chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3" red (wide) circle around 3/4 of arm. Itching - warm to touch - lasted 1 week. Saw pharmacist and she recommended reporting.
runny nose, headache, sore throat, sneezing & cough & fatigue current temp orally 98.2 10/9/19 @ 1056.
Approximately ten minutes after receiving the vaccination I got very dizzy and passed out. I was out for 3-4 minutes and came to. Subsequent to passing out I vomited a few times and could not hold anything down. I also urinated on myself at some point when out. I was not getting better so 911 was called and I was transported to the emergency room via ambulance. Once the ambulance arrived at the hospital I vomited again filling about half of the vomit bag. I arrived at the hospital and an IV was not able to be administered so I was given Zofran for nausea and Gatorade to try and hold down. I spent approximately 4 hours in the ER, was able to finally get to the point where the nausea calmed down and I was able to walk around. I was then discharged.
On 20-APR-2015, the patient was vaccinated with a doses of MMR II (lot #, expiration date, dose and route were not reported), LIQUID PEDVAXHIB (lot #, expiration date, dose and route were not reported), (Oka-Merck) PROQUAD (lot #, expiration date, dose and route were not reported), RECOMBIVAX HB (lot #, expiration date, dose and route were not reported), VAQTA (lot #, expiration date, dose and route were not reported), (Oka/Merck) VARIVAX and GARDASIL 9 (lot #, expiration date, dose and route were not reported) as well as 5 other unspecified vaccines (non Merck manufactured) all in one visit. On 22-AUG-2015, the patient experienced severe ear infections, weight gain, lack of energy, sleeplessness, dragging along at school, her eyes were hollow, she was showing no signs of emotion anymore. The mother reported that her daughter looked like she had been poisoned. There was no labs diagnostics studies performed. The patient was treated with ibuprofen, ofloxacin and amoxicillin. The outcome adverse events was reported as not recovered. The patient sought medical attention via visiting her doctor. The relatedness between adverse events and suspected therapies was not reported. Additional information has been requested.
Chills, body aches, slight headache, slight dizziness,  Fever yesterday of 100.9. Today 99°. Dehydration bur when I drink water feel sick to my stomach.  Eating ice chips at this point. Took 1 acetaminophen this morning at 2:45AM.
L arm redness, 1.5? diameter lump & pain at injection site onset 12 hours post booster; within 24 hours, diffuse swelling in armpit and down L breast, lump in left armpit, lump at injection site enlarged to 2.5? diameter and hardened, bilateral tinnitus, L hip stiff/difficulty walking, L chest pain?these symptoms persisted over two to two and a half weeks; symptoms seemed to subside; January 22, 2022, intense episode of L armpit burning and discomfort, pinching and sharp stabbing sensations, several soft enlarged lumps in L armpit, painful/tender; armpit burning and breast fullness persisted; ultrasound L axillary January 26, 2022 revealed enlarged lymph nodes (up to 27mm) but radiologist reported that the nodes otherwise appeared ?normal?, intense stabbing whem pressure of ultrasound wand applied to L armpit; February 17, 2022, L hand and arm swelling and bright red after routine walk on flat trail, redness worse when arm lifted above head, soft lumps persist, burning in armpit, arm and hand, positive Addison?s test by two primary care providers, referred to vascular ultrasound for suspicion of TOS; March 2, 2022 revealed thrombosis in L subclavian vein, no underlying risk factors identified by vascular surgeon other than recent Pfizer booster, started on Xeralto and referred for bloodwork and to hematology; bloodwork negative for underlying condition that would predispose to clotting other than positive anti cardiolipin antibody IgG (negative IgM) and beta-2-glycoprotein IgG (negative IgM).
chills; headache; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced very bad chills for 4-5 hours and had a headache after the first dose on unspecified date. The patient received her 1st dose last 11Mar2021 then she experienced chills, and now she was complaining of her headache and she was asking which medication she could take as she does not want TYLENOL. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial unsolicited report received from physician on 11 Jun 2018. This case involves 12-year-old female patient who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications was not reported, but it was reported that the physician thinks that, the patient has an egg allergy but has not had a blood test done to confirm it. On an unspecified date, following the vaccination, the patient has swelling that affected her whole arm and the patient felt very sick. It was reported that, last year patient had FLUZONE QIV and had swelling really bad at administration sight. Lab data and corrective treatment were not reported. The outcome of the events was not reported. List of documents held by sender: none.
Sore throat; Ear infection; This is a spontaneous report received from a contactable consumer (patient). A 69-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) on 01Apr2021 at age of 69-year-old via an unspecified route of administration at arm right at single dose for COVID-19 immunization. Patient said she received the shot at 11 am or 12 pm that day. Medical history was reported as none. The caller declined being sick at the time of vaccination. Concomitant medications (other products) was reported as none. There was no additional vaccines administered on same date of the Pfizer suspect. There was no prior vaccinations (within 4 weeks). The caller said she was supposed to get another shot tomorrow but her doctor and her pharmacist didn't recommend it because she had a very sore throat and an ear infection. She was calling to try to reschedule her appointment. She said both the sore throat and the ear infection started a week ago, maybe a week and a half ago. She said she has been using sprays out of the drug store and the pharmacist was showing her different things to use because she was waiting for her doctor's appointment. She said she just had a physical in Mar2021 and she didn't think she has anything to report. She says she was trying to wait another week because she wanted to get in with her doctor before she gets all of that. Events were still persisting at time of reporting. Patient received pharmacy's Oral Relief for sore throat. When probed for any NDC/UPC, Lot number or expiry date, the caller explained she didn't have her glasses with her right now and stated she wouldn't be able to read all of that stuff. It was also reported that the events didn't require a visit to emergency room or physician office (as reported). She said she was just trying to patch her stuff up at home. Patient said maybe this didn't come from the shot, she didn't know. Outcome of sore throat and ear infection was not recovered.  The caller was referred to her place of vaccination or her local health department for second dose rescheduling guidance.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Myalgia CHILLS, COLD, SHAKES, BODY ACHES Narrative:
Fever; Chills/Shivering; Muscle Aches and Soreness; Fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 37-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration in right arm on 06Jan2021 08:45 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took bupropion hydrochloride (WELLBUTRIN) and clindamycin, both experienced drug allergy, previously received 1st dose of BNT162B2 in right arm in Dec2020 at 08:45 AM for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. The patient experienced fever, chills, shivering, muscle aches and soreness, fatigue on 06Jan2021 22:00. No treatment received for events. The outcome of events was recovering. The case was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had bot been tested for COVID-19.
Information has been received from a physician concerning his daughter who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced breakthrough varicella characterized by a few papular vesicles. The physician suspected non-wild type varicella. Medical attention was sought. The patient's outcome was recovered. There was no product quality complaint. This is one of several reports from the same source. No further information is available.
dizzy; A spontaneous report3w2aq was received from a 83-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness.  There is no previous reported medical history of the patient as such.  On 18th Jan at 07:00 pm, approximately nine hours after receiving the first  dose of mRNA-1273 (Lot number: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection, the patient started feeling dizziness. The feeling was gone at around 03:00 am on 19th Jan, the following morning.   Action taken with mRNA-1273 in response to the events was not reported.   The event, feeling of dizziness were considered resolved on 19th Jan 2021.
chest pain each day since vaccination administered. mid-sternal. squeezing/tight pain, constrictive, last about 1-2 mins, hard to catch breath. no alleviating/exacerbating factors
medication error due to administration after a possible temperature excursion with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case is linked to case IDs 2022SA161486 and 2022SA159339.  This case involves medication error due to administration of pentacel to 3 infants after a possible temperature excursion with no reported adverse event involving the vaccines IPV (vero) [ipol] and diphtheria/tetanus/5 hybrid AC PERTUSSIS/IPV(mrc5)/HIB(PRP/T) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date 3 dosage forms (DF) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Batch number: UJ474AAA) were administered to 3 infants and one dosage form of IPV (vero) (batch number: unknown) after a possible temperature excursion with no reported adverse event (product storage error) (latency: unknown) (formulation, strength, route, administration site expiry date unknown for both vaccines).  It was reported that "Vaccine Compliance Officer called for guidance. She had unpunctured IPOL x5 and unopened Pentacel x3 and fluzone QIV (caller could not confirm presentation of FLUZONE) x1. Caller states due to a change in staffing and this "being a high-profile case" no temperature data has been taken since 1-Feb-2022. Caller stated before that date the temperatures were known to be in recommended range. Since no temperatures could be given, no stability information could be given. Caller was requesting information on whom to reach out to next for more information. Caller requests callback. Outbound Call to caller made at 3:45pm, where caller was directed to the CDC Vaccines Storage Handling Toolkit for further direction regarding her vaccines. Upon this outbound call, caller informs agent that 1 dose of IPOL was administered, 3 doses of Pentacel were administered and 1 dose of Fluzone QIV was administered. Caller provided information regarding the vaccines being unopened that could be inconsistent with the information provided regarding the administration to patients. Caller was unable to give most safety report information due to the "high priority status of this case". This reports AEs for potential administration following a temperature excursion regardless."  Action taken: Not applicable with both suspects.  Outcome: Unknown.  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 guidelines. 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.
extreme chills; headache; very achy; This case was reported by a consumer via (Shingrix GSK and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE).   On 26th April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than a week after receiving Shingrix, the patient experienced chills, headache and ache. On an unknown date, the outcome of the chills, headache and ache were unknown.   It was unknown if the reporter considered the chills, headache and ache to be related to Shingrix.  Additional details were provided as follows: The reporter had reported for herself. The age at vaccination was not reported. The patient received Covid 19 vaccine, 10 weeks back from the date of reporting. After receiving Shingrix, the patient had extreme chils, headache and she was very achy to the point of not been to be able to. The followup would not possible as no contact details were available. This case had been linked with case US2021AMR094527, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094527:Same reporter, husband case
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 02-JAN-2014 the patient was vaccinated with the third dose of GARDASIL. Dose, route and lot number were not provided. No concomitant medications were reported. It was reported that the patient received the first dose of GARDASIL in November 2012 and the second dose of GARDASIL on 16-NOV-2013. This is considered to be a medication error ("Inappropriate schedule of vaccine administered"). No adverse effects were reported. Additional information has been requested.
Patient received Pfizer COVID vaccine on 4/13/21 and 5/10/21. Patient was diagnosed with COVID-19 pneumonia on 11/27/21 and was staying at home. On 12/8/21, patient came to the ED and was ultimately discharged home. Since then patient had profound SOB and dyspnea and ultimately was admitted to our inpatient unit on 12/11/21 with main indication acute hypoxemic respiratory failure due to COVID-19. Patient received tocilizumab on 12/12/21 and was started on dexamethasone. Patient  continued to recover rapidly and was medically stable for discharge on 12/14/21 only requiring 2L of oxygen at rest and with activity.
My first week after the vaccine, I had what I would have considered typical side effects. I had some fatigue, headaches, a sore underarm lymph node, and I had a boil appear on my back. At this point, I was able to take ibuprofen for headaches as needed and go about my day. In the second week, the side effects increased in intensity. The underarm lymph nodes increased in size, I started to get more boils, I was getting some lower grade fevers and struggling to push through my regular day. By the end of the second week, Tuesday August 10th, in evening I had a temp of 102.5, was freezing and taking ibuprofen every 4 hours to keep headaches, and fever at bay. Every time the ibuprofen ran out, my fever went back up and I was soaking sweat through my clothes multiple times a day and night. After a couple of days of this my fevers kept increasing, boils kept popping up (which I have never had before) and my lymph node was huge. I started adding acetaminophen to the ibuprofen routine to try to keep fevers down and was messaging my dr at this point. By Friday at 5:00, my temp was 103.5 and all side effects were increasing. My husband took me to urgent care where they treated me and told me not to get worse. I was home for a short time that evening when the fever came back. I ended up in the emergency room and the Drs there admitted me to the hospital. In addition, at this point, I had increased heart rate and low blood pressure as well. I was released late Tuesday afternoon August 17th.
soreness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in an unspeified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, but taken as an adult as per vaccine indication. The pharmacist said that she had heard complaints from patients that the Shingrix injection gave soreness at the injection site. The reporter did not consent to follow up. .
Information has been received from a consumer concerning her son who on unspecified date was vaccinated with a dose of MMR II (Dose, route and lot# not reported). The consumer stated that her son on unspecified date had experienced high fever after receiving MMR II. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information is not expected.
Site soreness; Ibuprophen 200 mg one at night both night of and night after shot; relieved Low grade fever (99.2); day after and 2nd night after shot; Ibuprophen as above; relieved Night sweats 2nd night after shot relieved on waking; not sure about 3rd night yet.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 18-MAY-2018, the patient was vaccinated with a dose of VAQTA (dose, frequency and route were unknown) lot # N012324 that had expired on 05-APR-2018, for prophylaxis. No adverse effect was reported.
Intense pain, inability to walk, multiple physicians have said I am experiencing Guillian Barre Syndrome. The pain is horrific and I trip over myself when I walk.
This case was reported by a consumer via patient support programs and described the occurrence of pneumonia in a 73-year-old male patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included chronic obstructive pulmonary disease. Concomitant products included fluticasone propionate, salmeterol xinafoate (Advair) and salbutamol sulphate (Ventolin Hfa). On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced pneumonia (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the pneumonia was unknown. It was unknown if the reporter considered the pneumonia to be related to Influenza vaccine. Additional information received as follows: The patient stated that he came out from the hospital due to getting the flu shot and he caught pneumonia. This is 1 of the 3 linked cases reported for the same patient.
Vasculitis - 5 weeks of itching and lesions covering my entire body.   Elevated liver enzymes requiring a referral to further specialists.
The patient is a healthy 32 yo with a history of  AE after Pfizer Covid vaccine #2 (lot #EL1284, receipt 06 January). She reports receipt of vaccine at about noon. She developed nausea about 30 minutes later. She developed headaache about 1-1 1/2 hours later. She fetl lethargy and fatigue about 4-5 pm and was asleep by 18:00. She slept through until noon the next day when her mother awoke her due to concern for her breathing pattern. She said she felt exhausted and unwell like 'a terrible hangover'. She could not stand and her limbs felt weak and flaccid. Family called the nurse help line who instructed to call EMS. She was soaked in sweat, but no fever and reports she was told her BP was elevated, her extremities were numb but tingled as they improved, and she recalls very severe headache and breathing was hard due to feeling 'heavy'. She felt better as she got near the hospital. She notes her recall of the events is hazy. She was treated with IVF and Toradol and discharged with tylenol, motrin and zofran. She denies emesis, but recalls severe myalgias, knee arthralgias which continued with fatigue for about 10 days, and still has discomfort to her right knee. She reports chest tightness with exertion, which resolved. She denies cough, diarrhea, or any immediate reaction suggestive of IgE. She reports local site reaction of erythematous plaque with smaller peripheral macules, centrally located at the injection site with smaller macules peripherally down her arm.  She denies history of AE with other vaccines.  Per ER notes, states EMS report HR 114, diaphoretic, HTN,, febrile, tachypneic, received 500 cc bolus. Triage states crying, anxious and tachypnic, guided in deep breathing,  BP 95/65, HR 100, RR 26  sat 97%, T 98.3; documented as ill appearing. cc: fatigue, weakness, sweating, nausea, malaise, headache. Only diagnostic is EKG which was normal. She was treated with Ofirmev, in addition to IVF and Torrodol.
TINGLLING AT VAX SITE Narrative: 1025 PT C/O TINGLING FROM VAX SITE TO ELBOW BP 129/79 74 1035 PT STATED TINGLING WENT AWAY 124/80 74 95 % RA D/C STABLE 1038 INTERVETION: WATER
This spontaneous report as received from nurse refers to an unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose, route and lot number was unspecified) which was improperly stored. No adverse effects were reported. No product quality complaint was involved. This case is linked to (MARRS# 1411USA013447, 1411USA013446) with the same reporter link. No further information provided. Additional information is not expected.
A little pain and swelling in the chest area.  Took 800 mg Ibuprofen for 2 days and symptoms went away.  Haven't had any recurrence since then.
Patient complained of all over itching and red blotchy spots present.  Patient had verbalized similar allergic reaction to prior medications.  Patient did not take benedryl before vaccine visit but has taken it in the past for prior reactions.