chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever, vomiting, abdominal pain, back pain occurred the evening of same day vaccines were given. Evaluated in ER & discharged on 6-16-10. Re-evaluated in office on 6-17-10 & admitted to hospital. Diagnosed with possible viral illness.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient called on 05/27/2021 after receiving covid-19 vaccine on 05/19/2021 to report a rash on lower back and inner thigh. Patient says it is not itchy. Patient noticed it appeared around Monday 05/24/2021.
ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM
Severe shaking started at noon. I was shaking so bad, I could not make a phone call on my smartphone.  Cold hands felt like my hands were in ice. Shaking lasted until 5:00 PM. Body aches and pains. Beginning at 5:00 PM, I went to bed. My heart felt like my heart was beating out of my chest until about midnight. The next day, I felt better but still had body aches. On Sunday (third day), I had chest pains during moderate exercise. This is the first occurance of this. On Monday, I am still having occassional chest pains. I will seek medical attention tomorrow if the chest pains continue.
Fever, chills, weakness, muscle aches, nausea, soreness at site, tiredness
Headaches day after shot 10/27/21 ER Room - "Bells Palsy" Diagnosis 11/04/21 Severe Droop "Right Face. No eyelid movement. Blurred vision right eye" Right eye irritation due to eyelid no longer functioning. Issues continue 11/08/21 Follow up today 11/08/21
unconsolable for over 3hrs p/vax;1 dose of APAP given @ time of vax; 2nd dose given 16:15; inc consolability, feeding well;4JAN96 fussiness stopped @ 3:00; no fever;no rash
Edema of both lips;Tingling around mouth. Applied Neosporin to area and took 25mg.-50 mg. Benadryl on an irregular basis.Given ice pack for lips and 25m. Benadryl on 11/5/09-day it was reported.Advised to consult personal physician.
Initial case received from a consumer, who is also the patient, on 10 November 2014. A 53-year-old male patient, with a history of genital herpes, GERD, and "BENADRYL anaphylaxis", received a fourth injection of IMOVAX Rabies (lot number not reported) on 29 October 2014. The patient had previously been taking VALTREX, but had discontinued after "reading information on the internet". Two days after his fourth dose of IMOVAX Rabies (also reported as Day 14), on 31 October 2014, the patient developed erythema multiforme and a large outbreak of genital herpes. He had such severe swelling in his mouth that he was only able to take liquids for one week. He saw his primary care physician and dermatologist, and was prescribed steroids for 5 days. He reported significant improvement since then, with only redness and scabbing at the time of the report. The patient outcome is recovering. Documents held by sender: None.
18MAR96 1930 pt c/o pain in jaw, next morning pain but went to school;1600 19MAR96 returned home from school w/swelling lt cheek;By 3:00 on 20MAR96 severe pain-went to MD 10:30 that day dx rxn to vax;
Pt with decreased ROM at R/shoulder & swelling & erythema (4x4cm) after 24 hrs of vaccine administration.
angioedema, hives on chest and legs. ER administered epinephrine and prednisone
2PM Thursday, patient received Td and MMR on right arm. Right arm was red and raised. On Friday morning, site warm, sore, but no fever.
Swollen (area of the site of injections) at the site area and even below the arm it hurt!!! Warmth and a pinkiness, 4" x 1", meandering. Then on Day 3 and for 24 hours, never-before-experienced severity of diarrhea, to dehydration and fainting twice.
Vaccinia rash, no treatment, occurred 17 days following immunization with Varivax, DTaP, and Prevnar.
Faltigue, headache?, nausea, diarrhea, shortness of breath on exertion ( no difficulty breathing), dizziness.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a 51 year old  female. Initial information processed with additional information received from reporter on 25-MAR-2022. The patient's height, and weight were not reported. The patient's past medical history included: non alcohol user, and concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. There was no drug abuse or illicit drug usage. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered at right arm on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-OCT-2021, the patient received booster non-company suspect Moderna covid19 vaccine (Spikevax) (elasomeran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination.  On 21-MAR-2022, the patient started with headache and on the next day (22-MAR-2022) she was not feeling well and her symptoms progressed to wet cough, congestion and sore throat which all seem to be getting worse and patient experienced Suspected covid-19 infection (dose number in series 2). The patient had not taken any medication for her symptoms and she was planning to consult a doctor virtually for her symptoms as she did not want to visit the doctor's office at that point. On 24-MAR-2022, the patient experienced Suspected clinical vaccination failure (dose number in series 1). The laboratory data included: SARS-CoV-2 test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from Suspected covid-19 infection and the outcome of Suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220357912. This report was associated with a product quality complaint: 90000223502.; Sender's Comments: V0-20220354365-Covid-19 vaccine ad26.CoV-2.s-Suspected Clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
severe explosive diarrhea on 1/20/2021 and 1/22/2021 with generalized abdominal pain   stayed at home and forced fluids, recovered slowly over three days
she has not experienced any adverse symptoms; she received her first dose of GARDASIL 9 on 08/31/2019 and her second dose on 9/29/2019; This spontaneous report was received from a female patient of unknown age, who was reporting on herself. No information regarding, the patient's medical history, concurrent conditions and concomitant medications was provided.  On 31-AUG-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date and route of administration were not provided) for prophylaxis. On 29-SEP-2019, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot#, expiration date and route of administration were not provided), that was considered as inappropriate schedule of product administration. The patient did not experience any adverse symptoms.
no adverse reactions, she received a booster of Moderna which isn't approved for her age so I am required to complete this form.
A couple of hours after receiving the injection, I started feeling like I had the flu. It progreesed through the night and got worse, fever, chills, hot flashes and sweating, serious headache. It continued the next 2 days, the day after being the worst. I still feel like hell today 4 days later.
SOB, L arm tingling, lightheaded. Evaluated by EMS-Transported to Emergency room/department or urgent care.
Overnight 2/27-2/28 had low rectal temperatures to 33.8C. Was also undergoing rectal irrigations and bowel cleanout so unclear if low rectal temps due to this as oral temperatures later obtained at the same time were normal while rectal temps remained low. Infectious work up negative (blood, urine cultures UA; CXR not obtained as no respiratory symptoms). May also be secondary to underlying autonomic instability with neurologic dysfunction though previously has not had hypothermia outside of infections. Temperatures have since normalized
RED, SWOLLEN, HOT, RAISED PATCH ON OUTER LEFT ARM (2 1/2 BY 1 1/2 INCH)
pt recvd vax & began crying & continued for approx 2 hrs; unable to comfort pt given apap; pt was fussy through night; t 101.6; cry nl next day;
Rash all over my skin from scalp to toe. Body feels on fire. Intensifies in evening. On-going from 4 months. Have to take anti allergy medicine every day.
Paresthesia; Cough; Photophobia; General body aches; Increased fatigue; Headache; Left temporal temperature of 99.3; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Paresthesia), COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches) and FATIGUE (Increased fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse effect (no medical history provided).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches), FATIGUE (Increased fatigue), HEADACHE (Headache) and BODY TEMPERATURE INCREASED (Left temporal temperature of 99.3). On an unknown date, the patient experienced PARAESTHESIA (Paresthesia). At the time of the report, PARAESTHESIA (Paresthesia), COUGH (Cough), PHOTOPHOBIA (Photophobia), PAIN (General body aches), FATIGUE (Increased fatigue), HEADACHE (Headache) and BODY TEMPERATURE INCREASED (Left temporal temperature of 99.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Body temperature (97-99): 99.3 (Borderline) degrees. On 10-Jan-2021, White blood cell count (4,500-11,000): 4 (Borderline) no left shift.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Patient is only 16 and should not have received Moderna. Patient did not have any reaction.
Child was given Novartis Vaccine only approved for children ages 4 years and up. No adverse reaction reported.
Date of Vaccination 8/3/07 @ 8 a.m.  Date of adverse event onset 8/3/07 @ 8 p.m. ER visit 8/4/07.  Mom reports that client had a seizure. She leaned over and they could no awaken her. After this "spell happened a third time"  the mom took client to ER. The diagnosis at that time was a low grade fever with no mention of seizures.  Evaluation by PMD 10/12/07 stated possible reaction. According to the mom, the  PMD plans to have her vaccinated and observed at Medical Center. Clinic nurse called to confirm mom's report with PMD, but still PMD states still not sure was reaction.     Mom reported event  to Health Department 10/12/07.
Localized Redness, Itching, Swelling, Heat. Applied cold compress and Benadryl spray.
Patient stated that within 30 mins after taking the shot she felt that her neck was starting to swell she took a pic. It didn't bother her anymore. The next Monday her neck was hurting and swollen. A week after that her neck was still swollen. Patient has a DR. Apt on 8/11/2021. Patient also mentioned that she is having stomach discomfort.  Had a reaction to the Technis shot. Lymnodes became enlarged.
2-4 hours later = mild flu shot like pain in the left deltoid; 9-10 hrs later low grade fever with mild chills; next morning = moderate fatigue that lasted about 36-48 hrs.  Pain in the deltoid present at 72 hr, but mild.  I was at Day 26 after PCR confirmation of C-19 and about Day 28 from exposure to a single source (employee).
This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient. A 75-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2022 as dose 2, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing); "RA" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: No other medication was reported in 2 weeks. No Known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID 19 and the suspect drug BNT162b2.
Information has been received from a physician concerning a patient with "allergy to malprotein" who was vaccinated PO with the first 2.0 ml dose of Rotateq (not lot# provided). One to two days after vaccination, the patient experienced a "malprotein allergy." The patient also experienced severe diarrhea and was hospitalized for approximately a week." Subsequently, the patient recovered. It was noted that the patient was not immunized in the specialist's office. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Initial misuse report received from a healthcare professional on 17 June 2013. An 18-year-old patient was administered a booster dose of MENACTRA vaccine past expiration date. No adverse event was reported. List of documents held by sender: none.
Vaccine was received at 6:15 on 02/02/21.  Around 11:00 pm pt. reports 1st loose stool, at 3:00 am pt. had a second loose stool.  The following day 02/03/21  at approximately 1:00 pm pt. developed a red rash on her face and chest.  She had no other symptoms at that time.  The rash was not itchy or painful- she was just red.  It was recommended that she contact her primary care physician.  At approximately 3:38 pm she contacted me to let me know that she had taken Benadryl as recommended by her primary care physician.  She reports that about an hour later the red rash was gone.  She denies any other symptoms.
09/06/22 presents to ED for "headache and vomiting". PMHx of "GERD"
PT came to get his first covid 19 vaccine (pfizer), pt was nervous when he got the shot. TECH gave pt the vaccine and after pt went to sit in the chair in the designated post vaccination waiting area he fainted and fell from the chair and hit his head within 20-30 seconds. rph rushed and he was responsive turned him around and kept him laying down. his blood pressure was 138/111 but he was responsive for all question (name, place) asked if he have any anaphylaxis symptom like shortness of breath or swelling and he was not experincing any symptom. he stated he faints from giving blood but first time from getting vaccine. pt said no pain in the neck or the back from the fall but had swelling bump on his head from the fall. EMS was called and code white right away. pt then stated he have pain in his knee and head (from the fall from the chair). EMS came and pt refused to go to the hospital or get his sugar checked. pt felt fine but had sore head and arm (probably from the fall) and used cold compress to help with sorness. pt wife came to pick him up.
This vaccination gave me a sore arm again and I was extremely tired. This started immediately following vaccination. The tiredness lasted about 2 days. I did not go to see a doctor. In April 2022, I had congestion from sinuses and thought it was a sinus infection. My husband tested positive for COVID. I tested myself with the government COVID test and it was positive. I felt as it progressed, I felt very exhausted and very tired. I still get like this sometimes, it is not as bad. I had a lot of drainage and mucus. I ended up getting a cough from all of the drainage. I never got a headache, and the fever I had was 99.3 and didn't last. I ended up taking Mucinex in liquid form and I used a Netti Pot. I was told to continue using my Flonase. I went to an urgent care afterwards and was diagnosed with a sinus infection and given medication for that, 2 weeks after testing positive for Covid.
Two episodes of extreme paleness/lethargy/unresponsiveness. First occurred about 6 hrs after immunizations - lasted about 10 minutes. Second occured while in ER and was witnessed by medical staff. No choking, gagging, spitting or vomiting.  No jerking or abnormal movements. No cyanosis or apnea.  05/01/2007 Record received for an o/n hospital stay for 2 episodes of extreme paleness, lethargy, and shallow breathing.  Parent reports child initially looked pale and sleepy, but later noted he turned white, became unresponsive, and was difficult to arrouse.  The episode lasted ~10 minutes. Breathing was shallow but did not stop.  No cyanosis.  A 2nd witnessed episode occured in the ER.  PE: WNL. Assessment: Possible Life Threatening within 6 hours of 2 mon. imms.
PT EXPERIENCED DIZZINNESS, SWEATING AND LOW BP WITHIN MINUTES OF VACCINE - BUT RECOVERED AFTER SHE WAS LAID ON HER BACK AND HAD TWO COLD COMPRESS ON HER NECK AREA, BP WAS MONITORED AND IMPROVED FROM 91/50 T0 117/77 WITHIN 10 MINUTES - PT WAS ABLE WALK OUT ON HER OWN FROM PHARMACY FACILITY
Patient called next day to say she had a rash on her arm after receiving the H1N1 vaccine.
Onset of pain left chest along T7 dermatome on the 4 th day after receiving second dose. Over the following six days, symptomes frogresses to extreme skin sensitivity and diffuse aching of chest cage and muscles, back, associated with fatigue and stiffness of joints especially after being at rest and trying to move. By the 6th day after onset of symptoms, an erythematous eruption developed along the left T7 dermatome, becoming more pronounced on the 7th day, but not the true vesicular rash we usually see in zoster dermatitis. Discomfort is relieved by taking excedrin and tylenol. I did not try NSAIDs due to gastritis reaction. No fever or chills, sore throat, cough, etc. I started Valtrex today  to be taken tid.
Dermatitis just below injection site, bright red, hot and itchy. (appeared 1 day post injection - had same reaction on day 8 after first injection) (have photo of both if requested) Swollen axillary lymph notes on same side as injection. Low grade fever (99) and chills
Swollen, red right arm; sent to hospital. The hospital discharge summary received on 3/23/04 states cellulitis.
pt had varicella vaccine, within 2 hrs of vaccine, he developed fever. About 13-14 hrs after vaccine had developed pox. Mother reports child has over 100 pox.
Runny nose that wouldn''t stop; when I was at rest it was well, sitting up wasn''t much help but if I lay down it kind of quit too though I get ''that'' a little bit; I always have a little cough; the cough got worse; whole upper body achy; can't hear/hearing problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 95 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Nov2021 (Lot number: FF8841) at the age of 95 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU) (Lot number: Unknown). Relevant medical history included: "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: LOSARTAN taken for blood cholesterol. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose that wouldn''t stop; when I was at rest it was well, sitting up wasn''t much help but if I lay down it kind of quit too though I get ''that'' a little bit"; COUGH (non-serious), outcome "unknown", described as "I always have a little cough; the cough got worse"; PAIN (non-serious), outcome "unknown", described as "whole upper body achy"; HYPOACUSIS (non-serious), outcome "unknown", described as "can't hear/hearing problem". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for influenza vaccine was unknown. Therapeutic measures were taken as a result of rhinorrhoea. Additional information: I finally got a antihistamine (treatment) yesterday and that's help my nose." When confirmed if had a flu shot before vaccine: Consumer stated, "Yes, but not that day I had that a few weeks ago  No follow-up attempts are possible. No further information is expected.
Patient had a severe headache on 6/14/10 with severe flu-like symptoms, chills, rapid heartbeat, weakness & nausea.  This last until 6/16/10 when she was finaly able to get up out of bed.  Today 6/17/10 she is still having some weakness but is doing better.
Pain and swelling in L arm post vaccination. Immediate care clinic visit. Took X Ray. MD said vaccine was given in the wrong place per pt. She received pain medication and had developed a cough.
numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness). At the time of the report, HYPOAESTHESIA (numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported. Treatment information was not reported
Arthralgia, UrticariaPruritus, fatigue, arm pain Narrative:
Hives on chest/face, itching, headache.  1120 - BP 107/72, P = 83, Resp = 16, O2 Sat = 99%, Room air temp 98.1, patient reported to clinic at 1115.
Swollen lymph nodes in the left shoulder area/upper chest, very painful to touch.  Still larger than normal, but with no pain. Strange nerve pains, shooting down left arm (only a few times, couldn't wear my fitbit because it seemed more frequent with it on); has settled down since then. I've been in menopause for 14 years with no hot flashes,etc.; I started having hot flashes again after the second shot. I've been more tired than normal and not felt 100% healthy since the second shot.
Information has been received from a consumer concerning her 10 year old daughter with no pertinent medical history and no drug allergies who on 13-AUG-2009 was vaccinated with the first dose of GARDASIL. There was no concomitant medication. On 13-AUG-2009 the patient had a headache. The patient did not seek for medical attention. No lab diagnostics studies were performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.