04-DEC-2023; strength, dose, route of administration, and anatomical location were not provided), administered by a health professional for prophylaxis (expired product administered). And there were no temperature excursions reported for the vaccine. No side effects were reported, and no other medical information known. No additional adverse event (AE) was reported (no adverse event).   This case is non-valid due to lack of patient's identifiers.  Follow-up information has been received from an administrator on 10-FEB-2024, referring to the 12-month-old female patient.   The patient had no illness at time of vaccination. She had no pre-existing phyaician-diagnosed allergies, birth defects, or any medical conditions. The patient's concomitant medications included pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), hepatitis a vaccine inact (HAVRIX), varicella virus vaccine live (oka/merck) (VARIVAX) (manufacturer unknown) and influenza vaccine inact split 4v (FLUARIX QUADRIVALENT).   On 03-JAN-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, administered subcutaneously on right arm.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called for TE evaluation MMR II. Caller stated that the MMR II had been administered to multiple patients after the TE. No reported adverse effects from administered vaccines. Limited information was provided. Permission to contact HCP was given.; No reported adverse effects from administered vaccines; This spontaneous report was received from a nurse refers multiple patients of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patients were vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # w007040, has been verified to be valid, expiration date: 29-FEB-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There was no additional information about this temperature excursion. Limited information was provided. There were no additional adverse events reported (no adverse event).  This case is non-valid due to lack of patients' identifiers.  Follow up information received on 12-FEB-2024, from the registered nurse. The case was no longer considered to be invalid. The nurse reported the patient demographic information: a currently, 1-year-old female patient.  On 04-OCT-2023, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) and with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W008712 has been verified to be valid, expiration date not reported, but upon internal validation established as 14-MAR-2024 ) (exact dose, route of administration and anatomical location were not reported as prophylaxis.  This is one of the several cases reported from the same source.; Sender's Comments:  US-009507513-2402USA005567: US-009507513-2402USA005568:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; received their second dose of PROQUAD at 24 months on 13Feb2024; This spontaneous report was received from a medical assistant referring to a 24-month-old patient with unknown age. The information regarding patient's concurrent condition, relevant medical history and drug reactions or allergies were not reported. The patient's concomitant therapy included hepatitis a vaccine inact (HAVRIX).  On an unknown date in February 2023 (reported as 12-month-old), the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (dose, lot number, expiration date, route of administration, anatomical location and frequency were not reported) for prophylaxis. On 13-FEB-2024 (reported as 24-month-old), the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) injection (1 dose, lot number X023316 has been verified to be a valid lot number and expiration date was 19-MAR-2025, route of administration, anatomical location and frequency were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (AE) reported (no adverse event).
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: a breakout of hives on her neck and that went around on to her; This spontaneous report was received from a nurse via company representative, referring to a female patient with unknown age. The patient's current conditions, concomitant medications, pertinent medical history and drug reactions/allergies were reported as unknown.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, lot#, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, lot#, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date in 2016, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, frequency, lot#, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  The first 2 doses were fine, but on an unknown date in 2016 (reported as after the third dose), the patient experienced a breakout of hives on her neck and that went around on to her chest. It was unknown if the patient sought medical attention or gave treatment for event. The outcome of hives was not reported. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and hives was not reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Product underwent an excursion and was administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a 12-month old patient of unknown gender. There was no information about the patient's pertinent medical history, concomitant medications or drug reactions and allergies provided.  On 05-FEB-2024, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) injection, 0.5 milliliter, lot #X022923, expiration date 12-MAR-2025 (injection site and route of administration were not reported) for prophylaxis.  Administered dose of vaccine experienced the temperature excursion of 5.8 degrees Fahrenheit for 15 minutes. No previous temperature excursion had occurred. There was no adverse effects reported.  This is one of several reports received from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: headache; Muscle Pain; body aches; fever; nausea; This non-serious case was reported by a consumer and described the occurrence of headache in a 68-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29-SEP-2023, the patient received the 1st dose of Shingles vaccine. On 30-SEP-2023, 1 days after receiving Shingles vaccine, the patient experienced headache (Verbatim: headache), muscle pain (Verbatim: Muscle Pain), general body pain (Verbatim: body aches), fever (Verbatim: fever) and nausea (Verbatim: nausea). On 08-OCT-2023, the outcome of the headache, muscle pain, general body pain, fever and nausea were resolved (duration 8 days).   It was unknown if the reporter considered the headache, muscle pain, general body pain, fever and nausea to be related to Shingles vaccine.     It was unknown if the company considered the headache, muscle pain, general body pain, fever and nausea to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 07-FEB-2024 The patient was self-reported. The patient states that she scheduled for the 2nd shingrix shot on Friday and wondering if should get it. The symptoms were treated.  The reporter stated that the 2nd shot was worse than the first. The reporter requesting consent to follow up.
Age: 66.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Anxiety, Balance disorder, Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: Burning sensation; tingle sensation; Anxiety; Numbness hands/feet; balance issues; This non-serious case was reported by a consumer via patient support programs and described the occurrence of burning sensation in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-NOV-2023, the patient received Arexvy. On 15-NOV-2023, less than a day after receiving Arexvy, the patient experienced burning sensation (Verbatim: Burning sensation), tingling sensation (Verbatim: tingle sensation), anxiety (Verbatim: Anxiety), numbness of extremities (Verbatim: Numbness hands/feet) and balance difficulty (Verbatim: balance issues). The outcome of the burning sensation, tingling sensation, anxiety, numbness of extremities and balance difficulty were not resolved.   It was unknown if the reporter considered the burning sensation, tingling sensation, anxiety, numbness of extremities and balance difficulty to be related to Arexvy.     It was unknown if the company considered the burning sensation, tingling sensation, anxiety, numbness of extremities and balance difficulty to be related to Arexvy.   Additional Information: GSK Receipt Date:13-FEB-2024 This report was submitted via the online direct entry reporting system. The patient stated that he took the Arexvy vaccine and was still having bad reaction like burning and tingle up and down entire body, balance issues, Anxiety, numbness in hands and feet. The patient stated he was still having these issues. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: RSV, RSV
Symptoms: Burning sensation, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: Burning sensation; tingle sensation; Anxiety; Numbness hands/feet; balance issues; This non-serious case was reported by a consumer via patient support programs and described the occurrence of burning sensation in a 66-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 15-NOV-2023, the patient received Arexvy. On 15-NOV-2023, less than a day after receiving Arexvy, the patient experienced burning sensation (Verbatim: Burning sensation), tingling sensation (Verbatim: tingle sensation), anxiety (Verbatim: Anxiety), numbness of extremities (Verbatim: Numbness hands/feet) and balance difficulty (Verbatim: balance issues). The outcome of the burning sensation, tingling sensation, anxiety, numbness of extremities and balance difficulty were not resolved.   It was unknown if the reporter considered the burning sensation, tingling sensation, anxiety, numbness of extremities and balance difficulty to be related to Arexvy.     It was unknown if the company considered the burning sensation, tingling sensation, anxiety, numbness of extremities and balance difficulty to be related to Arexvy.   Additional Information: GSK Receipt Date:13-FEB-2024 This report was submitted via the online direct entry reporting system. The patient stated that he took the Arexvy vaccine and was still having bad reaction like burning and tingle up and down entire body, balance issues, Anxiety, numbness in hands and feet. The patient stated he was still having these issues. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old patient who received Herpes zoster (Shingrix) (batch number y7pp4, expiry date 07-MAY-2025) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-FEB-2024 The reporter reported that the staff administered Shingrix vaccine 2nd dose for all to the three patients using a generic diluent. The reporter stated that the patients were contacted and rescheduled for a new dose with correct diluent or adjuvant and staff was educated. The medication error category was medication error without harm. This case had been linked with US2024011377 and US2024AMR018461, reported by the same reporter for different patients. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024011377:Same reporter, different patient US-GSK-US2024AMR018461:Same reporter, different patient