chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client was vaccinated by vaccinator, despite client's age being 11y at time of vaccination.
Patient received 4th dose (2nd booster) and within less than 1 month developed severe and refractory thrombocytopenia requiring hospitalization. Also noted to have a bone marrow biopsy that is concerning for ACUTE LEUKEMIA
Hives after one hour, numbness in arm of injection site, pins and needle in hands and feet, dizziness, blurry vision, chills, fever (100.2), fatigue, nausea, scratchy throat
CLIENT HAD UNUSUAL SORENESS (WITH MALAISE) TO SITE OF MEN B- IN RIGHT DELTOID.  SORENESS, REDNESS AND A "KNOT" STARTED DAY AFTER VACCINATION. THIS SITE BECAME MORE AGGRAVATED( MORE REDNESS, HEAT, KNOT  AND MALAISE) AND CLIENT DID NOT FEEL WELL ON THURSDAY, 2/24. SYMPTOMS SLOWLY RESOLVED OVER FRIDAY, SATURDAY AND SUNDAY WITH SUPPORTIVE CARE (OTC ANALGESICS). PARENT CALLED TO DAY JUST TO REPORT SITUATION. CLIENT STILL DOES NOT FEEL 100% YET BUT HAS NOT MISSED SCHOOL ON ANY DAY SINCE THE VACCINE. PARENT IS CONCERNED BECAUSE CLIENT HAD AN UNUSALLY SEVERE REACTION TO EBV- RESULTING IN 12 DAY HOSPITALIZATION HOSPITAL. CLIENT SEES A PEDIATRICIAN AND PARENT WILL FOLLOW UP WITH HCP BEFORE ALLOWING THE BOOSTER SHOT TO  BE GIVEN.  THE CLIENT DID NOT HAVE A SIGNIFICANT REACTION TO THE MENVEO BOOSTER.
Had hives over chest, legs and arm. No shortness of breath. he was given Benadryl. Did not take epi. Hives resolved within 6 hours.
On Sunday March 28 (one week after vaccination), discovered a painful lump in my left armpit. The lump has decreased in size but it still painful to palpation today (Wednesday March 31st). On Tuesday, March 30, developed an erythematous circular rash approximately 5 cm in diameter centered over the site of the injection. No pruritis or pain with the rash.
Patient states immediately following her first dose of Pfizer, she began to feel "tightening" and "tingling" in throat. Patient did not notify medical personnel on site. Patient left facility after 15 minutes in observation area. Patient denies shortness of breath. Patient states symptoms resolved on their own after a few hours.
Patient received the vaccine at 4:15 pm.   4:27  staff notified of symptom onset. 4:30   BP 110/88   P 92  Patient reports feeling lightheaded and throat feels swollen 4:35  Lightheadedness comes in waves.  Last ate around 12 noon.  Feels like "lump in throat" slight pain with swallowing.  Denes SOB, itching or N/V 4:57  No progression of symptoms, no new onset of symptoms.  educated patient and Dad on signs and symptoms of severe reaction.  Left with Dad at 4:57
pt admitted to hospital for worsenting shortness of breath. covid +, sob related fluid overloas started on diuresis and iv antibiotics. when stable pt discharged back
Moderna COVID-19 Vaccine EUA. Patient suffered excessive and frequent menstruation with regular cycle lasting 18 days. Menstrual Cycle began on March 1, 2021 and concluded on March 18, 2021.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient appeared to have a seizure/fainting episode ~60 seconds after vaccination.  The episode lasted ~ 30 seconds.  Patient knew where she was, and came too rather quickly.  EMS called and consulted with patient, her mother came to drive her to a dr's office for neurological evaluation.  She did not hit her head.
Information was received from a lawyer 08-AUG-2017 regarding a case in litigation concerning a plaintiff of unspecified age and gender. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 28-SEP-2011 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 24-JAN-2016, the plaintiff was treated by a Family Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles interference into the eye. As a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information was requested.
patient received second Adacel doses one week apart; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 years old female patient who received 0.5 ml second dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5980EA (Expiry date 22-Jun-2020) via intramuscular route in the right deltoid on 07-Aug-2019 and she also received a first dose of the same vaccine with an unknown batch number via unknown route in unknown administration site on 31-Jul-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL).  It was an actual medication error case due extra dose administered.   It was reported that that patient received a dose of Adacel on 31Jul2019 at another clinic with one parent and received a 2nd dose on 07Aug2019 with the other parent.  At a time of vaccination no adverse events were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  Information on batch number of first vaccine is requested.  List of documents held by sender: none.
On 04/20/2021 I had a pain a couple days before my event happened. I had a pain in my left side where my lymph nodes are. I thought this was menstrual cramps and I took Ibuprofen, and it didn't go away and that was strange, so I just moved on. On the day 4/22/2021 I woke up with my entire left arm numb. Could not feel it at all and I had this ringing in my ears and the most incredible headache/eye pain that I've ever felt in my whole life. Felt like the back of my eyeballs. I also had gotten Covid this past October 2021 and that was the exact pain I had felt before. So, I got up and felt nauseous and I did take an ibuprofen and tried to put food in my body. I began to vomit violently, and it was vomit like I had eaten piles of food and I just woke up. It was bile liquid and blood. Husband came and I came out and sat down, and I lost use of my limbs and collapsed, and I said the headache was so bad. And I just kept throwing up and throwing up blood. I tried to sit up in my bed and I tried to drink water. I tried to take care of it, and I just couldn't. I was sitting in bed, and I was just really hot and sharp shooting pain in my body. I could describe it as if I was burning from the inside. I just kept throwing up blood and we finally got a hold of my doctor. Asked if I had a fever or if I was around anyone with Covid. He prescribed anti-nausea medicine and said to take fluids. And I had a breakthrough seizure which I haven't had in years. That was scary. I had the seizure, and I was throwing up again and doctor said to call EMS. The ambulance came and checked my vitals, and they weren't too helpful. I never stopped throwing up blood and went to the ER and was checked and they left me. Still throwing up blood. Covid patients were everywhere so we actually left the ER. I went home and rode it out at home. Took fluids and took anti-nausea medication. This went from 6AM and went to about 2-3PM and took any type of pain medicine that I could. Sleeping and waking up and passing out. At about 10PM at night after passing out again. I woke up and felt like I had a hangover, and I went to the bathroom. Drank more fluids, ate, got up the next morning and had a headache and had a cup of coffee and crackers. I was dehydrated and tired. The whole day was just me doing a little bit and taking a nap and keep taking in fluids as much as I could. Light foods. I kept doing that as much as I could. I went to the doctor for follow up and they did a bunch of tests, and everything was normal. Gave me omeprazole for the stomach lining for 6 days. I wasn't better until maybe Saturday or Sunday later that week where I could function. Follow up with doctor, he said that was scary, but we got through it. Called Neurologist about it as well and that I had a seizure and she said that other patients were having seizures as well. Was told to take it easy.
Has received DTaP and IPV on LA on 9/26/02. Pt have on 9/28/02 with swelling and redness. Tylenol chewables 2 q warm moist compresses.
I had seen my primary doctor on Feb. 11th and felt fine.  On Friday,  Feb. 12, I received my 1st dose of vaccine and by Monday I had a really bad sore throat and was very fatigued and tired.  I had just started working so was not sure what it was.  I went in for a COVID test on Feb. 23rd and that was negative.  I  saw my doctor on March 3rd and we discussed that my symptoms could be Ebstein Barr Virus re-activation.  My doctor took blood to confirm positive EBV which it was.  She told me to get as much rest as I could.   In June I was still not well.   My doctor took more lab work and confirmed EBV was still positive.  Now I'm considered to have Chronic EBV and still suffering.  I'm taking Valacyclovir medication.
Dr. felt pain at the time of the injection (but was not concerned) on 12/20; by that evening the left, around elbow & above, was swollen & stiff.  Had a slight fever (about 99 degrees F).  12/21-area above L elbow very warm, red, swollen.  12/22-redness traveled below elbow, very stiff, went to urgent care.  Was given Decadron IV & clindamycin.  On 12/24-also saw own infectious disease Dr. who agreed that there was no abscess, rec. d/c clindamycin (he took about 6-7 doses total).  As of 1/2/08, completely recovered.
Patient is a 82 y.o. female who presented to Hospital on 11/2/2021 from assisted living facility. The patient is known COVID-19 positive and presented with increased weakness and found to have AKI and hypokalemia. While hospitalized she received IVF resuscitation and her AKI resolved. She received aggressive potassium replacement during her hospitalization. Upon discharge will continue KCl 40meq daily. The patient was noted to have COVID-19 viral pneumonia. She never showed signs of respiratory distress and remained on room air throughout her hospital stay. The patient has been vaccinated, she was not a candidate for remdesivir or decadron. Given the increased weakness she was evaluated by PT/OT who recommended Rehab, unfortunately there were no available beds at rehab hospital accepting patient with COVID and the patient was unable to return to assisted living until 11/12/2021. Thus the patient will be discharging to her daughter's home and was set-up with a lift and hospital bed. Patient will need a follow-up TSH in 6 weeks as her levothyroxine dose was reduced to 175mcg daily due to low TSH, with an elevated t3 and t4. Would also consider follow-up BMP. Recommend follow-up with PCP in 1 week for post-hospitalization follow-up and coordination of care. Other medical issues addressed this hospitalization: Late onset Alzheimer's disease with behavioral disturbance.- At baseline  Type 2 diabetes mellitus with diabetic neuropathy, with long-term current use of insulin - Repeat A1C 7.8 - Reduced home lantus and novolog dose to prevent hypoglycemia, continue outpatient follow-up for management . Class 2 severe obesity with serious comorbidity in adult. - Complicating risk factor for COVID-19 - Recommend outpatient follow-up with PCP , Atrial fibrillation - Not on OAC at baseline due to high risk for falls - Rate controlled
24 hours after first dose of pfizer vaccine, had palpitations and GI upset, vomited.
Client treated at ER for steam burn and received a Td shot.  Later that day, arm swelling, general malaise, diarrhea, nausea, chills, fever onset.  The symptoms continued for about 72 hours.  client was re-evaluated on 7/20/09 at Health Dept. and treatment started.
bud 4/07/2022 administered 4/11/2022.Pfizer could not submit stability data beyond 04/09/2022  and recommended an additional Booster provided on 05/10/2022
She was hospitalized on 01/04 but exact situation unknown. COVID +. Hospitalized at Medical Center.
Patient with known seizure disorder, on Keppra, had a 3-minute seizure 5-10 minutes post second Moderna vaccine. This was observed by the  officer and safety nurse. She had no reaction with the first vaccine four weeks ago, and stated that over the last four months she has had five seizures; her physician is aware and they are modifying her medication. Immediate return to baseline, no post-ictal period, no soiling with urine or feces. Patient reports new onset of seizures at age 18. She did not have rescue medication with her. She declined EMS transport.  Nurse waited with her while her husband came to pick her up. No additional seizure activity in the time she was observed, although she was shaking. She
Two days after receiving the covid vaccination my daughter develop a rash/bumps betwen her legs that look like mosquito bites. She said that there were itchy and burning. The rash/bumps than spread to her lower legs, ankles, arms, chest within a few hours. The spread of bumps then became clumped together causing wider and longer rash. She is  with a medium skin tone, the rash made her skin look red. I gave her Benadryl tablets but they did not help her symptoms of itchy and burning. She was very uncomfortable for a few days.
Approximately one week after receiving the Johnson & Johnson COVID-19 booster shot (second dose), I developed small, dry, itchy, red patches of skin on my right leg below the knee that looked like eczema. Soon it spread to my left leg below the knee as well. I tried to treat this myself with a variety of skin creams and over-the-counter eczema lotions but none of these cured the skin condition. By the second week after the booster shot, the skin on my legs -- now my arms as well -- began to feel bumpy like "chicken skin," and the itchy red patches on my legs continued. By the third week, I had itchy, full-blown hives and welts on my arms and legs, covering my whole arms and whole legs (not just below the knee). I contacted my dermatologist on 11/24/2021, and she advised me to take Benadryl every 4 hours around the clock for at least 5 days. She also told me to use Sarna skin cream and Calamine lotion as needed. I followed this advice, and at the end of the 5th day, the hives/welts disappeared and the itching stopped, but I still had scarred up patches of skin below the knees on both legs. I believe this allergic skin reaction was caused by the booster shot because I've never had these types of symptoms ever before, and nothing else about my diet or lifestyle had changed that could have caused such a reaction.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated an improperly stored dose of with PNEUMOVAX 23 (route of administration was not reported) lot # N011305 with expiration date 20-JAN-2019, lot # N025656 with expiration date 19-APR-2019 (also reported as "09-APR-2019"); or ROTATEQ per oral, lot # N029868 with expiration date 12-MAR-2019 and lot # reported as N0234400 with expiration date reported as 10-MAY-2019; both for prophylaxis. No adverse effects were reported. It was reported that the vaccines were exposed to a temperature between 9 to 25 (13.6) Celsius degrees for 17 hours. No previous temperature excursion was reported. A digital data logger was involved. Lot number N0234400 is an invalid lot number for ROTATEQ.
verbalized a stinging sensation felt immed p/inj into rt deltoid;by evening noted golf ball sized swelling @ inj site along w/pink blotches & cont stinging sensation;As of 27OCT swelling absent, blotches & stinging faded completely by 30OC
very hurtful for a couple of days on right arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EM9810) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "very hurtful for a couple of days on right arm".  Additional information: The patient had her first dose of vaccine on 06Feb2021 (Lot Number: EM9810) and was administered in her right arm  about noon. On 27Feb2021, the patient received the second dose of vaccine with reported lot number EM9810 and expiration date of 30Jun2021 . The second dose was administered in her left arm as her right arm  was very hurtful for a couple of days. The patient used her right arm for everything so the second dose was administered in her left arm.  The third dose was administered on 11Nov2021 (Lot Number: EN6202 and Expiration date: 01Apr2022), administered about noon in her left arm. The fourth dose was administered on 01Apr2022 (Lot Number: FJ9943), administered about noon in her left arm.. The fifth dose was administered on 08Sep2022 (Lot Number: GH9694) and administered in her left arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300185381 Same patient, same drug/different dose, different AE.;
Eryth. vesicular lesion/pruritic in crops < 7 cm trunk/neck/face.
This spontaneous report was received from a pharmacist referring a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 11-OCT-2016 the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU with lot number H013020, expiration date 09-OCT-2013, 0.65 ml, subcutaneously. No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Flu and pneumonia vac administered 10/6/14. Pt exp chills, severe pain (R) arm, mild redness, inability to raise or move arm well, fever, pain in fingers and mouth sores - approx 1 day post adm by hx. Pt reported events <T pharm on 10/10/14. Pt was counseled to see his primary care physician ASAP. Pt appears improved.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 18-JUN-2012, the patient was inoculated at a medical center with ZOSTAVA) (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-MAR-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her continued painful symptoms. As a direct and proximate result of these malfunctions, she has suffered painful injuries and damages. and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses. and pain and suffering, and other damages. Additional information has been requested.
On 01/30/2001, the patient developed varicella. Subsequently, the patient recovered.
I had a hard time breathing. I got very dizzy. I went to the ER. They said that I had a heart attack but I did not think it was a heart attack. Then I could not catch my breath. I went to my doctor and they said it was bronco asthma. I was in good health before the shot. Nothing wrong with my heart or lungs. I can hardly walk without losing my breath. I am on an inhaler now.
A purple/red rash appeared about 1 month after first and second COVID vaccine on breast, the rash remained. 3rd COVID vaccine was given and the rash started to increase in size. Visited a dermatologist who biopsied the rash and it was found to be superficial pre-vascular dermatitis. Dermatologist to prescribe topical steriods.
Received DTAP vaccine on 11/17/10 on (L) deltoid. Presents with 13cm x 14cm erythematous area surrounding injection site (L) upper arm with mild induration.
arm still sore underneath injection site; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and VACCINATION SITE PAIN (arm still sore underneath injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LISINOPRIL for an unknown indication.   On 19-Apr-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 19-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm still sore underneath injection site). On 21-Apr-2021, PAIN IN EXTREMITY (arm was sore) had resolved. At the time of the report, VACCINATION SITE PAIN (arm still sore underneath injection site) had not resolved. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Concomitant medications also included Vitamins and Supplements. Treatment information was unknown.
Complaints of feeling light headed and throat closing up. VS: 153/108-124-02 sat 99%. AOX4. No stridor, no wheezing, bilateral BS CTA x4. Voice audible. Water provided. Became upset and tearful and continues to report her throat was closing off. EPI 0.3mg injection given in left thigh IM. EMS called. EMS arrival evaluated and patient declined transport. Called 03/28/21 for follow up x3 with no response or call back. Advised to contact PCP
Information has been received from an office manager concerning a 77 year old female who on 23-OCT-2006 was vaccinated intramuscurlary with a 0.5 mL dose of Pnemovax 23 (either Lot # 651373/0320F or Lot # 651318/1006F). Concomitant therapy included HYDRODIURIL, alendronate sodium (MSD), NORVAX, LIPITOR and SYNTHROID. On 24-OCT-2006 the patient developed an injection site reaction that included a 6" x 3" area that was red, swollen, painful and warm to touch. The patient sought unspecified medical attention. The patient was treated with unspecified antihistamines and unspecified antibiotics. Subsequently, the patient recovered. Additional information has been requested.
Patient received Moderna COVID vaccine on 2/6/21 (lot # 013M20A), 3/6/21 (lot # 029A21A), 11/24/21 (lot # 065F21A), and 4/13/21 (lot # 033K21A). On 1/9/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia due to COVID-19 pneumonia and chest pain NSTEMI likely 2/2 demand ischemia type 2 myocardial infarction.  As of today (1/13/23), patient is still admitted in the med/surg unit.