chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After second vaccine, I had a severe migraine headache the day after. Been three weeks since second dose, and have had a migraine every day to varying degrees since then. I've gotten migraines before, but never to this extent.; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Feb2021 at 09:15 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received medications within two weeks of vaccination. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Jan2021 at 12:15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 16Feb2021 at 08:00, the patient experienced had a severe migraine headache the day after. It had been three weeks since second dose and had a migraine every day to varying degrees since then. The patient got migraines before, but never to this extent. Therapeutic measures were taken as a result of migraine headache and included treatment with aspirin (MANUFACTURER UNKNOWN) and other type of pain medications from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event migraine headache was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Within minutes of administered the MMR and varicella vaccine reacted with welts to each of vac. ste. Ice applied and BENADRYL given.
Fever; Chills; BODY ACHES; After dosing,it was discovered the patient had already received two prior doses; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 5393G, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th June 2021, from batch number 7RJ2X with expiry date unknown). Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On 6th November 2021, the patient experienced fever, chills and general body pain. On 7th November 2021, the outcome of the fever, chills and general body pain were recovered/resolved. On an unknown date, the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that, the patient came in to pharmacy and requested second dose of Shingrix to be administered,and injection was administered after dosing, it was discovered the patient had already received two prior doses, which led to extra dose administered. The patient previously received 2nd dose on 19th August 2021. The pharmacist reported that, the patient had the normal side effects post third dose of fever, chills, and body aches, and as of yesterday on 7th November 2021, the patient had returned to her normal state of health. The pharmacist did not have the expiration dates for the vaccines administered. The health care professional gave permission for follow-up
both hands swelling, small blisters on wrists, both ears swelling starting the morning after vaccine and lasted for 24 hours
30 out of 150 pts had titerschecked FEB or MAR92 p/3 doses of Engerix did not respond; total of 500 people were vaxed; 3rd dose were administered JUL or AUG91;
On the way home from vaccination (1/29/21), felt like something stuck in her throat but resolved within hours. One week later (2/5), woke around 2am with same feeling, but at time of report (10:0am, 2/5), she has taken Allegra and using throat lozenge and feels throat symptoms are improving. She reports that she does battle environmental/seasonal allergies, has been experiencing post nasal drip and some intermittent itchy eyes and scalp this week so this could be related to allergies. She also c/o red "rash" at injection site about the size of 50 cent piece which she first noted today - denies pain or swelling.  Writer advised she continue daily allergy medicine, consider using Benadryl as directed on the day of 2nd vaccination, and at any time between now and following administration of 2nd vaccine, if she should have worsening symptoms to seek care immediately. Also recommended 30 minutes observation period following 2nd vaccine - due 28 days from 1/29/21. She verbalized agreement with all.
Information was received from a nurse concerning a 4 year old male who on 01 MAR 2005 was vaccinated in the right arm with 0.5ml dose of MMR.  On 01 MAR 2005 immediately after vaccination the patient "broke out in hives at the injection site".  The patient was treated with oral Benadryl.  Subsequently on an unspecified date, the patient recovered from hives at the injection site.    The nurse requested a lot number check.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards of the Center for Biologics Evaluation and Research and was release.  Therre was no product quality complaint involved.
Cellulitis of left leg (thigh). Treatment: antibiotics. Redness on thigh started the day after shots. Still being treated.
fever; bodyswell; colds; eyes hurt; sore throat; Sickness; This is a spontaneous report from a Pfizer sponsored program COVAX Support. A male contactable consumer (patient) reported for himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as Dose 2,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. on 2021 The patient second dose 27APR2021 last month. Patient experienced fever, body swell, colds and eyes hurt, sore throat and sickness after his second dose. Caller would like to know if he can take medications or go to Doctor. Outcome of events was unknown.    Information on lot/batch number has been requested.  Follow-up attempts completed. No further information is expected.
reports severe pain in mouth, reports muscle spasms on right side of body, pain/spasms severe enough to require medication, patient is contacting her MD
Redness /at injection site; Swelling at injection site; Fever; Chills; Weakness; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms. On an unknown date, the outcome of the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, fever, chills, weakness and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that he received first dose of Shingrix. The patient experienced redness and swelling at injection site, fever, chills, weakness and flu like symptoms. The patient stated that the symptoms went away after a few days. The reporter was referred to health care professional. The reporter did not consent to follow-up. Limited information was obtained. All these symptoms also experienced post second dose. For second dose refer linked case US2021168407 (same reporter).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021168407:Same reporter
high temperature; Renal Failure; This case was reported by a physician via call center representative and described the occurrence of renal failure in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number AG7M9, expiry date 6th May 2022) for prophylaxis.   On 12th November 2020, the patient received Shingrix (intramuscular). In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced renal failure (serious criteria GSK medically significant) and fever. In November 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the renal failure was unknown.   It was unknown if the reporter considered the renal failure and fever to be related to Shingrix.  Additional details were received as follows: The age at onset could be 62 or 63 year old. The patient had renal failure and high temperature post dose 2 of Shingrix. The patient went to the hospital on 24th November 2020. The fever resolved. The patient was in the Doctors office today 25th November 2020 (date of report) still searching for questions about the renal failure The reporter consented to follow up.
black outs/cold sweats/heart racing w/o any activity;severe h/a, worse than ever in the past;dizzy & clumsy @ times & loose balance, mood swings;exp joint & muscle pains; weakness;memory problems;fatigue;weight loss, rash;swollen glands  Per follow-up, pt has not recovered, he is still sick and he is unable to hold a job or support his family on a regular basis.
She immediately got cold symptoms, high fever, wheezing, asthma attacks, throwing up from coughing so hard during attacks EVERY night, a full body rash. Took her back several times and the cdc told me to go to a different dr and they started her with albuterol, bensonide, tylenol/advil, prednisolone, and an asthma allergy medicine. One year later and we still cant get her asthma under control. Shes stopped breathing a couple times from asthma attacks and still throws up at night.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No information on patients concurrent conditions and medical history was provided. On an unknown dates between the August 2014 and May 2015, the unspecified number of patients was vaccinated with improperly stored GARDASIL (dose, route, frequency, lot # and expiration dates were not provided). No adverse effects were reported. This is the one of the several reports from the same reporter source. Additional information has been requested.
Patient got Moderna 1st dose.  Patient registered for appointment online for 2nd dose and chose Pfizer.  Pfizer was administered for 2nd dose instead of Moderna.  There was no adverse event, just reporting that wrong covid vaccine was given on 2nd dose.
Feverish; Chills; Heart racing; Tightening in my chest; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 13:03 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the Covid 2nd vaccination this afternoon at 1:03 PM (15Feb2021 13:03) and about 25 minutes ago, the patient started to feel feverish and had chills and a racing heart and about 5 minutes, the patient started to feel tightening in chest. The patient wanted to know whether this was standard reaction from the second vaccination or the patient should call the ambulance. The patient did not want to go to the hospital because the patient did not want to catch it before the second vaccine ticks in. The patient did not consider it a bad experience, the patient just want to know if this was a normal reaction, or the patient should just lay out. The patient stated, it's a good thing, the patient was not dying. Outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
redness at injection site; with stress on left arm; first and second dose received 3 or 4 weeks apart. Caller; experiencing pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In May 2021, the patient received the 2nd dose of Shingrix. In May 2021, immediately after receiving Shingrix, the patient experienced injection site pain, injection site erythema, arm discomfort and drug dose administration interval too short. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving and the outcome of the arm discomfort and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema and arm discomfort to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient reported that receiving both the 1st and 2nd dose of Shingrix in the left arm in May of 2021, the reporter was uncertain of exact dates, but stated they only received 1st and 2nd dose 3 or 4 weeks apart which led to shortening of vaccination schedule. The patient experiencing pain and redness at injection site immediately after receiving 2nd dose of Shingrix. The event redness had lessened but was still visible.  The pain was moderate, consistent, and ongoing.  The pain worsens with stress on left arm or if he sleeps on the left arm. The reporter consented to follow up. For tolerance in 1st dose refer case US2021200827.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021200827:Same case US-GLAXOSMITHKLINE-US2021200827:Same patient,2nd dose
Case number PHEH2014US025109, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 57-year-old female. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
itch; a rash surrounding the site of the needle; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itch) and VACCINATION SITE RASH (a rash surrounding the site of the needle) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: tdap. Past adverse reactions to the above products included Vaccination site rash with tdap.    On 18-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PRURITUS (itch) and VACCINATION SITE RASH (a rash surrounding the site of the needle). At the time of the report, PRURITUS (itch) and VACCINATION SITE RASH (a rash surrounding the site of the needle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications included alcohol..
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L043213, expiration date 28-AUG-2017 (dose and route of administration were not reported). There was no adverse effect reported. No product quality issue was involved. Administered dose of vaccine experienced the temperature excursion of low -28 degrees Fahrenheit for 5 hours on 22-APR-2016. Data logger was involved. There were no previous excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Date and time adverse event started:  1st Dose: covid-19 arm day after, body aches and chills few days after (4-5 days) 2nd Dose: evening of shot got covid-19 arm, throughout the night started feeling symptoms Date and time of vaccination: (list both if they received both shots):  1st Dose: 3/13/21 11:30AM 2nd Dose: 4/10/21 11:30AM   Brand and lot of vaccine:  1# - Moderna #011A21A 2# - Moderna #011A21A  4/121st dose: : "covid-19 arm" rash all the way down arm (looked like a sunburn), itching in arm area, nausea, body aches - took 3 days to subside from symptom onset. 2nd dose: "covid-19 arm" rash above elbow to shoulder, itching in arm area, nausea, body aches, fever (102F throughout the night, now 99F), constipated (Chron's disease, shouldn't get constipation according to patient), thirsty. All symptoms still occurring now. Recommendations: Stay hydrated with fluids such as pedialyte. Can take anti-histamines for "covid-19 arm" rash to help with the itchiness. PCP recommended use of hydrocortisone cream for the rash should also be fine. Talk to your PCP if you have "Flu-like" symptoms for more than 4 days. Can take OTC pain reliever/anti-fever medication if you feel the need too; however, you mentioned that they gave you stomach pains the last time you took them so you may want to discuss that with your PCP.
Fever, fatigue, passed out, vomiting, headache, nausea, abdominal pain, joint pain, dizziness, pain, dehydration
COUGH, CHILLS, HEADACHE, FATIGUE, DROWSINESS, SLURRED SPEECH, WHEEZING, O2 LEVEL LOWER, BP SLIGHTLY ELEVATED GLUCOSE HIGHER THAN NORMAL.  ON 01/20/2013 + TROUBLE CONCENTRATING, AF, SHORTNRSS OF BREATH. ON 01/21/2013 + DIARRHEA.
Red flat rash to anterior throat with feeling of "a lump in my throat" approximately 2 hours after injection. Pt was evaluated, no difficulty breathing or SOB, no facial swelling, vital signs WNL. Pt received 25mg IM Benadryl with good control of the rash, and was discharged with PO Benadryl and instructions to call 911 if signs of anaphylaxis develop.
PATIENT HAD SORENESS IN THE AREA OF INJECTION SINCE MAY TILL PRESENT TIME
11/02/22 presents with "altered mental status" "syncopal episode". PMHx of "PAF on warfarin, cardiomyopathy, DMII, CAD, PVD, asthma, colon cancer, and BPH".
Fever; nausea; headache; achy. Fever lasted several hours starting around 11:00 pm. Nausea lasted 36 hours (about), aches and pain lasted about 48 hours. Tylenol for fever.
Prior to getting my COVID19 vaccination, I was rarely (but occasionally) in A-Fib, most likely caused by my Mitral valve stenosis.  After my 2nd Moderna vaccine, I went into A-Fib, and have not had a normal sinus rhythm recording since then (almost 3 months straight, every day). I have a ECG monitor, so can read my ECGs anytime, and was checking them 3-5 times per day for several weeks after my 2nd shot. I know the vaccination did not CAUSE my A-Fib, but since the vaccine seems to have some metabolic effects beyond just producing protective antibodies (helping folks with long-haul, etc.), I believe it may act as a catalyst which precipitated events leading to "pushing" me into A-Fib 24/7. I just thought you would want to know.
Client received vaccine at 1:25  pm.  After approximately 15 minutes client reported feeling nausea. Instructed to stay for an additional 15 minutes for extended observation.  Approximately 25 minutes after vaccination client feeling faint and described feeling of acid reflux, difficulty recognizing people and disoriented.  Also pale, not clammy.  assisted to supine position.   EMTs onsite and doctor notified.  Nausea continued.  Vomited x 2.  After approximately 60 minutes client was able to sit up.  Spouse arrived and accompanied patient out of the building. Patient ambulated with limited assistance by her husband.  Husband given recommendations on follow-up, if needed.
Acute onset Dementia and Severe Audio and Visual Hallucinations followed by aggressive and combative behavior. This began on March 13th and has gotten progressively worse since that date
Severe swelling, edema, hives, at injection site.  Swelling down whole arm, injection site size of softball.  Started swelling in two hours of shot time.  Took Motrin and Benedryl.
ANTERIOR TONGUE NUMBESS FOR ABOUT AN HOUR THEN ITCHY RASH BILATERAL HANDS FOR A COUPLE OF HOURS
pt recvd vax & 8 days p/vax pt exp tingling in neck & palm of hand, lt arms soreness & an inflamed inject site; given DPH & cold compresses;
Case number PHEH2015US000686, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 60 years old male patient. Medical history and concomitant medications were not reported. On 28 Oct 2014, the patient received FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLULVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed as non-serious. No adverse event was reported following this medication error (incorrect storage of drug).
This case was reported by a nurse and described an adult male pt who did not respond to the Engerix-B immunization series. The nurse stated many adult males were immunized and that "one out of three" have not responded to the immunization series; however, no pt identifiers were provided. On unspecified dates, the pt received 3 doses of Engerix-B (lot AHBVA068AA). On an unspecified date later, a hepatitis B surface antibody titer was "negative".
Extreme Soreness and redness to the elbow.  Mostly bruised near the inner upper arm above the elbow
injection site reaction 15 minutes after dose, Itchiness, small red bumps. 3 days later red hard 2 in diameter bump at injection site. painful, itchy and red. symptoms resolved within 7 days of dose
pt devel fever to 103.5h;ad 2min gen sz occurred approx 4hr p/vax;
Symptoms: SkinRash & itching Treatment: DIPHENHYDRAMINE 50 MG ONCE, METHYPREDNISOLONE 30 MG ONCE, PREDISONE 40mg today, 20mgx2d, 10mgx2d MG
Flu-like illness for 72 hours, followed by extreme weakness and dizziness. Latter has not gone away six weeks later.