chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information in the form of medical records was received from a pediatrician, regarding a 12 week old female infant with thrush, and a history of contact dermatitis, newborn feeding problems, neonatal jaundice, shoulder dystocia and an upper respiratory infection, who on 11-DEC-2007 was vaccinated with the first dose of ROTATEQ. Concomitant vaccines administered included the first doses of PEDIARIX, PREVNAR, and ACTHIB. On 03-JAN-2008, the infant was brought to the physician with diarrhea of 5 days duration and watery, yellow green stool with onset 6-7 days prior to visit; she had also vomiting up to 4 times daily. The infant was diagnosed with viral enteritis. Skin turgor and elasticity were good, with no dehydration noted. On 14-FEB-2008, the infant was brought to the pediatrician's office for a routine 4 month old check up. The child was noted as "healthy child with normal growth." A second dose of ROTATEQ, PEDIARIX, PREVNAR, and ACTHIB were administered. On 20-FEB-2008, the infant was brought to the office with the mother's report that the infant had no stool for 2 days over the weekend. Treatment included glycerin chip, with a hard stool resulting. On 19-FEB-2008, the infant had no stool, and glycerin was again administered, with a yellow and soft resulting. The mother had been giving 1 -2 drops in a bottle once daily. Treatment prescribed included Karo syrup, 1 tsp per bottle for 2 bottles and adjust as necessary. The physician noted that the parents had symptoms of an upper respiratory infection. On 27-FEB-2008, the infant was brought to the physician with reports of congestion and cough for 1 week, but with no fever. An upper respiratory infection was diagnosed. On 07-MAR-2008, the infant was seen by the physician with improvements other nasal symptoms, no respiratory distress, but "her breathing is more rattling." The physician assessed the URI as improving. On 28-MAR-2008, the infant was brought to the physician with her mother's reports of "for the last 4 days she's been pulling at ears." There was no fever nor URI symptoms noted, and the physician diagnosed teething syndrome. The outcome of teething syndrome was unknown at the time of this report. Additional information has been requested. All medical records will be provided upon request.
Patient called on 10/11/2022 at 10:30am. Patient participated at the School public flu event on 10/7/2022 at 8:05am. Patient sat in chair with the nurse at approximately 8:10am and immediately after receiving the influenza vaccine felt shooting pain down arm. Patient iced arm that night but when the pain continued through the weekend went to an urgent care on 10-9-2022. Patient was told the flu vaccine was given in the wrong area - it was injected too high towards the shoulder and caused compression of the nerves. Patient was advised to alternate Ibuprofen and Tylenol and well as ice and to seek an appointment with an orthopedic specialist.
29May2021 my bells palsy started. I woke up and I had trouble spitting toothpaste because the left part of my face was paralyzed. 28 my lips were numb. I was wondering if I had a stork , On the 31May2021 , I went ER at hospital. They checked it was a stroke and it was bell palsy . Started meds on 31 May2021 and the week of jun14-18, it was better by June 21,2021, my face was normal but I still had hearing loss. My hearing loss started in mar/apr 2021 after my 1st dose. I see a doctor every other week for my allergy shot. I went to ear, nose and throat doctor in august and cat scan of my head and audiology test and test the pressure of my ears and he recommended to my ear specialists. I take my allergy shots every other week. Two shots, one is for trees and grass and other for grains,
He developed Parsonage Turner Syndrome (aka Neuralgic Amyotrophy) about 2 weeks after the vaccination. He was previously vaccinated with J&J vaccine 4/21 and received his first Moderna mRNA vaccine on 11/26/22.
moderate pruritic, urticaria on trunk 3 days p/MMR: poss egg allergy now suspected;
Initial unsolicited report received from a consumer or non-healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2017528310) on 02-Jan-2018. This case involves a female patient (onset age not reported) who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (TETANUS DIPHTHERIA) (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination the patient was allergic to the vaccine. Laboratory investigations and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none.
felt real rotten; sweating; nausea; chills; Bad headache; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills) and HEADACHE (Bad headache) in a 39-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (Bad headache) and FATIGUE (Really tired). At the time of the report, FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (Bad headache) and FATIGUE (Really tired) outcome was unknown.        SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) dosing remained unchanged.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742748 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742748:Master case (spikevax 2023-2024)
Since 2009, Gradual decrease of cognitive skills, memory loss, loss of speech, symptoms of dementia, catatonia, tremors, anxiety, irritability, insomnia,  slowness of motor functions.
Pt father reported "it looked like hives all over" - Rash-1wk- after MMR II, VARIVAX, HAVRIX given. Red itchy papules 2mm-1cm varying site and location. Lasted 1mo. No resp sx. No intercurrent illness.
Rash 3 inches in diameter around injection site that lasted approximately 2 hours. Itching from start of rash and continuing through today.
6:30am 12/31/20 pt c/o stiffness, dizziness, injectionsite pain, cough, runny ose, mental fog. Temp 100.1. Given 2 tylenol 500mg c/o chills and weakness and fatigue - continues through the day. 7:30 pm pt oriented to person and place but not time could not follow direction to check blood sugar extreme chills. Temp 102.3 called on call internist and was instructed to give 400 mg motrin with 2 tylenol fever roke at 9pm pt was lucid.
Had  MPOX vaccine on 1/5/2023 . Presents with FEVER AND RIGHT GROIN CELLULITIS.
Development of hives on forearms on the inner aspect.  BP=162/70-98%- 68 hr at 0845.  By 0900, BSS BP 128/68-68 hr and 98% oximeter reading.  Benadryl 25 mg given po for itchiness and 1 to take at home if needed.  Discharged to home with no further problems.  No further communication received so assume resolution of sxs.
rightleg, rt side on tongue was numb, slight headache, funny tasete in mouth, arm soreness
"brain fog," blurred vision, extreme mucous, body aches, fatigue, bowel incontinence
3RD DOSE OF MODERNA COVID VACCINE GIVEN 10/22/21, LOT #012F21A.   4TH DOSE OF MODERNA COVID VACCINE GIVEN 4/8/22, LOT #065K21A. pt brought to ED after a fall; found to be positive for COVID in ED; CXR showed possible aspiration into right lung without diffuse pneumonia; noted to have carotid disease, seen by vascular surgery; seen by cardiology for Atrial Fibrillation; given Dexamethasone; pt's condition worsened significantly requiring increase in vasopressors; lower BPs; increase in leukocytosis/lactic acid; transitioned pt to comfort care and he passed away in the hospital
pt recv vax & w/in min became lightheaded, dizzy & pale then began to c/o throat feeling tight & sore;given epi;HR 60-64, BP 94/60, 110/60;
Patient received Menveo second dose; Menveo reconstituted with sterile diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA765A, expiry date 31-DEC-2023) for prophylaxis.   On 05-APR-2023, the patient received Menveo. On 05-APR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Patient received Menveo second dose) and inappropriate preparation of medication (Verbatim: Menveo reconstituted with sterile diluent). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 10-APR-2023 Medical Assistant reported that, the patient received Menveo second dose (2 vials presentation), which was reconstituted with sterile diluent. The reporter had consented to follow-up via mail. At the time of reporting, the patient only had received the vaccine which was reconstituted with sterile diluent, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Right after vaccination, she said she felt like her "arms were going to fall off". She woke up the following morning feeling nausea. She slept all day. When she woke up in the afternoon, she was dizzy and "felt tachycardic". She also felt tingling of her fingers. These symptoms subsided within 48 hours.
Patient presented to emergency department on 1/1 with complaints of fever, chills, nausea, vomiting and shortness of breath.   In ER patient was tachycardic, febrile, in respiratory distress, EKG shows sinus tachycardia with heart rate of 129, nonspecific ST T-wave changes, lactic acid was elevated to 2.5, CBC showed WBC of 12.2,, CMP, COVID-19 test positive, sepsis protocol initiated, patient received 2 L fluid bolus, initially on BiPAP and wean down to nasal cannula, with his high risk for pulmonary embolism by CT was done which ruled out PE, mild patchy area of alveolar disease in the left lung base concerning for pneumonia.  Patient was admitted for COVID-19 pneumonia was initially on 4 L of nasal cannula, he was started on azithromycin, ceftriaxone antibiotics, treated with dexamethasone, remdesivir, vitamin supplements, zinc supplements, his symptoms improved, patient weaned off oxygen supply. He was discharged home on home health care.
This is a 73-year-old female with past medical history of DVT/PE fibromyalgia, RA, CAD status post stents, CKD who presented to the ED for complaint of cough. Patient reports she noted the cough started 2 days ago and just feeling weak. In the ED, patient was noted for temperature 100.8, 95% on room air which had decreased to 91% and was placed on oxygen. Lab work notable for bicarb 32 creatinine 1.41 procalcitonin 0.11 INR 1.8. Urinalysis notable for WBC 21-50. Patient tested positive for COVID-19. Chest x-ray unremarkable. Venous Doppler negative for DVT. In the ED, patient was given Macrobid, 1 L IV fluids and Decadron. Due to above concern with patient's symptoms and oxygen status, patient be admitted for further evaluation treatment. DEATH SUMMARY: Patient admitted for dyspnea respiratory distress, diagnosed with COVID pneumonitis, treated with BIPAP for acute respiratory failure.
the third day I had chills, fever, fatigue, joint pain lower body. I still have severe stuff joint pain. Doctor sent for blood work and x-ray upcoming. diagnosed as inflammation so far.
4 hours post inj had sm red area on RD. later in the day became a rash all over the body. SOLU-MEDROL 40 mg inj. given. BENADRYL, Prednisone, Promethazine for N/V.
On 9/11/2022 I experience an ischemic stroke after receiving my booster shot for covid-19. I received the Pfizer shot for all 3 doses. I was lucky enough to not suffer any long term deficits, however, I now have to live with extreme fatigue, anxiety and depression due to the stroke.
Still have a welt, hot to the touch, and knot after a week from getting the vaccine
Tinnitus - ringing in my ears started 24 hours ago.  Went online and read that this is a side effect, so have not done anything about it.
Pain at the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the Injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the Injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the Injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
The vial had been left at room temp for longer than 2 hours. The expiration  time  was noted at 7pm by a floating pharmacist so I gave the dose around 6:15p thinking I was ok.  It was not until after we closed at 9pm that I realized the vial had been punctured at 1pm and has been left in the basket with an expiration time being 7pm. The previous pharmacist believed that the dose was good for 6 hour at room temperature when in fact it is only goof for 2 hours. The patient has NOT reported any adverse reactions. I have contacted Janssen directly and filed a report. I was also informed with a clinical specialist that there is absolutely no data to support what will happen to the patient if he/she were injected with an expired dose. I have contacted the facilities clinical team and have also filed a discrepancy report according to our company policy.
Jan. 21, 2021, first  shot. No side effects directly following it, but 10 lays later on about Jan. 31 suffered mild body aches and fatigue for 24 hours. No fever. Feb. 18, 2021, second shot. No side effects directly following it, but 4 days later on about Feb. 22 suffered sudden chills and fatigue for 24 hours. No fever. Complete recovery in both instances.
devel hot red lump @ inject site followed by a rash in axilla (bil) that looked like broken blood vessels-called own MD; OK now, but rash is scaling;
Tingling in nose and face on the 3rd by the 7th trouble urinating and defecating sought treatment at Hospital. Referred to Internal Medicine at the hospital and then referred Neurology off-post on the 26th of February 2010.
Patient experience severe arm pain (at injection site) (upper left arm).  She reports excessive swelling (twice the normal size).
Patient reported feeling lightheaded and itching within 15 minutes of vaccination; BP 152/110.   Given Benedryl and released to home.
12:18 RECEIVED VACCINE, STATED "I DON'T FEEL WEEL", ASSISTED TO FLOOR, LOC <30 SEC EMS ACTIVATED. 12:21 AAO X3 B/P 90/52, HR 59, 02 SAT 97%, STATED "I'M FINE", IS DIAPHORETIC AND PALE. 12:26 AAO X3 STATES WANTS TO GET UP B/P 105/72 HR 92, 02 97%, PT. LYING ON GROUND. 12:28 AAO X3 RESPONDING TO QUESTIONS APPROPRIATELY. 12:38 B/P 125/75, HR 78, 02 SAT 98 % SITTING UP TO CHAIR WITH ASSISTANCE, STATES "I'M GOOD NOW" 12:41 EMS ARRIVED AND EVALUATED AND RECOMENEDED PT GO TO HOSPITAL , DECLINES FURTHER TREATMENT SIGNES AMA. 12:56 EMS DEPARTED, PT STATES LEAVING I'M LEAVING NOW. 12;57 PATIENT LEFT AMA, GAIT STEADY AAO X3
Flu like symptoms; This spontaneous case was reported by an other caregiver and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Hx syncope in past . Sister felt dizzy, watching brother get his flu shot. Had just received her flu shot. Fainted with 2 seconds LOC. Hit head -> ER for evaluation.
injection site sore; low-grade fever of 101 °F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site sore) and PYREXIA (low-grade fever of 101 °F) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (injection site sore) and PYREXIA (low-grade fever of 101 °F). At the time of the report, VACCINATION SITE PAIN (injection site sore) and PYREXIA (low-grade fever of 101 °F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: high (High) low-grade fever of 101 °F.         Concomitant medication not provided. Treatment medication included Ibuprofen    This case was linked to MOD-2021-077587 (E2B Linked Report).; Sender's Comments:  MOD-2021-077587:1st dose of vaccine
Guillain Barre syndrome (LE Weakness, numbness and tingling in extremities, severe back pain). TX: IV Ig.    10/23/09:  Hospital Records and Discharge Summary received for dates of service 9/28/09 to 10/14/09.  GBS, Severe back pain, UTI, Hypokalemia, Hyponatremia, Constipation, Syncope, Left humeral fractures, Accelerated HTN, PVD, Dyslipidemia, Osteoporosis with degenerative joint disease and disk disease, Anxiety. Assessment:  Presented with severe abdominal and back pain (8/10) after syncope episode.  Had some nausea and vomiting 36 hours prior to admission.  Patient fell recently and had left humeral fractures.  C/o numbness and tingling in LE's and UE's and significant pain not well controlled by meds as well as LE weakness.  Neuro consult & LP done. IVIG started for 5 days with slight improvement in motor function and motor strength.  Placed on a fentanyl patch and morhpine sulfate for back and hip pain.   UTI was treated which reduced pelvic and hip pain. Had trouble swallowing and and NG Tube was placed but pt. began gurgling up with NG tube, so a PEG tube was placed.   Blood pressure fluctuated throughout LOS, thought to be due to vasormotor instability secondary to GBS.   Discharged to long term care facility.
Fever, chills, extra sensitivity, joint stiff and has gone on for a month after vaccination.
Information has been received from a pharmacist referring to 3 newborns (numbered 223, 224 and 225). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 25-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Large rash at injection site with inflammation, and mild pain and discomfort. Patient was seen by the nurse practitioner on site here at pharmacy. Who mark the rash to see if it grew any large. I contact the patient on (9/30/2015) and she stated that she was feeling better and that the sweeling had gone down.
In Health Dept 4/11/07 @ 4:30 p.m. Right arm red, hot to touch from elbot to clavicle. Swollen and Tight. Painful and Itching. Splotchy redness notedto arm pit area. Dr. notified; Instructed given for cool and warm compresses, ibuprofen, benadryl, check radial pulses; If s/s worsen or persist to take child to ER. To TC 4/12/07 for recheck; Returned 4/12/07...Resolving.
Dizziness, vomiting x2, lip swelling approx. 12 hours later
Pt experienced vomiting, nausea, diarrhea, and lethargy for the day following vaccination.
Enlarged lymph node near right clavicle, chest X-ray and CBC was performed to rule out lymphoma.  The following day, I experienced fever, chills and body aches.
Headache, Myalgia, Fever, NauseaVomiting, CHILLS, FATIGUE Narrative:
Headache, chills, body ache, fever, sore throat, cough. Started the night of Jan 22. Last most of the day Jan 23 however, started felling better that night. As on Monday Jan   25 all symptoms came back and I have been like this for three days now. I feel like I have the flu.
Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 14-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) and PRODUCT STORAGE ERROR (Patients were administered Moderna vaccine booster beyond 30 day use by date, stored in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No concomitant medication was reported.  Date the vial was initially stored in the refrigerator was13-JAN-2022.   This case was linked to MOD-2022-482141, MOD-2022-482218 (Patient Link).