chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Malaise; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.  It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were reported as follows: The reporter reported the case for her sister. The reporter requested to be anonymous. The age at vaccination was not reported. The reporter reported for the patient that the patient received shingrix vaccine in arm and had malaise for few days then recovered. The reporter did not consented to follow up. This case is linked with US2021179659, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179659:same report
29MAY found unarousable mid-morning proceeded to grand mal sz & resp arrest; airlifted to hosp; En route had full cardiac arrest; total 10 grand mal sz;
palpitations, urticaria to neck area, anxiety.  10/26/09 ED medical records received service date 10/11/09. Assessment: Adverse reaction H1N1 flu vaccination. Patient presents with sudden onset of hives, anxiety, palpitations and an erythematous rash across the neck. No problems with other flu vaccinations.  10/23/09 PCP medical records service dates 10/08/09 to 10/23/09. (Includes addtional ED visits.) Most recent assessment: Viral pharyngitis. Sorethroat, headache, sinus congestion.
She got her vaccine, that night she went to bed early as she was tired.  At 1:30 AM she felt real weird and had a headache, and went back to sleep.  Then she got up and was severely nauseated, didn't eat anything.  She then got really tired.  Then she went to bed at 4:00 that afternoon due to the nausea, and by 9:00 PM she had a fever of 99.7.  She went back to bed and the headache got more intense and the nausea kept going.  At 1:30 she woke up and she was sweating to the point of dripping wet, and had to change her clothes.  She took some Tylenol 650 mg to get rid of the headache, and went to sleep and woke up this morning and feeling fine.    Never had any reactions from the other two vaccines or any other vaccines that she has had.
This spontaneous report as received from a pharmacist refers to a 57 year old female patient with no known pertinent medical history and drug reactions/allergies. On 12-AUG-2013, the patient was vaccinated with ZOSTAVAX (lot # J001006) (dose, route, frequency and indication not provided). On an unknown date, after vaccination, the patient developed an injection site reaction, the injection site is painful, slightly itchy, shiny, very red, swollen and 4 inches in diameter. On an unknown date, the patient contacted the pharmacist. There was given application of ice as treatment for the events. At the time of the report, the patient had not recovered from the events. This is one of two reports received from the same source. Additional information has been requested.
I had some fatigue, not major. My lymph nodes were swollen to the point that they were painful. I massaged it and try to tuck an ice pack under my left arm, which I did for three days and then it started feeling better.
Case of misuse received on 08 October 2011 from a consumer. A 40-year-old patient had received on an unspecified date an injection of FLUZONE HIGH DOSE (batch number, number in series, route and site of administration not reported). No concomitant therapy was reported. On an unspecified date, the patient felt slightly "out of it", more than in previous years when the patient received the regular strength version of the vaccine. No corrective therapy was reported. The final outcome was not reported. Follow-up information was received from a consumer on 19 December 2011, who is also the patient. Verbatim: "Regarding this report I later spoke to the doctor's staff by phone regarding my concern of having wrongly received the High Dose Flu vaccine and they said they checked with the nurse who then said the High Dose vaccine was not mistakenly given to me. I don't know if they were trying to cover their tracks following a mistake or if perhaps the nurse was confused when she gave me the vaccine. Therefore, I don't know if I still need to fill out this form or not as it's not 100% clear which vaccine was actually given to me". Documents held by sender: none.
22SEP96 pt spiked a temp;temp was not taken but pt was talking out of head;mom place pt in bathtub w/warm (tepid) H20 throughout noc but cont to have inc temp;vomited 5 or 6 times;body hurts;virus;drinking & eating small amounts;
This case was reported by a consumer via call center representative and described the occurrence of irritability in a 4-year-old female patient who received KINRIX. On 24th February 2017, the patient received KINRIX (intramuscular). On 24th February 2017, less than a day after receiving KINRIX, the patient experienced irritability, fever, vomiting and sleepiness. On 26th February 2017, the patient experienced cyanosis. On an unknown date, the outcome of the irritability, cyanosis, fever, vomiting and sleepiness were recovered/resolved. The reporter considered the irritability, fever and vomiting to be probably related to KINRIX. The reporter considered the cyanosis and sleepiness to be possibly related to KINRIX. Additional details were provided as follows: The patient was the caller's daughter. The patient was usually in impeccable health. On 26th February 2016 (Sunday), 2 days after vaccination, the patient turned blue twice.
Pt with history of prematurity, non surgical necrotizing enterocoloitis and omphalocele.  Recieved routine 2 month immunizations - Pediarx, Hib, Prevnar and Rotateq on 11/28/06.  On 12/9/06 presented to ER isseptic shock secondary to necrotic bowel.  Patient dies.   2/16/07 Received medical records from reporter/provider which reveal patient was in usual state of health on day of vax.  Complicated PMH, see below.  Seen next on 12/5 for parental concern re pallor.  Afebrile, fussy, + weight gain, abdomen was mildly tympanic but soft w/+BS.  Return for vs on 12/7 & parents reported patient had improved at home, no further pallor episodes. temp stable, good appetite, no vomiting.  Had seen peds surgeon that day for f/u on omphalocele. Next scheduled visit was for 12/21. 2/16/07 Received Death Summary & Autopsy Report from reporter/provider which reveals on 12/9/06 patient experienced pallor, spitting up since afternoon of admit, fussy, irritable.  Exam in ER revealed rectal temp of 91.7, mottled skin, shallow breathing & in acute distress.  Had extremely rigid abdomen w/no bowel sounds.  Developed cardiac arrhythmias & seizures.  Transfused w/PRBCs.  Then omphalocele ruptured & had significant bleeding, continuing arrhythmias & finally asystole with unsuccessful resuscitation effort. Autopsy Report reveals probable COD is multisystem organ failure from septic shock secondary to ischemic small intestine within an unresolved omphalocele.
It was probably given in the joint. it caused the site to be swollen with possible bursitis. Fluids were taken out and tested. Everything came back negative. Dr. recommended for the flu shot to be given again.
Site: Redness at Injection Site-Mild, Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted twice, possibly due to low sugar because she did not ingest any food in the morning.  Family member stated that patient has fainted multiple times after vaccination.  Patient did not developed any swelling/inflammation.  Nurse offer to call 911, family declined.
Flushing of face and chest; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown) via unspecified route on 08Feb2021 at single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient experienced flushing of face and chest after receiving the 1st dose on 08Feb2021. The outcome of the event was unknown.  Information on the lot batch number has been requested.
I passed out about 10 min after receiving the vaccine.  The nurses said my BP dropped and kept me an hour after receiving the vaccine.  Within 3 hours of receiving the vaccine I felt nauseous and had arm pain around the injection site.  Two days after the injection the arm pain was gone but the nausea remained and I began having severe stomach cramps w/gas and feeling light headed.  The nausea, body aches, stomach cramps and gas remain on day 9 and the night of day 9 I woke up shivering and drenched in sweet while having a nightmare.  It is day 10 and I have nausea, stomach cramps, fatigue and mild body aches.
10 Days s/p receipt of smallpox vaccination. Presents with generalized erythema of injection site along with 1-2 days history of itchy rash.  PE sig for papules and vesicles on chest and back with a few on forehead.  No fever or sig malaise.
pneumonia; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program.  A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for pneumonia vaccine.  The patient's medical history and concomitant medications were not reported. The reporter reported for his late wife was convinced by her doctor to take Prevnar 13. Prevnar 13 was administered to his late wife a week or so before she passed away. She passed away within two weeks of pneumonia. Prevnar 13 obviously did not work and that colors his assessment of the drug.  The patient died of pneumonia on an unspecified date.  It was not reported if an autopsy was performed. Information regarding batch/lot number has been requested.; Reported Cause(s) of Death: Pneumonia
Pt devel swelling, redness, & warmth @ inject site p/receiving Influenza vax; pts upper arm was tender;
Upper respiratory infection; Got worse after the second dose.; Had not been feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), administration date: 01Mar2021, when the patient was 76 years old, for Covid-19 immunization, reaction(s): "Runny nose", "Congestion", "Inflammation of vocal cords", "Fatigue, so tired, exhaustion", "Shortness of breath/couldn't breathe", "Frozen shoulder/couldn't move her left arm. Clarified left arm was the injection arm", "Heavy in her chest", "Blood pressure was high,220/110", "Flushed face", "Couldn't speak", "Upper respiratory infection". The following information was reported: UPPER RESPIRATORY TRACT INFECTION (non-serious), outcome "unknown", described as "Upper respiratory infection"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Got worse after the second dose."; MALAISE (non-serious), outcome "unknown", described as "Had not been feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient did not visit with her family during the holiday because since she received the Pfizer vaccine, has been struggling with an upper respiratory infection. Reaction to it started the following week, following the first dose. Got worse after the second dose. They Clarified her reaction is the upper respiratory infection.  Her entire family has had the Pfizer COVID-19 Vaccine, including the booster, and they were infected with the COVID virus. Caller did not know which variant, but they were all positive. Caller did not go to this family gathering because she did not feel well. She had not been feeling well since the second dose of the COVID-19 Vaccine.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe fever of 101, with Ibuprofen and Tyenol. Body Aches , bruising at injection sight Nausea and upset stomach  Body chills
syncopal episode, client had history of syncope with vaccination that was not reported until after the fact.
Arthralgia, Fever, NauseaVomitin, Fatigue, Chills Narrative: Symptoms started dat after injection, got better over several days
Temperature for day and a half, achy all over, sore left arm-couldn't move it
That evening at about 5-6pm I started feeling achy and feverish, I did not take my temperature though. I did not feel good all around. I took some ibuprofen 2x. About 10-11p I took 2 more ibuprofen and then went to bed. I honestly have no idea what happened, but I woke on the floor 1am-2am. I had fallen out of bed and was in pain, I was sweating all over, I was feverish, I felt nauseous and felt like I was going to pass out. It woke my husband up because it was so loud. I'm not sure if I had hit the side table drawer that was open with my shoulder or hit the floor hard when I fell. I tried to go back to bed but couldn't sleep because it hurt so bad. The next morning 1/24/2021 it was excruciating so we looked for an ER that didn't have a really long wait time we went around at 8am. We went to a local health care facility. They did an X-ray and said it was broken and needed to put a brace system on it. They gave me a pain medication but I can't recall what. Then they referred me to a orthopedic surgeon. I told them I had just gotten the vaccine but they did not say anything. I was there for about 8-9 hours. On Weds 1/27/2021 I saw an Orthopedic Surgeon at the office I already went to for my back, not the one I was referred to because they could get me in a lot sooner. He took my cast off to do several more x-rays and showed me the severity of the break and the ball of the shoulder was in several pieces. He did not recommend pinning it back together, he recommended a partial shoulder replacement because there could be other issues from it. He gave me a sling for my shoulder. He had me scheduled the surgery with the surgery scheduler and we scheduled it sometime the first week of February. I had to wear a confining sling for 8-10 weeks than a different one for 6-8 weeks. I started physical therapy in April and still attend. I couldn't work until after 1 week post-surgery. Several post-op follow-ups.
I had hallucinations the night I received the first dose of my covid vaccine. I had this overwhelming feeling of gloom and an immense fear that I would die in my sleep and never wake up. I messaged my parents, telling them how scared I was, and I had no clue why. The next day my pulse was very high; it got to 204, I had a syncope, and my pulse was undetectable by my monitor; it only went to 60, I believe. It was undetected for 8 and then 4 minutes before being normalized. My QT was over 500, and I was diagnosed with LQTS; I'm currently seeing a cardiologist to confirm. I was on my back, stiff, with my arms in the air for 3 of the 8 minutes. My physical trainer told the paramedics it looked like it could be a seizure; however, the doctors later said it wasn't.
About 15 minutes after injection, started to feel a headache. BP 179/82, HR 72.  On recheck, BP 170/80.  EMS was called to evaluate the patient.  BP 196/87 - transferred to ED.  Patient was worked up - found to only be vertigo - meclizine given and helped.  Ruled out - no s/s of stroke. Discharged from the ED.
Developed fever (101F) and muscle spasms in both legs/thighs one day after receiving vaccines.
Fever (100.5 degrees) lasting from roughly 6pm to 11pm (or later), fatigue, muscle soreness at injection site, general muscle soreness in body
This case was reported by a healthcare professional and described the occurrence of injection site redness in a 35-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 13 November 2007 at 10:59 the subject received a dose of Fluarix at 0.5 ml in the right arm. On 14 November, 1 day after vaccination with Fluarix, the subject developed a 8 x 6 cm area of redness at the injection site. No treatment was required. At the time of reporting the events was unresolved. Follow-up received on 11 December 2007 via the nurse. The nurse reported that the subject had a history of hypertension. It was noted that the subject had no previous reaction to influenza vaccinations. It was reported that the injection site redness resolved on 19 November 2007. The nurse considered that the injection site redness was related to the injection site redness was related to the use of FLUARIX. She also considered that the events were not related to the use of FLUARIX. She also considered that the events were not serious.
1) Burning sensation at the injection site within 5 minutes of injection (went away about an hour later). 2) Cold, odd/metallic like taste in my mouth about 12 min or so post injection. This lasted for about 6 hours or so.  3) Today, my inner ears started itching like crazy (I have allergies, however this has never happened before) . Still experiencing intermittent inner ear pruritus.  4) Tingling in left arm and numbness/tingling in left leg briefly today.  5) Brief GI discomfort on 7/29 - afternoon 6) Pain at injection site (as expected). Has eased up considerably today.
Many PreAtrial Contractions. Approx 10 PACs per minute. This went on for 3 hours the first day, then 12 hours the next day, then 10 hours the next day, then 6 hours the next day.  Went to ER first day but PACs stopped before getting there.  The PACs returned the next day , I took ekg with home unit and sent data to Dr.  PACs stopped after 4 days.
No additional AE; RN called to report TE for vaccines and confirms that PROQUAD was administered on 2/10/2023. No additional AEs, no PQCs reported.; This spontaneous report was received from a registered nurse (RN) referring to a 4-years-old (reported as 4 years 5 months) female patient. The patient's concurrent conditions, historical conditions, concomitant therapies, and allergies were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneous Injection, at a dosage of 0.5 milliliters (ml) administered once (strength, vaccination scheme frequency, exact dose number, route of administration and anatomical site of application were not provided; lot number W028568 has been verified to be a valid lot number with an expiration date reported and established as 06-MAR-2024) for prophylaxis (product storage error).  No additional adverse events (AEs) were reported (no adverse event). Details about the temperature excursion were not provided.
Flushed from Abdomen to top of head, with numbness to the right side of his tongue with an associated metal taste.
about 12 hrs after booster shot, experienced burning, itching in R lower abdomen.  About 12 hrs after that, noticed bumps in ~6" patch across abdomen which are now displaying as pimple-like eruptions in the patch.  From prior experience in a medical center, this looks like shingles. OTC treatment+ advil/tylenol and topical 4% lidocaine
Patient immediately felt pain, nausea, dizziness, coughing and fast breathing. Skin color turned pale.
Patient was on his way out of the door and stated that he was feeling dizzy.  Patient sat down in the chair and became pale, sweaty, and he loss consciousness for a brief moment.  Patient's pupils were dilated and moving rapidly from side to side.  Patient quickly regained consciousness.  Patient stated that this happens every time that he receives a vaccination or has blood drawn.  Denies any history of seizures.  It appeared that patient had a focal seizure.  Patient's vitals were monitored until WNL and was able to fully regain consciousness.  Patient didn't want to go to the ED for treatment.  Patient advised not to drive and advised to follow up with PCP ASAP.
LAT swelling, redness w/generalized pt agitation w/tachycardia;
Tested positive 20May; Tested positive 20May; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "penicillin Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20May2022, outcome "not recovered" and all described as "Tested positive 20May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are needed. No further information is expected.
Signficant change in behavior within hours of receiving vaccines. Patient was "inconsolable" per mother and "cried all day" for 1 week straight. Reports fevers x2 days. After crying episodes stopped, patient regressing in milestones previously achieved. Stopped verbalizing sounds for 1-2 weeks. New behaviors include "eyes rolling" on occasion, more instability than previously had, fingers crossing and constantly in mouth
1 small Blister near injection site and cluster of bisters on the nose. Painful and sore, started to heal and scab over after 6 days.
pt recv vax 29APR96 & 22MAY96 pt pupils became enlarged & became totally blind;pt was non-ambulatory & could not walk around because pt could not see where was going;to MD dx w/severe bilat optic neuritis;
Fever to 101 and headache beginning this morning.  No treatment given.  States symptoms are beginning to improve.
Serious very unusual nose bleed. Difficult to stop.  Not explainable by any regular or current circumstance or possible cause. Likely combination of factors that vaccination  contributed to. Happened  again after second dose at roughly same time frame only more severe (30 minutes and sensitivity a couple days before and after)
Pt came in 5/1/23 stating he is having on and off pain in his left arm.  Pt states it started close to the time he received the vaccine.  Pt advised to speak with md.
Pt stated feeling light headed, difficulty breathing, dry mouth possible related to anxiety. Symptoms lasted about 8 min.
pt recvd vax 19JAN94 440PM & 445PM pt fainted; pt exp poss injuries redness approx size of coin on upper lt side of forehead;
Redness and swelling at the injection site on left deltoid. Advised patient to put cold compressions on site and to take ibuprofen and to return to clinic if worsen or no progress.