chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In the shot area it started to itch; In the shot area it was slightly swollen; Some soreness; it was quite swollen very hot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on 26May2021 as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The Historical vaccine included first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date not reported) via an unspecified route of administration on unspecified date as 1st dose single for COVID-19 immunization. On Wednesday 26May2021 at 11:30 (withheld), the patient received second dose of vaccine and on Friday the patient had itch and it was slightly swollen in the shot area. The patient reported late yesterday it started to swell a lot more and noticed that and a clockwise night (not clarified) it was quite swollen very hot, and it was still hot next morning, and it itches. There was some soreness, and it was not terribly serious. The patient noticed that, if the hand was not moved the itching stops and the patient did not feel anything except it was art (not clarified) the patient can put whole hand with fingers pressed and it covers the whole area of the swelling, the heat and the itching and was not sure what to do about it. The patient did not think it was anything serious as far as concerned but did not know anything about it and do have concern. The patient does not have a computer and the other person made the arrangements for COVID Shot (COVID Vaccine) and the patient received the second one. The patient asked that What to do about it, Will it go away or gradually go away. The patient asked was it okay to keep doing what patient was doing, was it safe for the patient for this to happen, was the patient okay and will it go away. The patient was to have to hang up because not getting anywhere. The patient was getting very, very nervous and very frustrated and the patient was elderly and cannot take this. The patient was going to get a hold of the person who made the arrangements the vaccine and go online use website to reach. The patient was not in a good position, was on oxygen and cannot do that. The outcome of had itch and it was slightly swollen in the shot area was unknown and outcome of some soreness and it was quite swollen very hot was not resolved.   Information on the Lot/Batch number has been requested.
Vaccine administered on 1/25/01, left deltoid. On 1/30/01, complained of muscle soreness with ROM limited secondary to pain. No erythema or edema. Treat with warm compress and NSAID. To follow-up with PMD if symptoms persist or worsen. Continues to be sore at LVA.
Nausea & vomiting approx. 5 minutes after receiving vaccinations. Not ill before or after this instance.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unspecified date since 25-JUN-2015, the unspecified number of patients were vaccinated with GARDASIL (lot# K011562 and expiry date: 08-APR-2017) (dose and frequency were unknown), which were exposed to temperatures outside of the recommended range on 25-JUN-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
very infected with covid-19 after receiving the first dose; very infected with covid-19 after receiving the first dose; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received first dose of BNT162B2(Solution for injection, Lot Number and Expiration date were not reported), via an unspecified route of administration on 04Mar2021 as SINGLE DOSE for COVID-19 immunization . The patient's medical history and concomitant medications were not reported. It was reported that Patient received the first dose of COVID-19 vaccine on 04 Mar 2021, at a hospital . He was due to get the second dose today and want to know what to do, since he was very infected with COVID-19 after receiving the first dose. He did not get too infected, he has been protected partly by the first dose. He would not provide his mailing address. Seriousness of the events were considered as Non-serious by the reporter. On an unspecified date in Mar2021 the patient underwent SARS-CoV-2 test and resulted as very infected with COVID-19. Outcome of the events was unknown.  Information related to lot/batch no. has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021333615 same reporter/drug, different patients.;US-PFIZER INC-2021333614 same reporter/drug, different patients.
COULD NOT STAND UP; COULD NOT WALK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-MAY-2021, the subject experienced could not stand up. On 20-MAY-2021, the subject experienced could not walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the could not stand up and could not walk was not reported. This report was non-serious.
pale, shaky, feeling weak initially, then sporadic twitching began, gait unsteady.  Increased wheezing noted, albuterol neb given, BP slightly elevated compared to when pt arrived.  Twitching continued but color improved, pt feeling better.  She went home however twitching continued so went to ED next morning.  Eval included labs, MRI +/- contrast of brain and spine.  No acute abnormalities.  She's still in hospital being observed, twitching decreasing.  Wheezing ongoing so getting q 2 hr albuterol  NO rashes,, vomiting or diarrhea, no swallowing difficulties.
Pt states that within 30 seconds of the COVID vaccine she began feeling dizzy, and that she began developing chest pressure/pain within 30 minutes. Patient transferred to the ED and received ibuprofen. Symptoms improved and patient discharged from the ED
I received the 2nd dose on March 24th around 1:30. The 25th I became extremely tired and extremely cold. That lasted throughout the night and into the next day where I could not work. I then felt fine, but on Friday evening my right arm throbbed and ached and nothing I took would relieve the achiness and pain. I then developed a raised rash that started around my injection site and has worked it's way to my thumb and pointer finger on my right arm only, They keep multiplying and are raising like hives with little water blisters. They are painful and feverish.
12/20/22 presents to ED for "coronavirus concern". PMHx of "CVA, dementia, non-verbal, HTN, pulmonary embolism on Eliquis, dysphagia s/p peg tube on TF"
Improperly stored; No adverse effects reported; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.   was vaccinated with an improperly storage measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) injection, rHA, 0.5 milliliter, lot #W029555, expiration date: 14-MAR-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No adverse effects reported  (No adverse event).
When the Immunizing Technician administered the Moderna vaccine the needle and syringe must not have been on tight enough and some of the vaccine leaked out of the syringe and did not go into the patient's arm.   The technician said that only a very small amount leaked out of the arm, that the majority of the vaccine went into the patient's deltoid as intended.  Per the Clinical Considerations the patient should have the dose repeated immediately.  When I told the patient the clinical recommendation she declined to get another vaccine since she saw and agreed that she received a majority/most of the vaccine and did not want to take the risk of getting more than the recommended dose of the vaccine.
PATIENT WANT TO CRAWL UNDER A ROCK; HEADACHE; FEVER; CHILLS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced subject want to crawl under a rock, headache, fever, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient want to crawl under a rock, headache, fever and chills was not reported. This report was non-serious.
anaphylaxis;vitals t98.3, P84, R16;BP 110/60;SOB;throat swelling;itch whole body;tx solumedrol;
Patient has been having pain in his arm since he received the flu shot.  Patient's wife stated that the patient had an injury in the past in the same arm so she is not sure what is causing the pain.  He tried ibuprofen and ice but is still having pain. It  was recommended that he see his doctor about the pain.
3RD DOSE MODERNA COVID VACCINE GIVEN 11/03/2021, LOT #058F21A; pt had a positive COVID test in SNF on 7/19/22; pt found unresponsive in room and cold on 7/31/22; CPR initiated; EMS called; pt pronounced deceased at Hospital,
11/20 vaccination 12/3 3:20PM He vomited on the school bus. I took him back home, he slept for 2 hours. He was very tired. I called his dr. Gave water, electrolyte solution. Fever 101; Sat. Fever 100; Sun.  12/3 COVID test; neg 12/6-12/7 He is feeling better
Violent shivers, the feeling of being very cold, low grade fever, chills,  body aches, headache hot/cold, sweating.  Started around 1 am, still very sore this morning, hot/cold flashes and sweats.  As of about 8:30am fever is fluctuating between  high 99?s and low 100?s.  Took 2 acetaminophen around 8:15am.
Pt. received the vaccine at approximately 2:44pm.  Before I could hand him his card, his hands began trembling and he looked pale.  I asked how he was feeling.  He reported feeling shaky, dizzy, and very hot.  I asked him if he was having any difficulty breathing, had tightness in his throat/airways, or even felt a tingle.  He said no.  Noting the time, I asked if he had eaten lunch.  I asked if he has ever felt this way before.  He said he had when he gets a "hypoglycemic attack."  While not diabetic nor on any medications, he said he will occasionally get very low blood sugar.  He said he had not eaten since early that morning.  Another employee brought some juice I requested.  I again asked him about symptoms related to anaphylaxis, to which was not an indication of an anaphylactic reaction.  I gave him the juice to sip.  I asked him again about symptoms.  Because he was still dizzy, I took his blood pressure/heart rate.  His BP was 160/119 and heart rate 96bpm.  His color became more gray over the next several minutes.  He was still too dizzy to stand, felt hot, shaky, and now nauseous.  He handed over the juice and was given a receptacle if he vomited.  We suspected a vasovagal response, but was still symptomatic after 10 minutes. Meanwhile, the other pharmacist tried to call his doctor's office.  We learned his doctor had moved away and he had not yet come in nor selected a new provider.   We asked him if he felt he needed to be seen by a doctor.  He said he did and agreed to us calling an ambulance.   The ambulance arrived around 3:10.  The EMTs took his BP.  It had come down, but he could not stand up without his knees buckling.  The EMTs got him on the stretcher and took him to the hospital.
During the evening of 7-3-13, pt reports S/E began with site itching, swelling et redness, also malaise. S/E increased over next couple of days. Returned to clinic 8-5-13. (L) deltoid with noted redness at site shot given and distal approx 7 x 11 cm, mild itching today, no swelling, denies malaise. Encouraged FU with MD.
Information has been received from a pharmacist concerning a female who was vaccinated with Zostavax (Oka/Merck) (lot#658082/0744U).  On the second day after vaccination, the patient developed a dark red, hot to touch and itchy 3 inch injection site reaction.  On day 3 the redness decreased but the site became lumpy.  Patients were treated with TYLENOL and cool compresses.  This is one report of several reports received from the same source.  Additional information has been requested.
Vasovagal syncope -- pt. passed out immediately after vaccine administration followed by seizure-like activity. She came out of it after about a minute and sat for ~15 minutes to recover. Family was present and aware of this possibility and were prepared of what to do.
Red, sore, itchy  3? diameter patch at site of shot 9 days after receiving shot. Also headache and body aches.
MD saw pt states had sz was taken to hosp but not seen due to time to fill out papers; referred to MD neurologist;
Feverish, heated rash developed within 24 hours of vaccine in the arm vaccine given in. Extreme itching and swelling initially. Originally the rash was the whole arm from shoulder to hand. Now it is resolving and just affecting the bicep area.
POTS SYNDROME- POSTURAL TACHYCARDIA 3 HRS AFTER THE VACCINE. EMPLOYEE HAD TO GO TO THE ER.
Fever, nausea, extreme fatigue, body aches - non-stop since a little after midnight.
Rash; Fever; Headache; This is a spontaneous report from a contactable consumer, based on information received by Pfizer(manufacturer control number: US-AMGEN-USASP2021053276), license party for etanercept (ENBREL).  This non-serious spontaneous report (USASP2021053276) was reported on 06/APR/2021 by a consumer and involves a 78 years old female patient who had rash [PT: rash], fever [PT: pyrexia] and headache [PT: headache] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included arthropathic psoriasis, unspecified. The patient's concomitant medications included cyanocobalamin, lisinopril and Vitamin D (colecalciferol). The patient's co-suspect medication included covid-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient received a second shot of covid vaccine. Subsequently, the patient had rash, fever and headache. No treatment information was received. The outcome of the events rash, pyrexia and headache was reported as recovered/resolved. The events rash, pyrexia and headache was resolved on an unknown date. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events rash, pyrexia and headache. The causal relationship between the events rash, pyrexia, headache and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. No follow up attempts are possible. No further information is expected.  Pfizer is a marketing authorization holder of covid vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of covid vaccine has submitted the same report to the regulatory authorities.
Patient tested positive for Covid 8-11-22. He was seen in ER 8-10-22 and admitted 8-11-22. All Covid medical therapies, he did not want intubation and was given non invasive ventilation. Placed on comfort measures. Passed away in the hospital on 8-31-22. Death Note includes Covid 19; respiratory failure; CAP; elevated troponin I level, new onset AFib, CHF, bright red blood per rectum, transient AFib/flutter.
This is an instance of breakthrough COVID-19 disease after which death occurred. The individual was vaccinated with the Pfizer product on 04/06/20221 and 04/27/2021. They tested positive for COVID-19 on 09/27/2021 x4. They were briefly admitted to hospital on 09/29/2021 after presenting to emergency department for shortness of breath, but were discharged back to the nursing home at which they were a resident. The individual was a DNR and on comfort care only. They died later on the same day, on 09/29/2021.
dizzy, nausea, vomiting x2. Evaluated by EMS-Transported to Emergency room/department or urgent care.
Localized reaction - Right arn, deltoid, swollen, tender, and hot to touch. Pt instructed to take BENADRYL 25mg every 4 hours and apply ice. Also instructed to go to ER if symptoms worse
Pt did not appear to have a adverse reaction. Pt is a stem cell patient and came in requesting a tetanus shot. The patient came in 12/10/18 requesting pneumonia shot and showed a list of shots he needed. Another pharmacist saw patient got BOOSTRIX shot on 11/8/18 but the patient needed a Dtap shot.
BREAKTHROUGH COVID: FULLY VACCINATED AND BOOSTERS 2X, COVID POSITIVE. 72 yo presented to a HCF 2 ADMISSIONS  after pt reports since having COVID 19 prior to 1st admission, tested positive. Pt reported she has been feeling drained, productive approximately 1 week ago, states the sputum is yellow in color, SOB and dizziness with her coughing spells. Denies fevers, chills, HA, CP, N/V/D, abdominal pain, dysuria or MSK complaints.  Admitted to the ICU with AFib with RVR and atypical pneumonia. Pt diagnosis of COVID pneumonia. Discharged 9/2/2022 and readmitted 09/12/2022 Presented with SOB for the last 2 day likely due to patients COVID PNEUMONIA.
This spontaneous report as received from a medical assistant refers to a 5 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 25-APR-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (strength and dose were not reported). The lot number and expiration date were unspecified (K011952 with expiration date of 17-JUN-2016 or lot number L010844 with expiration date of 16-NOV-2016), which were stored at 32.06 Fahrenheit Degree for 40 hours and 69.85 Fahrenheit Degree for 33 hours and 32 minutes. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No concomitant therapies nor adverse effect were reported. This is one of several cases from the same reporter. Additional information has been requested.
Body aches, weakness, nausea, diarrhea 40 hours after 2nd dose of Moderna vaccine.
COLLAPSED; TACHYCARDIC; HYPOTENSIVE; DIAPHORETIC; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, 1 total administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-MAR-2021, 6 minutes after vaccination, patient became tachycardic, hypotensive, diaphoretic and collapsed. Patient attended signature emergency room for clinical review and was later discharged that day. Patient stated, due to unexpected visit to emergency room, was unable to work and missed clinical shift due to illness.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tachycardic, hypotensive, diaphoretic and collapsed was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0. 20210612583-Covid-19 vaccine ad26.cov2.s -collapsed. This event(s) 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(s).
Patient is a 48 y/o  female who speaks only Spanish. Patient had interpreter present during client registration, vaccination and post vaccine occurrence. Patient was given Janssen COVID vaccine Lot # 1805031 in the left deltoid by this nurse at approximately 2:00PM.  Client left the event without c/o after 15-minute observation. 2:55PM Client returned to the event and according to the RN client c/o drowsiness and dizziness. RN reports client HR 80 bmp (strong & regular); client B/P in right arm 152/100. Client c/o a headache at #8, on the pain scale of 1-10. Client also c/o pain in the front of her head. Client was alert and oriented skin warm and dry, color WNL and no gross dyspnea noted; client c/o left side chest pain traveling up the left side of her arm. 2:57PM Explained to client 911 will be called and 911 will decide if emergency room visit was warranted.  3PM Client remains alert and oriented with some diaphoresis and change in color noted. 3:02PM Client color returned diaphoresis improved 3:04PM Client reports she is ?feeling better?. 3:05PM Paramedics arrived. Client evaluated by paramedics. Paramedics applied oxygen and checked client vital signs. According to the paramedic client breathing was normal with good oxygenation. Client reports to paramedics she had COVID last year. The paramedic conducting the client assessment reports he felt client is hyperventilating and has no s/s of an anaphylaxis reaction. Client relayed to paramedic her headache is gone but her head, left arm and leg feels ?numb?. Client agreed to go to the emergency room. 3:25PM client left with via stretcher for ambulance transport to  Emergency Room (according to paramedic ED was on diversion).  5/26/21 1:00PM Spoke with RN who reports client was discharged from the ED 5/25/21 to home and is feeling better. Per RN client plans to return to work 5/27/21.
Information has been received from a consumer and a physician concerning a 5 year old male who on 07/12/1997 was vaccinated SC with the first dose of varicella vaccine. Concomitant vaccination the same day included the third dose of hep B vaccine IM. On 11/14/2001, the pt developed chicken pox. Subsequently on 11/24/2001, the pt recovered. Additional info has been requested. The physician also reported that the pt's siblings, 3 females and 1 male, developed chicken pox after vaccination with varicella vaccine (WAES0112USA01251, 0112USA01252, 0112USA01253 and 01100739). The consumer reported that 14 patients at her children's school developed chicken pox after vaccination with varicella vaccine (WAES01110652).
I had nasal congestion and a runny nose. I also had a cough that produced flehm & chest congestion. I also had muscle spasms in my back. I was on a cruise & was given Rapid Test & they were positive for COVID-19.
pt states his left arm started to break out into a itchy red rash that spread to both arms, both legs behind the knee caps and torso. Pt went to ER where he was told to take Benadryl for his symptoms. Pt says he still has some itching but the rash went away.
Pain at infection sit, swelling, large lump, hot.  Concerned that side effects have not gone away.  Injection site is still hot, swollen and now itches but doesn?t hurt.
While working on the ranch, the patient stated he felt dizzy, experienced chest pain and shoulder pain. Stated "I feel like I'm going to die..."