chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of shingles (1) side of face in a 50-year-old male subject who was vaccinated with FLUARIX (unspecified formulation) (GlaxoSmithKline). In October 2013 the subject received a dose of FLUARIX (.5 ml, intramuscular, unknown deltoid). In October 2013, 1 day after vaccination with FLUARIX, the subject experienced shingles (1) side of face. In October 2013, within a month after vaccination with FLUARIX, the subject experienced could not work (nos). The shingles were located on the left side of the subject's face and scalp. As a result of the shingles, the subject sought medical attention and "had to miss one day of work". At the time of reporting the outcome of the events were unspecified. The healthcare professional considered the events were possibly related to vaccination with FLUARIX. Follow up was received from nurse via sales representative on 29 October 2013. The lot number provided identified the FLUARIX as the trivalent formulation. Per the nurse, on 3 October 2013, the subject received a dose of FLUARIX (unknown details). On 4 October 2013, one day after vaccination with FLUARIX, the subject experienced shingles. No further details were provided. Follow-up information was received on 26 November 2013 via nurse who reported the 50-year-old male subject was vaccinated with FLUARIX (.5 ml, intramuscular, right deltoid) on 3 October 2013. No action was taken with FLUARIX. The events occurred 4 October 2013 and resolved on 18 October 2013. The healthcare professional considered the events serious, however she did not indicate the specific seriousness assessment for the events. At the time of the report no other information was provided.
temperature excursion with no reported adverse event; Patient received MENQUADFI after the temperature excursion occurred with no reported adverse event; Initial information received on 08-Feb-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves a 10 year old male patient who received meningococcal a-c-y-w135 (t conj) vaccine (Menquadfi) after the temperature excursion occurred with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) as prophylactic vaccination.  On 02-Feb-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine at 0.5 ml, once (lot U6824AA, expiry date: unknown) via intramuscular route in the left arm as prophylactic vaccination.  It was reported that on 02-Feb-2022 the patient received meningococcal a-c-y-w135 (t conj) vaccine after the temperature excursion occurred (Product temperature excursion issue) with no reported adverse event (poor quality product administered, latency: same day).  Action taken with meningococcal vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the events (Patient received MENQUADFI after the temperature excursion occurred with no reported adverse event, temperature excursion with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient received menquadfi after the temperature excursion occurred with no reported adverse event and was Unknown for the event temperature excursion with no reported adverse event.  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 the guidelines. 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.
Right arm spasms causing tremors. Left leg from knee down bounces. Facial numbness periodically
71 year old patient received DT instead of TD vaccine/No AE; Initial information was received on 16-Mar-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 71-year-old female patient who received DIPHTHERIA AND TETANUS TOXOIDS vaccine instead of DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) vaccine.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On an unknown date, the patient received a 0.5 mL booster dose of suspect DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer) [lot C5J11AA, expiry date: 30-Aug-2020] via an unknown route at an unknown administration site instead of TD vaccine for prophylactic vaccination (wrong product administered).  It was case of actual medication error due to wrong vaccine administered to patient.  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 and Module VI of the 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.
Patient Received Moderna Booster (8077-0273-10) Patient received half of the adult booster dose.
Pain persisting at least 4 months of the left upper arm and left elbow most consistent with lateral epicondylitis
Before giving him his first dose of the Pfizer vaccine, I informed the pharmacist that Pt has had a cough for about a week prior.  They told me it was ok to give him the shot.  Approximately 12 hrs after receiving the shot, he got a fever which got up to 104, body aches, sore arm, tired, and chills.  It only lasted for 24 hours but his cough got worse.  I took him to his dr. on July 29, 2021,  He had a lung infection and was put on a 10 day course of antibiotics.  His cough subsided but did not go away.  His 2nd dose was given on August 18, 2021.  He still had a lingering  cough.  Approximately 8 hours after getting the 2nd dose is when the symptoms started.  He had a fever of 102, body aches, chills are tired.  His cough got worse.  August 20, 2021 I took him to his doctor for  a check up.  She ordered an X-ray.  X-ray came back showing he had some air pockets around his heart so we were told to go to the ER for further evaluation.  At the ER he was monitored, his vitals were all good so we were sent home with steroid liquid medication along with steroid inhaler.  He has a follow up appointment with his doctor later this afternoon.
Pt came to office after mother noticied this morning left thigh was red, warm to touch and large area around immunization site was swollen,  Parent advised by MD to apply Cool compress to left thigh as often as practical for the next 2 days and then warm compress thereafter;
had vaccines still got shingles/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had vaccines still got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-APR-2023 This case was reported by a patient via interactive digital media. The patient had the shingles vaccines and still got shingles 5 years later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Went to ER on 1/15/03 with increased erythema and edema. Dx'd with cellulitis. Treated with antibiotic IV and oral antibiotics. F/U in office on 1/16/03 with decreased erythema on left thigh, decreased edema and warmth with scattered vesicles. F/U appt. 1/21/03. Finish Amoxil Rx. DX: Left thigh cellulitis.
Patient is a 36 y.o. male w/ no PMH p/w 3d of palpitations and one episode of concomitant syncope.   Patient in perfect health until 5d PTA when he got COVID vax - had usual side effects (body aches, chills) for 1-2d. Then 2d PTA started getting palpitations which happen predominantly when he is laying down to go to bed. 1d PTA patient woke up, got up from bed then started feeling palpitations and light headed with dimming of vision - layed down on ground and raised legs, however still LOC for a few minutes. No prodromal flushing or dizziness, no tongue biting or incontinence, no post-ictal state. However felt fatigued when he woke up - still able to walk to bathroom. Notably patient is athletic and rides a bike >200miles/week and never has had presyncope or syncopal symptoms, and has baseline sinus bradycardia in 50s.    In ED patient AFHDS. Not currently feeling episodic symptoms described above. ROS positive for chills and body aches post vaccine but otherwise no fever, headache, uri sx, cough, shortness of breath, chest pain/tightness/pressure, Nausea and vomiting, diarrhea, constipation, melena/hematochezia, dysuria, brusing, rashes, weight gain/loss. Tele showing sinus bradycardia, ekg w/ right bundeloid pattern and LVH w/ repolarization abnormalities (no STE, I.e. no brugada). BNP neg, trop neg, POCUS w/ hypertrophy, IVS 1.4cm, however did not seem asymmetric.
1-14 noticed ache in left calf, slight swelling.  1-15 same symptoms only a bit worse. 1-16 at 7:54 went to ER.  Treated there by Dr . who did a blood test which I did have a blood clot, they then did a scan which determined there was a blood clot.  Tests done D- Dimer lab, Venous UniLat Arm or Leg diagnostic study.  Diagnosis - Deep venous thrombosis of the left popliteal vein (distal SFV, Lesser Saphenous V)
I don?t know the lot number. I guess my vaccination. Card might have that info. I started having severe chest pain & into my neck & L arm. All the symptoms of Pericarditis.
27SEP PM hot on inject site, red w/hard knot approx twenty five cent; 28SEP very red & hot, golf ball size; dx cellulitis mild 2nd to immun;
Case number PHEH2014US024629 is an initial spontaneous report received from a nurse on 05 Dec 2014. This report refers to a patient of an unknown age and gender. The patient was inadvertently vaccinated with only Men CYW liquid component of MENVEO (batch number: not reported) intramuscularly without reconstitution with Men A lyophilized component on 21 Nov 2014. No adverse event reported following this medication error.
Started running a fever the night of the injection, March 13, 2021. Fever of 101-102+ continued for 40 hours along with muscle (especially calves) and joint discomfort.  I had a bout of being nauseous and I had two soaking body sweats. After the fever broke, I was weak and tired and lightheaded.  It?s now eight days since the vaccine and I have noticed that at times I am searching for a word that I know, but I can?t pull it up in my mind. This has happened one or two times a day since I received the vaccine on March 13.   Seems like a mild neurological side effect.  Hopefully, this strange side effect will end soon.
12 hours after vaccine administered I began to feel feverish and had chills, sore arm, tweed was, and body aches. Took Nyquil and went to bed. 24 hours after vaccine administered fever was gone.  Took Advil for other symptoms.  Woke at 11 am almost 48 hours after vaccine was administered and have a rash/hives under my armpits, under my breasts and wrapping around my body to my back.  Too k a Benadryl. Hives are still present. May have to take another one.  All other reactions gone.
Four days after first shot, I had terrible muscle aches; congestion; ear infection (even with medication the congestion in my ear will not go away and it is is very uncomfortable); inability to clear sinuses (tried nasal spray, otc medication, and blowing my nose)
Myalgia, Arthralgia, SkinRash, UrticariaPruritus, NauseaVomiting, Fatigue, Pain at injection site Narrative:
pt recv vax;had chills;turned blue throughout body and lips;noisy when breathing occurring hours after immun per PAR.lasting 5 mins;apap given; pt brought to clinic for exam w/ T of 100.7;improved next am w/in  nl limits;
At first just a very sore arm. The next morning: flu-like symptoms--horrible headache, joint pain in hips and knees, temperature elevated by 1.5 degrees, fatigue. Slept about 20 hours that day. No appetite. Much improved on day 2--just a headache.
Aches and pains (ribs, breast, shoulder) started June 21 in PM. Pain kept getting worse, felt like broken rib and breast surgery. Shingles rash presented June 25 in PM. Went to doctor June 27 - insurance would only pay for 3 days of 7 day prescription of valacyclovir then got another 7 day prescription for acyclovir. Final med taken 7-6 in PM. Pain was severe June 23 to July 5.
6hr p/vax pt devel fever, chills & sweats episode followed by noc axillary adenopathy;the next morning 20hr later erythema & edema 5mm below inj site;
Information has been received from a physician concerning an 11 year old female who on 18-JUN-2009 was vaccinated with the first dose of GARDASIL (lot# 661953/1130X, route and site of administration not reported). Concomitant therapy included MENACTRA. On 23-JUN-2009 the patient came back in the office and presented her skin. The patient was diagnosed of urticaria all over her trunk and her leg in the thigh area. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
PT has light red rash noted on arms, truck and legs.  No open wounds.  Not raised rash.  No fever or other illness noted.
Myalgias, arthralgias, arm pain, fever (100.2), chills, and headcahe severe enough to not be able to work one day.
Hive reaction began on day 7 post vaccine, isolated to left arm, back, trunk.
This spontaneous report as received from a medical assistant refers to four patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses RECOMIBVAX HB injection, lot # L027733, expiration date 30-APR-2017 (dose and route of administration were not reported). No adverse symptoms were reported. The vaccine was exposed to temperature 47.1 Fahrenheit (F) for 4 minutes with previous excursion 46.8 F for 1 hour and 45 minutes. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a female who in October 2006, was vaccinated with a dose of PNEUMOVAX 23.  In October 2006, 3-4 hours after vaccination the patient's arm "swelled to twice its size".  At the time of the report the patient's outcome was unknown.  Additional information has been requested.
I went into antiflactic shock, brought over to the hospital, was given intravenous drugs and benadryl. Had to stay for 6 hours.
10 minutes post-inoculation, I developed an ice cold sensation in my chest that spread throughout body and extremities. I developed a metallic taste in my mouth, nausea, tingling in my hands and feet and lightheadedness.  This lasted 15 minutes, then repeated approximately 20 minutes later reccured as I was set to leave vaccinations site.
Facial/systemic hives w/papules gave BENADRYL and MEDROL.
shakiness-tremors-duration 15-20min;sx occurred 1 hr p/getting the vax;
I figured it was COVID-19 since my husband had it 5 days prior. I had a backache, headache, cough, sneezing very lethargic and loss of appetite. I went to the clinic in town and tested positive. They prescribed the PAXLOVID and steroids and that helped but I am still currently dealing with extreme lack of energy and thrush.
Evening of vax had inconsolable, high pitched cry x 2-3 hrs; t102 which would not come down w/APAP; Called MD;
Initial misuse report received from a healthcare professional on 20 June 2014. A patient received two doses of FLUZONE (no other information was provided regarding the patient). Thus extra dose administered but no adverse events reported. No adverse event was reported. List of documents held by sender: none.
developed an enlarged heart; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the parent.  A 29-year-old male patient received BNT162b2 (COMIRNATY NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "developed an enlarged heart".  Additional information: Patient's mother reported that her son was forced to take vaccine and developed an enlarged heart.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Often find myself dealing with = frequent headache, impaired sight, muscle fatigue and soreness often, frequent diarrhea, joint aches, nothing fellows. 04/12/2007-records received. DX: DDD Lumbar spine. hypertriglyceridemia. post traumatic stress disorder. knee arthralgia. neck pain. gerd. constipation. allergic rhinitis Labs: WNL except for triglygerides 773. Xray cervical spine, paravertebral muscle spasm. mild degenerative changes. CT lumbar spine mild discogenic disease at L4-L5. Complete knee x-ray normal. Complete wrist x-ray normal. Complete foot x-ray normal. Complete spine lumbosacal AP & Lat. straightening of the spine which may be secondary to position but inflammatory changes cannot be excluded. 1/4/09 Diahrrea, joint ache, back pain, road rage.
Itching, redness on arms, hands and trunk. Fatigue and chills for about 1 week.
I went to a drive through vaccine clinic to receive my vaccine. After around 9 minutes I began to feel really overheated and felt like I had something in my throat and that is when I felt like I couldn't breath which the doctor described as  respiratory distress. They rushed me to the nearest doctor where they gave me an I.V. and breathing treatments and some sort of shot that I believe was a steroid. I began to feel better shortly after. They prescribed prednisone for 10 days and advised that I don't get another dose of the vaccine. Since then, I've had multiple random health events such as headaches, skin problems, fatigue, and kidney issues. I also feel like my allergies to nuts have gotten more sensitive.  Around 6 months after the vaccine, I woke up with a swollen face and ended up in ICU but have no idea what caused that specific event.
within 15 minutes after vaccination, patient reported mild throat swelling, hoarseness, and eyes feeling funny or glossy. Blood pressure was 150/94. pulse 81. Patient gave verbal consent to have IM diphenhydramine. administered at 10:55am.  Patient stated at 11:30 am she was feeling reduction in throat swelling and had a dry mouth
Information has been received from a physician concerning a 24 year old female patient with no drug reactions or allergies and with no pertinent medical history who on 09-JAN-2012 (reported also as "09-FEB-2012") was vaccinated with the first dose of GARDASIL (dose and route not reported) in deltoid of left arm (lot number: 669794/1400AA) and on 17-APR-2012, was vaccinated with the second dose of GARDASIL (dose and route not reported) in deltoid of left arm (lot number: 669795/1516AA). Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, on an unknown date after the first dose the patient experienced pelvic pain which resolved before the second vaccination. After second vaccination, approximately in April 2012 the patient experienced left pelvic pain, racing heart, shortness of breath, chest pain and tightness, intermittent abdominal pain, numbness, tingling in her right leg and arm and left hand and constant fatigue. The patient had visited the Emergency Room and an Immediate Care Clinic. It was reported that the patient was unable to work. Lab diagnostic studies included: pelvic ultrasound, electrocardiogram, chest x-ray, echocardiogram, Magnetic resonance imaging (MRI) and Holter monitor (results not provided). There was no treatment given for AE. At the time of the report the patient's outcome was not recovered. The pelvic pain, racing heart, shortness of breath, chest pain and tightness, intermittent abdominal pain, numbness, tingling in her right leg and arm and left hand and constant fatigue were considered to be disabling since the patient was unable to work. Additional information has been requested.
approximately 30 minutes after injection of shot,  felt dizzy, confusion, face and throat swelling, rapid heart rate, feeling on the verge of passing out. Was driving home at the time and pulled over to call 911.  3 to 4 minutes of very intense reactions, had initial difficulty calling 911 and driving off the road to pull over. Paramedics arrived 10 minutes after the initial call to 911, symptoms had improved greatly after 3 to 4 minutes and after 10 was starting to feel back to normal.
within 24 hours, muscle aches, headache, lethargy, dizziness, sinus congestion, localized arm pain at injection site.  The sinus congestion, headaches, and dizziness persisted for 8 days.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498: