chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cataract; Clot blood; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (Cataract) and THROMBOSIS (Clot blood) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No reported medical history.  Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CATARACT (Cataract) (seriousness criterion medically significant) and THROMBOSIS (Clot blood) (seriousness criterion medically significant). At the time of the report, CATARACT (Cataract) was resolving and THROMBOSIS (Clot blood) outcome was unknown.            Concomitant medication was not provided. For Humira, reporter causality was not provided, causality as per Mfr. was no reasonable possibility. It was unknown if patient was enrolled in COVID-19 clinical trial. The patient had cataract surgery.  Company comment: This spontaneous case concerns a 68-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected serious (medically significant) events of Cataract and Thrombosis (AESI) which occurred unknown days after receiving booster dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient underwent surgery for the treatment of cataract. History of Crohn's disease and co-suspect drug adalimumab remain risk factors for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with relevant medical history of Crohn's disease, who experienced the unexpected serious (medically significant) events of Cataract and Thrombosis (AESI) which occurred unknown days after receiving booster dose of mRNA-1273 vaccine in the covid 19 vaccination series. Patient underwent surgery for the treatment of cataract. History of Crohn's disease and co-suspect drug adalimumab remain risk factors for the event thrombosis. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Moderna COVID-19 Vaccine EUA  Swelling of lips and tongue 1-2 hours after receiving the vaccine.
When receiving immunization felt a jolt down my arms and out my finger tips as is an electrical shock.  By that evening I had lost almost all range of motion in my left arm.  The loss of motion continues one and a half months later although not always as extreme.
sz 45min p/vax 27FEB97;t102, 02 suction;IV phenobarb unresponsive, tonic clonic movement, on adm;no sx obersved until saw sz;27FEB @ MN pt having sz-call 911;dx poss viral encephalitis or post pertussis encephalitis r/o leukemia
Received a vaccine which was more than 30 days in the refrigerator; Received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.  The patient received a vaccine which was 12 days in the refrigerator.
PATIENT GOT LIGHTHEADED AND PALE. PARENTS SAID SHE HAD NOT EATEN BREAKFAST. SHE DID NOT FALL DOWN. SHE SAT DOWN NEXT TO PARENTS. SHE DID NOT LOSE CONSCIOUSNESS. NURSE APPLIED COLD PACK TO BACK OF HEAD AND GAVE HER A LOLLIPOP TO EAT. FANNED PATIENT AND ASKED HER ORIENTATING QUESTIONS. AFTER 10 MINUTES HER COLOR TO FACE WAS BETTER THAN BEFORE AND STATED FEELING BETTER. WALKED UNASSISTED OUT OF THE CLINIC WITH PARENTS.
Pt. has had recurrent purulent abscess develop in location of injection. Wound culture collected was sterile. I and D produce expressed yellow/green thick cloudy d/c and parents report reaccumulation even after antibiotic treatment. Pt. being referred to dermatology as well.
60 year old male who presents to the ED accompanied by his wife for c/o syncopal episodes. They were at the Fair four days ago when he became dizzy, lightheaded, diaphoretic, and became nauseated and had an emesis. They walked to the first aid tent at the fair where a nurse checked his blood pressure and said maybe it was a TIA and if it happened again he should get checked out. Yesterday he was working on the combine at the farm and woke up on the ground. He was working on a snout of the combine and thinks maybe he was hit in the head. He has an abrasion to the right side of his forehead and a large skin tear to his left forearm. Today his 15 year old son was trying to call his phone and he wouldn't answer. His son found him lying down on the couch, and he said he was not "feeling well." The son called his mother to let him know he found dad and he wasn't feeling well, had emesis x2, and was "talking like a funny person."    His spouse states over the summer he has had issues with his balance and speech. She feels like he really has to think about what he is going to say and his words are "measured and precise." He has been having ongoing headaches and nausea. He went to his eye doctor approximately 6 weeks ago and was told his vision was improved, but he needed to see his PCP for a check-up and evaluated for diabetes. He also had skull plain films on 8/4/21 and MRI brain w/wo contrast 8/10/21 with no significant findings. He recently finished two courses of antibiotics for sinusitis which he doesn't think has completely resolved.
Redness, swelling, discoloration at injection site. Still swollen and discolored at time of second dose 4/15/2022.
Itching watery eyes followed by rapidly worsening angioedema, urticaria and anaphylaxis within 2 hour of vaccination. Patient was treated aggressively with IM dexamethasone, Benadryl and sub cutaneous epinepherine.  Symptoms initially improved but later worsened again.  At that time IV Solumedrol was given and patient was transported to the ER.  patient was discharged from the ER on oral steroids.  Later that evening developed a local swelling with numbness and tingling in Left arm and hand with a L sided facial droop.  He was referred both to an allergist as well as a neurologist.  He currently has a vaccine induced polyneuropathy with a brachial plexus neuritis and is following with Neurology.
The patient's mom stated the patient felt severe chest tightness and pain for about 8 hours after the vaccine then came back 2 days later and still having signs and symptoms.
Patient reports that she received MMR on 06/21/2012 and on 06/25/2012 developed a rash on her abdomen. Denies fever or other symptoms.
Per patient, has had cough for about 2 weeks (starting mid-August?). Presented to the hospital on 8/31/21 due to wound infection. Tested positive in the hospital on 9/1/21 and has mild cough as only symptom.
Received H1N1 2nd dose 12-17-09. Had nose bleed 12-18-09 at school. Went to see school nurse. Bleeding had almost stopped.
Severe, intense, prickly itching on upper left arm adjacent to the actual injection spot.   Took two 25 mg tablets of Benadryl and applied Hydrocortisone cream to affected area.   Symptoms subsided quickly.  It i now 19 hours later.   I feel slight symptoms.  I have applied the cream but have not taken any more Benadryl.
second dose greater than two years ago, has not received third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 2nd dose, greater than two years ago from the date of reporting).   On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete vaccination schedule. Pharmacist did not have dates of the first doses, nor lot number and expiration date information.   The pharmacist did not have patient information other than gender. The reporter consented to follow up. The reporter gave permission for follow up but declined to provide email address or mailing address.
11/03/2003. INFLUENZA VACCINE RECEIVED.  RASH DESCRIBED AS PEA SIZE, THEN BLOTCHY RED, ITCHY, HOT, PRICKLY.  STARTED ON WRISTS, PROCEEDED TO HANDS, TRUNK, LEGS, FEET.  11/06/2003.  THE RASH WAS NEARLY GONE.
Tongue became very dry, felt faint first few minutes, but thought i was nervous , left facility after waiting 20 minutes, At home after one hour lips began to swell , I then went back to  Hospital was admitted to ER , 50 mg Benadryl administered and I was monitored for several hours until lips began to return to normal
within one hour, felt nausea, loss of appetite.  After 4 hours, developed 102 fever, chills, vomiting, severe diaharrea, lasted several hours
client notified vaccinator that has had previous anaphylactic reaction with shingles vaccine, client put on 30 minute observation, within approximately 15 minutes client reported throat becoming raspy and uncomfortable, as this nurse was approaching client she gave her own epi-pen into her thumb but stated she stopped it immediately, this nurse gave second epi pen in client's left thigh at 10:35, Dr. on site assessed client after receiving epi, and reported airway appears client, negative swelling, lungs clear, no current respiratory distress, no rash. BP was 122/72, pulse 107. Client taken by ambulance  to Hospital ED. Dr. later reported client  had wheezing and required albuterol and prednisone. She was tachycardic and breathing comfortably. She was observed in ED for 3 hours.
Immunization given 11/13/2008 11:40PM call placed to Take Care 11/13/2008 11:45PM c/o nausea coughing, chest tightness, sweating, blurry vision.
This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. On an unspecified date after vaccination with Lymerix, the subject experienced joint pain and swelling, memory loss, headaches, flu like symptoms, hearing loss, decreased activities of daily life, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
15 minutes after vaccine, had flushing, hypertension and tachycardia. 50 mg benadryl liquid.  Patient anxious with these symptoms, feet shaking, felt heart "beating out of chest." Vitals gradually improved after benadryl over one hour. Sent home in care of husband. Will call tomorrow to check on patient and work with allergist on follow up vaccine before receiving.
I experienced pain, body pain and swelling, red blotchiness for three weeks. I had extreme fatigue which messed up my potassium levels, had infrequent bowel movements and diarrhea.  I had left arm pain and it was painful when doing my exercises. I had no fever, a horrible headaches that I was not hungry and felt very nauseated. I also experienced horrible chills but did not go to the hospital.
Numbness in the arm that I got vaccination in; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in arm on an unspecified date as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunisation. The patient had both of the vaccine doses and now the arm was starting like getting numb now (arm that got vaccination) and wondering if numbness in the arm was one of the side effects. The outcome of the event was unknown.   Information about lot/batch number has been requested.
01May97 pt recv vax SC 1st dose varicella virus vax live. 14Jan98 pt devel 5 fluid filled lesions on trunk. Pt brother had chickenpox 2 wk prior to pt exp.
Immediate redness, swelling, itching and have formation at injection site (Varivax) left later aspect upper arm.
Second Pfizer: I had a mild headache and sore R arm the evening of the 24th. The next day, I became very ill around 1pm with incontrollable chills, severe spinal pain from Cervical to sacrum, and severe radiating pain on both sides of my back. Pain ranked as a 7-8/10. Took 800 mg of Advil and then took Tylenol 3 hours later and no change. Thought about going to ER but did not go. The next day pain was reduced to a 3/10 and was extremely tired and no energy and was lying down most of the day with extremely fatigue. Gradually better the next two days for full recovery.
after about 4 days after taking the vax pt developed a severe rash all over her body that last from 4-8 hours and then disappeared.  On 4/28/21 pt developed four severe headaches that would come and go.  They were severe, short, swift and painful lasting approximately 5-7 minutes.  These headaches episodes were within an hour and half time period.   She still has had aches and pain in both arms and legs and both knees were swollen.  Pt has been taking Ibuprofen for the pain but it does not seem to help. Pt will reach out to her PCP for medical advice.
BRIGHT RED RASH WITH INFLAMMATION AT INJECTION SITE - SAW PHYSICIAN - DIAGNOSED AS IMMUNIZATION REACTION
Patient developed a skin infection (pustule) at injection site. Pt saw his dr for a course of cephalexin.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were provided No treatment medications were provided Action taken with mRNA-1273 is not applicable
Since day after vaccination, until the date of this filing...  I have experience ongoing, sometime debilitating brain fog, dizziness, ear-ringing, and phantom unexplained neck-pain.  I am currently hoping these symptoms go away, however, it has been 3 months and they are not going away.  I will be seeking a medical professional if they do not go away soon.
Information has been received from a nurse concerning an "around 21 year" old female patient who approximately on 21-AUG-2007 was vaccinated with a first dose of Gardasil.  The reporter reported that "the patient said her arm felt weird and she did not feel well after getting the dose of Gardasil.  She called back the office after she went home because she felt tightness in her chest.  The physician suggested her to go to the Emergency Room, where she was given BENADRYL".  No additional information was provided.  The outcome was unknown.  Additional information has been requested.
Severe muscle pain in back of thighs beginning October 10, much  worse today October11.  Can hardly stoop down to pick up things on floor.  No treatment at this time.   Hope symptoms will abate soon.
Vaccine was placed in refrigerator on 22 sep 21, expired on 09 oct 21 and administered on 22 oct 21; Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 22 sep 21, expired on 09 oct 21 and administered on 22 oct 21) and EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 22 sep 21, expired on 09 oct 21 and administered on 22 oct 21). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was placed in refrigerator on 22 sep 21, expired on 09 oct 21 and administered on 22 oct 21) and EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No temperature excursion happened after vial was placed in refrigerator on 22-Sep-2021. No adverse events were reported. Treatment information was not provided.
6/8 Patient presented in the Ed with weakness, tingling and numbness in the hands and lower extremity.  She reports symptoms for the previous 3 days.  LP remarkable for elevated proteins (80) with 0 WBC and RBC.  Recent questionable URI and a few episodes of diarrhea were reported.  Pt had "stocking-glove paresthesias suggestive of Guillain-Barre Syndrome and was placed on IVIG therapy.  Discharged from the hospital improved on 6/19/2021.
Administrative deviation only;no adverse event resulted from this deviation.This patient received a  mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer-box #4 reflects the date of the second dose).The decision to administer a mixed series to the patient was due to an " exceptional circumstance "  stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was due.We understand that although CDC provides considerations for a  mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting.Note second vaccination date is listed.
Large Pimple on Left Breast - very unusual for me.  (Reporting as I'd heard of some cases of lumps in breast nearest shot site.  2020 Mammogram noted a suspicious area which required an ultrasound .) Though Minor, I'm reporting to help determine if this is a result of the injection, and what signs should I watch.
Patient is a 34-year-old man who is otherwise healthy admitted following a syncopal episode at home. Yesterday afternoon, he received his first dose of the Moderna vaccine around 1pm. His arm felt sore afterwards, though otherwise he felt generally well. This morning when he awoke, he felt generally unwell with dizziness, lightheadedness, and presyncope. He attempted to walk to the bathroom to splash some cold water on his face. He then had a syncopal episode. When he awoke on the bathroom floor, he developed nausea and vomiting. His family was at his side and ultimately called emergency services. Shortly after arrival to the ER this morning, he then had another episode of loss of consciousness. He was laying supine in his stretcher at the time with no clear provoking factors. He then developed recurrent dizziness, lightheadedness, and presyncope followed by loss of consciousness. Review of his telemetry was notable for sinus rhythm with gradual slowing of his sinus rate followed by sinus arrest with an approximately 22 second pause/asystolic event. The team was at bedside preparing to start CPR. However, he subsequently regained consciousness with normal sinus rhythm on telemetry. His ECG on presentation was relatively unremarkable. His labs are notable for a mildly elevated creatinine of 1.3, otherwise unremarkable. His initial troponin, ESR, CRP, and NT-ProBNP were normal. He continues to feel unwell in general. He denies chest pain and chest tightness. He denies shortness of breath. He reports a remote history of syncope following a blood draw when he was a teenager. There is no known family history of sudden cardiac death. He denies any concerning symptoms prior to this morning.
Immediately after receiving the two vaccines patient stood up and felt lightheaded, was weak, said he felt bad and fell back into his chair. He trembled a little and father picked him up in his arms. I was called in immediately and was told he had fainted. He was pale and diaphoretic but responsive and oriented with normal vital signs. He stayed in the office for 45 minutes for observation.
Temperature 104 deg. F. Friday at midnight. Diagnosed with bilateral otitis media and respiratory syncytial virus.
45mm red, hot & swollen on the left side IM of arm. Pt grandmother gave her ibuprofen and hydrocortisone cream.
vertigo, chills, sweating, body aches, headache, fainting, soreness and redness at site of vaccination
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Concomitant medication and treatment drug were not reported.   This case was linked to MOD-2021-018165 (Patient Link).