chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via Pfizer regarding a female patient of an unknown age. The patient's relevant medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiry date were not reported) for an unknown indication. It was reported that the patient was allergic to PNEUMOVAX 23. The outcome of the event was unknown. The reporter considered drug hypersensitivity to be related to PNEUMOVAX 23. This is one of the several reports received from the same reporter. Sender's Comments: US-PFIZER INC-2013341054: WWID#. US-009507513-1903USA007749: US-009507513-1903USA008450.
Patient came in 9/21/17 complaining of Right shoulder pain that had already resolved, but now complained of pain in left knee. Patient was advised to visit MD for checkup to rule out causes.
hangover like headache; hangover like headache; right eye was swollen and painful; right eye was swollen and painful; This is a spontaneous report from a contactable physician, reporting for herself. A 33-year-old non-pregnant female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route on 27Mar2021 at a single dose of administration for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. The patient previously received the first dose of the bnt162b2 on 06Mar2021 at a single dose for covid-19 immunisation. No other vaccines administered within 4 weeks prior to the immunization. In Mar2021 (reported as 01Mar2021), the patient experienced hangover like headache for one day and morning right eye was swollen and painful, which required physician office visit. The events were further described as: hangover like headache for one day, resolved by next day, Monday morning right eye was swollen and painful. Therapeutic measures were taken in response to the events. There was no covid-19 prior to or post vaccination. The clinical outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3/4/03 pt presented with rash, night sweats, generalized fatigue x 24 hrs and rash x 12 hrs. (+) generalized papular rash on trunk, arms, hands, palms, legs and plantar surface of feet (+) erythema on palms of hands and feet with edema. Referred to derm. Zyrtec started on 3/4/03. Pt states he started feeling bad about three days ago (fever, chills, throwing up) and yesterday he noticed a rash come up on R wrist and hands and also on feet. Hands, wrists, ankles and soles-erythema, dermal papules with surr blanching. Uriticaria. Cortin Zyrtec qd. TAC cream 0.18. RTC if worsens. F/U on urticaria that has worsened since yesterday's visit. Pt states sx/s have become more painful to feet with some edema. Hands/wrist/feet-eryth plaques-confluent and multiple eryth papules. Feet-confluent erythem plagues with tender edema in arch. A/P urticaria and angioedema of feet. Prednisone 15 day 60, 40, 20 course. Elevate feet. RTC Mon. quarters x 48 hrs. Presenting with rash, "night sweats," gen fatigue x 24 hrs-rash-12 hrs. A: probable erythema multiforme. P: dermatology consulted-spoke with MD from dermatology. Plan to see pt Wed. 3/5 at 1300. Zyrtec 10mg, take 1 tab po qd for itching/rash. Local redness, whitish blister, local itching, body rash and feeling lousy.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 10-MAY-2016, the patient was vaccinated with improperly stored VARIVAX (which had a lot # of L042265 and an expiration date of 26-OCT-2017; however, dose, dosage number, route of administration and anatomical location were not reported). Information regarding concomitant therapies was not provided. The vaccines experienced a temperature excursion of 10 F for a time of 3 hours and 16 minutes. Reportedly, no previous temperature excursions had occurred and the aforementioned one was called out due to a data logger. Despite being vaccinated with such an improperly stored vaccine, no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient diagnosed with Kawasaki's disease in May 2011, after exhibiting possible symptom for a few months.
After administration of the vaccine (yesterday), patient began to experience itching at the injection site and slight whelps at the injection site.  He said he wasn't feeling great and reported having cold sweats and hot flashes.  He also had dry mouth that caused him to have difficulty swallowing.  I administered 50mg of diphenhydramine liquid and observed him for over 30 minutes.  I checked his blood pressure three times; it was elevated but within what he said was a normal range for him.  He had not had anything to eat nor taken his bp meds that am.  After 30 minutes, he was feeling some improvement and he and his wife left.  I spoke with her later and she said they had gotten something to eat and gone home and he was sleeping.  I spoke to him again this morning and he said later in the day he felt like his throat was swelling, but he continued to take diphenhydramine and felt better today.  He and I both reported this event to his primary care provider.
Information has been received from a physician concerning a 41 year old female who in June 2001 was vaccinated with hep b vaccine recombinant. The pt received the first dose in May 2001. In approx. June 2001, the pt experienced fever, body aches and became sensitive to touch. The pt underwent an examination and liver function tests, which revealed a serum alanine aminotransferase test of 252 and serum aspartate aminotransferase test of 161. Two weeks later the pt's serum alanine aminotransferase test was 20 and serum aspartate aminotransferase test was 19. Additional info has been requested. The follow up states info has been received from a physician concernign a 40 year old female with a Celcor allergy, described as rash, whoon 6/6/01 at 10am was vaccinated IM in the left deltoid with a second dose of hep B vaccine (637173/1264K). The pt received the first dose in May 2001. There was no illness at the time of vaccination. On 6/8/01 at 10am, 48 hrs after vaccination, the pt experienced fever, body aches and became sensitive to touch. The pt underwent an examination and liver function tests, which revealed a serum alanine aminotransferase tet of 252 and serum aspartate amiotransferase test of 161. The health care facility also reported that the pt experienced elevated liver function studies and viral type symptoms. Two weeks later the pt's serum alanine aminotransferase test was 20 and serum aspartate aminotransferase test was 19. Follow-up info from the health care facility indicated that the pt also experienced viral type symptoms. It was also reported that a hepatitis panel was performed, however results were not reported. Subsequently the pt recovered. No further info is available.
Ran 100 and 99 for 2 days, and had chills, also a little weak.... started at 3pm on the 28 and continued thru the 29th. Finally normal temp. on the 30th.
Approximately 15 hours after shot, I woke up with pain radiating from my left elbow to shoulder. I also had intense jaw pain localized to the left temporomandibular joint. My cheek was numb as well. Now, almost 48 hours after my shot, the jaw pain is worse, and my cheek is still numb.
Pt received a 0.5 ml dose of INFLUENZA should have been 0.25 ml dose. NO reaction noted. TO be monitored by parents
Vaccine- Induced Thrombotic Thrombocytopenia Portal and hepatic vein thromboses Diabetic Ketoacidosis
After receiving the vaccine about a month later I started experiencing this pain on the left side of my head it moved from my temple to the left side of my eye, also ear pain, and neck pain. I had a CT scan done of my temple and the results came back negative for anything. My doctor diagnosed it as having trigeminal nerve pain and he prescribed me a medicine that I can't remember the name of and was told to take it 3x day. After taking my prescription the pain and symptoms all went away.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 72 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 22Nov2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Acute Pancreatitis" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine, Mild. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound, about 1 week after testing Negative twice. Mild case; Negative, notes: Rebound, about 1 week after testing Negative twice. Mild case. Therapeutic measures were taken as a result of drug ineffective, covid-19.
This spontaneous report was received from a nurse referring to an unspecified multiple patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patients were vaccinated with a dose of improperly stored PROQUAD lot # M004895, expiration date of 26-JUL-2017 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 63 hours: >5 degrees Fahrenheit but < 14 degrees Fahrenheit; the highest temperature was 6 degrees Fahrenheit. Reportedly, there had been no previous temperature excursions. Furthermore, no product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested Sender's Comments: US-009507513-1701USA005959.
This spontaneous case was initially received on 19-Oct-2015. The case report was received from a Health Professional and concerns a patient with unknown age and gender. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 16-Oct-2015 - 16-Oct-2015, Batch no: U55106, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On 16-Oct-2015, 8 hours after starting/treatment with AFLURIA the patient experienced Fever of 102 degree F, Chills. Event treatment: No treatment. For relevant test results see appropriate report section. Reporter's assessment: The reporter considered events related to the suspect drug.
the patient received 0.05 mL dose of FLUZONE Quadrivalent, No AE; patient administered with a dose of Fluzone QIV that was exposed to 30 Fahrenheit, No AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 22 years old female patient who received a 0.05 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number and expiry date not reported) via an unknown route in the right deltoid for prophylactic vaccination on 09-Aug-2020 which was exposed to 30 Fahrenheit.  The patient's medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to product storage error temperature too low and it was a case of vaccine underdose.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information available on batch number for this case.
Adverse reaction to 2nd dose only (Note: Advil taken pre-injection to alleviate injection pain symptoms noted at 1st dose injection):  No noted adverse reaction until 16 hours post-injection of 2nd dose when experienced sudden onset of excessive tremors, shaking,  chills/feverish symptoms.  Dull, continued pain and  sensitivity at injection site.  Advil taken (OTC, 2 pills) which provided relief and sleep.   Six hours later (9am) feverish chills, fatigue symptoms returned - no tremors noted.  Advil taken (OTC 3 pills) which provided relief and sleep for two hours. Awoke and felt better throughout day until afternoon (6 hrs later) when symptoms returned, though milder.  Advil taken (OTC, 2 pills) and provided symptom relief and a brief nap.  No symptoms noted since.
Extreme chills, nausea. headache, fever, aches and pains, aggravated pinched nerve discomfort at neck, shoulder and down right arm
LIGHTHEADEDNESS/ DIZZINESS; NUMB LIPS; LOWER LIP STARTED TREMBLING; TINGLING IN ARM AND LEGS; TRANSIENT CHILLS; LOW GRADE FEVER; MUSCLE ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, psoriatic arthritis, and autoimmune disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced low grade fever. On 24-MAR-2021, the subject experienced muscle aches. On APR-2021, the subject experienced tingling in arm and legs. On APR-2021, the subject experienced transient chills. On 12-APR-2021, the subject experienced numb lips. On 12-APR-2021, the subject experienced lower lip started trembling. On an unspecified date, the subject experienced lightheadedness/ dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from low grade fever, and muscle aches on 26-MAR-2021, had not recovered from fatigue, headache, and lightheadedness/ dizziness, and the outcome of tingling in arm and legs, transient chills, numb lips and lower lip started trembling was not reported. This report was non-serious. This case, from the same reporter is linked. Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
After receiving the 2nd dose, I became very tired (chronic fatigue) ,  suddenly became forgetful / foggy, headaches, tennitis in hearing increased.  Swelling  / inflammation in my joints became constant.  To summarize, I was working out at 5:30 am before work prior to receiving injection. An alarm clock was never needed to wake up. The Phizer vaccination has made feel like I'm 90 yrs old, not my actual age (41).  Without question, this has been the most miserable experience I've ever had.  Its debilitating to no longer function at 100% and feel the way I have for so long. The memory loss has affected my work performance, among other things.  I've gained weight because exercise is physically draining and painful.  The short of it: I WOULD RATHER HAVE CAUGHT COVID AND SPENT 2 WEEKS IN ICU THAN TO HAVE TO FEEL THIS WAY ALMOST A YEAR LATER.
Vasovagal syncope a few minutes after vaccination.   Fever of 101.8F 24h after vaccination (3/10/2021). Fever is continuing today (3/11/2021), but is lower at 100.4F. Tingling fingers on hand from vaccination arm (left), swelling from vaccination injection site, headache, and neck pain all developed on 3/10/2021.  Headache and neck pain could be due to head trauma from vasovagal syncope. Tingling fingers were not observed on 3/11/2021.    *I have had vasovagal syncope in the past, but never with vaccines. It always occurs when I see my own blood.
Patient developed redness, swelling, itching at site of AVA within 12 hrs of receiving the vaccine. The next day, swelling and redness had increased in size to a soft ball and pain at site was a  5/10. Was deployed at the time. Did not miss duty time, but did see the medic on site. Was a given a shot of BENADRYL to help with his symptoms. All symptoms resolved within 4 days. Patient denies any residual effects.
3/4 10pm very itchy, arm, chest, back, neck - took benedryl, helped but still itchy, again sever itching, took another dose of benedryl around 330am 3/5 woke up with body aches, slight rash, migraine, temp 100.7, Left arm sore, armpit swollen and sore, took tylonol, and fluids, ice to under arm area 3/6 left underarm still sore and swollen, migraine, body aches 3/7 left underarm still sore and swollen, migraine 3/8 left underarm still sore and swollen, migraine, 3/9 migraine, under arm still swollen but seems to have gone down in size 3/10 migraine, under arm still swollen but seems to have gone down in size 3/11 migraine, under arm still swollen but seems to have gone down in size
Headache, 04/10/2013 4:00 AM started with abdominal pain and nausea which continued through 04/10/2013 5:00 PM which added diarrhea. At this time 04/11/2013 1:00 PM symptoms that continue are abdominal pain a nausea. And in addition is rectal pain and generalized weakness. Has eaten a handful of oyster crackers since 04/10/2013. Is drinking and urinating.
On 7/24/18, pt started having bilateral lower extremity numbness and tingling and some pain. This progressed to hand numbness and tingling, then gait instability. 8/15/18, pt developed perioral numbness and trouble swallowing. He has a change in his voice as well. Pt being treated at hospital for presumed Guillian Barre. LP pending. Starting IVIG 8/17/18.
Dose 1 was on 12/16/2020, 9 days after on Christmas I became violently ill with what I assumed to be a 24 hour stomach flu or food poisoning and was vomiting approximately every 15 minutes for about 3 hours. Today 1/15/2021, 9 days after my second dose of the vaccine I again became violently ill, vomiting about every 15 minutes for approximately 3-4 hours. I reported it once I noticed the coincidence.
Fatigue and aches: 48hrs time length. Chills: 5hrs during overnight.
Dose 2. I started after Dose vaccination started developing swelling and pain in the joints. Right arm and right side Started to swell in the joints and it was pain. Started in knee then pelvic, then shoulder. It does not hurt much unless weather. Call his physician because, she had a cane, and heating pad, hot and cold packs and resting that area. Every three months for diabetes condition. Routine doctor visits and made the doctor aware of new swelling Right side of after the vaccination. ex-ray, blood work, running test for auto immune disease and arthritics, gout and came back negative. Given a prescription for pain medicine and did not take it. Contacted the physician. Test results of blood work did not see a health issue. Currently, using a cane right side of body, specific knee, swelling moved up to shoulder never stop hurting in her leg and direct location on the right side of body.
On June 15th, 2021, I was passing blot clots that were not from my regular period, I called the ER they stated they couldn't help me. I waited until my insurance started with my job and seen doctor on 10/04/2021 tested positive for cervical cancer and have not tested positive before, have to go back every 6mos for checkup.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot# M034583 expiration date 27-JUL-2018, lot # M035141 expiration date 03-AUG-2018) for prophylaxis (strength, dose and route were not provided). It was reported that the vaccines were exposed to a temperature excursion between 5 and 14 Fahrenheit degrees for 63 hours. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012339:
01/28/22 presents to ED for "fever". PMHx of "dementia, CHF, recurrent aspiration pneumonia and UTIs"
Swelling in lymph node under left arm, one day after vaccination injection, plus soreness at injection site
PATIENT HAD SWELLING AND LOCAL FEVER AT SITE OF INJECTION MEASURING 3 X 5 INCHES THAT OCCURRED APPROX. 5 HRS AFTER ZOSTAVAX WAS ADMINISTERED.  PHYSICIAN PRESCRIBED CLINDAMYCIN (7 DAY COURSE) THERAPY ON 9/22/08
Headaches; Earaches; Muscle pain; Rash; Coughing; Difficult breathing; Fall down; Swollen rash; Dizziness; tiredness; bodyaches; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 22Jan2021, outcome "unknown", described as "Headaches"; EAR PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "Earaches"; MYALGIA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Muscle pain"; RASH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Rash"; COUGH (non-serious) with onset 22Jan2021, outcome "unknown", described as "Coughing"; DYSPNOEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "Difficult breathing"; FALL (non-serious) with onset 22Jan2021, outcome "unknown", described as "Fall down"; SWELLING (non-serious) with onset 22Jan2021, outcome "unknown", described as "Swollen rash"; DIZZINESS (non-serious) with onset 22Jan2021, outcome "unknown", described as "Dizziness"; FATIGUE (non-serious) with onset 22Jan2021, outcome "unknown", described as "tiredness"; PAIN (non-serious) with onset 22Jan2021, outcome "unknown", described as "bodyaches"; NAUSEA (non-serious) with onset 22Jan2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 2/5/99; 10 min post vax pt exp faint feeling, weak/ thready pulse; tx=crackers &soda