chrisvoncsefalvay/vaers-outcomes huggingface dataset:
low grade fever last night of 99.1; felt like balloons, retaining water/weird feeling; That night her legs were really sore and last night her legs were in a lot of pain; both legs being swollen; large indentations like she was retaining water and they were pretty bad last night and her legs felt like balloons; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3183), via an unspecified route on 21Aug2021 (at the age of 38-years) as dose 1, single in the right arm for covid-19 immunisation. The patient medical history included COVID-19 on Feb2020, immunocompromised and had Major Surgery (half of her kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice) kidney removed and disconnected and reconnected to her bladder. Also an artery moved, states she was in the hospital twice on 18May2021. The patient concomitant medications included HPV VACCINE Injection on 20Aug2021 for unspecified indication. On 21Aug2021, the patient experienced night her legs were really sore and last night her legs were in a lot of pain. They felt like balloons, retaining water and this morning when she checked her socks she had sock lines- she took a bath and still had the sock lines. They are major indentations. It only happens at night when she's at rest. She also had a low grade fever last night of 99.1. The sock lines really hurt, annoyingly and in both legs. Last night after it was more painful and this morning when she was retaining water she figured she would call and see if this was a normal side effect. Patient stated that she know soreness is a normal side effect but the fact she got sock lines and her legs were like balloons and she felt like she needed those things you get after surgery that they put on your legs and her legs are painful. Patient had a weird feeling. Patient was assured that HPV Vaccine the day before the Covid Vaccine would not interfere with Covid Vaccine. Patient stated that she took pictures of her sock lines on her legs and showed her friend who told her she should call Pfizer. She states the symptoms only seem to occur when her legs are at rest at night. Says they are sore the next morning, but that it goes away. Patient did not visited to Emergency Room/ Physician Office. The outcome of the events was unknown.
TESTED POSITIVE FOR COVID; This spontaneous report received from a parent concerned a 19 year old male.  The patient's weight, height, and medical history were not reported. 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 MAR-2022 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 19 years old. No concomitant medications were reported.  On 05-JUL-2022, the patient experienced tested positive for covid. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This case, from the same reporter is linked to 20220712200.
Woke up with a loud heartbeat and severe chest pain, especially when breathing in - shortness of breath, dizzy/confused, anxious. Went to the emergency room and was given an ECG which was abnormal, tested positive in blood test for blood clot but was negative on a CAT scan. Doctor stated it was minor myocarditis,  was perscribed ibuprofen and percocet and sent home
The shot was given on my right side, but it was my left side that went numb after 15 mins, and then went right into a pins and needles feeling mostly in my left arm and left leg as if they were asleep. There was no treatment. I was just monitored and told to call back the clinic. The worst of the sensation lasted ALL day, and decreased a little each day after a period of about 7 days.
I had a reaction the second vaccine in my covid vaccine series. I got home from work the next day (4/19/2021) and had hives on my wrist that were swollen and itchy. I woke up in the middle of the night on the 19th with my lip swollen experiencing angioedema. i called the doctors office and they said to take benadryl and if it wasnt better in the morning to come in. i  went to the doctor the next day 4/20/2021 as it was getting better but not completely. after the swelling was gone i was fine for about a month until i started getting hives and devleoping the angioedema again. i then went to the doctors and they sent me to the ER because of having a swollen lip. i was put in steroids for the swelling and sent home. the hives subsided taking the steroids but then once the course of steoids was over they came back aggresively. this continued to be a routine for months. i went to an allergist who put me on zyrtec and pepcid to help and then we added in singular and doxepin and i still was not able to come off the steroids with out an aggresive flare up. we then began working on getting xolair approved for injections as nothing else was working and i cant take steroids forever at a varying dose. i started getting xolair injections in july of 2021 and they began to help and i was able to go off the steroids. i was experiencing hair loss after about three injections so we had to stop them. while getting the injections i was also able to stop the doxepin. now that we have stopped the injections we are being able to manage the hives with the zyrtec pepcid and singular and only having an occasional flare up that warrants more medication such as benadryl or steroids.
Arm pain from shoulder to elbow; Chills; Fever OF 102-103 F; Joint pain; Muscle pain; A spontaneous report was received from a Healthcare Professional concerning a 22-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, fever of 101-102 f, arm pain from the shoulder to elbow/pain in extremity, joint pain/arthralgia, muscle pain/myalgia  The patient's medical history was not provided. No relevant concomitant medications were reported.  No relevant lab data was reported by the reporter.  On 31 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events chills. fever of 101-102 f, arm pain from the shoulder to elbow, joint pain, muscle pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 1 Feb 2021 the outcome of all events was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient ran fever the day after shot, Saturday, didn't take temp Sunday or Monday.  Tues evening the patient felt tired, Wednesday patient felt bad and was running a fever of 101.7 that evening.  Thursday patient took Tylenol every 4 hours as doctor directed.  Friday morning at 7 am his  fever was 103.1.  I took him to ER.  Prior to these events he was in wonderful health.
Immediate itching at injection site, red, burning, hives. Headache, light headed was/dizziness
pt recv vax; rt deltoid became weak and w/ in one wk, abscess on rt axilla;md felt this was secondary to bacteremia introduced by flu shot; tx w/ atb; doing fine
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007264 with expiry date 02-MAR-2017 and lot # K011562 with expiry date 08-APR-2017, dose and route of administration not reported). No adverse experiences were reported. This is one of several reports from the same reporter. Additional information has been requested.
Effective on 12/99, I began to experience joint pain and swellling that migrated to ankle, knee and shoulder, etc. Treated by a physician on 12/99.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient was inoculated with ZOSTAVAX for routine health maintenance and for the prevention of shingles (dose, route, and lot # not provided). After receiving ZOSTAVAX (onset date not further specified), the patient developed vision loss and loss of visual acuity. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred and will continue to incur medical expenses and other economic harm as a direct result of use of ZOSTAVAX. The outcome of the events was not recovered. Causality assessment was related. The lawyer considered vision loss and loss of visual acuity to be disabling. Upon internal review, vision loss was considered to be a medically significant event. Additional information has been requested.
Pain in left shoulder, then pain moved to include muscle from shoulder to near the base of my neck.  As of this date, the pain is somewhat less but still is painful enough that I am taking Ibuprofen several times each day.
I received the J&J vaccine at 10:00am on March 18, 2021 at the Community Center. By about 5:00pm, I started to feel minor flu-like symptoms, but as the night progressed it got significantly worse. Around 8-9pm, I was bedridden with the worst chills/shaking I've ever experienced in my life. Around 9:30-10:00pm, I was filling water at my sink and projectile vomitted multiple times into the sink and could not make it to the bathroom. Subsequently, I ate a bagel and drank lots of water, knowing my vomitting could make me dehydrated. Throughout the night, I was awake and shaking, and drank and filled my water bottle repeatedly. At 8:00am, I was filling my water, and without my knowledge of awareness, fainted on my kitchen floor, dropping the Brita filter and likely hitting my head. My roommate heard the commotion and saw me passed out in our kitchen. He tried to wake me up and I phased in, but then subsequently phased out again 20-30 seconds later as I was trying to stand and likely hit my head again. My roommate eventually got me over to our couch and called EMTs. Upon their arrival, EMTs checked my pulse, which was fine, and saw an open laceration on the back of my head, so they took me to Hospital to access the Trauma Center. On the way, I threw up repeatedly and was very lightheaded. Upon my arrival at Hospital, I was checked for any neck bone breaks, given an IV, a CT  scan, an EKG, and staples were placed in the back of my head to heal the laceration. After my release, I was bedridden for 2-3 days and required a daily nap during work (1-2) hours for the next 1 1/2 to 2 weeks. For a while, everything was fine, but recently during the first two weeks of April, it has become apparent that my head is foggy and reacts to changes in the weather, which leads me to believe that I likely banged my head pretty good when I fainted those two times.
Clinical Summary Patient is a 75 y.o. male with a history of parkinsons, HTN who tested positive for COVID 12/29/22 as outpatient and was about to start paxlovid but was found down 12/30/22 and presented to hospital 12/30/2022 for further evaluation. Consulted by trauma for medical management and then assumed care. Hospital course complicated by sinus pause 1/3/2022.    1. Vertebral fractures: Age indeterminate on CT C spine and CT CAP on admit. Mild T3 and T12 fractures which appear new since CTA PE 10/5/2022. Also noted subacute mild L2 fracture with chronic L1 fracture. Unable to get MRI imaging. Neurosurgery followed, recommended conservative care.  PT OT recommended SNF. 2. COVID 19: Vaccinated. Symptom onset around 12/27-12/28, tested positive 12/29/22. S/p   Paxlovid. Was on 2L O2 but weaned to room air 1/3/2023.  3. Acute metabolic encephalopathy: sec to acute COVID infection, dehydration and missing on parkinson's meds. Resumed sinemet and amantadine, improved.  4. Paroxsymal Atrial Fib with RVR/ sinus pause:Noted 12/30/22 night- EP initially had patient on Cardizem and flecainide, but both discontinued given sinus pause on tele 1/3/2022. Not on AC due to fall risk - family refusal.  Outpatient heart monitor.  Cardiology follow-up 5. Parkinson's Disease: advanced, on amantadine and sinemet. Continued.  6. Akinesia: with increased muscle rigidity- suspect related to not taking parkinson meds x 48h prior to admission, improved with resumption of Parkinson's meds and trial of Valium. Continued valium taper until 1/5/2023.  7. HTN: On valsartan/hydrochlorothiazide amlodipine and metoprolol at home?held. Reported that he gets dizzy if drops below 140. Likley due to autonomic dysfunction due to parkinsons.  Liberal BP goal. 150-160 systolic esp if dizzy and orthostatic.  Can be restarted as outpatient if needed. 8. Neuropathy: Continued home gabapentin. Dose adjusted  9. Dysphagia: Likely due to Parkinson.  Contributing to weight loss? 1/3/2022 with modified diet.  If worsen may need outpatient EGD.  Speech followed. 10. Code status: Full code?
Headache Narrative: Reports Posterior Headache 8/10 Aching began 10 minutes after injection - reduced to 6/10 prior to departure
Day after vaccination patient experience swollen painful and red right deltoid muscle. Treatments: ice and MOTRIN. Will follow up with patient next week.
This spontaneous report as received from a registered nurse regarding herself: a 65 year old female patient. Medical history was not reported. On 07-DEC-2012 the patient was vaccinated with PNEUMOVAX 23 lot # H013581, intramuscular (indication not reported). Concomitant therapies included METOPROLOL. On 14-DEC-2012 (discrepancy: reported as 14-DEC-2013), 8 days after onset of therapy the patient experienced flu like symptoms including fever, chills, body aches and headaches, and an upper respiratory infection. The outcome of flu like symptoms (including fever, chills, body aches, headaches) and upper respiratory infection was reported as recovered after about one week. No further information was provided. Additional information has been requested.
Patient experienced generalized weakness and inability to ambulate.  He presented to the ER on 2/24/21 and was found to be hypoxic 88% on room air and was stated on O2.  He presented with a rash at site of vaccination on left arm over deltoid muscle.  He had a red petechial rash on anterior chest and upper abdominal wall.
Development of microemboli on distal, fourth right phalange on the ventral surface. Just past the DIP. Small blue hue below skin surface with mild tenderness on deep palpation.; This is a spontaneous report from a non-contactable Physician (patient). This adult female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on 23Dec2020 09:30 at single dose on right arm for COVID-19 immunisation. Medical history included migraine with aura. Concomitant medication included propranolol, loratadine (CLARITINE) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefprozil (CEFZIL) and experienced allergies. The patient experienced development of microemboli on distal, fourth right phalange on the ventral surface. Just past the DIP. Small blue hue below skin surface with mild tenderness on deep palpation on 24Dec2020 12:00. The event was considered as non-serious. Treatment for the events was unknown. The outcome of the event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event microemboli on distal phalange with BNT162b2 can not be fully 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.
11-4-04 at 1415 0.25ml of influenza vaccine administered Left VL IM as per CDC guidelines for 6months to 23 months of age. At 1435 after waiting 20 minutes, two hives were noted above injection site. Child less active than prior to vaccine administration.  Child taken into exam room and all clothes removed.  Hives noted on arms, trunk, back, neck, and behind Right ear.  Health officer notified per phone.  Orders received to administer epinephrine Sq per emergency protocols.  1446 Epi administered Sq left arm. Apical HR 128 beats/min. Resp. 44 breaths/min.  Resp. non-labored. Skin W/D and pink.  Child remaines alert and moving all extremeties.  Child wrapped in blanket.  1451 HR 144 beats/min. mouth/lips dusky and pale. Child placed in supine position on exam table. Some coughing and sneezing begining.  Began to administer PO Benadryl per pharmacist dosing advisement of 3/4 to one teaspoon. 1455 1ml benadryl given PO.  1459 1ml benadryl given PO. 1501 Had mother hold child to comfort.  Child crying.  Skin W/D.  Mouth pale. 1ml benadryl PO given. 1504 1ml benadryl given PO.  Color improved.  No paleness noted.  Lips pink. Hives remain.  No new hives noted. A total of 10mg benadryl PO given.  Advised mother that child should be taken to ER to be examined by a physician. 1510 called ER. Spoke with RN and updated.  1515 went with mother and child to ER.  Seen by ER physician.  Liquid baby prednisone given PO.  Instructed to see FMD 11-5-04.  Released from ER around 1615.  1700 mother returned child to ER D/T child becoming moist and clammy and skin temp. cold. Axillary temp 97 and 96.  Child observed in ER for one hour and then released home.  11-5-04 Child acting normal per mom. Seen by FMD on call.  Prescription for prednisone decreasing dosing schedule given.  Instructed to have child seen by FMD in one week.
Sleepy all the time; Fever blisters; Arms swollen for seven days; Shortness of breath; Has no energy/she wants to do is lay down; Feels like crap; Has been tired / extremely fatigued; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy all the time), ORAL HERPES (Fever blisters), PERIPHERAL SWELLING (Arms swollen for seven days), DYSPNOEA (Shortness of breath) and ASTHENIA (Has no energy/she wants to do is lay down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and OXYCODONE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, 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 experienced SOMNOLENCE (Sleepy all the time), ORAL HERPES (Fever blisters), PERIPHERAL SWELLING (Arms swollen for seven days), DYSPNOEA (Shortness of breath), ASTHENIA (Has no energy/she wants to do is lay down), FEELING ABNORMAL (Feels like crap) and FATIGUE (Has been tired / extremely fatigued). At the time of the report, SOMNOLENCE (Sleepy all the time), ORAL HERPES (Fever blisters), DYSPNOEA (Shortness of breath), ASTHENIA (Has no energy/she wants to do is lay down), FEELING ABNORMAL (Feels like crap) and FATIGUE (Has been tired / extremely fatigued) outcome was unknown and PERIPHERAL SWELLING (Arms swollen for seven days) had resolved.            Additional concomitant medications was thyroid medication.  Laboratory detail was thyroid numbers are messed up.  No treatment information was provided.   This case was linked to MOD-2021-218849 (Patient Link).
An attorney reported that a female child received a series of Tri-immunol, Tetramune, Tripedia, Orimune, Recombivax, Hepatitis B vaccine and MMRII vaccines. It is alleged that as a result of exposure to Thimerosol in the vaccines, she experienced mercury poisoning. This case was considered serious since mercury poisoning was considered medically important.
5 year old male patient was inadvertently administered an expired dose of IPOL, no AE; Initial information received on 02-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 5 years old male patient who was inadvertently administered an expired dose of IPV (VERO) [IPOL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included second dose of VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  On 01-Feb-2021, the patient received a 0.5 ml fourth dose of suspect IPV (VERO) (lot P1F541M and expiry date: 07-Dec-2020) via an subcutaneous route in the left leg for prophylactic vaccination.  It was a case of actual medication error due to expired product administered (latency on same day).  Reporter relationship: health care professional (HCP), Product used: used, First time product used: no Still using product: no  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.
Pt developed rash and redness speading approx 5 inch - also said she developed 2 hard nodule.