chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lethargic; Allergic reaction; Sick; This spontaneous case was received on 29-Sep-2020 from a nurse via agency (reference number: SEQW20-02517) and concerned a female patient of an unreported age.  The patient's current condition included lots of preservative allergies. The patient's concomitant medications were not reported.  On 18-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: deltoid and route of administration: not reported) for influenza prophylaxis. The batch number reported was 276553, expiry date: 30-Jun-2021.   On the same day, the patient had an allergic reaction to the vaccine. In the evening, the patient felt sick.  On 19-Sep-2020, reported as on Saturday, the patient was lethargic.  At the time of initial reporting on 29-Sep-2020, the outcome of the events was unknown.  The reporter assessed the event of allergic reaction as related to Flucelvax QIV. The reporter did not provide a causality assessment for other events.  The reporter assessed the case as non-serious.  Company comment: A patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed hypersensitivity and malaise. One day after, the patient developed lethargy. The patient's current condition included lots of preservative allergies. The patient's concomitant medications were not reported. More information regarding experienced hypersensitivity reaction is needed. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.; Reporter's Comments: The patient had an allergic reaction to the vaccine.; Sender's Comments: A patient was administered Flucelvax QIV vaccine. On the same day, after vaccination, the patient developed hypersensitivity and malaise. One day after, the patient developed lethargy. The patient's current condition included lots of preservative allergies. The patient's concomitant medications were not reported. More information regarding experienced hypersensitivity reaction is needed. With information available, causality is assessed as possibly related for all events due to plausible temporal relationship.
Approximately 22-24 hours after receiving the shot I developed upper abdominal  pain and exhaustion. The pain continued to get worse over the next several days. I then developed chest pain and ended up in the emergency room. It has now been 2 weeks since the day I got the vaccine and I am still not better. The doctor thinks the chest pain was my esophagus  having a spasm.  I have  had an EKG, an ultrasound, extensive blood work, a rectal exam, a blow test and 2 exams and I still do not have a definitive answer as to what is wrong with me. I missed several days of work. I also have Vertigo since getting the vaccine, although this is something I?ve experienced before. I also had an increase in heart palpitations and on Sunday I developed palpitations that I could not get to stop for quite some time, and then my face started to go numb as well as my feet and arms. This lasted about 5 minutes. It was very scary and I do not know what was going on with that.  As of today I am mainly just dealing with the upper abdominal pain. I am taking a prescription medication that I started yesterday for acid relief but so far it?s not helping.  I will not be getting the second dose. I was healthy with no issues before the vaccine. I am confident this is a result of how my body reacted to the vaccine.
PT CAME TO THE PHARMACY COMPLAINING ABOUT RASH , REDNESS AND TIREDNESS. PT WAS DIAGNOSED WITH SHINGLE ON 09/09/2019 AS WELL
Persistent induration, pain & swelling 6 days post injection. Indurated region 2"x3/4".
This spontaneous report as received from a pharmacist refers to a 31-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. The patient was vaccinated with the mixed regimen of Human Papillomavirus vaccines: on 30-JUN-2016, the patient received dose GARDASIL injection (dose, route of administration, lot# and expiration date were not provided), on 30-JUN-2016 GARDASIL 9 injection (dose, route of administration, lot# and expiration date were not provided), and on 23-FEB-2017 again the dose of GARDASIL 9 injection (dose, and route of administration were not provided; lot# M023169, expiration date:13-JUN-2018). there was no adverse reactions. The outcome of the event was unknown. The relatedness between the event and the vaccines was not reported. Additional information has been requested.
Case number PHEH2014US024961, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 90- year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 03 NOV 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 (incorrect storage of drug). No further information was provided.
Fever 102-103 degrees F wouldn't crawl or sleep or eat for 2 days very uncomfortable and just wanted to be held.  I get angry because I could have gotten DTAP by lying but felt that was wrong to do.  The leg it was administered in got a bit of a knot in it too.  Attention problems followed. Anger & frustration unusual to situations followed.
Lightheaded, dizzy post vaccination. PT AMA recorded at ER  Janssen COVID-19 Vaccine EUA
Ache and pain in legs got worse especially in my knee on right side and on the back. At the doctor's office was given Ultrasound, no issues discovered. Blood work showed no issues, either. Started physical therapy on November 8 and had some improvement but still an issue. I have not yet recovered.
Pt. rec. FLUZONE QUAD and 40-45 min later pt. had syncopal episode and when became responsive within a min - had lg. emesis.
pt recvd vax, devel fever, m-p ?nonedafluent erythematous rash;irritability,diffuse shotty,adenopathy; t 103 range for several days;
Headache, Fatigue, injection site pain and swelling, joint pain (knees and shoulder), brain feels foggy Narrative:
Reported to employee health that she had red raised area on left thigh where vaccine was given, complainied of hot, painful. Instructed to watch. She later sought treatment by emergency MD that prescribed clindamycin for "cellulitis" at vaccine site.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case is linked with 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851(Same reporter source, same vaccine). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had flu. It was reported that every year patient received flu shot and had flu. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Got up to use bathroom in middle of the night (about 12 hours after vaccine). Upon standing, felt like was going to vomit, then lost consciousness and fell backward hitting tailbone and head. Regained consciousness upon hitting floor. Followed by cold sweat and chills/rigors. After fall, was dizzy, had headache, and ringing in ears (likely mild concussion). Still continuing at time of reporting, but are improving (~30 hours later). Body aches from fall (tailbone, neck, back of head).
Day 2 scratchy throat Day 3-4 headache, chills, nausea, aches, dizziness  Day 5 loss of smell & taste Day 6 continues
A few days after 1st dose I started my period. I thought nothing of it, as it was actually due. I am in premenopause and get my period approximately every three to 4 months. It's been this way for at least 2 years.  I got my 2nd dose yesterday and today I started my period. This is only 3 weeks since my last.  I know this isn't right.
Information has been received from a physician concerning a 23 year old female who about 5 weeks ago, in approximately August 2008, was vaccinated with an unspecified dose of GARDASIL (lot#0250X), intramuscularly. Subsequently on an unspecified date, the patient experienced severe arm pain at the site of her last GARDASIL vaccination. The patient sought medical attention in the office. At the time of reporting her symptoms had continued. This is one of two reports received from the same source. Additional information has been requested.
Flu shot 10/17/2005, left deltoid - 10/23/2005 had bruising below bicep at elbow and tightness in tricep muscle.  No swelling, tenderness, or pain.
Patient reports large "crater" or "divot" in left deltoid after receiving Moderna first dose. "Crater / divot" was visualized in clinic and is substantial. Nickel sized divot noted upon visualization.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004530: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004536:
Site: Pain at Injection Site-Mild, Additional Details: Patient came in and said she had pain running up and down her arm.  I looked to see if i had caused bursititis by injecting her too high, but I then realized I injected her opposite arm so bursititis was ruled out.  I told her to get take 800 mg ibuprofen 3 times a day and stop if red stool appears. and asked if she had ever had any kidney trouble just encase. she said no. i said if pain is not better by tomorrow please seek additional care.
Stomach cramps happened within 90 minutes of shot and lasted a couple hours.  Headache  happened next day and still has headache  Hives on the back of the neck happed a few hours later and last for about 3 hours.
Myocardial injury: The pt was found to have an elevated Troponin in the setting of waking from sleep with chest discomfort.  An Echocardiogram was performed: no wall motion abnormalities, EF of 68% D dimer was negative at 456. A cardiac CT scan was done that showed normal coronary arteries with no atherosclerotic disease.  It was presumed in the setting of her bodies reaction to her second COVID dose that she had this troponin leask associated chest pain as there was no cause identified.
Hour after vaccine shot started with Slightly swollen lips & numbness in the lips red color of cheeks. . Took Benadryl and 16 ounces of water around 1hour 15 minutes after shot Two hours after shot experience slight sore throat lightheadedness head cold symptoms Symptoms lasted another six hours took a second then a drill. Rank another three bottles of water Symptoms became lighter with a little bit of a headache After 20 hours everything went away except tiredness and  light headaches
At 11:15 p.m. (10 hrs. after shot), I woke up nauseous, sat up in bed and felt weird, got up and made it to the foot of bed and passed out. When I came to, had my husband get me a cold rag, but then I felt diarrhea  hit, I crawled to the hall to the bathroom, stood up and had the uncontrollable shakes so bad the whole toliet shook with me. After I finished in bathroom I went back to bed and literally shook for 1 1/2 hours and was up most of the night.  This was my 2nd shot. On the 1st shot it made me feel like I was in a fog, like when you pass out and come to and your not all there. Took 3 hours to shake that one. I don't know what is in the freakin thing, but my body cant take this kind of stuff and I WILL NOT be doing any more of this quickly made, quickly approved vaccines. Count me out for any further ones. I'M DONE !!! I have never taken the flu shot ever so I WON'T be doing any more of these no matter how much the CDC pleads with me
This spontaneous report was received from a healthcare worker refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 09-FEB-2016, the patient was vaccinated with improperly stored ROTATEQ (lot # L008966, expiry date: 01-DEC-2016). The vaccine underwent a temperature excursion of 28 degrees Fahrenheit for a duration of 2 hours. No adverse effect was reported. Additional information has been requested.
Child had fever x 1 night, crying, screaming x 4 days could not be pacified, difficulty nursing.
developed s/s of Covid 8/17, was admitted to the hospital 8/20 and tested positive COVID
This case was reported by a other health professional via call center representative and described the occurrence of hives in a adult female patient who received SHINGRIX. On 4th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced hives, pruritus, pain in arm and skin bleeding. In May 2018, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the hives, pruritus and skin bleeding were unknown. It was unknown if the reporter considered the hives, pruritus, pain in arm and skin bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient received her SHINGRIX vaccine on Thursday of that week and by the next she started itching, on her head, ankles, calves, forearms, fingers to the point of bleeding and basically all over. Besides, the sore arm for the last 3 days. The vaccine costs her 179 dollars from the local pharmacy that night and she was scheduled for her second SHINGRIX on or around May 4th two months later for another cost of 179 dollars at pharmacy. The patient wanted to know how much longer would the hives last and should she take BENADRYL. The patient would prefer a call.
Per pt.'s grandmother, patient developed hives all over her body that required Benadryl every 4 hours around the clock for 24 hours.
SEIZURE; SEVERE MUSCLE ACHES; This spontaneous report received from a patient via a company representative 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced seizure and transported to hospital. CT scan performed -no problems. Patient experienced sever muscle ache. Laboratory data (dates unspecified) included: CT scan (NR: not provided) No Problem. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure and severe muscle aches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210530480- covid-19 vaccine ad26.cov2.s-Seizure. This event is considered un assessable. The event 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.
woke up the next day with bilateral leg weakness; woke up the next day with bilateral leg weakness, numbness; inability to get up out of bed; inability to get up out of bed; This is a spontaneous report from a contactable physician. A 52-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot Number: FF2587), via intramuscular, administered in Arm Left on 21Oct2021 (at the age of 52 years old) as dose 1, single for COVID-19 immunization. Medical history included complex regional pain syndrome right hand type 1, Hyperlipidaemia. Concomitant medication(s) included gabapentin (GABAPENTIN), nortriptyline (NORTRIPTYLINE), diclofenac sodium (VOLTARENE). The patient previously took codeine and epinephrine experienced drug hypersensitivity. The patient did not receive any other vaccination in last 4 weeks. The patient did not have COVID prior to vaccination. The patient is not pregnant at the time of vaccination. On 22Oct2021 the patient woke up the next day with bilateral leg weakness, numbness, and inability to get up out of bed. The patient was hospitalized for 7 days with the events woke up the next day with bilateral leg weakness, numbness, and inability to get up out of bed. The treatment received IV Solumedrol 1000 mg for 5 days. The patient underwent lab tests which included sars-cov-2 test negative on 26Oct2021 Nasal Swab. The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
80 year old nursing home resident, no acute illness. 10/18/04, dark, cloudy urine noted; UA ordered (10/24 lab report: numerous proteus mirabilis). On 10/22/04 at13:10 patient observed unresponsive and pale; no pulses, no respiration, no BP. CPR initiated, but unsuccessful. Note: Order written for 1cc flu vaccine; documented administration same, though facility says patient actually received 0.5cc. Nurse follow up on 11/01/04 states: "UTI." Death Certificate received on 11/16/2004 states causes of death are hypertension and CVA.
TICKLING ON HAND AND FEET; DIZZINESS; CONSTANT MILD HEADACHE; This spontaneous report received from a patient 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) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-APR-2021, the subject experienced dizziness. On 22-APR-2021, the subject experienced constant mild headache. On MAY-2021, the subject experienced tickling on hand and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant mild headache, and dizziness, and the outcome of tickling on hand and feet was not reported. This report was non-serious.