chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 13-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
had the vaccine and have shingles now/ Suspected vaccination failure; have shingles now; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had shingles vaccine and had shingles now. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
pt recv vax 7AUG97 & shortly p/vax pt devel a fever of 104 which inc to 106 on 9AUG97;pt was dx w/OM;tx w/ATB & the fever resolved;10AUG97 pt awoke not using lt arm;seen in ER unable to move lt arm;dx brachial plexus neuritis;
Metastatic melanoma most likely a recurrence from the 2014; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, administered in left arm on 29Jan2021 13:00 (at 37-year-old) at single dose for COVID-19 immunization. The vaccine was administered at military base. Medical history included stage 1b malignant melanoma lesion removed from right shoulder in 2014. The patient was not diagnosed with COVID-19 prior to vaccination. None known allergies to medications, food, or other products. Concomitant medications included multivitamins [VITAMINS NOS]; fish oil. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a stage 1b malignant melanoma lesion removed from his right shoulder in 2014 and had completed all required follow-up. On 06Feb2021 06:00 PM, about a week after receiving the first dose (left arm), patient noticed a small marble-sized lump in his right armpit. The lump continued to grow rapidly, and he went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. The patient received the second dose on 18Feb2021 (left arm) and noticed the lump in his right armpit grew much faster and he had a reaction (swollen nodes) in his left armpit as well. The melanoma was limited to his right armpit. They were reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because they are  investigating the biopsy/pathology of the tumor in the right axilla as there were features, they had never seen before in melanoma. The event was reported as non-serious. It resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included immunotherapy. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Exactly 2 weeks after receiving the first vaccine I felt dizzy and lightheaded.  I felt like I was leaning to the left from around noon and for the rest of the day.   Extreme dizziness.  I felt unsafe to walk and had to hold on to the walls.
Low grade fever, redness at vaccine site, bodyaches, fatigue. All symptoms lasted 3 days. Vaccine site still has redness and light swelling when patient was seen 4 days after vaccine administered.
"Yesterday morning around 11 am I had my first High Dose Flu Vac.  I felt ok & the sun came out so I decided to drive to Cemetery where my husband is buried. I got there about 1:30 pm & just drove in & my stomach started to feel uncomfortable & soon I was very nauseated.  I had a tough time making it the 13 miles back home, luckily having a plastic glass in the car!  After home there was more vomiting & I finally made it to bed where I remained the rest of the day & night.  I would be cool at times & too warm at times. Today my stomach is sore & I don't feel like eating anything. I know this is not the "normal" reaction to a flu vac but I don't believe it is just coincidence.  This is just FYI as the injection nurse said patients are all reporting no problem. I felt I should report it."
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients were vaccinated with improperly stored ZOSTAVAX (dose and batch no. unknown). No adverse effects were reported. The outcome of events was unknown. This is one of the two reports from the same reporter. Additional information has been requested.
Shingrix vaccine Reactions to vaccination: chicken pox rash.  I was traveling I thought at first I had mosquito bites  But they were in odd places where clothing covers.  Eventually they were on my belly, back, thighs, folds around my elbows and knees.  That?s when I began to suspect an out break of chicken pox! They are starting to scab over as of yesterday October 11.     As a child I had chicken pox,  I cared for all four of my children when they had chicken pox!  Has this happened to anyone else?
DRUG EXPOSURE THROUGH BREASTMILK; This spontaneous report received from a parent concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient's parent received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported.  On an unspecified date, the subject experienced drug exposure through breastmilk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of drug exposure through breastmilk was not reported. This report was non-serious. This parent/child case is linked to 20210416758.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage ROTATEQ, lot number as reported M012454, expiration date 25-JAN-2018, lot number as reported M02254, expiration date 15-NOV-2017, lot number as reported M037636, expiration date 06-APR-2018, lot number M018958, expiration date 03-MAR-2018, lot number M019706, expiration date 24-OCT-2017, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA002897: US-009507513-1702USA007382: US-009507513-1702USA007380: US-009507513-1702USA007381.
(Rt) upper arm swollen 6" x 5" - pink- per pt site was larger & red-states swelling down same-warm to touch/tender. Warm moist pad to site-TYLENOL-RTC PRN.
This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in a 25-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 November 2012 at 15:00 the subject received unspecified dose of FLULAVAL (.1 ml, unknown, right arm) and experienced wrong vaccine administered. On 7 November 2012, within a week of the vaccination with FLULAVAL, the subject experienced wrong vaccine administered, injection site redness, injection site swollen and hotness at injection site. The subject was supposed to receive a Tb test, but 0.1 ml of FLULAVAL was placed in the right arm instead of Tb test. The subject's arm was red, swollen and hot, like it would occur with a concentrated reaction at the site of administration. The reporter could not provide any additional details. At the time of reporting the outcome of the injection site redness, injection site swollen and hotness at injection site were unspecified. Follow up was received from the healthcare professional (occupational health nurse) on 8 January 2013. The nurse reported that on 10 November 2012, the events of injection site redness, injection site swollen, and hotness at injection site had resolved. The nurse did not consider these events serious. The nurse stated that these events were the result of erroneous administration where they "administered flu vaccine instead of PPD."
Developed diarrhea without blood or mucus. No N/V. Slightly decreased appetite, no significant cramping. Improving with OTC loperamide started on 7/4.
liver lymphoma; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown), for COVID-19 immunization, reaction(s): "liver lymphoma". The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "liver lymphoma". Per clinical course, patient developed liver lymphoma after receiving both COVID-19 shots and booster. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the event lymphoma and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200106296 same patient/drug/event, different dose;
1 hive below site of MMR (LT) minutes after1 yr injections. Given 5cc BENADRYL orally and iced site briefly.
not an adverse event, however incident reached patient.  Nurse called patient to her station with guardians. Nurse followed proper protocol and obtained documents, showed questionnaires, and obtained consent before preparing and giving the vaccine. Pediatrics patient was antsy during the whole vaccine prep. The nurse instructed both parents to properly hold the pediatrics limbs, especially the legs. The nurse prepared to administer and once the needle punctured the skin, the pedi patient jerked, disloging the needle out of the limb, causing none of the vaccine to be administered. The nurse reported to the Supervisor. Dr. was called and he recommends that the patient can get another vaccine today.
103 fever from 2PM - 10 PM freezing cold, then burning hot, along with body shakes and aches from 2PM - 10 PM 101.6 fever started again around 12 AM, symptoms started over again with freezing cold body shakes and aches, followed by extreme sweating throughout night until 8 AM.  100 fever from 8AM (24 hours after shot) until 1 PM. Extreme fatigue and sore body for next 24 hours.
On 5/17/00, Mom called reporting soreness, knot, fever and redness at the left deltoid injection site. States child extremely tired. On 5/22/00, Mom called reporting loss of appetite, vomiting and stomach pains after eating. Instructed Mom to take child to physician. Still complaining of tiredness. Also has had fever off and on since vaccine, up to 101.
Patient reported to pharmacy on 9/11/20 in the late afternoon with reports of reaction. She received shot in the morning of 9/10/20. Patient reported later that day her whole arm from shoulder to elbow had become swollen. Injection site was red, hard, was itchy and hot to the touch.  When patient reported to pharmacy swelling had went down. There did not appear to be any redness or hot to the touch but area was still hard and patient stated it still hurt.
Bubble where needle punctured arm, labored breathing, lightheaded. Appendicitis with perforation occurred approximately on 11/11/2016.
The first day after vaccination I started to feel tightness of chest, a short time later I started having dry mouth and I could not swallow correctly. I started feeling overly tired and difficulty breathing and swallowing became worse. The signs and symptoms appeared gradually and slowly. It was about a 2 hour duration from the start of the symptoms until I took BENADRYL and then I felt a little better. During the third day, I started having seizures, which I had already stopped having for approximately two months before the vaccination, they appeared once again. When the seizure would end my chest felt tight and with difficulty breathing. I have a lot of pain and sensation of electric shock on vaccination arm.
My whole arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My whole arm is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History information reported.).    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 PERIPHERAL SWELLING (My whole arm is swollen). At the time of the report, PERIPHERAL SWELLING (My whole arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided by the reporter. Treatment medication were not provided by the reporter.   Reporter did not allow further contact
Fatigue, body aches, fever (100.5 f), headache, chills and nausea. Symptoms began about 10 hours after injection and subsided about 26 hours after injection.
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 12/22/2020    Patient:   Date:  12/22/2020                                                                                           Subjective Patient is a 55 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the right deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience   Racing heart rate.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Pt presented with Rapid heart rate and palpitations.  Had episode of chest pain 6 weeks ago and was seen in ER.  D-dimer was positive and CT negative.  No FU since.    Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis.       Review of Systems  Cardiovascular: Positive for palpitations.  All other systems reviewed and are negative.        Objective    Vitals Vitals:   12/22/20 1453 12/22/20 1505 12/22/20 1526 BP: 133/87 133/85 123/81 BP Location: Right arm Right arm Right arm Patient Position: Sitting Sitting Sitting Pulse: 95 96 96 SpO2: 100% 99% 95%     Physical Exam Vitals signs reviewed.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Regular rhythm. Tachycardia present.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.   Pt released to go home at 3:25 pm.  No symptoms at that time.       12/22/2020 3:30 PM
Headache, Sedation, Phlebitis, Diarrhea, sore throat, eye pain wand warmth Narrative:
Flu and Pneumonia vaccines given 10/17/2005. Pt noted hives in afternoon 10/18/2005. Complained of hives on face neck, torso,extremities. Lips slightly swollen. Denies SOB, fever or difficulty swallowing. Dr ordered pt to take her routine allergy Meds (Allegra, Zantac).
BRIEF OVERVIEW: Admission Date: 9/2/2023 Discharge Date: 9/5/23 Discharge Disposition:  home health care svc   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute prostatitis [N41.0] Hyponatremia [E87.1] Elevated troponin [R77.8] AKI (acute kidney injury) [N17.9] Septic shock [A41.9, R65.21] COVID [U07.1]   HOSPITAL COURSE: Patient is a 80 y.o. male with past medical history significant for  coronary artery disease, ulcerative colitis, hypertension, hyperlipidemia, multiple myeloma currently undergoing chemotherapy, abdominal aortic aneurysm, inflammatory arthritis, obesity, cerebral infarction, thoracic aortic aneurysm, anemia, benign prostatic hypertrophy, history of DVT, presenting to the emergency department with chief complaint of generalized weakness. Patient states that he started coughing two weeks ago and for the last 3 days have had no appetite with decreased oral intake. Patient reports mild headache, profound weakness over last day being unable to get out of bed and sleeping excessively. Patient reports chronic nocturia. Reports chronic neuropathy to bilateral feet from chemotherapy. Reports sweats and chills, upset stomach. Reports diarrhea last week, but none now. Denies nausea or vomiting, denies shortness of breath or chest pain, denies abdominal pain, no leg swelling or leg pain. Denies any new rashes or sores. Patient is immunocompromised on Plaquenil.   Vital signs upon presentation to the emergency department with evidence of fever of 103.3, tachycardia, and tachypnea.  Patient also developed hypotension in the emergency department despite fluid resuscitation.   Laboratory values reviewed with evidence of leukocytosis of 16.7, normocytic anemia with hemoglobin of 9.1 and hematocrit of 27.4, thrombocytopenia with platelet count of 138, hyponatremia of 128, acute kidney injury with BUN of 45 and creatinine of 1.84, hyperglycemia of 186, hypocalcemia of 8.3, hypomagnesemia of 1.5, NT proBNP elevated at 12,225, troponin elevated at 67 and 61 respectively, lactic acid elevated at 3.4 and 2.4 respectively after fluid resuscitation, COVID-19 positive, urinalysis with trace ketones, positive for nitrites, moderate leukocytes, large amount of blood, WBCs.  CT of the abdomen and pelvis with evidence of prostatitis.  Two-view chest x-ray with no acute cardiopulmonary process. EKG with no acute ischemic process.   Treatment in the emergency department:  Tylenol a 1000 mg PO, cefepime IV 1 g, ibuprofen 400 mg orally, Mag-Ox 400 mg orally, 0.9% normal saline 2500 mL IV bolus, norepinephrine IV.   Patient was admitted to the intensive care unit for further evaluation and treatment.     He remained asymptomatic from covid and was discharged on prolonged course of abx for prostatitis. He had successful voiding trial and foley was removed. He was discharged in stable conditions with plans to follow up with pcp.   Patient later admitted on 9/19/23-9/23/23 to Hospital for PRESENTING PROBLEM: Dyspnea on exertion [R06.09] Severe sepsis [A41.9, R65.20] AKI (acute kidney injury) [N17.9] Multiple myeloma not having achieved remission [C90.00]  Patient passed away on 9/25/23
Ringing in ears that I still have a week later.  (I know of two friends in other parts of the country that are also suffering with this.)  Also, around 12 hours after shot I had four hours of extreme muscle pain and shivering.  This was on my first dose.  I know it's prevalent on the 2nd dose.  I'm not worried about that but am concerned with my hearing.
3 HOURS AFTER VACCINES,  LOTS OF SWELLING IN RIGHT ARM WHICH IS THE ARM THAT GOT THE PNEUMO SHOT.  6 HOURS LATER STILL SWELLING, PAIN, ITCHY, AND FEVER.  FEVER AND SWELLING IN ARM LASTED 3 DAYS. A FEW DAYS AFTER VACCINE SHE DEVELOPED SWELLING ON LIPS AND EYES AND LASTED 15 MIN. PT SAYS NOW HER BODY IS STILL ITCHY AND ITS BEEN 7 DAYS. NO BREATHING PROBLEMS. PT IS STILL TAKING REGULAR MEDICATIONS.
Approximately 10 minutes following vaccine, experienced L  shoulder swelling (surrounding vaccine site) and swelling and pustular rash and swelling with redness of L hand