chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient complains of sever swelling redness and hot feeling on both arms. More on the arm that the shingrix was administered. Symptoms progressed and showed fully when patient woke up the next day.    Apply a cold compress to the site for approximately 15 minutes if the patient has any inflammation/swelling/or soreness. Recommend an analgesic such as acetaminophen or non-steroid anti-inflammatory drug. An anti-histamine can be used for any swelling make sure to observe and discuss with the patient signs of generalized anaphylaxis
Information has been received from a physician concerning a 30 day old male patient who on 19-AUG-2009 was vaccinated with a dose of ROTATEQ and RECOMBIVAX HB. No adverse effect reported. The patient sought unspecified medical attention. Additional information has been requested.
Skin on the side of my forearm is hypersensitive and paimful to the touch. It is the same arm as I received teh injection.  It first presented after my first dose (03/19/2021 and started to subside. After the second dose the pain and sensitivity increased.  It has bee 1 week since second dose.
chills throughout the night, fever of 101.4 the for 12 hours. Felt fine after about 20 hours of getting second shot.
REDNESS AROUND INJECTION SITE AND MILD ITCHING. NO PAIN OR SORENESS REPORTED.
Severe abd pain and nausea 5 minutes after shots hives on face, chin, forehead and around mouth- 1 hr after vaccine once at ER-asthma exacerbation.
Client c/o soreness 6 sites of injection R + L deltoid and fatigue, Temp 97.7.
Patient fainted after the needle was removed. She quickly regained consciousness. Blood pressure was low. She waited 15 min. Blood pressure was good. Pt felt fine. She left with her Dad.
Increased jerking at night as dozing off to sleep and then a few months later with single jerking, especially in the legs, while awake which persists.  Some vision changes in the Lt eye with increased myopia.
Information has been received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored GARDASIL 9 (lot # M007764, expiration date 30-JAN-2018, lot # M009378, expiration date 23-APR-2018; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had an irritation in my throat, I used a home COVID-19 test that came back negative. The second day the irritation got a little stronger so again, I tested with a home COVID-19 test, it again came back negative, On day three, I woke up feeling nausea, my throat really hurt, I again used a home COVID-19 test that did come back positive this time. I called and had a telehealth visit with my doctor, I am not able to take the Paxlovid because of my medication Plavix, I was prescribed Lagevrio. I did take a few days before I was able to pick it up from the pharmacy, by that time I was starting to feel better so I choose not to take the medication. I still have little irritation and cough, but I am feeling better.
episode of shaking extremitie & cyanosis w/altered consciousness, postical appearance; t103, rt OM;
For 24 hours, I experienced alternating chills and fever which responded to Tylenol. I took Tylenol every 4 hours which kept the fever to 100.0 degrees Fahrenheit or below. I was pregnant throughout this time. My due date is July 16, 2021.
Patient was vaccinated against COVID as of March 2021. Patient presented to ED and was diagnosed with COVID-19 infection resulting in hospitalization
I had a red eye with a lot of discharge. I went to the urgent care while on vacation and the PA saw me. She looked at me thoroughly and said I had an eye infection. She prescribed Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution eye drops. I was to use those eye drops 4 times a day for 7 days and the infection is now gone.
Vaccine given with Shingrix diluent and no antigen, no symptoms reported to date.
P C from mother of client states approx. one hour after vaccination child had redness swelling on thighs to knee area, child limping and not wanting knees to be touched.  Gave Motrin every 6 hours this reaction lasted for six days and today client has rash also on right outer thigh.  Small red bumps and child still limping.  Has not taken child to physician yet.  Instructed to do so
Total body outbreak accompanied with oozing and excessive itching three weeks after initial vaccination. First diagnosis was atopic dermentitis, treated with atopic cortizone creams, which were unaffective. Total duration of symptoms three months and counting.  Skin is still oozing toxins with accompanied with excessive itching. Scheduled to see dermatologist 5-2-06.
Patient diagnosed with Covid-19 on 11.28 - followed by progressive cough, SOB, low oxygen saturation in the 80's with ambulation, presented to ER. Creatinine 2.2 (baseline 0.7), CRP 24.66, Procal 0.58, Ferritin 888, D-Dimer 1.73. Admitted for respiratory failure with hypoxia due to Covid-19 PNA, did not meet criteria for Remdesivir, treated with Decadron and 2 doses of Actemra. Continued to require high-flow oxygen. Discharged on high-flow oxygen.
Elevated blood glucose readings, beginning 3:00 AM 12/23, fully resolved by 9:00 AM 12/27. Self-managed via humalog insulin injections as necessary. Averaged roughly an additional 8-10 units of humalog insulin a day during this period, which is unusual for me. For reference, last A1c (08/2020) was 6.8. Blood glucose levels during the time mentioned above frequently >300, up to 350-ish. I also noticed that my elevated blood glucose readings required more correctional insulin than usual to address during this time. No illness or symptoms beyond typical dry mouth that accompanies high glucose readings. No call to physician as I was able to manage manually. No impact on my ability to function and perform daily activities, other than the inconvenience of additional insulin injuections. Potentially related to minor changes in activity and eating practices during "holiday" period, but it mirrored blood glucose elevations I've experienced in the past when ill.
Extreme chills, fatigue, burning sensation covering entire back, muscle aches, large rash around vaccination site beginning day after vaccine (itchy, red, getting larger each day)
Pt recvd Engerix-B & exp Hepatitis; Pt recovered;
Next morning, felt nauseous, vomited, joints and muscle pain, fatigue, bad headache, 101.2 fever
Information has been received from an office manager concerning a 15 year old female, allergic to penicillin, who on 12-AUG-2008, was vaccinated with a first dose of GARDASIL (Lot # 660620/0571X), 0.5 ml. It was reported that the patient did not experience any adverse event on first dose. On 29-OCT-2008, the patient was vaccinated with a second dose of GARDASIL (Lot # 659184/0843X). Concomitant therapy included medroxyprogesterone acetate (DEPO-PROVERA) and vitamins (unspecified). The office manager reported that the patient fainted after getting the second dose of GARDASIL on 28-OCT-2008.The patient recovered the same date. No lab/ diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
a female 1 year old patient received Kinrix instead of meningococcal vaccine; a female 1 year old patient received Kinrix instead of meningococcal vaccine; previously got 3 doses of Dtap and IPV; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Dtap (previously got 3 doses of Dtap on an unknown date) and IPV (previously got 3 doses of IPV on an unknown date).   On 18-AUG-2023, the patient received Kinrix. On 18-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a female 1 year old patient received Kinrix instead of meningococcal vaccine), wrong vaccine administered (Verbatim: a female 1 year old patient received Kinrix instead of meningococcal vaccine) and inappropriate schedule of vaccine administered (Verbatim: previously got 3 doses of Dtap and IPV).     The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-AUG-2023 Medical assistant informed 1 year old patient received Kinrix instead of meningococcal vaccine and the patient previously got 3 doses of Dtap and IPV, which led to inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Pt to ED 10/12 for shortness of breath. PT COVID+ 10/12, maintained on Zosyn and vancomycin. 10/13 pt has been weaned off the ventilator, on supplemental oxygen. 10/14 Vital signs stable, pt A&Ox4. 10/15 Pt states shortness of breath has improved, crackles still present in bilateral lower lobes with slight expiratory wheeze in upper lobes. 10/18 pt respiratory status has been improving. 10/20 pt discharged.
One week after Dose 1, I exercized heavily with my arms.  The next day, my vaccine location was again red, warm, and raised.  There was no rash, as in patients describing "covid arm."  It was not very painful, either.. but I did do a good job keeping my arm mobile for both vaccines.  Two weeks after Dose 1, I got a rash for the first time in my adult life (I'm almost 35 years old).  The rash was localized to be just on my "seat" area... literally.  That took over a week to dissipate, but eventually I didn't notice it.  One week after Dose 2, I woke up with red swollen hands, a swollen rash on the undersides of my forearms, a little on my stomach, and a little rash on just the instep arches of both feet.  The rash was spreading, so I was advised to go to a clinic.  Unfortunately, that clinic didn't do any bloodwork, but they sent me home with scripts for prednisone and famotidine thinking I was having an allergic reaction to the pizza I ate the previous night.  I also got a shot in the butt.  The rash and swelling dissipated by over 50% by the next morning.  However, after a day of work and movement, I realized the rash was still spreading and I was now gaining weight.   It is now 3/26, which is two weeks after receiving the 2nd dose of the Moderna vaccine.  The rash is still spreading around my skin.  I completed my medication and now I am monitoring the rash on my own.  The oldest sites seem to be healing.  It is now contained to my stomach, mostly lower abdomen, around the sides and to the back... also very swollen and itchy (now) in my seat and groin area.
12/30/2021 Covid symptoms began with cough, extreme nasal congestion and discharge, headache, and weakness. The symptoms got a little better at the beginning of January but not completely gone away with the nasal congestion and cough. Even today I'm not completely better. I had extreme coughing and my head felt like it was going to explode. By January 3, it was starting to ease off. Then, I started a whole other set of problems. I started having severe abdominal pain and nausea which lasted until 01/07/2022. My infusion was on 01/04/2022 and the abdominal pain started and I hadn't been able to eat in 2 days. I did go to the ER and they did an abdomen CT scan and didn't find anything and said my esophagus was inflamed but they blamed it on Covid. The lingering symptoms I had last week was just profound weakness and any little thing such as taking a shower felt like I had worked all day and needed to go to bed. I also had the inability to go to sleep and my brain was on full kilt and I couldn't shut it off. I was exhausted but couldn't sleep. Testing positive on 01/02/2022
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of PROQUAD (Merck) (lot # not reported) that were improperly stored. No adverse effects were reported. Additional information has been requested.
THERE WERE NO ADVERSE EVENTS, OUTCOMES OR SIGNS/SYMPTOMS IN OUR FOLLOW UP.
Pt received shots on 3/11/02. Pt expired, during sleep, on 3/11/02. COD as per autopsy report: SIDS Per F/U 5/16/02 fo autopsy report: There are florid thymic petechiae.
PT CAME TO GET FLU SHOT ON 9/4/2019 AND REPORTED THAT WHEN SHE GOT HER 2ND DOSE OF SHINGRIX 8/15/2019 THEN NEXT DAY HER ARM WAS VERY SORE. STATED THAT SHE BEGAN TO BECOME LIGHT HEADED AND HAD A LITTLE NAUSEA. STATED HER ARM GOT SORE TO POINT WHERE SHE DIDN'T WANT TO USE IT FOR ROUGHLY 48 HOURS. SAW HER MD AND HER DOCTOR TOLD HER TO REPORT IT TO US (DR.) MD STATED IT MAY HAVE BEEN MYALGIA PER PT REPORT
Diffuse urticarial reaction over arms, abdomen and legs; starting with in 10-20 minutes after immunization. Rx with Benadryl on next day.
After receiving the vaccine, the patient passed out and hit his head.  An ambulance was called and the patient went to the hospital.  He was evaluated and released.  He said he was fine today.
Evening of 3rd dose had the expected sore arm; chills and tiredness On 1-22-2022 had to go to the Hospital ER in excruciating pain and vomitting. Diagnosed with Kidney Stones. No prior history of kidney stones or any urinary tract problems.
Two days after administration presented in clinic with cellulitis to injection site. Left thigh redness and warm to touch. Antibiotics given KEFLEX (250g/5ml) 5mL PO BID x 3 days.
4 am redness and induration at site. -No treatment mildly warm to touch.
Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever Started on abx - cephalexin
Flush immediately after shot Severe sweating evening of shot Severe headache 2 days after shot Lump at injection site 3 days after shot
The patient is a healthy 19 yo male with a history of CP who received SPV #1 (ACA Lot number the V03019C) on 26 September, 2018 to his R upper arm in addition to Hep B (SKB lot #1034864), typhoid (lot #N1k12) & Anthrax (MIP #FAV570A). He reports he has a history of chest pain intermittent sharp fleeting 1-2 times a month at mid chest he reports he did not take time to have this evaluated. He reports approximately 1 week after SPV receipt he developed new severe sharp, aching near continuous chest pain midsternal and periphery to the heart area 8-9 out of 10. He reports it was worse supine and would wake him from sleep. It continued throughout the day and worsened at night. It would improve after sitting up and have episodes of 10-15 seconds of worsening pain. He states he experienced shortness of breath prior to this onset that would improve with deep breathing and that this was worsened with the onset of his pain. He describes palpitations when awoken at night with the pain which have improved. He denies peripheral edema, nausea or vomiting, or diaphoresis. He saw PCP day 7, but had normal exam & EKG. He was seen again on day 16 and had EKG ST elevation changes consistent with pericariditis.
Patient was standing against the wall. She leaned her head back and hit her head on the wall, at which point she dropped her phone. The patient then proceeded to bend down and pick up the phone when she passed out and hit her head on the door hinge. The pharmacist was immediately called into the immunization room and the patient's mother helped the patient sit up. After approximately 1 minute, the patient was helped up and sat down on the bench. The pharmacist checked on the patient and offered her a bottle of water. Although the patient was bleeding from a cut on her head, the patient and her mother refused ambulatory services and were given the room. The pharmacist periodically checked in on the patient and after approximately 10 minutes, the patient and her mother left the facility.
Pt recvd vax & approx 3 1/2 wks later pt exp Bell's Palsy & devel an altered sense of taste the sx resolved p/2 wks & the pt is now considering to take the final dose in the series;
Burning; Tingling; Numbness; Muscle ache from shoulder, bicep, forearm and hand.; Heaviness and arm feels weak; Heaviness and arm feels weak.; Dose 1: 09Aug2021; Dose 2: 14Oct2021.; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 at 09:45 (Lot number: FF8841) at the age of 57 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "None". There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot Number: FA7484, Anatomical Location: Left arm, Administration Time: 10:00, Route of Administration: Unknown), administration date: 09Aug2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 14Oct2021 at 09:45, outcome "unknown", described as "Dose 1: 09Aug2021; Dose 2: 14Oct2021"; BURNING SENSATION (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Burning"; PARAESTHESIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Tingling"; HYPOAESTHESIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Numbness"; MYALGIA (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Muscle ache from shoulder, bicep, forearm and hand"; LIMB DISCOMFORT (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Heaviness and arm feels weak"; MUSCULAR WEAKNESS (non-serious) with onset 01Nov2021, outcome "not recovered", described as "Heaviness and arm feels weak". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of burning sensation, paraesthesia, hypoaesthesia, myalgia, limb discomfort and muscular weakness.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported that the events kept getting worse daily. Since the vaccination, the patient had been tested for COVID-19 and tested negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
A non-serious spontaneous report of "inadvertent administration of expired H1N1 LAIV" was received from a registered nurse/health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medication have been reported for the patient. The vaccine expired on 10-Mar-2010. On 23-Mar-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
still red; big, red bull's-eye; flaming red; hot; very very itchy; low grade fever; giant circle rash; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events big, red bull's-eye, flaming red, hot, really big, huge, very very itchy, low grade fever, giant circle rash, still red.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 15 Feb 2021, the patient experienced the event(s) big. red bull's-eye, flaming red, hot, really big, huge, very very itchy, low grade fever, giant circle rash, still red.  Treatment for the event, included Claritin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), big, red bull's-eye,flaming red,hot,really big,huge,very very itchy,low grade fever,giant circle rash,still red was unknown.
PATIENT ONLY 62 YEARS OLD AND RECEIVED HIGH-DOSE FLU VACCINE.
Vaccinated with Varivax on 11/29/01. Developed chicken pox on 3/30/2002
Large egg-sized swelling at injection site; injection site hot and red for 48 hours; injection site hot and red for 48 hours; body aches; chills; fever of 102.9; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid nodule and mild hypertension. Concomitant medications included levothyroxine sodium (UNITHROID) and metoprolol (MANUFACTURER UNKNOWN), both on unknown dates for unspecified indications. The patient had no allergies to medications, food, or other products. Patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 12:45 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 05Apr2021 at 15:45, the patient experienced large egg-sized swelling at injection site, injection site hot and red for 48 hours, body aches, chills, fever of 102.9 and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events injection site hot and red for 48 hours was recovered on 07Apr2021 while the outcomes of large egg-sized swelling at injection site, body aches, chills, fatigue and fever of 102.9 (unspecified units) was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I went for a routine mammogram in March after waiting the time period recommended, and even longer. Mammogram  results indicated that more visits were necessary due to suspicious images.  Diagnostic mammography and ultrasounds were ordered, and not covered by insurance,  and the outcome was Immunosuppression as a result of the Covid 19 vaccine.
04/09/2021 c/o mild headache, then 04/10/2021 severe headaches, sensitivity to light, slept with knit cap over eyes. Pt took Excedrin. 4:00 am and 9 am. Headache last until about 3pm on Saturday. Pt states "I did not feel right until Sunday afternoon, tired and sore from headache and tension." 04/13/2021 started with moderate headache around 3 am this morning, took Excedrin and the headache eased off.
Rash developed on arm at injection site 7" x 4", inflamed and tender, and hot - patient had low grade fever.