chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad cold; chills; sore throat; Hot; Very sick like she was coming down with a cold; to bed and woke up about 3 hours later and felt fine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 03Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 09Feb2021 morning, 6 days after first dose of vaccine, the patient experienced bad cold; really bad chills; sore throat; hot; very sick like she was coming down with a cold; and went to bed and woke up about 3 hours later and she felt fine. Patient was feeling ok but was very careful at her work. Second dose was scheduled for 24Feb2021. The clinical outcome of all the events was resolved on unspecified dates in Feb2021.  Follow-up attempts completed. No further information expected.
No adverse reaction in September after the vaccine, until I got COVID, with no fever, only cough, congestion, fatigue, runny nose. I have the home test for COVID-19, and it was Positive. I called the doctor on Monday March 27th, and he prescribed Paxlovid, I took it for 5 days, 2 doses per day. Last Sunday I tested Negative, following the CDC giddiness, I waited 48 hours, when I tested it was Positive on April 4th. I don't feel good now with congestion and running nose
pt. experiencing pin and needle on the L arm the vaccine was administered.  pt. not in any distress and states that the pins and needles are fading.
incorrectly administered covid vaccine; A spontaneous report was received from a non-health care professional concerning a male patient, of unknown age, who was administered Moderna's COVID-19 and incorrectly administered covid vaccine (Product administration error).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.     The patient was administered mRNA-1273 vaccine incorrectly, on an unknown date. No treatment information was provided.  Action taken with the first dose of mRNA-1273 in response to the event was not reported.    The event, incorrectly administered vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273. There were no reported AEs associated with this case.
This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patient's concurrent conditions and medical histories were not provided. On 14-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
starting to get scarring from scratching; itching on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching on my arm) and SCAR (starting to get scarring from scratching) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history provided.  Concomitant products included METOPROLOL for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching on my arm). On an unknown date, the patient experienced SCAR (starting to get scarring from scratching). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching on my arm) and SCAR (starting to get scarring from scratching) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has an appointment with her doctor on Friday.
No adverse event; Medical assistant reported that a 14 year old patient received PROQUAD.; This spontaneous report has been received from a medical assistant regarding a 14-year-old adolescent female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 21-JUL-2022, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) for prophylaxis, one dose (1 dose), administered in the left arm, (strength, exact dose, route of administration, and frequency were not provided) (lot number U029296 had been verified to be a valid number; expiration date was reported as 19-MAR-2023, and upon internal validation established as the same date) (Inappropriate age at vaccine administration). The outcome of inappropriate age at vaccine administration was reported as recovered.  No additional adverse events were reported.
8/23/07 Developed fever of 102.4 and started to break out in rash. 8/27/07 Numerous random and wide spread macropapular reddish lesions, erythematous knot at injection site on left and right upper arm.
Pt developed itchy feeling in arms and hands/but states not stomach issue/no swelling in throat/no sob/no difficulty swallowing. Patient needed a dose 50mg of liquid benadryl due to swelling in hand and feeling of itching @1518; checked  patient again @ 1523 stated still feeling itchy; @1526 timer went off after waiting 30 min.; asked if patient wanted to stay around a little longer (told him have epi-pen on hand could use if felt needed-patient stated didn't feel needed/no stomach issues or swelling in face or swelling in throat stated), he said no should be fine. Patient purchased some diphenhydramine to take home to use. Pt has hx of RA in hands-felt maybe vaccination was triggering that some. Will take more diphenhydramine soon; told him max 300mg per day; if gets home and has any of the above sx's needs to contact EMS asap; patient did not want to stay around any longer. Tried to contact patient prior to close-no answer on phone call. Followed-up with patient next day-stated doing better but still some itching from time to time. Event Details
Worst outbreak of cold sores since initial breakout over 40 years. Also, developed a Plantar Wart on foot that will not heal and will need to be surgically removed.
p/vax pt devel inconsolable crying, lt leg warm & swollen (not from nurse states rt leg swollen); T99;duration of screaming 9hr;
Since getting the vaccine, I have developed multiple strange health conditions. The first is that I have been nauseous and usually vomiting every day for at least the past 2 to 3 months. Also since getting the vaccine I have developed nerve pain and paresthesia in my hands that does not get better with rest and that I am now being treated for because it is so bad that I cannot work on my computer anymore. I also can no longer eat gluten without severe gastrointestinal distress, despite the fact that I have never had issues with gluten in the past. Finally, I have also developed two strange growths on both of my feet in the same spot on both feet. My primary care doctor thinks that they are ganglion cysts and are benign, but I thought it strange that I would develop the same thing on both of my feet in the same spot at the same time.
Became weak and lost most all endurance.  Lost ability to focus and be productive in all aspects on life.  Most noticeable in work environment.   Medical testing determined enlarged heart and very low pumping efficiency.  Started a treatment on multiple heart medicines and hope for recovery to a functional level.  This will require the use of medication for the rest of my life....
Developed anticubital fossa bright red and hot rash after COVID vaccine injection #1. Rash turned bright red and very hot to the touch, forming a circular patch around left inner elbow. Rash lasted for several days, developing red bumps within the bright red and hot area. Rash slowly faded, then returned, sometimes spreading above the left inner elbow, going away, and a few days later it returned spreading lower onto forearm. Always very hot to the touch and painful when touched when first activated. The patient's CRSP flares now appear to trigger recurring coincidences of this rash. Rash continues to return, only on left arm, inner elbow.
Infant reported in paper as deceased. No contact with parents. PHN who gave vaccine had remembered that infant died and had received immunizations from local health unit on 010308. This was triggered by report of another infant in same county who dies at 3 mo. of age and was given same vaccines but with different lot #s of some vaccines.
At most she experienced a headache or sore arm, but that's it.; At most she experienced a headache or sore arm, but that's it.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (At most she experienced a headache or sore arm, but that's it.) and HEADACHE (At most she experienced a headache or sore arm, but that's it.) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     Patient had no relevant medical history, allergy and COVID-19 diagnosis. Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (At most she experienced a headache or sore arm, but that's it.) and HEADACHE (At most she experienced a headache or sore arm, but that's it.). At the time of the report, PAIN IN EXTREMITY (At most she experienced a headache or sore arm, but that's it.) and HEADACHE (At most she experienced a headache or sore arm, but that's it.) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-748230, MOD-2023-748238.
BLUE COLOURED HANDS; This spontaneous report received from a pharmacist concerned a female of unspecified age. 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 not reported, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter stated that, on 11-MAR-2021, after receiving the Janssen covid19 vaccine the patient had blue coloured hands. Pharmacy staff was monitoring the patient and, the patient was further instructed to go to ER if condition worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blue coloured hands. This report was serious (Other Medically Important Condition).  Additional information was received on 22-Mar-2021. The following information was updated and incorporated into the case narrative. Updated patient gender (from Unknown to Female).; Sender's Comments: V1: Additional information received in this version is regarding update on gender of patient. The follow up information does not change the previous causality assessment.  20210322152-covid-19 vaccine ad26.cov2.s -Blue coloured hands. This event is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient states she has noted changes in her menstrual cycle since receiving 3 rd dose of Moderna COVID vaccination on 11/21/21
I got a second Recombinant Zoster(Shingles) Vaccine RZV and that night I started getting chills, then sweats and chills when I bundled up, and then violent hip flexor muscle spasms for an hour.  I got out of bed and hobbled to the bathroom when my fist cramped in a clenched position and got two ADVIL. Then I went to bed and the my legs stopped the up and down spasm tiring my hip flexors after the medicine kicked in. My head also had a headache in the morning, when I woke up exhausted from all the spasms the night before.
Yellow skin color / suspected jaundice for 2 days, headache, malaise/ body weakness
pain down length of  L arm swelling L arm  nerve pain as if carpal tunnel syndrome L arm shooting pain at times in L forearm muscle numbness in tips of fingers L hand sometimes soreness in knuckles or bones of L hand sometimes bone pain in L arm sometime muscle pain in L arm similar to "charley horse" in calf i had gotten when younger  Never had any of this before , nor any prior vaccine reaction
Started feeling tired on day 7 after receiving vaccine. Then it progressed to headache, body aches, fever, chills, and sinus drainage.
chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) 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 CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
On Sunday, 10/23/2022, it started with a slight headache, but that went pretty quickly. The following Tuesday, in the early morning, I woke up with the worst sore throat I've ever had. I went to my volunteer job that day and only coughed once all day. Wednesday though, I woke up with a stuffy nose. I went to get tested for COVID-19, as I do once a month. After I tested positive, I met with the doctor. He suggested that I take cough medicine and TYLENOL. My primary care doctor prescribed PAXLOVID which I will begin taking this morning. I still have a runny nose and nasal congestion but no fever or chills.
1/2 hr S/P vaccination-C/O SOB, increased pulse, dizziness and apprehension. A/P 104-irreg B/P/28/74 Resp 18 O2 2l applied-98 %-Lungs clear. c/s 85 1240-A/P 72, RRR, no SOB, no dizziness, 99% RAO2 follow/up 1330-no c/o calm, pulse RRR
Arm sore and swollen after shot for two days locally, then progressed to sore entire arm, neck and past shoulder/back area. Still bruised 6 days later when in office 11/12/02.
Started having severe pain in right arm from injection site to under arm & by the next day (02/01/11) the pain began speading down the under side of right arm & down my right side / rib cage which continued to 02/02/11 then by 02/04/11 (today) I have a severe headache & still have the severe arm pain.
Starting with slight muscle aches, general blah feeling. at 1 am running fever, aches in joints and muscles. Next day (currently) some nausia, joint and muscle aches, headache, bad taste in mouth, tired.
Pt developed fever,chills, and soreness. She reported to ER on 12/05/2009 and was admitted and kept overnight with a diagnosis of cellulitis. She was given IV antibiotics and sent home the next day with a prescription of Amoxicillin. She felt worse on Sunday evening when she went to another hospital. Again she was admitted with symptoms of fever and increased WBC and placed on IV rocephin and vancomycin. She is currently still an inpatient being treated.
the day following injection, I woke up with a headache and felt nausea.  I didn't sleep well due to soreness at injection site on hip.  These symptoms cleared up by around 7:00 pm so I was able to shower. After the shower I was putting lotion on my legs (as I usually do) and suddenly I had lower back pain and fell to floor.  I was unable to get up without help of a chair and my husband.  The pain continues today (2nd day after injection).  I have used a heating pad and a tens machine to alleviate the lower back pain but haven't achieved that yet.
Rapid Breathing; First signs on 7/19/05, 19 days after vaccination. Still continues, admitted to hospital after an ER visit on 7/31/05 with rapid breathing and desaturation; hospitalized for 7 days in Pediatric Unit. Put on Atravent and Xopenex Q3, Pulmicort 2X daily, Singulair 1X daily, Orapred 45mg daily; required an oxygen tent and blowby oxygen regularly. Patient continues oxygen and monitoring via PulseOx to date at home. Doctor diagnosed with Viral Pneumonia; two other doctors referenced it as RAD. Per follow up report- Pt still has desaturation issues during his periods of sleep.
tiredness & erythema/inflammation @ inject site are reported in a pt who recvd 1 dose of flu vax; pt exp redness in inject site w/warmth & tenderness;
Discharge Provider: MD Primary Care Provider: MD Admission Date: 6/6/2022 Discharge Date: Jun 8, 2022  PRESENTING PROBLEM: COVID-19 virus infection COVID-19    HOSPITAL COURSE: 79 y/o F with a PMHx of chronic lower back pain, progressive age-related cognitive decline, depression, overactive bladder and recurrent UTI who presented with weakness. She also reported associated subjective fevers, chills, headache, shortness of breath, confusion, fatigue, and frequent falls. She also had diarrhea prior to presentation.   In the ED patient was found to be afebrile with vital signs WNL.  Ambulatory pulse ox showed oxygen saturation dropped to 86% on room air.  CBC WNL.  CMP with hyponatremia 130 and AKI with creatinine 1.58 otherwise WNL. COVID-19 PCR was positive. CXR negative for acute changes. Urine culture from 6/3 was significant for Enterococcus. EKG showed sinus rhythm with Qtc 443. Patient was given Decadron, 1L IVF bolus, fosfomycin and transferred to a hospital for observation.   Patient's diarrhea resolved and her symptoms improved. AKI and hyponatremia were most likely due to GI losses from diarrhea and were improving with IV fluids. She was not requiring oxygen and did not complain of SOB. PT/OT recommended home with assist and a 4-wheeled walker. Home care was arranged and a walker was delivered. Patient was discharged home in stable condition.
Bilatrel legs weaknesses & numbness, low back pain especially on left side a few weeks after vaccination. Unable to make appointment with doctors until September 9, 2021. Got xrays, blood test & referral to Neurologist. October 5 EMG tests conducted by Neurologist confirmed Guillain-Barre Syndrome. Admitted to Hospital the same day undergo 5 sessions of plasma-parisis. Discharged October 14. Physical theraphy for 10 days. Neurologist indicated that I have to undergo a second sessions of plasma-parisis in January 2021.
Rash appeared on upper left arm, near the injection site, exactly two weeks after I received Dose #1. Mild soreness in upper left arm as well. The arm soreness has been happening on and off for the past two weeks. The rash, however, only appeared this morning. It was a splotchy, bright red rash, a couple of inches wide. No itching or hives, yet my skin was warm to the touch in the area of the rash. No other physical symptoms and I felt fine otherwise. I took a Benadryl Liquidgel and two Tylenol shortly after discovering the rash. Later in the morning, the rash started to fade and arm was no longer warm to the touch. After doing some reading, the rash seemed very similar to what is known as "Covid arm."
Patient developed alopecia areata about 4-6 weeks after her second dose of Covid vaccine. She developed patchy bald spots at the back of her scalp. She was seen by her PCP a week after mother became aware of the condition and has seen a dermatologist since December. She has received 3 rounds of steroid injections in her scalp. The condition is improving.
pt devel cellulitis in inj area-red, warm to touch, fever 101;parents took to ER x 2;
BODY ACHES, SINUS CONGESTION, COUGH, MAB INFUSION
Generalized seizures x 2 on 2/29/08 lasting 2-5 minutes after DTaP. Better on the same day.  03/11/2008 MR received for 2 ERvisits 2/29 and admission 3/1-2/2008 with DX: Grand Mal Seizure. 2' DX:  otitis media. New onset seizure (afebrile). ???vaccine reaction.  Two hour after receiving vax pt was noted to have become unconscious while clenching fists and arms.  Brought to Er and d/c after (-) sepsis w/u.  Several hours after d/c pt had another witnessed sizure which included clenching of arms and wrists, eyes rolled back, and pt became unconscious x 2 minutes. Pt had 3 day hx of diarrhea prior to vaccines.   Admitted with Impression: seizure and dehydration after 2nd episode.
pain / swollen area where injection given. joint pain in every joint in my body - never had this before vaccine.  Facial muscel spasms; both eyes and left side of cheek area. Never had this before.
Subject is enrolled on a clinical trial that is evaluating the monovalent HPV vaccine in cancer survivors. Subject received 3 doses  of HPV-9 vaccine (given on 8/22/16, 11/2/16 and 3/8/17). On 11/10/17, subject was diagnosed with a secondary malignancy (anaplastic astrocytoma) which has been deemed by the site responsible physician as unrelated to the HPV vaccine and likely related to the radiation that the subject received for treatment of his primary cancer. Treatment in progress.
Injection site pain; low grade fever; Slight headache; Slept most of 36 hours straight; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included nasal allergy, asthma and gout. The patient was allergic to several antibiotics (unspecified). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 13:00 as single dose for COVID-19 immunisation. Concomitant medications included multi vitamin (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN), oxybutynin chloride (MANUFACTURER UNKNOWN) and montelukast sodium (MONT), all for unknown indications and from unknown date.  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 26Mar2021 at 4:00, the patient experienced injection site pain, low grade fever, slight headache. It was reported that she slept most of 36 hours straight. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site pain, low grade fever, headache and sleepy was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.