chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fibrin D dimer increased, Gallbladder disorder, Haemorrhage
Clinical narrative: By early summer 2021, pt reported having having SOB and decreased energy, difficulty with typical activities. Throughout the summer she reported progressive symptoms including lightheadedness, tightness in her chest with any actiity, generalized weakness and groggy, mild dull headaches.  She had syncopal episodes in September with 2 ER visits. Elevated D-dimer noted at that time. Sinus bradycardia/Ventricular standstill, complete AV block, Mod left ventricular hypertrophy were diagnosed; she underwent pacemaker placement on 09/21/23.  Following pacemaker placement, she continued to have spells , reporting being lightheaded or groggy, SOB, tightness in the chest. She had limited energy and minimal tolerance to activity.  Across continued visits and care with Cardiology and Pulmonology from fall 2021 to present the following additional diagnoses have been given: Chronic Diastolic right heart failure, Moderate persistent asthma, enlarged RV (mild), LA (mod) wall motion hypokinesia, moderate COPD. On ER visit in August 2022, CT revealed mild tortuous aorta, gallbladder lesion, renal cyst.  Treatment/Outcome no cardiac treatment or meds were provided. Pulmonologist prescribed nebulizer treatments, now pulmonary rehab. She continues to be limited in her activity with dyspnea on exertion and poor endurance.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia, Left atrial enlargement, Left ventricular hypertrophy, Loss of personal independence in daily activities
Clinical narrative: By early summer 2021, pt reported having having SOB and decreased energy, difficulty with typical activities. Throughout the summer she reported progressive symptoms including lightheadedness, tightness in her chest with any actiity, generalized weakness and groggy, mild dull headaches.  She had syncopal episodes in September with 2 ER visits. Elevated D-dimer noted at that time. Sinus bradycardia/Ventricular standstill, complete AV block, Mod left ventricular hypertrophy were diagnosed; she underwent pacemaker placement on 09/21/23.  Following pacemaker placement, she continued to have spells , reporting being lightheaded or groggy, SOB, tightness in the chest. She had limited energy and minimal tolerance to activity.  Across continued visits and care with Cardiology and Pulmonology from fall 2021 to present the following additional diagnoses have been given: Chronic Diastolic right heart failure, Moderate persistent asthma, enlarged RV (mild), LA (mod) wall motion hypokinesia, moderate COPD. On ER visit in August 2022, CT revealed mild tortuous aorta, gallbladder lesion, renal cyst.  Treatment/Outcome no cardiac treatment or meds were provided. Pulmonologist prescribed nebulizer treatments, now pulmonary rehab. She continues to be limited in her activity with dyspnea on exertion and poor endurance.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Renal cyst, Right ventricular enlargement, Right ventricular failure, Sinus bradycardia, Somnolence
Clinical narrative: By early summer 2021, pt reported having having SOB and decreased energy, difficulty with typical activities. Throughout the summer she reported progressive symptoms including lightheadedness, tightness in her chest with any actiity, generalized weakness and groggy, mild dull headaches.  She had syncopal episodes in September with 2 ER visits. Elevated D-dimer noted at that time. Sinus bradycardia/Ventricular standstill, complete AV block, Mod left ventricular hypertrophy were diagnosed; she underwent pacemaker placement on 09/21/23.  Following pacemaker placement, she continued to have spells , reporting being lightheaded or groggy, SOB, tightness in the chest. She had limited energy and minimal tolerance to activity.  Across continued visits and care with Cardiology and Pulmonology from fall 2021 to present the following additional diagnoses have been given: Chronic Diastolic right heart failure, Moderate persistent asthma, enlarged RV (mild), LA (mod) wall motion hypokinesia, moderate COPD. On ER visit in August 2022, CT revealed mild tortuous aorta, gallbladder lesion, renal cyst.  Treatment/Outcome no cardiac treatment or meds were provided. Pulmonologist prescribed nebulizer treatments, now pulmonary rehab. She continues to be limited in her activity with dyspnea on exertion and poor endurance.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: By early summer 2021, pt reported having having SOB and decreased energy, difficulty with typical activities. Throughout the summer she reported progressive symptoms including lightheadedness, tightness in her chest with any actiity, generalized weakness and groggy, mild dull headaches.  She had syncopal episodes in September with 2 ER visits. Elevated D-dimer noted at that time. Sinus bradycardia/Ventricular standstill, complete AV block, Mod left ventricular hypertrophy were diagnosed; she underwent pacemaker placement on 09/21/23.  Following pacemaker placement, she continued to have spells , reporting being lightheaded or groggy, SOB, tightness in the chest. She had limited energy and minimal tolerance to activity.  Across continued visits and care with Cardiology and Pulmonology from fall 2021 to present the following additional diagnoses have been given: Chronic Diastolic right heart failure, Moderate persistent asthma, enlarged RV (mild), LA (mod) wall motion hypokinesia, moderate COPD. On ER visit in August 2022, CT revealed mild tortuous aorta, gallbladder lesion, renal cyst.  Treatment/Outcome no cardiac treatment or meds were provided. Pulmonologist prescribed nebulizer treatments, now pulmonary rehab. She continues to be limited in her activity with dyspnea on exertion and poor endurance.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Bivalent vaccine given when patient was due for his second monovalent dose
Age: 67.0
Sex: F
Vaccine: COVID19-2, PNC20
Symptoms: Blood test abnormal, Flank pain, Hepatic enzyme increased
Clinical narrative: Routine blood work done at primary care office (physical) 11/17/22 Liver function test bad - repeated - 12/19/22 - normal I had flank pain after vaccines. took a couple of weeks to resolve. I went to Dr. office for routine blood work R/T taking Atorvastatin. all my liver enzymes were elevated - but this result has since been removed from my potal. 12/19/22 - my portal says stable labs 3/9/23 - repeat normal labs (increase .39 improved ALT) May have been an error in labs. I don't know.  FYI - I tried to do this on line but halfway I got timed out and it wanted me to start over - too much for us seniors.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cold sweat, Condition aggravated, Cough, Dizziness
Clinical narrative: Abnormal breathing patterns,lightheaded, cold, clammy, primary impressions: respirations/acute distress/breathing difficulty Secondary: Allergic reaction (ht:86, BP: 148/92, R: 20, T: 99.0) Hx of first inoculation included mild respiratory reaction, treated with Benedryl. EMT arrived post swelling of entire face and sinuses. Post vaccination patient experienced increased sensitivity to known food "sensitivities" and airborne allergens. Patient was diagnosed with asthma as dry cough was continuous. Patient was prescribed asthma medication: Symbicort, Losartam-HVTZ, Nasacort and Zertec. Cont,
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Food allergy, Hypersensitivity, Nasopharyngitis, Respiration abnormal
Clinical narrative: Abnormal breathing patterns,lightheaded, cold, clammy, primary impressions: respirations/acute distress/breathing difficulty Secondary: Allergic reaction (ht:86, BP: 148/92, R: 20, T: 99.0) Hx of first inoculation included mild respiratory reaction, treated with Benedryl. EMT arrived post swelling of entire face and sinuses. Post vaccination patient experienced increased sensitivity to known food "sensitivities" and airborne allergens. Patient was diagnosed with asthma as dry cough was continuous. Patient was prescribed asthma medication: Symbicort, Losartam-HVTZ, Nasacort and Zertec. Cont,
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory distress, Sinus congestion, Swelling face
Clinical narrative: Abnormal breathing patterns,lightheaded, cold, clammy, primary impressions: respirations/acute distress/breathing difficulty Secondary: Allergic reaction (ht:86, BP: 148/92, R: 20, T: 99.0) Hx of first inoculation included mild respiratory reaction, treated with Benedryl. EMT arrived post swelling of entire face and sinuses. Post vaccination patient experienced increased sensitivity to known food "sensitivities" and airborne allergens. Patient was diagnosed with asthma as dry cough was continuous. Patient was prescribed asthma medication: Symbicort, Losartam-HVTZ, Nasacort and Zertec. Cont,
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Pain, Peripheral swelling, Rash
Clinical narrative: Difficulty breathing after 20 minutes of having vaccine and soon after got a rash. By August 9, my feet began to get swollen & I felt pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, C-reactive protein, Full blood count, Genital herpes, Genital rash
Clinical narrative: Patient developed painful rash on buttocks and right perineal area. The rash on the buttocks were vesicles with erythematous base at sacral dermatome S3-S5. The perineal rash is on the right labia majora - confluent ulcerations with necrotic base and S2 dermatome. All lesions appear herpetic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital ulceration, Herpes simplex test, Laboratory test, Metabolic function test, Perineal rash
Clinical narrative: Patient developed painful rash on buttocks and right perineal area. The rash on the buttocks were vesicles with erythematous base at sacral dermatome S3-S5. The perineal rash is on the right labia majora - confluent ulcerations with necrotic base and S2 dermatome. All lesions appear herpetic.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Skin necrosis
Clinical narrative: Patient developed painful rash on buttocks and right perineal area. The rash on the buttocks were vesicles with erythematous base at sacral dermatome S3-S5. The perineal rash is on the right labia majora - confluent ulcerations with necrotic base and S2 dermatome. All lesions appear herpetic.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Pt states got Pfizer #2 @ Employee Vaccine Clinic as above vax administered by RN who asked "pt did she feel that - I hit your bone" She said she did not feel pain out of ordinary @ time of vaccine. No redness. No shock like pain. Developed normal shot soreness over next day in upper arm, but soreness has not gone away. 1/10 pain @ rest in Deltoid/tricep region increases to 6/10 with reaching movements. No weakness numbness or tingling. No better No worse
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: THE PATIEND ANSERED THE COIVD VACCION CONSET FORM. WHEN ASKED ABOUT PREVIOUS COVID VACCINES HE ANSWERED "NO". WHEN THE VACCINE WAS ENTERED INTO THE SYSTEM, IT WAS NOTED THAT HE RECEIVED 2 DOSESOF MODERNA ON MARCH 4 & APRIL 1. THE PATIENT STATED SINCE HE WORKED IN EDUCATIONHE THOUGHT HE NEEDED ANOTHER SHOT
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, No reaction on previous exposure to drug, Weight decreased
Clinical narrative: 1st dose taken in left shoulder; no adverse events  2nd dose taken in left shoulder: Sore shoulder lasted less than two weeks. An episode of diarrhea 24-48hours after dose: no thirst or dehydration, Just normal loss of digestive fluids. Also experienced wight loss of approximately 15lbs over the course of one week: could feel my thyroid gland more active than usual. Also felt as if digestive fluids were overactive. Approximate weight before 2nd dose: only 155LBS (normal)  Treatment: consuming more red meat protein. Also used powdered meal supplement daily
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cough, Dyspnoea, Productive cough, Pulmonary function test
Clinical narrative: Starting sometime in March 2021 I started with wheezing, congestion, cough. Thought it was allergies so did nothing about it, It persisted and I have been on several rounds of Prednisone, different inhalers. Once I am done with the medication I feel better however it keeps coming back. I have also had one xray at the beginning of my symptoms and consult with clinic. A breathing test was also performed along with blood work for allergies. Everything is coming up negative but I am still having trouble with my breathing, increase congestion, coughing (sometimes productive)
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Wheezing, X-ray
Clinical narrative: Starting sometime in March 2021 I started with wheezing, congestion, cough. Thought it was allergies so did nothing about it, It persisted and I have been on several rounds of Prednisone, different inhalers. Once I am done with the medication I feel better however it keeps coming back. I have also had one xray at the beginning of my symptoms and consult with clinic. A breathing test was also performed along with blood work for allergies. Everything is coming up negative but I am still having trouble with my breathing, increase congestion, coughing (sometimes productive)
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Pain in extremity, Toothache, X-ray dental normal
Clinical narrative: Sore Arm, feeling weak & tired, extreme tooth ache #33 which to hot & cold, dissipated to zero pain after 3 months-gradual dissapation. Still weak & very tired after 5 months.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Blood test, Brain fog, Decreased appetite
Clinical narrative: My lymphatic system is in a state of dysfunction. I have had swelling all over my body, came on gradually to the point of it being probably 12-15 lbs of lymphatic fluid in my body. Fluctuations can be pounds daily of ever day or two. Loss of appetite, smell, tastes, desire to eat almost anything and everything. Feeling of dehydration, dizziness, fog brain, feverish with no fever, shortness of breath, fatigue, muscle, body aches, congestion of head, throat and waves of nausea.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Dizziness, Dyspnoea, Fatigue, Feeding disorder
Clinical narrative: My lymphatic system is in a state of dysfunction. I have had swelling all over my body, came on gradually to the point of it being probably 12-15 lbs of lymphatic fluid in my body. Fluctuations can be pounds daily of ever day or two. Loss of appetite, smell, tastes, desire to eat almost anything and everything. Feeling of dehydration, dizziness, fog brain, feverish with no fever, shortness of breath, fatigue, muscle, body aches, congestion of head, throat and waves of nausea.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Fluid retention, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: My lymphatic system is in a state of dysfunction. I have had swelling all over my body, came on gradually to the point of it being probably 12-15 lbs of lymphatic fluid in my body. Fluctuations can be pounds daily of ever day or two. Loss of appetite, smell, tastes, desire to eat almost anything and everything. Feeling of dehydration, dizziness, fog brain, feverish with no fever, shortness of breath, fatigue, muscle, body aches, congestion of head, throat and waves of nausea.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Respiratory tract congestion, Swelling, Weight fluctuation
Clinical narrative: My lymphatic system is in a state of dysfunction. I have had swelling all over my body, came on gradually to the point of it being probably 12-15 lbs of lymphatic fluid in my body. Fluctuations can be pounds daily of ever day or two. Loss of appetite, smell, tastes, desire to eat almost anything and everything. Feeling of dehydration, dizziness, fog brain, feverish with no fever, shortness of breath, fatigue, muscle, body aches, congestion of head, throat and waves of nausea.
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Friday 07/23/2021  LPN contacted Pharmacy regarding incorrect dilution of Pfizer Vaccine for 2 patients (husband and wife). LPN was directed to draw up left over diluent to determine how much was injected into Pfizer Vaccine. The leftover diluent was approximately 0.6 ml. Pharmacy directed LPN to contact someone else in the Pharmacy  LPN contacted pharmacy and informed in of incorrect dilution of Pfizer Vaccine. He informed LPN that patients receiving the first dose of vaccine usually do not experience side effects. He reports that, in the event that higher than authorized dose volume were administered, patients may experience elevated side effects (fevers, body aches, chills). He informed LPN that patients should be contacted to make aware of the error and to report any side effects.  He reports that depending on the patient side effects, if any, may determine whether patient receives a second dose of vaccine. He reported that errors needed to be reported, sent email with information on how to do this to both LOM and Practice Manager. LPN contacted Practice Manager and informed her of the incorrect dilution of Pfizer Vaccine, and the information that was given by Pharmacy.  LPN spoke with the patient's provider; who contacted both patients to inform of error and potential side effects. Patients comprehended and understood. LPN and practice manager discussed a strategy which will be implemented, so this does not occur again.  The plan going forward is the following:    When diluting Pfizer vaccine, will have another person verify correct dilution and correct dosing and initial (on a     copy of the schedule)  Practice manager contacted Dr, and informed him of the incident and follow up. Practice manager will enter the incident into VAERS, per the direction of the Pharmacy Director, and will also ensure the dosage is also entered into system, as per the direction of the CDC.
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Friday 07/23/2021  LPN contacted Pharmacy regarding incorrect dilution of Pfizer Vaccine for 2 patients (husband and wife). LPN was directed to draw up left over diluent to determine how much was injected into Pfizer Vaccine. The leftover diluent was approximately 0.6 ml. Pharmacy directed LPN to contact someone else in the Pharmacy  LPN contacted pharmacy and informed in of incorrect dilution of Pfizer Vaccine. He informed LPN that patients receiving the first dose of vaccine usually do not experience side effects. He reports that, in the event that higher than authorized dose volume were administered, patients may experience elevated side effects (fevers, body aches, chills). He informed LPN that patients should be contacted to make aware of the error and to report any side effects.  He reports that depending on the patient side effects, if any, may determine whether patient receives a second dose of vaccine. He reported that errors needed to be reported, sent email with information on how to do this to both LPN and Practice Manager. LPN contacted Practice Manager and informed her of the incorrect dilution of Pfizer Vaccine, and the information that was given by Pharmacy.  LPN spoke with the patient's provider; who contacted both patients to inform of error and potential side effects. Patients comprehended and understood. LPN and practice manager discussed a strategy which will be implemented, so this does not occur again.  The plan going forward is the following:    When diluting Pfizer vaccine, will have another person verify correct dilution and correct dosing and initial (on a     copy of the schedule)  Practice manager contacted Dr, and informed him of the incident and follow up. Practice manager will enter the incident into VAERS, per the direction of the Pharmacy Director, and will also ensure the dosage is also entered into system, as per the direction of the CDC.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction to report, However pt was given an additional dose of MMRV and DtaP:IPV. Pt has just received them on 7/28/21, and received them again.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: -Post vaccination conversation with patient Revealed that he had already Received a "vaccine" -When checking with Registration we discovered that pt Had Received J&J on 3-10-21. -during completion of checklist, pt stated he had no vaccine - but when he was reminded of return date pt states this was his second dose but that nobody had called him for second.
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiac stress test abnormal, Echocardiogram abnormal
Clinical narrative: Prior to 2020, annual physical, stress test, and EKGs no Afib Annual physical examination by primary care physician (PCP) on November 23, 2020. I did not have Afib. Received my COVID 19 vaccinations in January 2021 (dates above) March 9, 2020 office visit with my PCP for a complaint of ear pain. AFib diagnosed at that time during blood pressure screening and confirmed with 12 wire EKG. April 28, 2021, PCP referred me to cardiologist. Persistent AFIB diagnosed by ECHO and stress test.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cancer screening, Cardiovascular evaluation, Carotid artery aneurysm, Chest pain
Clinical narrative: (1) 3 days after 1st vaccine - headache, fatigue, weakness, loss of appetite, nasal congestion (2) Symptoms continued till 2nd shot and 3 mo. after (3) Headaches, eye discomfort till present time Saw ENT & (opthomologist-several times) Eye pressure normal - one episode of (L) drooping eye lid with pupil in corner of eye -> resolved in few hours. (1) As of the past 3 weeks, I am feeling better. The only remaining symptoms are daily eye discomfort with intermittent headaches. (2) Remaining test: Follow-up CT of aneurysm in September. (3) I am an active & healthy 81 year old, until I received my first Covid shot on 2/17/21. The past 6 months have been difficult. If a booster vaccine comes out & recommended; I will not be receiving it! (4) As you see from my attached form; I have many allergies & sensitivities to meds; but nothing compared to this! (5) I reported my side effects shortly after my symptoms started to the clinic. She said she would report them to the appropriate place. You may have that record. CT of sinuses, head, eyes - complete heart work-up after ER visit for chest pain & shortness of breath. aneurysm discovered in (R) coratid - saw neurologist for this and possible TIA when went to hosp for confusion - All labs & test results may be obtained from: Clinic & Hospital
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Decreased appetite, Dyspnoea, Eyelid ptosis, Fatigue
Clinical narrative: (1) 3 days after 1st vaccine - headache, fatigue, weakness, loss of appetite, nasal congestion (2) Symptoms continued till 2nd shot and 3 mo. after (3) Headaches, eye discomfort till present time Saw ENT & (opthomologist-several times) Eye pressure normal - one episode of (L) drooping eye lid with pupil in corner of eye -> resolved in few hours. (1) As of the past 3 weeks, I am feeling better. The only remaining symptoms are daily eye discomfort with intermittent headaches. (2) Remaining test: Follow-up CT of aneurysm in September. (3) I am an active & healthy 81 year old, until I received my first Covid shot on 2/17/21. The past 6 months have been difficult. If a booster vaccine comes out & recommended; I will not be receiving it! (4) As you see from my attached form; I have many allergies & sensitivities to meds; but nothing compared to this! (5) I reported my side effects shortly after my symptoms started to the clinic. She said she would report them to the appropriate place. You may have that record. CT of sinuses, head, eyes - complete heart work-up after ER visit for chest pain & shortness of breath. aneurysm discovered in (R) coratid - saw neurologist for this and possible TIA when went to hosp for confusion - All labs & test results may be obtained from: Clinic & Hospital
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Intraocular pressure test normal, Laboratory test, Nasal congestion, Ocular discomfort
Clinical narrative: (1) 3 days after 1st vaccine - headache, fatigue, weakness, loss of appetite, nasal congestion (2) Symptoms continued till 2nd shot and 3 mo. after (3) Headaches, eye discomfort till present time Saw ENT & (opthomologist-several times) Eye pressure normal - one episode of (L) drooping eye lid with pupil in corner of eye -> resolved in few hours. (1) As of the past 3 weeks, I am feeling better. The only remaining symptoms are daily eye discomfort with intermittent headaches. (2) Remaining test: Follow-up CT of aneurysm in September. (3) I am an active & healthy 81 year old, until I received my first Covid shot on 2/17/21. The past 6 months have been difficult. If a booster vaccine comes out & recommended; I will not be receiving it! (4) As you see from my attached form; I have many allergies & sensitivities to meds; but nothing compared to this! (5) I reported my side effects shortly after my symptoms started to the clinic. She said she would report them to the appropriate place. You may have that record. CT of sinuses, head, eyes - complete heart work-up after ER visit for chest pain & shortness of breath. aneurysm discovered in (R) coratid - saw neurologist for this and possible TIA when went to hosp for confusion - All labs & test results may be obtained from: Clinic & Hospital
Sex: M
Vaccine: DTPPVHBHPB, FLU4, HEPA, PNC13
Symptoms: Hyperhidrosis, Joint swelling, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Joint swelling; Mobility decreased; Peripheral swelling; Pain in extremity; Hyperhidrosis; Pyrexia; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2477955-1. The original narrative from the sender is the following:  Mother states that symptoms began that night. Mother reports that child had a fever of 101 and was very sweaty. Mother reports giving child Tylenol, and that it is helping with the fever. Mother reports that child has been saying his legs hurt, hasn't been running around as much, and that the Childs feet/ankles seem swollen. Nurse informed mother that symptoms, aside from swelling of feet/ankles, were normal. Nurse informs mother that a VAERS report will be filled. Nurse instructs mother to call doctor. Nurse instructs mother to bring child to urgent care/hospital if symptoms worsen/continue.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Joint swelling", "Mobility decreased", "Peripheral swelling", "Pain in extremity", "Hyperhidrosis", and "Pyrexia".  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB, FLU4, HEPA, PNC13
Symptoms: Pyrexia
Clinical narrative: Joint swelling; Mobility decreased; Peripheral swelling; Pain in extremity; Hyperhidrosis; Pyrexia; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2477955-1. The original narrative from the sender is the following:  Mother states that symptoms began that night. Mother reports that child had a fever of 101 and was very sweaty. Mother reports giving child Tylenol, and that it is helping with the fever. Mother reports that child has been saying his legs hurt, hasn't been running around as much, and that the Childs feet/ankles seem swollen. Nurse informed mother that symptoms, aside from swelling of feet/ankles, were normal. Nurse informs mother that a VAERS report will be filled. Nurse instructs mother to call doctor. Nurse instructs mother to bring child to urgent care/hospital if symptoms worsen/continue.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Joint swelling", "Mobility decreased", "Peripheral swelling", "Pain in extremity", "Hyperhidrosis", and "Pyrexia".  No further information is expected
Sex: M
Vaccine: COVID19, DTPPVHBHPB, FLUN4, HEPA, MMRV
Symptoms: Exposure to communicable disease, Extra dose administered, Loss of personal independence in daily activities, Pain in extremity, Pyrexia
Clinical narrative: Loss of personal independence in daily activities; Exposure to communicable disease; Pain in extremity; Extra dose administered; Pyrexia; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2480320-1. The original narrative from the sender is the following:  Child got varicella vaccine 2 days in a row. On 11-OCT-2022 exposed to varicella at school. On 12-OCT-2022 vaccinated at school with Varivax with father's consent (name spelled different and 2nd last name omitted on consent) present during education and consent completion. On 13-OCT-2022 mother brings child to vaccine clinic and screening had occurred on 11-OCT-2022. Mother consented through which indicated child needed varicella vaccination. Error was not noted until entry after clinic. Call to mother 14-OCT-2022, child had mild fever treated with acetaminophen on 13-OCT-2022 and mother kept him home from school next day due to arm pain, but states child is eating and paying normally 24 hours after vaccination.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Loss of personal independence in daily activities", "Pyrexia" and "Pain in extremity".  The causal relationship between Vaxelis and the reported events "Exposure to communicable disease (Child exposed at school)" and "Extra dose administered" were assessed as not related and not applicable respectively, due to the nature of these events.  No further information is expected
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Erythema, Irritability, Peripheral swelling, Rash
Clinical narrative: Erythema; Feeling abnormal; Swelling; Rash; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2483155-1. The original narrative from the sender is the following:  Swollen red right thigh, rash on torso, fussy.  The reporter did not provide an assessment of causal relationship between Vaxelis and the events "erythema, feeling abnormal, rash and swelling",  No further information is expected.
Sex: F
Vaccine: DTAPIPV, DTPPVHBHPB, PNC13
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb; Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb; This case was retrieved during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2490934-1. The original narrative from the sender is the following:  Gave quadracel vaccination out of age range; Notified mother of incorrect vaccine product used and vaxelis product given in same limb.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "Wrong Product Administered," and "Overdose."   No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Barium enema, Blood culture positive, C-reactive protein, Full blood count, Haematocrit
Clinical narrative: Vomiting; Pallor; Unresponsive to stimuli; Found to have intussusception; Abdominal X-Ray; Barium enema; Blood culture positive; C-reactive protein; Chest X-ray; Full blood count; Hematocrit; Laboratory test; Moraxella test positive; Ultrasound abdomen; Urine analysis; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2519196-1. The original narrative from the sender is the following:  Child has history of vomiting, pale appearance and unresponsiveness. Found to have intussusception and subsequent follow up for + blood culture of Moraxella. He was seen after this in ER and given ceftriaxone IM with repeat blood culture with ID consult.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vomiting", "Pallor", "Unresponsive to stimuli", "Found to have intussusception", "Abdominal X-ray", "Barium enema", "Blood culture positive", "C-Reactive protein", "Chest X-Ray", "Full blood count", "Haematocrit", "Haemoglobin", "Laboratory Test", "Moraxella test positive", "Ultrasound abdomen", and "Urine analysis".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Intussusception, Laboratory test, Moraxella test positive, Pallor, Ultrasound abdomen abnormal
Clinical narrative: Vomiting; Pallor; Unresponsive to stimuli; Found to have intussusception; Abdominal X-Ray; Barium enema; Blood culture positive; C-reactive protein; Chest X-ray; Full blood count; Hematocrit; Laboratory test; Moraxella test positive; Ultrasound abdomen; Urine analysis; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2519196-1. The original narrative from the sender is the following:  Child has history of vomiting, pale appearance and unresponsiveness. Found to have intussusception and subsequent follow up for + blood culture of Moraxella. He was seen after this in ER and given ceftriaxone IM with repeat blood culture with ID consult.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vomiting", "Pallor", "Unresponsive to stimuli", "Found to have intussusception", "Abdominal X-ray", "Barium enema", "Blood culture positive", "C-Reactive protein", "Chest X-Ray", "Full blood count", "Haematocrit", "Haemoglobin", "Laboratory Test", "Moraxella test positive", "Ultrasound abdomen", and "Urine analysis".  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Unresponsive to stimuli, Urine analysis, Vomiting, X-ray abnormal
Clinical narrative: Vomiting; Pallor; Unresponsive to stimuli; Found to have intussusception; Abdominal X-Ray; Barium enema; Blood culture positive; C-reactive protein; Chest X-ray; Full blood count; Hematocrit; Laboratory test; Moraxella test positive; Ultrasound abdomen; Urine analysis; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2519196-1. The original narrative from the sender is the following:  Child has history of vomiting, pale appearance and unresponsiveness. Found to have intussusception and subsequent follow up for + blood culture of Moraxella. He was seen after this in ER and given ceftriaxone IM with repeat blood culture with ID consult.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Vomiting", "Pallor", "Unresponsive to stimuli", "Found to have intussusception", "Abdominal X-ray", "Barium enema", "Blood culture positive", "C-Reactive protein", "Chest X-Ray", "Full blood count", "Haematocrit", "Haemoglobin", "Laboratory Test", "Moraxella test positive", "Ultrasound abdomen", and "Urine analysis".  No further information is expected.
Sex: M
Vaccine: COVID19, DTPPVHBHPB, FLU4, PNC13, RV5
Symptoms: Expired product administered
Clinical narrative: After administration of COVID vaccine, it was discovered that the vaccine had expired.; This case was retrieve during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JAN-2023 with the following VAERS Primary ID 2526877-1. The original narrative from the sender is the following:  After administration of COVID vaccine, it was discovered that the vaccine had expired. Vaccine diluted 11/30/22 at 11:35AM, expired 11/30/22 at 11:35PM. Vaccine administered 12/1/22 at 8:50PM, approximately 9 hours and 20 min after expiration. Pfizer contacted for stability report. No further information available. Pfizer recommending communicating with their supply chain department as they may have further stability report. Dr. called and informed mom of event. Pt doing well, no adverse symptoms. Received word from supply chain department that they do not have stability reports to support effectiveness of vaccine. Called and spoke with mom. Pt is doing well and does not appear to have any adverse symptoms from vaccine.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported event "After administration of COVID vaccine, it was discovered that the vaccine had expired".  No further information is expected
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient woke and ate the next morning, then went down for a nap. Father sat next to him on the bed watching a program, and noticed the baby was still. Tried to wake him and he would not respond / was not breathing. Patient was treated for cardiac arrest at the hospital and was never revived. He passed away.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5, DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Cardiac arrest, Death, Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Patient woke and ate the next morning, then went down for a nap. Father sat next to him on the bed watching a program, and noticed the baby was still. Tried to wake him and he would not respond / was not breathing. Patient was treated for cardiac arrest at the hospital and was never revived. He passed away.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Angiogram cerebral, Angiogram pulmonary, Antibody test, Audiogram, Blood immunoglobulin G
Clinical narrative: No adverse event; 4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022).    No concomitant medication was reported.    No treatment information was reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Cardiac monitoring, Differential white blood cell count, Echocardiogram, Electrocardiogram, Feeling abnormal
Clinical narrative: No adverse event; 4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022).    No concomitant medication was reported.    No treatment information was reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Full blood count, Grip strength decreased, Impaired work ability, Injection site pain, Laboratory test
Clinical narrative: No adverse event; 4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022).    No concomitant medication was reported.    No treatment information was reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Magnetic resonance imaging head, Malaise, Pain in extremity, Product administered at inappropriate site, Scan with contrast
Clinical narrative: No adverse event; 4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.  No Medical History information was reported.   On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (4th dose Moderna COVID-19 Bivalent Booster administered on 31-AUG-2022 5th dose Moderna COVID-19 Bivalent Booster administered on 22-OCT-2022).    No concomitant medication was reported.    No treatment information was reported.