chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate irregular, Joint swelling, Pain, Spinal pain
Clinical narrative: Unexplained swelling of joints, toes, knees neck are the worse pain up and down my spine being the worse below my shoulder blades and above. Irregular heart beat, blurry vision. Always swollen but the pain comes and goes will last for a week to 2 weeks and subside a little never completely going away. It sucks because I can no longer be as active and I have gained weight even though I do my best to be active it hurts and I'm depressed actually almost at the lowest point I have ever been in my life. I'm uncomfortable, I hurt, I'm so tired unless I am going to work I fight doing anything, because  it hurts. I don't know what good it's even going to do to report this, I've been to the Dr, x-rays, ctscan, ultra sound and have had blood drawn. Nothing, it's frustrating. I was sent to a rumotoligist and told to go
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan, Vision blurred, Weight increased, X-ray
Clinical narrative: Unexplained swelling of joints, toes, knees neck are the worse pain up and down my spine being the worse below my shoulder blades and above. Irregular heart beat, blurry vision. Always swollen but the pain comes and goes will last for a week to 2 weeks and subside a little never completely going away. It sucks because I can no longer be as active and I have gained weight even though I do my best to be active it hurts and I'm depressed actually almost at the lowest point I have ever been in my life. I'm uncomfortable, I hurt, I'm so tired unless I am going to work I fight doing anything, because  it hurts. I don't know what good it's even going to do to report this, I've been to the Dr, x-rays, ctscan, ultra sound and have had blood drawn. Nothing, it's frustrating. I was sent to a rumotoligist and told to go
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Urticaria
Clinical narrative: 1 day after vaccination, I noticed I was itchy on my butt and ankles but was out and didn?t see under my clothes. Then this morning, 2 days after vaccination, I developed urticaria. It started on my butt, feet, and hands and got progressively worse over a period of 15 minutes.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Gene mutation identification test positive, Ovarian cyst, Ultrasound pelvis abnormal
Clinical narrative: A cat scan was taken  to ck my bladder. It was neg for any problem however it showed a large cyst on my left ovary . I followed up with my Gynogoligist Dr he ordered a pelvic ultrasound and confirmed large cyst on left ovary not there at my recent internal pelvic exam and pap test. He reccomended I see a gynogologist oncologist to ck for cancer of ovary. Dr. at Hospital. He sugested blood work for Braca Gene it was very slightly elevated but not enough to be concerned he did a 6 month follow up of pelvic ultra sound size was 6.2 mil he said he would follow up in 6 months if size grew to 9 mil would consider removal unless i had symptoms like stomach pain or pressure then call him and a decision would be made as to next step . Since i was. Post menopausal for many many years it seemed starange that this cyst had suddenly appeared everything shrinks older you get .i am still doing follow ups and have a pelvic ultra sound sceduled for Wed 12/14/2022
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received 2 flu shots within 2 months. First flu shot was given on 10/06/2022. Patient came in 12/09/2022 and received another flu shot . Patient is feeling fine, no side effects at all.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23)-
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt had itch, swelling and rash from injection site to forearm. Parents have given ibuprofen, benadryl and claritin. Pediatrician has referred pt to an allergist and told parents not to give her any more flu shots until her allergies are determined.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt had itch, swelling and rash from injection site to forearm. Parents have given ibuprofen, benadryl and claritin. Pediatrician has referred pt to an allergist and told parents not to give her any more flu shots until her allergies are determined.
Age: 41.0
Sex: F
Vaccine: COVID19-2, FLUA4
Symptoms: Blood test, Urticaria
Clinical narrative: Hives/urticaria on bodamy, migrating to different areas every day without medication to suppress it. Ongoing problem since two weeks after vaccinated
Age: 17.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Syncope
Clinical narrative: Patient experienced vasovagal syncope after receiving both vaccinations lasting less than 1 minute.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I am diabetic and have not had symptoms.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: Severe pain in left arm the night of injection (9/21/22). Used ice packs throughout the night to ease pain. Had telephone appointment visit with Dr. to discuss continued pain in arm and shoulder. I indicated to Dr. the ful injection was quite high on my arm and the person injecting the vaccine apologized that the vaccine was going in so slowly. Dr. recommended Physical Therapy and prescribed Meloxicam. I had two PT visits, exercises focused on shoulder. Pain increased. I stopped PT and pain lessened. Lifted something on Thanksgiving and pain increased. Wen back to PT, did more exercises and pain became very severe. Have stopped PT again, slight improvement. Prescription for Melocicam is finished. I continue to have limited range of motion. I wake frequently during the night because of the pain. I spend several minuetes moving my arm up and down and around to stretch the muscle or tendon to make the arm feel better. There really isn't any shoulder pain to speak of, it is in my upper arm. I return to PT on Friday December 16 to discuss possible alternatives to the past exercises. Dr. has suggested considering a steroid shoulder injection. Without knowing where the pain is or coming from, I hesitat to do that. Would that heal or hide the pain?
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Antineutrophil cytoplasmic antibody, Antinuclear antibody, Autoimmune haemolytic anaemia, Blood smear test, Borrelia test
Clinical narrative: Encephalopathy Autoimmune Hemolytic Anemia  Pancytopenia  Severe ITP
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cardiolipin antibody, Condition aggravated, Coombs test, Encephalopathy, Full blood count
Clinical narrative: Encephalopathy Autoimmune Hemolytic Anemia  Pancytopenia  Severe ITP
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Haptoglobin, Immune thrombocytopenia, Metabolic function test, Pancytopenia, Serum ferritin
Clinical narrative: Encephalopathy Autoimmune Hemolytic Anemia  Pancytopenia  Severe ITP
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Feeling abnormal, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Never pregnant. It was an Influenza Vaccine- I don't know the exact name or Lot #. Initially I was fine. Seven hours later, I got sick to my stomach, body aches, intense headache, chills. I don't know if I had a fever or not, I didn't take my temperature.  I took a hot shower, put hot compresses on my head and around my neck and rested. I was in pain the whole night. I was a little stiff the next morning. I felt bad for a few days. By the 10th I felt better.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Never pregnant. It was an Influenza Vaccine- I don't know the exact name or Lot #. Initially I was fine. Seven hours later, I got sick to my stomach, body aches, intense headache, chills. I don't know if I had a fever or not, I didn't take my temperature.  I took a hot shower, put hot compresses on my head and around my neck and rested. I was in pain the whole night. I was a little stiff the next morning. I felt bad for a few days. By the 10th I felt better.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Sore arm around injection site, rash on arms and torso
Age: 16.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Dysstasia, Gait inability, Laboratory test abnormal, Magnetic resonance imaging normal, Sensory loss
Clinical narrative: 10 days after receiving his 2nd shot his right leg from around the knee lost all feeling.  He could not stand nor walk.
Age: 69.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Psoriasis, Rash
Clinical narrative: Patient went to Dr and Dr described the rash as a Psoriasis Type Rash , even though patient has never been diagnosis with psoriasis in the past
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypotension
Clinical narrative: Light headed and dizzy feeling.  They took my blood pressure and it was low then after a little bit they took it again and it was rising.  Drank some water and felt a little better and drove home and rested for the rest of the day.  Also got a small headache for 2 days.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Dyspnoea, Myalgia
Clinical narrative: Got COVID said that was a crossover event and I should report it.   Ran fever of 100+, congestion, cough, severe chills, body and muscle aches, trouble breathing.    Tested at home with home test kit according to all directions and rules - called Dr.  Was prescribed a medication that was acceptable for those with heart condition and high blood pressure.  Alternative med to most common one prescribed (can?t remember the name)
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Got COVID said that was a crossover event and I should report it.   Ran fever of 100+, congestion, cough, severe chills, body and muscle aches, trouble breathing.    Tested at home with home test kit according to all directions and rules - called Dr.  Was prescribed a medication that was acceptable for those with heart condition and high blood pressure.  Alternative med to most common one prescribed (can?t remember the name)
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Computerised tomogram, Full blood count, Gastrointestinal viral infection, Liver function test
Clinical narrative: patient presented to ED on 12/10/22  for two separate visits for afebrile seizures. patient was eventually transferred to hospital for neurology. patient was afebrile but had been dealing with a GI virus.
Age: 1.25
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Seizure
Clinical narrative: patient presented to ED on 12/10/22  for two separate visits for afebrile seizures. patient was eventually transferred to hospital for neurology. patient was afebrile but had been dealing with a GI virus.
Age: 67.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching all over body, Benadryl lotion and Benadryl allergy caplets.  After several days rash and itch went away.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Spoke with patient and no adverse event reported by patient. She does not recall getting the vaccine on 11/22/22 and cannot find her COVID card stating it was received on that date.  Moderna Bivalent vaccine received on 11/22/22 and 12/09/22.
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pruritus
Clinical narrative: within 2 hours, i felt nauseous and queasy; I had eaten nothign to cause that.  Later in the day, I had itching all over my skin and even at my eyes,  inside my ears, my scalp and the bottom of my feet..  I took 35 mg dose of benedryl to help with the itching.  The benedryl helped and when I woke up this morning I still had some itching in my ears and eyes  but not too severe. I did not take more benedryl.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Back pain, Blood culture positive, Magnetic resonance imaging spinal, Myositis, Pyrexia
Clinical narrative: Gradual onset back pain developed 4 days after receiving the vaccine. Symptoms progressed to include fever the next day. Went the ER and got diagnosed with Myositis (MRI T/L Spine), admitted for Sepsis. Subsequently 6 of 8 blood cultures were positive for MSSA. Currently recovering at home with Intravenous Antibiotics.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Staphylococcal sepsis
Clinical narrative: Gradual onset back pain developed 4 days after receiving the vaccine. Symptoms progressed to include fever the next day. Went the ER and got diagnosed with Myositis (MRI T/L Spine), admitted for Sepsis. Subsequently 6 of 8 blood cultures were positive for MSSA. Currently recovering at home with Intravenous Antibiotics.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breast induration, Breast pain, Breast swelling, Injection site induration, Lymphoedema
Clinical narrative: I began experiencing pain & lymphedema within 6 hours .  By the next morning 6am my entire left arm and left breast were indurated and very swollen & painful.   By 10 am on Oct 19 th my left leg became weak & would buckle when I walked.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscular weakness, Pain
Clinical narrative: I began experiencing pain & lymphedema within 6 hours .  By the next morning 6am my entire left arm and left breast were indurated and very swollen & painful.   By 10 am on Oct 19 th my left leg became weak & would buckle when I walked.
Age: 40.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bell's palsy, Exposure during pregnancy, Facial paralysis
Clinical narrative: 7 months pregnant. Began to experience facial paralysis, left side two days after injection. Went to ER, diagnosed with Bell's Palsy.
Age: 40.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Bell's palsy, Facial paralysis, Maternal exposure during pregnancy
Clinical narrative: 7 months pregnant. Began to experience facial paralysis, left side two days after injection. Went to ER, diagnosed with Bell's Palsy.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional medical device removal by patient
Clinical narrative: On 12/11/2022 Pediatric 5-year-old Patient was accompanied to the COVID-19 vaccination site by his father for his first dose in the Moderna 6months-5years old primary series (LOT#AS1412B). Patient was vaccinated by CMA who provided this following written report to Charge Nurse, RN to complete this VAERS.  Per CMA?s written report:  ?Patient pulled his arm away as the needle entered his Left arm deltoid which caused the syringe needle to withdraw prematurely out of the patient?s arm before any dose was administered. No vaccine was administered by this CMA. Vanish point needle remained intact. Full vaccine dose still observed in the contaminated vaccination syringe which I gave to the Charge Nurse, RN who I alerted for assistance, and the Charge Nurse safely disposed of the contaminated syringe and noted vaccine wastage. Charge Nurse, RN then notified Site Supervisor, RN who intervened and spoke to the child?s father with me. Parent consented to a second attempt at vaccination. Parent requested that they wanted the second attempted vaccination in the same left arm. Site Supervisor, RN aware of parent request and described risks to parent, and the parent acknowledged yet still wanted in same left arm. Child vaccinated in left arm at 1312 (1:12pm). No patient concerns noted during post-vaccination period. Patient ambulated safely out of the clinic with parent.?
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Coma, Intraventricular haemorrhage, Respiratory failure, Subarachnoid haemorrhage
Clinical narrative: Patient in coma, respiratory failure 2/2 intracerebral hemorrhage, intraventricular hemorrhage, and subarachnoid hemorrhage.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site swelling, Neck pain, Pain in extremity
Clinical narrative: Sharp pain in arm almost right away. Then arm was sore and swollen at injection site next day. Swelling got worse and then arm below elbow had a large swelling site next day. The pinkie and next finger were very painful and whole arm and neck continue to hurt. Still having same problem. Will be seeing neurologist soon.
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angiogram, Blood test, Chest pain, Computerised tomogram, Confusional state
Clinical narrative: Chest pain  1 month later , unsure of onset because I was so depressed I was confusing physical symptoms  as being mental
Age: 55.0
Sex: F
Vaccine: COVID19-2
Symptoms: Depressed level of consciousness, Electrocardiogram, Myocardial infarction, Myocarditis
Clinical narrative: Chest pain  1 month later , unsure of onset because I was so depressed I was confusing physical symptoms  as being mental
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: Vaccine induced Alopecia (if unfamilliar with the term it means hair loss &/or balding).
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Pyrexia
Clinical narrative: I wasn't having a fever when I got the flu vaccine. But later that night, the fever came back, and I developed Guillain Barre syndrome (mild but progressive, I was almost paralyzed). Now I'm still recovering from this syndrome.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Anxiety, Blood test, Computerised tomogram, Musculoskeletal stiffness, Tremor
Clinical narrative: After vaccinating for flu on the right deltoid, patient appeared to stiffen, deflate, and then start shaking.  I held onto her body so that she wouldn't topple over from the chair.   After a few seconds, the shaking stopped, and the patient opened her eyes.    I asked her if she was OK and if this has happened before & she said after a flu vaccination as a freshman in high school.    She appeared stable, so I told employee to call management.   Pt.'s parents introduced themself when management arrived, and they recounted the flu shot episode and that this occurred as well after giving blood earlier this year.   Patient had been examined (via blood work & CT scan) and was just diagnosed with anxiety.    I told them she should be seen by provider ASAP; they refused a call for ambulance.   After sitting in vaccination room for about 5-6 minutes, I asked pt. to sit with her parents in the waiting room for 10 minutes.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: I received the 2nd vaccination on 2/ 26/2021.  I have had raised area on both arms since the vaccines. I kept thinking they would go away, like it says in the warnings, but it hasn?t. They don?t hurt, but it?s like a line of raised skin, on both arms. This couldn?t have been caused by anything else.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Brain natriuretic peptide increased, Chest discomfort, Dyspnoea, Echocardiogram abnormal, Ejection fraction decreased
Clinical narrative: Patient presented to the hospital on 12/6/2022 with 2 days of progressive shortness of breath as well as a sense of central chest pressure and squeezing and a nondescript left lower chest discomfort.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Left ventricular dilatation, Left ventricular dysfunction, Magnetic resonance imaging heart, Myopericarditis, Pericardial disease
Clinical narrative: Patient presented to the hospital on 12/6/2022 with 2 days of progressive shortness of breath as well as a sense of central chest pressure and squeezing and a nondescript left lower chest discomfort.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia, Troponin, White blood cell count increased
Clinical narrative: Patient presented to the hospital on 12/6/2022 with 2 days of progressive shortness of breath as well as a sense of central chest pressure and squeezing and a nondescript left lower chest discomfort.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Bone scan normal, Dizziness, Mobility decreased, Vertigo
Clinical narrative: Began with a few dizzy spells in the afternoon. 10:00 p.m. while sitting in bed, became extremely dizzy with room spinning. Began vomiting and continued all night even with a slight turn of the head. Unable to move.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Began with a few dizzy spells in the afternoon. 10:00 p.m. while sitting in bed, became extremely dizzy with room spinning. Began vomiting and continued all night even with a slight turn of the head. Unable to move.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Myalgias, fever, headache
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test positive, Anaphylactic reaction, Seasonal allergy
Clinical narrative: Develop allergies to grass. Went into anaphylaxis for the first time, twice in less than 24hours in march 2022.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia
Clinical narrative: persisitent pain in elbow and shoulder, with periods of higher intensity pain, occasional numbness
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Asthenia, Full blood count normal, Gait inability, Metabolic function test normal, Myalgia
Clinical narrative: Fever, weakness, myalgias, unable to walk 24 hours after vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever, weakness, myalgias, unable to walk 24 hours after vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Fatigue, Gait disturbance, Injection site erythema, Injection site swelling, Neck pain
Clinical narrative: Fever, weakness, myalgias, unable to walk 24 hours after vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Fever, weakness, myalgias, unable to walk 24 hours after vaccine
Age: 4.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Abdominal pain, Arthralgia, Face oedema, Gait inability, Inflammatory marker increased
Clinical narrative: diffuse/generalized migrating rash severely pruritic, facial edema, elevated inflammatory markers, severe arthralgia limiting ability to ambulate, fever.   Started as joint pain and hives about 22 hrs after vaccination. Progressed to urticarial appearing rash and inability to walk due to pain about 12 hrs later.  Rash and arthralgia waxed and waned. Peak severity of rash on day 3, accompanied by severe sudden onset abdominal pain and fever 101.5.
Age: 4.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Mobility decreased, Pain, Pyrexia, Rash pruritic, Urticaria
Clinical narrative: diffuse/generalized migrating rash severely pruritic, facial edema, elevated inflammatory markers, severe arthralgia limiting ability to ambulate, fever.   Started as joint pain and hives about 22 hrs after vaccination. Progressed to urticarial appearing rash and inability to walk due to pain about 12 hrs later.  Rash and arthralgia waxed and waned. Peak severity of rash on day 3, accompanied by severe sudden onset abdominal pain and fever 101.5.
Age: 31.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The patient was given Pfizer Bivalent Booster vaccine 4 days past beyond use date on 12/06/2022.  The patient was not able to be reachable and we are not able to gather any information on any symptoms, sings, time course, etc.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Respiratory arrest, SARS-CoV-2 test positive
Clinical narrative: DEATH; RESPIRATORY ARREST; COVID-19; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 2027928) concerned an 80 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JUN-2021 for unspecified indication. No concomitant medications were reported.  On 25-DEC-2021, the patient experienced respiratory arrest (Pulmonary arrest), covid-19 and was hospitalized for 8 days. On same day Laboratory data included: SARS-CoV-2 test Positive. On 01-JAN-2022, the patient died from covid-19, respiratory arrest, and sars-cov-2 test positive. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19, respiratory arrest, and sars-cov-2 test positive on 01-JAN-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000262416.; Sender's Comments: V0: 20221214683-Death. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221214683-Covid-19, respiratory arrest, sars-cov-2 test positive . The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; RESPIRATORY ARREST; SARS-COV-2 TEST POSITIVE
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Respiratory arrest, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: DEATH; RESPIRATORY ARREST; COVID-19; SARS-COV-2 TEST POSITIVE; This spontaneous report received from a health care professional via Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 2027928) concerned an 80 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 03-JUN-2021 for unspecified indication. No concomitant medications were reported.  On 25-DEC-2021, the patient experienced respiratory arrest (Pulmonary arrest), covid-19 and was hospitalized for 8 days. On same day Laboratory data included: SARS-CoV-2 test Positive. On 01-JAN-2022, the patient died from covid-19, respiratory arrest, and sars-cov-2 test positive. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid-19, respiratory arrest, and sars-cov-2 test positive on 01-JAN-2022. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000262416.; Sender's Comments: V0: 20221214683-Death. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221214683-Covid-19, respiratory arrest, sars-cov-2 test positive . The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event is considered inconsistent with vaccine administration.; Reported Cause(s) of Death: COVID-19; RESPIRATORY ARREST; SARS-COV-2 TEST POSITIVE
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza virus test negative, Pain in extremity, Pyrexia, Rash
Clinical narrative: Fevers, joint pain, and rashes beginning ~5 days after the first dose of the COVID-19 Moderna Vaccine. Seen by her pediatrician and urgent care multiple times and ultimately diagnosed with a serum sickness like reaction to the vaccine. Treated with anti-pyretics.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Rash pruritic, SARS-CoV-2 test negative, Urticaria
Clinical narrative: Fevers, joint pain, and rashes beginning ~5 days after the first dose of the COVID-19 Moderna Vaccine. Seen by her pediatrician and urgent care multiple times and ultimately diagnosed with a serum sickness like reaction to the vaccine. Treated with anti-pyretics.
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pyrexia, Rash, Serum sickness-like reaction
Clinical narrative: Fevers, joint pain, and rashes beginning ~5 days after the first dose of the COVID-19 Moderna Vaccine. Seen by her pediatrician and urgent care multiple times and ultimately diagnosed with a serum sickness like reaction to the vaccine. Treated with anti-pyretics.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID infection. Tested positive 12/03/2022. Patient reports "several days" of feeling ill, fatigued, also experiencing vomiting with a cough.  Denies shortness of breath.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cough, Fatigue, Malaise, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID infection. Tested positive 12/03/2022. Patient reports "several days" of feeling ill, fatigued, also experiencing vomiting with a cough.  Denies shortness of breath.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine breakthrough infection, Vomiting
Clinical narrative: Breakthrough COVID infection. Tested positive 12/03/2022. Patient reports "several days" of feeling ill, fatigued, also experiencing vomiting with a cough.  Denies shortness of breath.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abnormal faeces, Blood test, Cardiac stress test, Dizziness, Faeces discoloured
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Head discomfort, Musculoskeletal discomfort, Paraesthesia, Paraesthesia oral
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Blood test, Cardiac electrophysiologic study, Cardiac stress test, Chest discomfort
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Confusional state, Contusion, Dizziness, Dysphagia, Dyspnoea
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram abnormal, Fatigue, Muscle tightness, Neck pain
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Paraesthesia oral, Sensory disturbance, Supraventricular tachycardia
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vasodilatation
Clinical narrative: After receiving the first Pfizer vaccine I started experiencing tingling in my lips, mouth,; face, upper and lower extremities along with a weird sensation in the middle of my chest. I noticed more confusion, right chest and sore neck and back. After receiving the second shot i started experiencing heart palpitations, intense tingling in face, lips, neck, back; upper and lower extremities along with increased tiredness, fatigue, SOB along with a tight neck, popping of blood vessels in my hands, feet that are Leaving bruises. My chest feels tight and the ability to swallow has become discomforting I?m extremely dizzy at times and feel light headed almost everyday. I was on a portable ekg for two weeks and there were signs of SVT noted. I?m still experiencing the same side effects and the tingling in the face has increased along with the go issues and pain in neck and back. I?ve been to multiple Doctors? regarding  this and have indicted to all of them all the above signs and symptoms. I even indicated I felt like I was going to have a stroke. Something is wrong, I know my body very well.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu-Like Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-Like Symptoms) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu-Like Symptoms). On 02-Aug-2022, INFLUENZA LIKE ILLNESS (Flu-Like Symptoms) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after the 2nd booster (Moderna COVID-19 Monovalent), patient had flu like symptoms: fever, aches, pain and fatigue. The symptoms lasted 2-4 days. No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-684740 (Patient Link).
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella virus test negative
Clinical narrative: patient who received the VARIVAX in 1993 (he was 8 years old at the time) and has negative varicella titer; This spontaneous report has been received from a nurse and refers to a 35-year-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 1993, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route and anatomical site of administration were not provided).  On 26-SEP-2022, Varicella titer test was negative (varicella virus test negative). The reporter wanted to know if the patient would receive one dose o 2 doses of the varicella virus vaccine live (oka/merck) (VARIVAX).  At the time of reporting, the outcome of the event was not provided.  The causal relationship between the event and the suspect product was not provided.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; An expired dose of RECOMBIVAX HB was administered to a patient; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 01-DEC-2022, the patient was vaccinated with an expired dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) syringe piston, 0.5 milliliters once, lot number U019135 has been verified to be a valid lot number with expiration date on 22-NOV-2022, administered as prophylaxis (strength, vaccination scheme, route of administration and anatomical location was not provided). No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Rash
Clinical narrative: a 12 month old patient received MMR II vaccine on an unknown date and 12 days after patient developed a rash all over. The rash resolved itself; This spontaneous report has been received from a nurse referring to a 12-month-old patient of unknown gender.  The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dosage, route of administration, anatomical site of injection, lot number and expiration date were not provided).    On an unknown date, also reported as 12 days after the vaccination, the patient developed a rash all over. The rash resolved itself. Caller was inquiring if the patient received the 2nd dose will the patient had a similar reaction. No further information provided.  The causality assessment between the event and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) was not reported.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Aphonia, Cough, Fatigue, Headache, Illness
Clinical narrative: fatigue; came down with a cold; little cough/bad cough/cough drops; sick/ffeling sick; lost voice; sinus draining; headache; Platelets dropped; throat hurt; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 48-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included niraparib (Zejula) capsule for malignant neoplasm of ovary.   On 11th November 2022, the patient received Flu vaccine and Zejula 100 mg 300 mg once daily (300 mg daily). In November 2022, less than 2 weeks after receiving Flu vaccine and Zejula, the patient experienced fatigue, cold, cough, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain. The action taken with Zejula was unknown. On an unknown date, the outcome of the fatigue, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain were unknown and the outcome of the cold was recovered/resolved and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, cold, cough, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain to be related to Flu vaccine and Zejula.     Additional Information: GSK Receipt Date: 23-NOV-2022. Reporter's Comments: This case was reported by Patient via Program. Patient reported adverse events of fatigue and came down with a cold when she first started Zejula. Patient reported the cold has resolved except for a little cough.   Follow up information received on 01-Dec-2022 Reporter's Comment:  The adverse Events of cold and missed doses the duration was ongoing.  The patient was sick and flu shot same weekend started it (Zejula began therapy 11/11).  The patient experienced cold, bad cough, throat hurt, cough drops, lost voice, sinus draining, feeling sick, headache.  The patient platelets was dropped told me to stop taking it 29 November, start it up two weeks to a month depending on my labs. Summary of changes: Updated product tab, event tab, narrative.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain, Platelet count decreased, Sinus disorder
Clinical narrative: fatigue; came down with a cold; little cough/bad cough/cough drops; sick/ffeling sick; lost voice; sinus draining; headache; Platelets dropped; throat hurt; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 48-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included niraparib (Zejula) capsule for malignant neoplasm of ovary.   On 11th November 2022, the patient received Flu vaccine and Zejula 100 mg 300 mg once daily (300 mg daily). In November 2022, less than 2 weeks after receiving Flu vaccine and Zejula, the patient experienced fatigue, cold, cough, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain. The action taken with Zejula was unknown. On an unknown date, the outcome of the fatigue, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain were unknown and the outcome of the cold was recovered/resolved and the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the fatigue, cold, cough, sickness, loss of voice, sinus disorder, headache, platelets decreased and throat pain to be related to Flu vaccine and Zejula.     Additional Information: GSK Receipt Date: 23-NOV-2022. Reporter's Comments: This case was reported by Patient via Program. Patient reported adverse events of fatigue and came down with a cold when she first started Zejula. Patient reported the cold has resolved except for a little cough.   Follow up information received on 01-Dec-2022 Reporter's Comment:  The adverse Events of cold and missed doses the duration was ongoing.  The patient was sick and flu shot same weekend started it (Zejula began therapy 11/11).  The patient experienced cold, bad cough, throat hurt, cough drops, lost voice, sinus draining, feeling sick, headache.  The patient platelets was dropped told me to stop taking it 29 November, start it up two weeks to a month depending on my labs. Summary of changes: Updated product tab, event tab, narrative.