chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had almost no side effects for the first week.  I only had a little soreness at the injection site.  Now, one week later, I have a large red welt at the injection site.  It is tender, but not super painful.  It is red and non-symmetrical.  It is swollen to the point that I can see the skin is raised.
Patient noticed increased pain sensitivity in right arm/hand on 3/16/16.  On 3/17/16 around 8am patient noticed a raised red oval area, no blisters but looks like the same shape as previous shingles.  General aches and pains in that arm/hand.  Pt had pre-existing neuropathy pain but has notices increase in that since getting the shot.
Patfient received the PPV23 vaccine on 11/14/05 sc left arm;  site became extremely red and painful the evening of 11/16/05.  Pt says she put ice on it yesterday.  This is patients second pneumococcal vaccine.  The first was given greater than 5 years ago.  The flu shot was also given at the same time IM, left arm also, as patient had surgery in the right arm.  Patient not in any acute distress.  She was concerned about the redness since she has never had any problems from receiving the flu shot every year.  She will continue cool compresses, take alleve as needed.  Recommended to call her PCP if redness worsens.
Injection site pain, malaise, for 3 days; rigors for 1 hour.
I had a missed abortion or a miscarriage. I had no signs or symptoms; it was identified on an OBGYN 11/28. At that time they did an ultrasound that reflected there was no longer a heartbeat. I found out on October 28 that I was pregnant. I did not know at the time I got the vaccine that I was pregnant. I was scheduled to have a DNC which was completed. I was prescribed ibuprofen. My due date would have been June 29, 2023.
104 fever  Tylenol Temp 104 on 10/27/2010
Significant vaginal bleeding with clots the size of fist. Progressively got worse through the week. Sat the 23 started soaking through an ultra tampon and pad both every 10 minutes. Several large clots.
At 19 weeks pregnant got the first dose of vaccine, had heart pain and went to the emergency clinic but nothing was found and it went away after a week. Went for my second dose on October 13th and had heart pain for one day after vaccine. Then at 30 weeks pregnant my doctor suddenly notices a change in the amniotic fluid. It has increased a lot since my 20 week ultrasound. Things seemed fine except for the baby then started to grown at a lower rate from that point. Her heart rate was still showing okay until the 36 week point when it just stopped beating 1 month before her due date 1/22/22 at 4 pounds 12 .7 ounces.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB, intramuscular (dose and frequency were not provided). No symptoms were reported. This is one of several reports received from the same reporter. Follow-up information has been received from a receptionist on 03-JUN-2015. The reporting medical assistant was no longer at the facility. The receptionist was familiar with the vaccine storage issue and would forward the request for patient identifiers, lot numbers and dates of vaccination to a new office manager. Additional information has been requested. AEs and the narrative have been updated.
Headache, NauseaVomiting, EXTREME FATIGUE. Narrative:
Patient came in seeking a Pfizer Covid vaccine. It was not known to the staff that patient had previously been vaccinated twice with Pfizer (on 01/06/2021 and on 01/12/2021 at County Health department). When Pharmacist gave immunization we talked about this being the first dose and that the second dose would need to be given in 3 weeks. It is the store policy that our state registry is checked before shot is given, however, this did not happen due to miscommunication. The patient did not have any known underlying immunosuppression that would qualify him for the booster at the time. We tried several times reaching out to the patient to find out if he was immunosuppressed (after the shot) and left voicemails. No return phone call was made.
Injection 3/24/2021. Slight pain over next 4 days, took Acetaminophen about 4 times. 3/29/2021 arm was very itchy, did not notice anything at bedtime. This morning when showering noticed a significant rash around injection site. Arm is warm to the touch.
After 15 minutes discomfort in Chest raising blood pressure also  Numbness in lips after 6 hours and after 24 hours. Is it due to vaccine reactions
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. An elderly patient received BNT162b2 (BNT162B2), on 18Feb2021 at 17:30 as dose 2, single (Lot number: WTEM9509) intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "ESRD", start date: 10Feb1996, stop date: 20Sep1998, notes: CAPD; "Renal Tx", start date: 20Sep1998 (ongoing), notes: Still working; "HFPEF" (ongoing), notes: Aortic valve replacement 2011; "Aortic valve replacement", start date: 2011 (unspecified if ongoing), notes: Aortic valve replacement 2011. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1st, Time (24hr): 11:15, Anatomical Site of injection: Arm, Route of administration: Intramuscular, Batch/Lot number: EL9261), administration date: 29Jan2021, for COVID-19 Immunization, reaction(s): "Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots"; TDap (Anatomical Site of Injection: Arm), administration date: 14Jan2021, for Immunization. The following information was reported: EPISTAXIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Had completely forgotten about the nosebleeds I got after my Covid vaccine initial shots".  Additional information: Patient forgotten about the nosebleeds, got after COVID vaccine initial shots. Patient never wrote it down as patient thought he/she could access vsafe to get the dates but patient can't. They lasted less than 24 hours but each time patient had several over the course of a few hours.; Sender's Comments: Linked Report(s) : PFIZER INC-PV202200098796 same patient, same drug, different dose/events(2nd dose);
Patient presented to clinic on 10/16/2016 stating he had broken out in hives/felt "feverish" 12 hours after the vaccination. Denied trouble swallowing or shortness of breath. States he didn't try calling the clinic or didn't seek emergency care. Took Benadryl with some relief.
administration of PENTACEL which had expired 5 days prior to use with no reported adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4-years-old female patient who was administered diphtheria/ tetanus/ 5 hybrid AC pertussis/ IPV (vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] which had expired 5 days prior to use 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 measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (oka/merck) (Proquad) for Prophylactic vaccination.  On 14-Sep-2023, the patient received 0.5 mL Booster dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine, Suspension for injection (Strength: standard; Frequency: once) (batch number: UJ7578A; expiry date: 09-Sep-2023) via intramuscular route in the left thigh for immunization which had expired 5 days prior to use with no reported adverse event (expired product administered) (same day latency).  Reportedly, Medical assistant called to know if the administered PENTACEL would still count as a valid dose even though it had expired 5 days prior to use. Caller mentioned that no adverse reaction was experienced by the patient. (Treatment : Immunization)  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.
Within 3 minutes of being escorted to our waiting area and starting  the timer, patient made a complaint of sweating. within moments patient was heavily perspiring and lost all color. Flushed and confused. Pt starting asking "how long have I been here?".  then while being escorted back to our vaccine room patient experienced a brief syncope. He fainted and was escorted to the ground. Increased pulse and continued confusion. Patient was placed in supine position with ice packs on face and nape of neck. EMS was called. we stayed with patient until EMS arrived and took over. Patient declined going with them to the hospital after his evaluation and was cleared by EMS to leave.
I WENT FOR A FOLLOW UP CT SCAN ON MY LUNGS POST COVID. WHEN THE SCAN WAS READ THEY NOTICED MY LIVER AND SPLEEN ARE ENLARGED. LIVER CAN BE PALPATED THROUGH ABDOMEN VERY EASILY.
Moderna vaccine was inadvertently administered past to 30 day use by date.  Moderna company was contacted and case ID CEA 1917 given.  No signs or symptoms reported at this time.
Acute ST-elevation myocardial infarction; highly unusual dual artery occlusion including  acute proximal occlusion of the RCA and simultaneous proximal LAD occlusion. At 24 hours later, both arteries re-occluded and required repeat stenting. Patient has critically low platelets and a positive PR4 antibody. Physicians seeing pt feel this is most consistent with vaccine-induced thrombotic thrombocytopenia.
Headache, diarrhea, tingling in legs, tingling in arm of shot,  Arm site where injection was red, warm, raised and got larger since vaccine. Arm pain and redness, warmth, raised continued still. All other symptoms gone
Suddenly felt very ill 20 min after getting vaccine. Shaking, heart racing, difficulty breathing,dizzy, weak, elevated blood pressure, frequent urination
varicose veins in legs; Chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (body aches) and VARICOSE VEIN (varicose veins in legs) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (body aches). On 03-May-2021, the patient experienced VARICOSE VEIN (varicose veins in legs). On 01-May-2021, CHILLS (Chills) and MYALGIA (body aches) had resolved. At the time of the report, VARICOSE VEIN (varicose veins in legs) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-106335 (Patient Link).
Onset approximately three hours post injection; pronounced flushing on face and anterior neck; slight rash on mid-chest with mild pruritus lasting 30-minutes. Diphenhydramine 50mg taken po.
Acute urticaria (hives) without angioedema, airway compromise, or anaphylaxis.
Patient is a 82 y.o. male patient of MD with PMH of Depression, DM, GERD, HTN, HLD, ESRD presented to the ED due to SOB.    Acute hypoxemic respiratory failure Due to GN pna/COVID Failed HHF/NNIPPV, acute worsening 1/4-1/6 Failed to improve/stabilize with bipap, intubated 1/7 Completed zosyn  Changed to DNR CCA DNI (do not reintubate)  Extubated 1/19 BiPAP/HHFNC started Palliative care consulted, transitioned to DNRCC 1/20/23 and patient expired   Septic shock Klebsiella Pneumonia  Due to HAP, required pressors overnight (1/8) Weaned from levophed (briefly resumed 1/10 d/t sedation) Started on midodrine Restarted Levophed BAL with Klebsiella Continued antibiotic coverage Now transition to DNRCC   Anemia Dropped to 6.7 with hypotension Consent signed w son   Transfused 1 U pRBC on 1/15 Monitor   ESRD on dialysis Fluid overload - improved On HD, last HD 12/26 Nephrology following for HD On a M/W/F regimen Dysphagia Dysphagia prior to intubation.  Ground solids, nectar thick liquids  Started tube feeds   Paroxysmal A. Fib with RVR Occasional RVR that improves with lopressor  Started on coreg (DC d/t shock)  Started on amio; (DC d/t bradycardia) Started amio bolus/infusion  Now comfort care only   Prolonged qt interval  Ok to continue zoloft, hold seroquel    Chronic Thrombocytopenia Platelets around 100K at baseline based on labs Mildly decreased, probably due to viral/acute illness   Sacral wound-POA Noted on a previous note at Drs. Hospital Patient was transferred to skilled nursing facility Wound was present on admission Wound care consulted, hygiene and barrier cream, frequent turns and repositioning Unstageable sacral pressure injury, unable to determine if present on admission as patient known to have stage 1 sacral pressure injury previously; and left ischial deep tissue injury developed after admission Specialty bed with low air loss mattress   Resolved hospital issues  Covid-19 Virus Pneumonia: Sx onset 12/25 (+) same day, out of isolation 1/4. Vaccinated (3 doses). Completed decadron/remdesivir
Fever >101° beginning approx 24 hours after injection. Fever gone with 200-400mg Ibuprofen. Fever would recur approx 6-10 hours later, lasting 48 hours. Nausea also.
After 5 minutes of administering vaccine, patient reported dizziness, felt like passing out, forehead sweats and feeling of nausea. Paramedics arrived and evaluated patient. They cleared patient app 30 minutes later  to go home after assessment.
Pt's left arm has been painful since 10/27/11 & weak. She has problem lifting her arm up high. She cannot lie on left side because it hurts.
Chills, fever (101.7), achy, headache, light headed/dizzy, congestion.
pt recv vax & devel a fever which lasted 7 days & went to 101.5;pt prefers to remain anonymous & declined to provide reporter info
Pt staes she felt dizzy and weak with intermintent trembles in hte evening after receiving flu shot. Pt states she has received vaccine in recent years with no adverse effects. Pt had temp of 101.3F when admited to ER.
High fever of 103.3 for 24 hours. Tylenol barely brought in down.
Received booster half dose (0.25ml) for first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received booster half dose (0.25ml) for first dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Dec-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 21-Dec-2021 at 5:45 PM, the patient experienced ACCIDENTAL UNDERDOSE (Received booster half dose (0.25ml) for first dose). On 21-Dec-2021 at 5:45 PM, ACCIDENTAL UNDERDOSE (Received booster half dose (0.25ml) for first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received first dose of Moderna COVID-19 vaccine as 0.25ml instead of 0.5ml. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
February 16 at night, I had temperature of 99 degrees, fever and chill. I have been taking my temperature reading every morning. On the 17th, chills and pain started. On the 18th, temperature was 100, chills and fatigue. On the 19th, temperature was 99 and I had trouble breathing, abdominal pain, chills and fever. On the 20th, temperature was 99, dizzy, chills, ache, pain and fatigue. On the 21st, all the way across. On the 22nd, temperature was 100 degrees and I was experiencing everything else. On the 23rd, I went to the emergency room at 6am. I was in the hospital through the 24th. They discharged me on the 24th. I had a nurse who told me about the diastolic heart failure so I made an appointment to see the cardiologist which I could see on the 4th of March. A nurse had pointed out the EKG test results indicating not heart failure but excess fluid in your lungs.
Fever, arm pain, restlessness, fatigue for 2 days.  Side effects happened 2. days after vaccine. They only lasted 2 days. I feel fine now. Waiting til August for my 2nd shot.
This spontaneous report as received from a nurse refers to a several anonymous patients of unknown age. On an unknown date, several patients were vaccinated with (Merck) VARIVAX (lot# L020002 and expiry date: 02-JUN-2017), post temperature excursion. No adverse effects were reported. Additional information has been requested.
* Mild fever during the night and following night of vaccination,  * Fatigue and tiredness for two days from the night of vaccination,  * Redness, swelling at the site of vaccine (left arm),  * Allergy at different parts of the body--knee, wrist, thigh, foot,  == Fever and fatigue went away naturally after two days but allergy remains. I am doing okay so far. ==
2 weeks after vaccines given, blisters w/ clear liquid and surrounding redness & swelling, itchy. Resolving as of 8/19/11. To left anterior thigh.
Patient's symptoms started with cough & headache on Friday. Later in the evening, she developed diarrhea, vomiting, and body aches which persisted through Saturday. She did not feel well until Monday.
Severe thumping headache, fever 102 f , chills with teeth grinding , arm soreness , red swelling edema , body aches
There was a slight chill that night and I may have had a slight headache, which I had on all the doses. Otherwise nothing unusual when I woke up. I just passed out. I just passed out, there was no dizziness or any warning. It was great difficulty to wake me up before the EMT's got there. I passed out and the EMTs woke me up. I hit my head on the counter and got a concussion. The skin peeled back and that was about it. My head injury was about an inch and a half on my forehead and they said there was a slight brain bleed. My physician told me it could be about 6 weeks to recover from the concussion. I have hip pain that subsides as the day goes on that was caused from the fall. I stayed over night in the hospital 1 night for observation.
Dizziness for two days, lightheaded ness for the next 5 days ,nausea for 5 days, vomiting, 1 day, lethargic 6 days. Unable to eat, 4 days In bed because of mentioned symptoms, 6 days Took Ibuprofen as tolerable Took anti nausea OTC.             Called the doctor twice and was told to ? hang in there?. Have never felt worse for so long in my lifetime.
Two days after injection noted aching pain in left arm. Seems to be positional, worse as the day progresses. No redness or swelling. Advised to use heat to area and take ibuprofen.
Senior Hi-Dose flu vaccine given before 65 yrs old  No adverse reactions known.
78-year-old male brought in from atrium rehab for hypoglycemia. Patient is lethargic unable to provide history history is taken from the chart and ER records. As per ER records patient was noted to be lethargic his blood sugar were checked and any was found to be hypoglycemic.Unclear from records if patient was treated for his COVID infection at the facility. On review of ER records a chest x-ray has not been done. It was ordered and will be followed
Pt started with fever of 101 at 17:30 which was controlled until 22:15. Temperature then went up to 101.8, and at 23:30 it was 104 even with prior cooling measures and Tylenol.
Soreness at injection site 12 hrs later; Fever; headache; chills; muscle aches; This is a spontaneous report from a non-contactable consumer (patient). A 25-years-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 11Apr2021 (Lot Number: En6208,) as SINGLE DOSE, for covid-19 immunisation. The patient medical history was not reported. There was no other vaccine in four weeks or other medications in two weeks. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 09:30 AM (Lot Number: EN6198) for Covid-19 immunization. The patient experienced soreness at injection site 12 hrs later on 12Apr2021, Fever, chills, headache, muscle ache. The patient received no treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering.   No follow-up attempts are needed. No further information is expected.
On 1/3/2021 redness, swelling, warmth, and welts with itching. Used cortisone cream. On 1/4/21 the redness was from top of shoulder to elbow, swelling, warmth, itching. Cortisone cream and Benadryl. The next day on 1/5/21 I had my scheduled eight week remicade infusion and the MD orders Tylenol, Benadryl orally with the infusion but also injects a steroid into the IV so by that evening it was much better and by the morning of 1/6/21 it was completely gone.
Expired Engerix B administered; 1st dose on 18Sep2021, 2nd on 03Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HBV (Engerix B) (batch number N4GA4, expiry date 2nd January 2023) for prophylaxis.   Previously administered products included Engerix B (On 18th September 2021, received 1st dose).   On 3rd January 2023, the patient received the 2nd dose of Engerix B. On 3rd January 2023, unknown after receiving Engerix B, the patient experienced expired vaccine used and drug dose administration interval too long. On an unknown date, the outcome of the expired vaccine used and drug dose administration interval too long were unknown.    Additional Information: GSK Receipt date: 03-Jan-2023. Reporter's Comment: The patient never went back for second dose.  Titers were collected which were negative, so the patient was restarting the series today (on the day of reporting). At the time of reporting, a repeat dose had not been given following the expired dose. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow- up. Additional Supportive Information: Patient received dose of Engerix-B of expired date, which led to expired vaccine used. Patient received 2nd dose of Engerix-B late, which led to drug dose administration interval too long.