chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a breakout of psoriasis. So a big scaly of patches of skin. First time it was on the ankle then it spread to the upper legs, then upper arms, my chest, my sides and belly, all over my upper and lower back, and back of leg. My husband had a prescription for it since he and my daughter have it so I used some of his medicine, until I saw my own doctor and got my own prescription of probetisol.
Swelling and soreness in fatty tissue of arm when injected.  'Lump' still sore as of 01/29/17 13:06 PM.  Headache all day of 01/28/2017 but appears gone as of 01/29/2017, 13:06 PM.
4 days after receiving vaccine I started getting palpitations.  Like I was skipping a beat. It is still happening but has reduced by about 50%
Classical pityriasis rose onsite with about 3 herald patches, slowly evolving rash on dorsal & ventral torso
pruritus, urticaria, facial rash started 8 hrs p/inject; these s/s were moderated by DPH; fatigue started 24 hrs p/inject & lasted 4 days;
Information has been received from a female nurse who on 06-DEC-2010 had a vaccine splash from a VARIVAX (Merck) (Lot # and expire date not reported) syringe onto her forehead and around eyes. The nurse flushed the eyes for a few minutes but wished to continue to flush the eyes some more. She had a warm feeling on her eyelids that had not resolved yet. There were no laboratory diagnostics test performed. The nurse did not seek medical attention. Additional information has been requested.
pt recv vax & exp negative titers by latex agglutination;MD reported 9 patients;
sore arm 1-2 days post vaccine, exactly 1 week post vaccine (12/30/2020) rash appeared around injection site on L arm, measuring roughly 2 in. across. Initial visit to urgent care dx of allergic reaction, prescribed triamcinolone 0/5% 2x/day and antihistamine as needed. Followup visit following day, separate doctor gave dx of cellulitis to spreading area now 4 in wide and long, given rx of doxycyclin 100 mg 2x/day for 10 days. On 1/9/2021 at followup visit doctor noted cellulitis was gone but rash still persisted. Given order to stop doxy, begin course of prednisone 50mg 1x/day for 5 days. Followup if needed post course of prednisone.
Anaphylaxis - presented 1 hr after vaccines with hives, wheezing, coughing. EPI PEN JR, BENADRYL, albuterol. Improved with treatment.
in ICU after developing GBS; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: in ICU after developing GBS) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-Mar-2023. The patient reported this case via interactive digital media. The reporter's mother got this and currently in ICU after developing GBS, a week after her second shot.
Petechial rash on (L) leg - same leg he had PENTACEL 3/28/16 - 20 days. 3/28/16 2 mos well visit - rash developed 4/16/16 and seen in ER 4/18/16 for rash on (L) LE purpuric.
I had severe pain in my shoulders, biceps, right buttocks', and weakness all over. I had some tests done and was in 3 weeks of pain. I was given antibiotics and steroid. I started taking a statin for cholesterol in September and was on it for 3 weeks before the pain started. Once pain started I stopped the statin and haven't taken it since. Presently the groin pain and right side buttocks pain is gone. The severe weakness, stiffness was still present until 2 days ago when I started the steriodi.
39 yo M with peripheral vertigo.  Pt feels like the world is spinning.  This is sudden/intense with movement.  Ceases when staying still.  No vision change.  no gait disturbance.  HA not sudden/first/worst/different.  no cp/sob.  no abd pain.  no dysuria/hematuria. no rash.  no fever.  Pt given Meclizine and Zofran and symptoms resolved.  Rp given.  FU with PCM.
Left arm is sore it hurts more at night. Pain seems to be less than what it was initially but it is still there.
severe rash on face also on neck following the carotid artery. Also presented on back. Eyes were burning as well as face, neck. Hard to swallow. Difficult to breathe. Described as felt like glass as breathing.
Moderna covid 19 vaccine was thawed and refrigerated on 05/13/2021. Per Moderna, vaccine is does not expire until 30 days have passed. The vaccine was mistakenly given to the patient 1 day past expiration date on 6/13/21. RPh reached out to Moderna manufacturer which stated that they did not have any evidence to support administering  another dose.
had local tenderness @ inj site which resolved as expected in 2-3 days; 2 wk p/vax had new onset of bilat arthralgia to shoulders, elbow, wrist, & fingers; c/o pain limiting ADL moderately; referred to MD or ER for eval;
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ----------------------------------------------------------------------------------------------------------------------------- ACUTE STROKE DUE TO EMBOLISM OF UNSPECIFIED ARTERY 4/15/2023 BILAT ASTIGMATISM
Immediate reaction was typical fever, rash, painful arm, fatigue, etc. Followed by extreme fatigue that never went away. The rash remained and was painful, tingling, (pins and needles) which was all over my body. It would fade, occasionally, and then return always coinciding with the neuropathy and pain. I started experiencing polyneuropathy which  progressively became worse by the day and began to impact my GI system causing constipation and pain. Weakness in my legs and numbness. Periodic electrical shocks that are always random in location. In general I cannot function, nor do any of the activities I was previously able to do.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4367626-00 (RA). A 67-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unknown (citrate free), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL OPERATION (medically significant), outcome "unknown", described as "back surgery". The action taken for adalimumab was dosage permanently withdrawn. Clinical course: Solicited report by a consumer of an elderly female with an event of back surgery with Humira (Adalimumab). On an unknown date, the experienced back surgery. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient stopped Humira for back surgery. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Did event abate after stopping drug? Yes. Causality for Humira (Adalimumab): The reporter's causality for the event (s) of back surgery with Humira (Adalimumab) was a reasonable possibility. Causality as per reporter (Drug/Vaccine) of Humira (Solution For Injection In Pre-Filled Pen) (Adalimumab) for event Back surgery (Spinal operation) was Probable and of Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran) for event Back surgery (Spinal operation) was Possible. The reporter considered "back surgery" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information currently available, The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
39 YO F AT COVID 19 SHOT CLINIC OBSERVATION AREA C/O ALL OVER TINGLING AND NUMBNESS WITH MILD NAUSEA. DENIES SOB, WHEEZING, DIFFICULTYSWALLOWING, HOARSENESS, ITCHING, HIVES, RASH, NAUSEA OR OTHER C/O. FOUND PT IN PASSENGER SEAT OF CAR APPEARING ANXIOUS WITH ABOVE C/O. HEENT - PERRL, NO JVD, NORM SOUNDING VOICE, NO SIGNS OF ANGIOEDEMA, NOSTRIDOR TO TRACHEA WITH AUSCULTATION, CX - LS =/CLEAR BILAT, NO RASH/HIVES TO CHEST OR BACK. EXTREM - PWD, GOOD PMS X4, MOVES ALL WITH PURPOSE.
arm swollen and pain, unable to eat or drink, body aches, fever chills, nausea vomiting,  headache, for 3 days. face numbness , all severe!!!!
Hi I had been given vaccine at 12:30 pm  Had very unusual burping non stop till  Later that day around 8 pm I got chills  Fir about few hours  I got tightness of the head  Then my body started to hurt , like my bones where braking , kidney very fast filled up with urine  I had to pee very often  Then I felt like every molecule of my body was burning  that was for few hours I couldn?t sleep  The burning was all over body  Though I didn?t take temperature I didn?t sweat  Was unusual burning not topical of high fever  It?s all stored by 2:30 am  I have noticed  that I got skin allergy  Rash  on my fingers  And also they are swollen  Like as if my body has holding liquid
Narrative:  Medical records show patient received COVID-29 vaccine (28 days apart, so most likely MODERNA) and experienced severe hives about 10 days after administration. He was told by clinic (no medical record documentation) in both instances that it was likely the Covid Vaccine. Patient reported this findings to clinical pharmacy specialist on 3/11/21 and explained they have improve significantly but is still recovering.
This was my booster shot. 24 hours after injection, the injection was dark pink in a 2-3 inch circumference. I began to have a rash all over my body. About 4 hours after that started, I felt feverish and had a 99.5 temperature. I felt run down and very tired. I called in to work the next morning and stayed home. That night the rash began to itch. I have been itching for nearly 24 hours now.  I do not know the brand of flu vaccine  that was given to me a few weeks ago.  I was not given any vaccinations with the shingles vaccine.
complained of dizziness; refused to stay to be observed extra 15 minutes; no other problems.
She took a home covid-19 test and it was positive.; This morning she has a lump underneath the armpit; 101F Fever; convulsions; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Mar-2022, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant) and PYREXIA (101F Fever). On 21-Mar-2022, the patient experienced COVID-19 (She took a home covid-19 test and it was positive.) and AXILLARY MASS (This morning she has a lump underneath the armpit). At the time of the report, SEIZURE (convulsions), COVID-19 (She took a home covid-19 test and it was positive.), AXILLARY MASS (This morning she has a lump underneath the armpit) and PYREXIA (101F Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2022, Body temperature: 101f (abnormal) 101F Fever. On 21-Mar-2022, SARS-CoV-2 test positive: positive (Positive) She took a home covid-19 test and it was positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication were provided  Company comment- This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced first the unexpected and serious (medically significant) event of seizure and then the unexpected AESI COVID-19, along with the non-serious events of pyrexia and axillary mass, starting the following day a dose of mRNA-1273 vaccine was administered. Patient experienced fever of 101F and had a lump underneath the armpit; she took home a COVID-19 test, and it was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced first the unexpected and serious (medically significant) event of seizure and then the unexpected AESI COVID-19, along with the non-serious events of pyrexia and axillary mass, starting the following day a dose of mRNA-1273 vaccine was administered. Patient experienced fever of 101F and had a lump underneath the armpit; she took home a COVID-19 test, and it was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
10 minutes, post vax, the pt complained of itching at the site. The area was red around the injection site. Ice pack was applied and after 5 minutes, the redness spread to her shoulder with a few wheals noted. All vital signs were normal. Treated with Benadryl 50mg, given IM in the right deltoid and signs and symptoms relieved within 5 minutes.
expired vaccine 9-11-2023, dose was given with no reported adverse event; Initial information was received on 24-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 weeks old female patient to whom expired HIB (PRP/T) vaccine [ACT-HIB] 9-11-2023, dose was given 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, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Pediarix); and pneumococcal vaccine conj 13v (crm197) (Prevnar 13).  On 24-Oct-2023, the patient received an unknown dose (total, once) of suspect HIB (PRP/T) Vaccine Powder and solvent for solution for injection (lot number: UJ798AB, expiry date: 11-Sep-2023, strength: standard) via unknown route in the right thigh for Immunization and expired vaccine 9-11-2023, dose was given with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On 18-AUG-2016, the patient was vaccinated with expired dose of GARDASIL, dose 0.5 ml, subcutaneously (expiration date 22-JUN-2016) (strength, anatomical location, lot# were unknown). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Pt presents to OHS to report possible reaction to the varicella vaccine received on 5/3/19 in OHS.  She has red pumps that are itchy that developed 5/15/19  to her back, arms, chest and behind her ear.  2 appeared on the train on her way to work.  She works as a CASS and has direct patient contact.  The site is red and itchy. Felt "warm" yesterday with a runny nose.  Has had chicken pox in the past but did not have full immunity on titer.
Pain in the  arm; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the  arm) and MYALGIA (Body aches) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the  arm) and MYALGIA (Body aches). At the time of the report, PAIN IN EXTREMITY (Pain in the  arm) and MYALGIA (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter called about own symptoms but mentioned that reporter family also had soft side effects like pain in the arm and body aches  No concomitant medication were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074984, US-MODERNATX, INC.-MOD-2021-075688 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074984:Wife case US-MODERNATX, INC.-MOD-2021-075688:Son case
Achy and tired. The next day, developed a fever that maxed out at about 103. Had bad headaches and was very dizzy. Symptoms lasted for a total of 2-3 days.
The patient had arm pain in the shoulder and still does. Has had cortisone shots that alleviate the pain but the pain comes back. This developed following the first shot of the SHINGRIX series.  Pharmacy notified of this 1/30/2019.
Pt states became dizzy approx 5 min p/getting shot; felt dizzy for 2-3 minutes also had nausea then fainted; required ER visit due to injury when fell.
On Friday August 20, 2021 I developed 2 round red bumps on my left arm/injection site. They were about an inch or two apart and both were red, swollen, itching, warm to touch, and both were hard. On Saturday August 21, 2021 the redness started to spread around both spots and had an irregular shape but remained red, slightly raised, slightly warm to touch.  On Sunday August 22, 2021 the redness from the two spots formed together to make a large, irregular shaped red area with a very noticeable red outline in an irregular shape and was moderately red and slightly warm to touch. On Monday August 23, 2021 same as Sunday except it was more red and felt like a sunburn and slightly warm to touch
Was not instructed to wait after shot so I went to my car. Drove for a couple of hours. Got out of car, walked forward and passed out with a seizure then throwing up when I came to. Received concussion. Taken to ER and admitted for 5 days. Still experiencing vertigo and nausea
Patient experienced dizziness and felt like she may pass out.  Given a sip of water and felt better.  Declined to be taken to the ED for further evaluation.
Right after I left the vaccine site my right arm began to hurt underneath. After a few minutes the site where I received the vaccine began to burn and I had shooting pain in my arm. As I continued to drive my arm began to spasm and my whole right side began to hurt. Suddenly after a spasm my hand closed and I could not get it to stay open. Soon after I could not feel my right foot. When I got home and got out of my vehicle I felt very dizzy and light headed and walking to my apartment was difficult. Once inside everything was spinning, my heart was racing and my chest felt tight, like I couldn't get a good breath. I then began vomiting. I had a temp of 99.8 later that evening. The next evening when I woke up, I still had the same symptoms. I called my Dr office and they told me I needed to go to the ER right away because of the extremity weakness. At the ER they did EKG, X-ray, and blood work. all came back fine. They gave me Benadryl and a medication they said was like ibuprofen. After several hours they said they didn't know why it happened but they couldn't find anything and to wait a few days and call my PCP if it worsens or goes away.  Since then everything comes and goes. for the most part i know can keep my hand open, sometimes it close, chest tightness is intermittent, as well as the fever. I still can not feel my toes in my right foot and still have right arm pain.
I had chills and body aches and headache the night after getting my vaccine, I took Tylenol which helped but felt very lethargic the next day. Then, on May 8th, I woke up  with ringing in my right ear and it has not gone away. The other symptoms have gone away.
I've been in menopause for approximately 2 years, but after receiving my second Covid vaccine, I experienced heavy "menstrual" bleeding .  It began Monday morning following my Saturday vaccine administration.    It was accompanied by headache and abdominal discomfort, different than typical menstrual cramps.  The bleeding continues, although it has lessened.   I did not experience this symptom after my first shot, but had the more typical flu-like symptoms. I had Covid in March 2019 and received positive antibody results in May 2019.
Expired vaccine dose administered/Dose administered >12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered/Dose administered >12 hours post puncture) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine on 02-Jun-2021 and Pfizer vaccine on 23-Jun-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 09-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered/Dose administered >12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine dose administered/Dose administered >12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Reporter stated that their facility administered an expired booster dose  of Moderna COVID-19 vaccine to 1 patient. The vaccine was given at 10am EST on 09-Feb-2022 from a vial that expired yesterday, 08-Feb-2022 at11:30pm. She stated that only 1 dose was given from after it was expired which was a booster dose. Dose was administered after 12 hours post puncture. Date the vial was initially stored in the refrigerator was on 08-Feb-2022, Date and time vial was first punctured was on 08-Feb-2022 at 8:30am, Date and time of administration of vaccine was on 09-Feb-2022 at 10am EST, the vial was stored post puncture in Fridge, the vial did not undergo temperature excursions. No treatment information was provided.