chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 16-MAR-2015, the patient was vaccinated with a dose of expired PNEUMOVAX23 strength: 25/0.5 DG, 0.5 ml/once, intramuscular, lot # K004930, expiry date 16-MAR-2015 also reported as 06-MAR-2015. No adverse effects reported. There was no concomitant medication provided. Additional information is not expected because the reporter refused additional contact.
Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 3 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
Sore arm; Tired; This is a spontaneous report from a contactable consumer reported for her husband. This report re-ceived from a Pfizer Sponsored Program. A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, administered in right arm on 19Feb2021 (at the age of 65-year-old) at 16:00, as 1ST DOSE, SINGLE DOSE for covid-19 immunization. There were no addition-al vaccines administered on same date of the Pfizer vaccine. The patient did not receive any Prior vaccinations within four weeks. The patient did not have any medical history (including any illness at time of vaccination). Concomitant medication included Aspirin [ACETYLSALICYLIC ACID]), fish oil ,VITAMINS NOS taken for an unspecified indication. All the medications were taken by patient only sometimes. It was reported that the reporter was not certain whether he took medications within the two weeks before the vaccine. On an unspecified date in 2021, after the vaccination, the patient ex-perienced sore arm and felt tired. It was reported that the consumer was not able to remember whether the tiredness and sore arm was after the first or second dose of the vaccine. There were no relevant Tests performed. The patient did not have any adverse events following prior vaccinations. The patient did not have any family medical history relevant to adverse events. The events were re-ported as non-serious. On an unspecified date in 2021, Outcome of the events was resolved.    Information on the lot/batch number has been requested.
Fever 100.5, nausea and vomiting, body aches, exhaustion, chilled and heavy sweating for 18 hours.
"Covid Arm." Swelling and Rash started on April 23rd one week after vaccination.  No Pain or itchiness, is going away slowly.
pt recv vax; fussiness, dec oral intake and apparent dizziness or incoordination starting 4-5 hr p/ vax; better 24 hr later;
Pneumovax administered in left deltoid.  Arm began to swell/itch 8 hours after immunization. Patient treated with Benadryl.  Swelling went down in 2 days.
pt devel hepatitis p/recvd flu vax; this was assoc w/abd discomfort, bloating, & nausea; pt was noted to be improving;
APPROXIMATELY 25 MINUTES AFTER INJECTION PATIENT COMPLAINS OF DIZZINESS AND THROAT FILLS TIGHT. PATIENT WAS ORIENTED AND VOCAL AND DENIED DIFFICULTY BREATHING BUT DOES ADMIT TO HAVING HISTORY OF ANAPHYLATIC REACTION AND IT FEELS SIMILAR PER PATIENT. ABMULANCE WAS ALREADY ON  SITE AND ACCOMPANIED NURSE AS  0.5 ML EPI IM ADMINISTERED.  EMT EVALUATED HER AS HER BREATHING STARTED TO BECOME MORE LABORED  AT 933 AFTER AMBULANCE WAS EVALUATING.. THEY TRANPSPORTED HER VIA ABMULANCE AT 934.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 27-DEC-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Swelling, redness, and warmth to right arm. Patient treated with Prednisolone and Cetirizine.
C/o leg craps and muscle spasms throughout body - states has pain when walking, from legs cramping.
On Monday, 4/12/21, I was given the 2nd dose of the vaccine.  There were no immediate symptoms other than a sore arm (from injection site) later that day.  Tuesday morning, my left arm was swollen and I experience joint pain in my fingers and wrist. The following afternoon, I began to feel extremely tired and had vertigo.  I laid down and slept the entire evening; still feeling the joint pain.  The following Wednesday morning, I woke up to a swollen arm with a knot at the injection site, blisters, body rashes, and whelps under my breast and whelps on my shoulder, legs, and feet.  I was even more exhausted. I took Benadryl for the rash and Advil for the pain.  Thursday, I continued to develop rashes that would come and go on the left side of my body and upper chest.  Friday, still experiencing the inflammation and pain, I visited my doctor who told me to continue taking the Benadryl and OTC pain meds.  For good measure, we ordered a d-dimer test.  Over the weekend, in addition to the other symptoms, I began to have a lot or ringing in my ears, a backache (throbbing sensation), and my hands began to painfully swell with blisters.  I could only taste the salt or sugar in foods and was extremely tired.  Monday morning, I received a call from my doctor advising me that the d-dimer test came back extremely high (1.23) and needed to have a vascular ultrasound to check for blood clots.  I visited an ER and had the test done.  No clots were found but I continue to experience ringing in my ears, severe pain in my back that limits my ability to walk and breathe, swelling of various extremities, a rash (and itching), and overall inflammation. The Benadryl isn?t working nor is the OTC pain medication. My doctor has prescribed Prednisone.
Information has been received from a pharmacist. The pharmacist reported a male high school sophomore was vaccinated with GARDASIL, Hepatitis A vaccine ("name unspecified but VAQTA could not be ruled out") and DTP (manufactured unknown) about a year ago. The male has been suffering from chronic fatigue. No additional information provided. No additional information expected.
Client reports: pinched nerve in spine, degradation of hip joint, atherosclerosis. First doctor visit 10/7/09. Client concerned about receiving Zoster vaccine with history of lymphoma. Lymphoma treated in 1984. Client has talked with manufacturer.
This spontaneous report as received from a pharmacist refers to a 67 years old male patient. The patient had none pertinent medical history. The patient had none drug allergies. "A couple of years ago" the patient was vaccinated with his one and only dose of PNEUMOVAX 23 (lot # not reported). Concomitant medications were reported as none. It was reported that "the next day" after the vaccination the patient developed red streaks down the arm where the vaccine was administered. The patient sought for unspecified medical attention and was treated with outpatient antibiotics. Lab diagnostics studies performed were reported as none. The present patient status was recovered. Additional information has been requested.
Headache and arm soreness at injection site only lasted 48 hours. The fever, chills, sweating, overheating, body aches, red rash at injection site, diarrhea, nausea, and exhaustion lasted 72 hours.
Pt had the flu shot and was fine, in less than 10 minutes Mom came back to Rx saying she is fainted. I went out and saw her laying on the floor. When I got to the site, she was conscious and told me she felt fine. The pulse was OK and she was a little sweaty. I offered to check her BP. When I came back with BP machine, she already sat up. I tried to measure her BP while she was sitting on the floor. All of a sudden, she fell down to the floor with short time unconsciousness and eyes turning/rolling up like seizure episode. After getting OK from the mom, we called 911. The team and I checked BP in different positions and were in normal range. After she got up, she felt the feeling of flash like the first time. Just called mom, she said they stayed in ER for 3 hrs and checked her BP, heart and couldn't find any abnormality.
DISCOVERED ON 10.12.17 THAT VACCINE WAS EXPIRED. CALLED PT TO SCHEDULE RE-VACCINATION TIME.
The second shot was on March 8th. I started feeling very dizzy later on that night, and the next day I felt really dizzy and tired, over the week the dizziness, muscle pain & weakness increased, to the point I could not walk, my muscles were constantly spasming almost like convulsing, I was seeing double, my ears were ringing, and it was so bad by Saturday the 13th of March, I was admitted to the neurology unit at Hospital under the review of Dr neurologist. By day 4, I left the hospital to go see an ENT to see if my ears were the reason for my dizziness. Since then, I?ve seen my rheumatologist (who?s tests showed an elevated SED and issues with my kidneys), I have another meeting with her this Monday. I have seen the ENT twice, and they told me my ears were normal and probably from the vaccine. I have seen an eye doctor, and she too found nothing wrong with my eyes to cause the hallucinations or dizziness. My eye sight has gotten worse in one eye. I am still suffering from dizziness, nausea, bone pain, and muscle spasms.
No additional AE reported.; expired MMR II and VARIVAX were administered to a patient yesterday (1/10/2022); This spontaneous report was received from a medical assistant, referring to a 17- month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 10-JAN-2022 (also reported as yesterday), the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number S035356, expiration date was reported and validated as 05-NOV-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, vaccination scheme, anatomical site of vaccination, and route of administration were not reported; lot number S035125, expiration date reported and validated as 04-NOV-2021), both therapies as prophylaxis (expired product administered). No additional adverse events reported.
There had been intermittent issues with soreness on the injection-site arm and muscle weakness in upper arms and legs from shortly after the injection until about May 9 when I stopped reporting it on V-safe.   Beginning about June 4, both began to increase, but still intermittent.   Beginning about July 13, the arm of the injection alternated between a constant, mild "pinching" sensation to a extremely sharp stabbing (like a poker on raw skin) with aching that lasts from a few minutes to a few hours.  Even a gentle touch on the skin in that area produces a sharp stinging/tingling pain  but nothing is visible on the skin.  The muscles in my upper arms and legs are intermitedly very achy and sore (much more than initially) and which I never experienced before the vaccine. For about a month, I've been experiencing what might be achilles tendon issues that some and go (most on waking up) but I don't know if that's related.
Patient is a 25 year old female. She presented to the clinic for her second dose of Moderna LOT #003C21A.  According to patient's husband she has no significant past medical history but has ?passed out? with vaccines.  No reaction noted with her first COVID vaccine.  Approximately 10 minutes after receiving her injection today she told her husband that she wasn?t feeling well.  She said was light headed and nauseated.  Patient then proceeded to become nonresponsive.  Her eyes deviated upward and her whole body became stiff.  Her skin had notable pallor.  She was lowered to the ground by staff, myself, and her husband, and put in a supine position with her legs elevated.  911 was called. This episode lasted approximately 40-60 seconds when she became responsive and cried out for husband.  Her muscles relaxed and she became notably upset.  She kept saying she wasn?t able to see or feel her extremities.  Her lack of vision resolved within 10-15 seconds. She had weakness in her arms and legs but was able to squeeze her hands on command.  She was alert and oriented X3.  BP was 130/90.  The patient was stable when the ambulance arrived to transport her to Hospital.
immed p/vax pt devel allergic rxn characterized by hives;no further info was available @ the date of report;
The patient was administered an expired Act-HIb, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (Reference number- 00515355) and transmitted to Sanofi on 11-Mar-2021.  This case involves a one year old female patient who was administered a 0.5 ml dose of suspect HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ183AAQA; expiry date: 12-Feb-2021; Strength: standard, Single dose vial) via intramuscular route in unknown administration site for prophylactic vaccination on 22-Feb-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  The patient's concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) and HEPATITIS A VACCINE [HEPA] for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated, they administered an expired Act-HIB vaccine to a child that was expired for ten days. The reporter wanted to know if they need to revaccinate the patient. The reporter was not sure what site the vaccine was administered. They had to pull the shot out of the system because they had entered it as the wrong lot number. No further information was provided.  At the time of report, no adverse event was 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 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.
After the second shot I hard a 99.3 temp at 1:30 a.m. Thursday morning also chills and ache all over. That night I noticed I had a lump near my collarbone and neck (lymph nodes. Very tender. I was taking 1,00 mg tylenol since the second shot. I called my dr. at 12:30 pm 2/20/2021 and told him about my neck and that my temp, chills and aches were gone. He said he had never heard about anything like this but to continue with 500 mg of tylenol every 6 hours. I told him I had a friend you had a much larger lump on her neck and her dr. gave her antibiotics since her lymph nodes were swollen. I said I had a antibiotic and he said I could take it. If it was still swollen on Monday to make an apt. The swelling is down some on 2/21/2021 but I can feel the nodes more. I will call dr. on Monday. I has researched this and see it is a side effect but rare.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient had a pre-existing facial palsy that resolved "right before GARDASIL use." The patient received GARDASIL via wet SD 120 Y on an unspecified date "within 2-3 weeks" (approximately 0n 25-SEP-2014) (dose, lot # and expired date were not reported) intramuscularly. Concomitant therapy was not reported. "About a couple of days later (after the GARDASIL injection)" (on an unspecified date in 2014), the facial palsy returned and the patient also "developed some vision issues." The patient was recovering. The patient sought medical attention by going to see a physician. No treatment was given for adverse events. The reporter did not assess the causality between adverse event and GARDASIL. Additional information has been requested.
BRUISING AND SWELLING AT INJECTION SITE. INJESTION SITE IS RED AND WARM. RAISED AREA APPROXIMATELY 3 INCHES IN DIAMETER. NAUSEA AND VOMITING X1 DAY.
This non-serious initial spontaneous case, was received from other Non-health professional on 04-Oct-2017, concerning a 67-year-old elderly female patient. The patient's medical history and concomitant medications were not reported. On 03-Oct-2017, the patient was administered with influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, manufacturer, trade name: not reported). On the same day, at 3:00 am, the patient experienced severe diarrhea which lasted till 6 pm and was suggested for colonoscopy. The outcome of the event was recovered. The reporter assessed the report as non-serious.
Developed chest tightness around right side of chest into back and SOB 50.5 hours after vaccination. Went to local ER and found to have a right lower lobe pulmonary embolism.  Treated with Xarelto and sent home with outpatient follow up.
Pt received flu shot, a couple of minutes later pt passed out and started seizing. After a couple of minutes pt was feeling ok. I called paramedics but they did not take him to the hospital.
10cmX10cm area of induration and mild erythema of the left thigh. in the center there is a superficial blister. started on oral antibiotic course and antihistamines. bactrim prescribed after culture results came back.
Severe pain in area of injection. Limited mobility of arm. It has now been over 2 weeks and it seems to be getting worse. Cannot lift arm to remove pullover shirts. Have trouble sleeping as pain is persistent.
This spontaneous report as received from a pharmacist, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with second dose of PNEUMOVAX23 (lot #, dose, site and route of administration not reported). The patient had received PNEUMOVAX23, five years previously. On an unknown date the patient experienced bad, bad rash after receiving PNEUMOVAX23. The patient sought medical attention  saw the pharmacist. The outcome of bad, bad rash was unknown. The relatedness between PNEUMOVX23 and event was not reported. Additional information has been requested.
Swelling, erythema & tenderness of rt upper extremity; site of pneumovax inject;
typical pain at injection site subsided in 2 days, followed 10 days after booster new pain at injection site spreading to upper back and arm approximately 6 inches diameter from injection site, especially upon waking in the morning, called in sick one day and took ibuprophen on 12th day, pain does not get worse but keeps spreading out slowly, by 14th day feeling nerve pain down left arm (like a tingling) that comes and goes, now on 18th day, pronounced sensation like pain upon waking every morning in a specific diameter from injection site, diameter increasing each day, approximately 9 inch diameter now, this only happens once upon waking, continued nerve pain down left arm that comes and goes, it is very disconcerting,
A nurse reported that a female received a flu vax approximately 2 years ago and subsequently became very ill with flu-like symptoms. The pt stated that she may be allergic to eggs. No further information was available at the date of this report.
Shortly following, developed fever, then increased work of breathing tmax 100. Then blank/fixed stare, desaturated to 88% Transferred to ER, diagnosed with febrile seizure and viral URI, fever (7/21/23) 7/22/23: Rectal temp 104.1. Fever broke 7/23/22.
Generalized hives beginning about 12 hrs after injection. Injection site slightly hyperemic but no swelling. Lasted 4 days.