chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient erupted in bullous lesions involving initially mouth which resolved with PO prednisone. Subsequently eruption in bullous lesions involving sun exposed areas. Bx consistent with bullous pemphigoid. Blood ANA+, BP 180+ with ARUP panel. Concern for bullous pemphigoid, ddx including bullous lupus due to patient's age/gender and sun exposed areas.
I received my vaccine on January 4, 2022 and started having cramping and vaginal bleeding 8 days later on January 12, 2022. I had a confirmed miscarriage on January 17, 2022. We do not know the estimated delivery date. I was in my first trimester of pregnancy. After my vaccine, I had a low grade fever of 99.8F and body aches and fatigue.
pt recvd vax 31JAN95, had temp up to 101 til 130PM on 1FEB95 when temp inc to 103, pt shaky & crying, tepid bath & t dec to 98-99;
discharged. 58-year-old man presenting to our institution with shortness of breath for a day.  He reported that the shortness of breath was worsened with exertion, alleviated at rest.  He had some lightheadedness, which is longstanding since his diagnosis with COVID-19 in 2020. Patient is homeless, and lives currently at Facility.  He has a history of COVID-19 leading to ARDS in 2020, and he did recover without the needs for oxygen.  In the emergency department he was found to be hypoxemic on room air, 85%.  He tested positive for COVID-19.  EKG and chest x-ray as well as CT head did not reveal acute findings.  CT cervical spine revealed no acute findings.  Shoulder x-ray was consistent with arthritis.  He was admitted to the institution for further management of COVID-19 pneumonia with hypoxemia.  In regards to his COVID-19 infection, the patient has been vaccinated with the Johnson and Johnson vaccination by has not received a booster.  Given his hypoxemia he was placed on dexamethasone 6 mg daily.  He also was placed on remdesivir, though this was discontinued because of his bradycardia.  Patient was able to wean off of oxygen at rest, however he was identified to require 2 L of oxygen with activity.  Because of this, he was not a candidate to go back to Facility until he was out of his isolation.  Patient did have an intermittent pleuritic chest pain, with elevated D-dimer, upper and lower extremity Dopplers unrevealing, CT angiogram thorax revealed no pulmonary embolism however did reveal some minimal patchy airspace disease in left lower lobe and coronary calcification was as well as severe emphysema.  EKG revealed no evidence of ischemia.  Patient noted to have resting bradycardia as well as bradycardia overnight.  He had normal chronotropic response.  It is recommended he be tested for sleep study as an outpatient.  Patient experienced no complication from his alcohol use disorder, no withdrawal, received thiamine, folic acid and multivitamin. Treated for body lice, clinically improving. Seen by PT and OT for frequent falls, will need to use a cane. Patient continued to improve through out his stay and was performing his usual activities of daily living on the day of discharge.
of 200 people @ this facility who recv vax a "few" subsequently devel an inj site rxn;no further info was available @ the date of this report;reporter was not able to specify the number of people who exp this event;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 31-JUL-2013 the patient might have received VARIVAX (Merck) (lot # H019449, expiration date 25-OCT-2014, 0.5 ml, subcutaneously, dose in series unspecified) one month too early (Inappropriate schedule of vaccine administered). No adverse effects reported. Additional information has been requested.
Started with headache on the evening of injection, both husband and I could not sleep the evening of 4/1/2021. Minor headache and fatigue for approx 2-3 days. Approx.4/8-4/9/2021 had SEVERE abdominal pain and abdominal swelling. Loss of appetite, extreme fatigue. These symptoms continued until about 4/15/21. I had video call with primary care physician on Mon. April 12,2021 due to unusual abdominal pain and swelling. Swelling would come and go. Most symptoms subsided by mid April 2021.
Patient hospitalized on 7-3-2022 with covid 19 and pneumonia.
fever, nausea, hot/cold flashes, local pain, swelling & redness take 2 ASA for inflammation/pain;
Patient came in for covid booster.   She was accidently given the whole  vial of pfizer 6 doses by the medical assistant who did not dilute before administering.  The patient had no reaction and left after 15 minutes.   Then it was discovered by the MA that she had made a mistake and given entire vial.  Clinic Director, office manager, and chief of Infectious Disease were all notified.  Dr. was patient.  Vital signs were taken and blood pressure was initially 183/96 with pulse of 98 but came down to 163/83 with pulse of 88.  Blood sugar was 226.  Patient called daughters.  Was given tylenol for slight headache and then eventually left office at about noon.
About 24 hours after Tdap was administered, client developed chills, fever, somach pain, and was extremely fatigued.  This continued for the next 36 hours. For one whole day she felt as if 'someone was sitting on my chest, like I had an ulcer.  I took Mylanta all day.'  Also 'my arm was very painful.' After 36 hours this began to subside and systemic symptoms were gone by 44 hours.  By then, her arm hurt, but 'that was no big deal'
Headache first, Injection site swelling, then hives in the middle of the night at injection site, woke up with muscle aches everywhere, diarrhea started mid day, fever 100.4
Arm swelled to size of watermelon. Bubbles and blisters. Hard and hot.
Pt recv vax on 11/20/97; on 1/28/98 pt exp an elevated liver
Field based employee is reporting an adverse event on behalf of a nurse. Caller states the nurse (name, demographic information not provided) reported her 13 year old son received the first dose GARDASIL 9 on an unspecified date experienced flu-like; This spontaneous report was received from a nurse, referring to her son, a 13-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date, the patient experienced flu-like symptoms (influenza like illness) and would not be receiving the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The outcome of influenza like illness and the causal relationship between the event and the suspect therapy were not reported.
HYPOTENSION ACUTE RESPIRATORY FAILURE 1/16/2023,  1/17/2023,  1/24/2023,  3/21/2023  -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
PATIENT REPORTED ABOUT 45 MIN AFTER VACCINE HER FACE TURNED BRIGHT RED, FELT HOT, AND FELT TIGHT. SHE ALSO HAD TROUBLE EATING DINNER BECAUSE SHE FELT LIKE SHE HAD TROUBLE SWALLOWING
I had some severe allergies, I start feeling like my usual allergy; An external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe; I then got sick; My throat sore; Swollen tongue; Its persisting may be worsened; Sleepy; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0150 via an unspecified route of administration, administered in Deltoid Right on 07Apr2021 (at the age of 50-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I had some severe allergies, I start feeling like my usual allergy, an external itch; feels like little ants are crawling all over you head to toe; the external itch from my head to my toe, I then got sick, my throat sore, swollen tongue, its persisting may be worsened and sleepy. Therapeutic measures were taken as a result of I had some severe allergies, I start feeling like my usual allergy. The patient reported that, I understand my allergies and I took Benadryl (treatment) right away, I woke up this morning and I feel the same way. I have been to the emergency room enough to know the test what they gave me because of my allergy. The patient was scheduled for second shot of vaccine on 28Apr2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt called public health facility on 6/1/2021 to report continued numbness and tingling of left arm from shoulder to fingers, starting day of vaccination, 5/6/2021, dose 2. Site viewed 6/1 without redness or induration or warmth to touch. Grip strong. + circulation check. Advised patient to see a provider and report back with follow up. No acute distress. Other symptoms were flu-like in nature lasting 1-2 days post vaccination.
Here for check up, lungs clear. No hives. Within 5-7 minutes of administration of flu vaccine, pt skin erythemic with multiple hives face/neck and chest extending to entire body. By 20 min past injection, occ wheezing at ER: Epi 1/1000 0.1ml + Benadryl 2.5 cc po. Resolution of symptoms with treatment. Medical records state increased cough, allergic reaction. msv
Initial symptoms were normal but progressively got worse in a matter of minutes to include pain/burning at the injection site, feeling of warmth through body, dizziness, lightheadedness, and extreme craving for sugar followed by tightness upper chest and throat, and difficulty breathing/swallowing. Symptoms lasted around 30-60 minutes. Was able to breath through nose, not mouth, for the duration of the symptoms. The tightness in chest/throat did not go away.
1st  dose was with no effects. 2nd dose seemed ok on Tuesday,the first day, but my arm was sore and by Wednesday. the next morning  my arm was more sore & began to itch.  When I looked, I had a bright red rash about 6 inches long & slanted downward from 4 inches across. It did not change at all on Thursday  or Friday so I am now on a course of antibiotics
I got my first r my first dose of the pfizer vaccine dose at 9 am that morning and around 10 hours later around 8 pm I got hives on the left side of face and hives/ swelling around left eye and my nose was literally dripping mucous like a faucet onto the floor and I started getting a super itchy and tight through. Obviously an allergic reaction, I took two benedryls fell asleep and woke up fine.   I am not sure if I should get my second dose tomorrow.
I received the 4th dose on 04/11/2022. I noticed my hand was trembling and then I had the chills with body shaking for about 2 hours, I had fever of 100.5. Then I felt like I was having trouble breathing. I called my daughter and she helped me to get down Tylenol, then I went to lay down. On 04/12/202, I had headache, nausea, diarrhea, body aches, brain fog and over whelming fatigue. On 04/13/2022, my fever was 99.5, I was able to eat a little bit, and I still had headache, nausea, diarrhea and fatigue. By 06/14/2022, I no longer had a fever, but periods of intense fatigue and nausea. On 06/15/2022, I was beginning to feel better, I still had bouts of fatigue and nausea. It was about 3 weeks until I felt really good again.   On 06/28/2022 I started to have symptoms of COVID-19 with a sore and scratchy throat and headache. The home Covid-19 test was negative and I assumed it was just a cold at that point. By 06/29/2022, I felt really bad. I kind of half staggered to the home testing station about 2 blocks away. That test eventually came back a few days later and it was positive. I had runny nose, sore and scratchy throat, cough, nausea, diarrhea, headache and my temperature was 100.5. On 06/30/2022 my daughter tested positive, and I still had all of the same symptoms. By July 1st, now that I knew I had Covid-19 as I also tested positive with my home test, my temperature was 98.8 and I was feeling somewhat better. I did call my doctor. The sore throat was gone, the cough changed from a light type to a deeper cough in my throat. My doctor recommended that I not use Paxlovid as she thought I was coming along okay. She said Paxlovid is very strong and it has side effects including the rebound infection, so she recommended that I continue with my Tylenol.  I am still recovering as symptoms come and go. Where I have no energy, cough and I feel warm.
Family states patient never recovered after 2nd Moderna dose.  Entered hospital with extreme shortness of breath.  Ventilated after several days.  Passed away while in hospital.
Patient cried/screamed after injection IPV. Then, he became quiet, limp and pale moments after. I (mother) thought he just wore himself out and quickly fell asleep.  I was concerned as I put him in the car, because he did not act this way with other injections. But, I did not realize he was having a reaction. I was not given a VIS, nor was I explained warning signs of rxn. Episode about lasted about 1.5 hrs., with limbs limp, and unresponsive to typical tactile stimulation of limbs. Slowly my son became responsive to touch and verbal stimuli, and regained completely normal behavior by 2 hours. Doctor not notified, as I did not realize S/S of adverse rxn. With some research, I understood he experienced what seemed to be HHE (hypotonic-hyporesponsive episode) w/o apnea. I did notice at the time, his anterior fontanelle was pulsating. I had not noticed this previously.
Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022; No adverse event; Vaccine administered after the 12 hr period/ post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022).    Concomitant medication was not provided.  Nurse reported that only 2 doses were administered from the vail and size was 2.5 ml. The vial was stored post puncture in refrigerator. The vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-679129 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679129:Patient 2 (Crosslink - MI case # MOD22-030049)
Moderna COVID-19 Vaccine EUA. On Friday 1/8/2020 I noticed an itching, soreness, increased warmth at site and three bumps on left upper arm. Took benadryl, applied hydrocortisone cream, and ice packs to site. The next day the redness had increased, itching and soreness, and increased warmth at site remained. Continued to use same treatment as day before. Symptoms began to resolve on Sunday 1/10/2021.
Patient complained of exacerbation of multiple sclerosis symptoms, chills, fatigue, numbness or tingling in limbs, difficultly moving arms or legs, and infection in the navel. Symptoms started on day of vaccination and persisted for three days.
27th Jan 2021-Chills & fever, fatigue-doesn't feel good. 28th Jan 2021-Chills on/off, fever-fatigue-doesn't feel good. 29th Jan 2021-AM  doesn't feel good PM-feeling better Yes, you can take Tylenol /and or motrin please, if you get worse-go to the ER, and Call your PCM
stiff neck & arms w/in 2hrs of vax;24OCT lt arm swelling-chills, T100 inj given in lt deltoid;2hrs later pain, edema in lt deltoid, progressed to shoulder, neck stiffness, Tmax 100
Initial and follow-up information was received from a pharmacist concerning a female patient "in her 40's" who in "October or November 2004" was vaccinated with a dose of PPV.  Subsequently the patient developed "swelling and pain from the injection site to the neck area which subsided with treatment".  It was reported that the patient sought unspecified medical attention.  The patient recovered on an unspecified date.  There was no product quality complaint involved.    Follow-up information from the pharmacist indicated that there was "no problem".    Additional iformaiton is not expected.
"I am employee and took the egg and perservative free vaccine on Tuesday 10/20/15. After about 2 hours I had a constant headache and racing pulse of 100 to 120 until on Sunday. Starting on Wednesday the injection site was red warm and had a knot on it. Starting on Thursday I got my first fever blister and have had green diarrhea since this time. I had no reaction at all last year."
Presented with SOB, non productive cough, h/a, mild congestion x 3 days; + Covid in ED; Admitted for Covid infection; tx with steroid, remdesivir, Vit B12, singulair, zinc. Discharge Condition: Stable.
pt recvd vax 19JUL94 afternoon; mom called 21JUL94 AM w/concern ? react; had 4" x 2 1/2" erythemia area-edema on site & going underarm; had APAP x 4; no fever; later that evening edema went down to chest 8" x 8" from nipple area;
unopened prefilled syringes of FLUZONE HIGH-DOSE QUADRIVALENT from last year which expired on 30-JUN-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-SEP-2021 with no reported adverse event; Initial information was regarding an unsolicited valid serious case was received from a consumer/non-health care professional via regulatory authority (Reference number- 00794818) and transmitted to Sanofi on 01-Oct-2021.    This case involves an unknown demographic patient (unknown age and unknown gender) who had INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] unopened prefilled syringes from last year which expired on 30-Jun-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-Sep-2021 (expired product administered).  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 30-Sep-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ500AA, expiry date-30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired product administered (latency: same day).  It was reported "box containing unopened prefilled syringes of FLUZONE HIGH-DOSE QUADRIVALENT from last year which expired on 30-Jun-2021 was accidentally left in the refrigerator and administered to 4 patients on 30-Sep-2021".  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Acute Horrible abdominal pain, vomiting, went to ER they did a CT scan without contrast and diagnosed me with severe constipation. Sent me home with bowel clear plan.  Did not really work and pain continued. Went back to ER on that Friday had another CT scan WITH contrast where they saw a blood clot to the spleen resulting in an infarction as well as a blood clot to the right kidney.  Stayed in hospital overnight and placed on blood thinners.
Patient given 3rd dose Hepatitis B vaccine 11:00 AM 04/09/2004 - Had itchy rash develop after dose #2 11/04/2003 Provider made contact with CDC NIP Immunization Safety Branch and was advised. "I advise careful discussion and reassurance with parents, re-immunization on schedule, pre-medication with antihistamine and close monitoring withh telephone follow-up for first few days" - Patient given 50mg Benadryl 1 hour prior to administration of vaccine - repeated that evening and next day - child doing well on Sunday evening 04/11/2004 - Monday 8:00AM 4/12/2004 mother received call from school nurse advising of itchy rash - mother states rash on arms , back & chest- no tightness in throat or difficulty breathing - given Benadryl 50 mg family physician notified Benary repeated Monday eve- child returned to school Tuesday 04/13/2004 with some rash but minimal itching
About 35 days later I woke up early morning about 4:30 a.m. with a sharp pain in my left underarm. I felt a lump about the size of a quarter in my left armpit. Contacted doctor's office and went to see the my primary care physician the following day who determined or believes I had a infection possibly of the glands and wanted to wait a week before doing anything. After 7:00 or 8 days the pain subsided and the lump was smaller. Today July 2nd 2021 the lump is gone down considerably and there is no more pain.
03/24/2021 after 10-15 of the vaccine at 11:50AM, I started feeling the analectic, red rash, hot, I was itching, scalp, mouth, arms, all over my body. The pharmacy tech gave me Benadryl, I became very dizzy. My husband took me home. I slept a lot, I missed work. I was tired I couldn't function well. On April 27/2021, May 07,2021 and May18,2021, I had tight throat, red rash, red face, scalp itching, I took allergy medication. I past out 2 twice on mid April. I was diagnosed with nerve damage vertigo. To help nerve damager I went to physical therapy, May-August stimulation therapy. On May at the same time my local primary care doctor got me transfer to more doctors. I went to 12 doctors which are dermatology, neurology, cardiovascular disease specialist, allergist, physical therapist, otorhinolaryngology, COVID doctor, 5 times I  went to the emergency room. 2 were ambulance transfers.