chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 month old given shots at about 1:30 PM. Went to sleep, woke up, was playing and at 4:00 started crying and not wanting to walk. Red raised areas on bilateral thighs R > L where shot given.
PATIENT REPORTED THAT SHE WAS FEELING DIZZY AND WARM ABOUT 10 MINUTES AFTER HER SHOT (NO PREVIOUS VACCINE REACTION REPORTED), SHE LOST CONSCIOUSNESS SECONDS LATER.  ELEVATED FEET AND MONITORED BP OVER NEXT 20 MINUTES, FIRST 95/66, PATIENT REGAINED CONSCIOUSNESS SECONDS LATER AND SECOND BP AFTER ELEVATING FEET 98/67 LESS THAN 1 MINUTE AFTER FIRST, THIRD BP 100/67 AFTER 5 MINUTES, FOURTH BP 135/90 (PATIENT WAS TALKING AND MOVING), MOVED PATIENT TO SITTING POSITION IN CHAIR AND CHECKED AGAIN AFTER 5 MINUTES MORE 112/88, PATIENT GIVEN ORANGE JUICE AND WAS SIPPING AND REPORTING FEELING BETTER, WAITED ANOTHER 5 MINUTES AND BP WAS 105/85 PULSE 77.  PATIENT REPORTED FEELING RECOVERED AND EXPRESSED CONFIDENCE IN LEAVING TO GO HOME (5 MINUTES FROM STORE).  WILL CHECK IN WITH HER LATER TODAY TO SEE IF SHE IS FEELING OKAY.
non toxic-does not appear ill;macular erythematous rash, chest, abd w/vesicles in different stages of devel
Patient administered vaccine at 4:05 pm on 4/24/21. No signs or symptoms of adverse event.
10/24/2015 excruciating pain left arm at injection site, high deltoid region. Also pain in shoulder blade and extending to armpit. Tenderness and sorness Left arm tingling and numbness extending into hand and fingers. Tingling and numbness subside after a minute or so. Cannot put any pressure on left hand, arm. Pain would not subside. Went to urgent care 10/24/2015 8:00 PM. Was seen by PA, told it was pinched nerve, given one injection of prednisone and one of Toprol. Told to take Aleve as needed, given Rx of 4mg Prednisone 2x daily for 5 days. Injections eased nerve pain SLIGHTLY, range of motion somewhat better. 10/31/2015 Bad pain still there but felt more in elbow than shoulder blade. Pain severe now still with numbness and tingling in left arm and extending into hand and fingers. Ice helping somewhat to dull the pain, Aleve not helping at all. Made appointment with primary care physician. Couldnt get in until Nov. 9. Nov. 9, went to see primary care physician. Explained symptoms. Rx 300 mg capsule Neurontin 1 at bedtime for nerve pain, and Diclofenac 75 mg 2xday for pain. I have never taken this much medicine in one months time for any reason. I am so discouraged. I am hoping that this pain will eventually go away!!!!!
I had some initial swelling and soreness at site, then about a week later injection site got red and hot.  The area was about the size of a 50 cent piece.  This lasted 24 hours then subsided.
Fever, body aches, headache, joint pain, fatigue, runny nose, and back pain.
Shortly after vaccine was administered patient exhibited symtoms of seizure-like activity then fainted. Her mother was able to catch her and helped her to lay on floor. Withins a few seconds she woke up and was able to state her name and date of birth. Within a few minutes patient was placed in sitting position in a chair and observed for several minutes. She was pale, yawning, able to speak, able to take sips of water. Blood pressure was checked at approx. 5:15pm and was 97/67 with pulse 77. At approx. 5:30pm she was able to stand and walk out of store. Contacted patient's mother by phone at approx. 7:30pm to follow up and was informed by mother she took her to local Emergency room due to continued pallor and yawning. Mother reported tests were being ran. Contacted patient's primary care physician office 1/11/18 at 1:45pm and reported incident to employee in office. She reports patient was seen in office this morning for follow up to what was reported to them as fainting due to watching her little sister receive a vaccine. Per employee, patient appears to be doing okay.
Extreme headache, chills, with fever. Fever reached 103.0 degrees fahrenheit in which I self medicated with Tylenol and cold compress/wash clothes. I then became severely hypertensive with tachycardia and presented to the ER on 8/3/2021.
"typical flu-like side effects"; fevers; Local reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of  patients who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and FluLaval Tetra 2020-2021 season. On an unknown date, less than a week after receiving Fluarix Quadrivalent 2020-2021 season and FluLaval Tetra 2020-2021 season, the patient experienced influenza-like symptoms, fever and local reaction. On an unknown date, the outcome of the influenza-like symptoms, fever and local reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms, fever and local reaction to be related to Fluarix Quadrivalent 2020-2021 season and FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received Fluarix Quadrivalent 2020-2021 season and experienced influenza-like symptoms and fever. The reporter's clinic group has administered 975 flu vaccines to patients in 4 days.  The reporter stated that normally it is spread out and his gut is it's a combo of a high vaccination rate and hyperawareness of what symptoms to look for. The reporter will get additional information regarding the 2nd reaction and others specific cases as well, brand administered/lot numbers, and provide to Agency within the next week. The reporter consented to follow up. No further information was available. This case was linked with case US2020AMR206412 and US2020AMR206466 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR206412:same reporter US-GLAXOSMITHKLINE-US2020AMR206466:same reporter
She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022; She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 10Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "unknown" and all described as "She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Positive.  Clinical course: It was reported that patient was asking when she can get the booster dose of the Pfizer BioNTech Covid vaccine. She has had four previous boosters of the Pfizer Covid vaccines, the last being administered on 10Aug2022. She developed a mild case of Covid on 09Sep2022, and tested positive 13Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11 pm same day chills and aches started along with soreness at injection site. 10 am 9/18 continuing chills and aches along with tiredness, strong headache/migraine, and low fever of 99, tylenol taken. 2 pm - 5:30 pm 9/18 chills and aches along with sustained fever of 103.8 and headache/migraine, ibuprofen taken at 3 pm. 6 pm 9/18 went to ER, tested for possible flu and Covid came back negative, temperature down to 102.7. 6-9 pm 9/18 waiting at ER, headache pain decreased but full body sweats started. 9 pm 9/18 fever down to 99, migraine cocktail of saline, Benadryl, and Compazine given. 10 pm 9/18 temperature 98.5, migraine subsided. 12 am 9/19 more ibuprofen taken. 9 am 9/19 temperature 99.5, more ibuprofen taken. 1 pm 9/19 temperature normal.
Patient felt faint after immunizations. Assisted pt to the floor, elevated feet, cold  cloths applied to pt and fanned her. Other RNs assisted as well. BP taken 116/65  with pulse of 87. Pt sat up for about 5-10 minutes before attempting to stand  with help. Pt gained her color back to her face and stated she felt better.  Mother reported child had not eaten before coming in today. Advised pt to wait  in the waiting room for an additional 10-15 min to be sure she felt okay.  Pt was fine when she left clinic.
Joint pain; Fever between 99.8 and 100.2; Injection site warm to touch; Pain; Muscle aches; Sore injection site; A little swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to touch), PAIN (Pain), MYALGIA (Muscle aches), VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE SWELLING (A little swollen injection site) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to touch), PAIN (Pain), MYALGIA (Muscle aches), VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE SWELLING (A little swollen injection site). On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever between 99.8 and 100.2). On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, VACCINATION SITE WARMTH (Injection site warm to touch), PAIN (Pain), MYALGIA (Muscle aches), VACCINATION SITE PAIN (Sore injection site), VACCINATION SITE SWELLING (A little swollen injection site), PYREXIA (Fever between 99.8 and 100.2) and ARTHRALGIA (Joint pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Body temperature: 100.2 °F (High) Initial temperature was 99.8 and latest temperature is 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included blood pressure medications.  Treatment for the first dose events were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: follow-up document received on 17-APR-2021.The product details and concomitant medication was updated. The event joint pain was added. On 04-Aug-2021: Follow-up 1 received on 05-AUG-2021.Event outcome updated
Sudden onset of diabetes. First symptom was skin infection 4 weeks after the shot, January 19. Glycosuria February 3. High blood glucose readings per home monitor. Began losing weight, being extremely hungry, getting sleepy after meals. Officially diagnosed April 13 with type 2 diabetes, but oral medications and lifestyle changes were ineffective. Had to go to ER April 28 and May 6 for ketosis. Second opinion May 18 diagnosis was type 1 diabetes.
adverse reaction or side effect: sore arm; This spontaneous report was received from a consumer regarding a retired female patient of currently 76-year-old. The patient concomitant medication, concurrent and historical conditions were not provided.   On 27-FEB-2009 and on 14-JAN-2020, the patient was vaccinated with pneumonia vaccine (manufacturer unknown) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On an unknown date, the patient experienced sore arm (pain in extremity), which was reported as an adverse reaction or side effect to the vaccine. The outcome of the event was not provided.   On an unspecified date, the patient experienced blindness, cerebrovascular accident, lacrimation decreased, nasal congestion, pinguecula, tension headache and rash vesicular; on an unspecified day in July 2010, the patient experienced herpes zoster; on an unspecified day in September 2010, the patient experienced malaise; on 22-MAR-2011, the patient experienced eustachian tube dysfunction, nasal dryness, nasal mucosal disorder, nasal oedema, nasal septum disorder and sinusitis; on 04-JUN-2013, the patient experienced herpes zoster; on an unspecified date in 2017, the patient experienced herpes zoster; on an unspecified date in 2018, the patient experienced pemphigoid, pemphigus, herpes zoster and varicella zoster virus infection; on 14-MAY-2018, the patient experienced dry eye, post herpetic neuralgia and trigeminal neuralgia; on 23-MAY-2018, the patient experienced vitreous detachment; on an unspecified date in March 2020, the patient experienced ophthalmic herpes zoster; and on 25-MAR-2020, the patient experienced conjunctival follicles and eyelid margin crusting (captured in MARRS # 2001USA003126).  The reporter considered the event to be related to pneumonia vaccine (manufacturer unknown).; Sender's Comments:  US-009507513-2001USA003126:
Left deltoid erythema, swelling and discomfort with palpation larger than softball size.
I tested positive for COVID-19 on 1/3/23. I had a cough, congestion, fatigue, fever, and a headache. I contacted my doctor and was prescribed 5 days' worth of PAXLOVID. After taking PAXLOVID for a couple days I felt a lot better. I am feeling much better now.
Seizure, 20 seconds, twitching, unresponsive, subsided on its own, pt assessed by MD, sent home.
While checking inventory that Pediarix was documented as given, but vaxelis was actually adminstered; Received 2 doses of Hib in error; No adverse reaction was reported; This non-serious case was received during the Reporting System monitoring on 12-JUL-2022 with the following Primary ID 2312795-1. The original narrative from the sender is the following:  No adverse reaction was reported. It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered.  Baby received 2 doses of Hib in error. Mother/guardian of child was telephone on 6/1/2022, at number provided in patient's record, but message ""not accepting calls"" was received. Her voice mail box was full, so no message was left.
Patient developed chest pain and presented to the emergency department and was found to have an acute inferior MI.  He was admitted and underwent a cardiac catherization and underwent stenting to the right coronary artery.  He was also found to have a 70% mid left main lesion that will need to be revascularized at a later date.  Patient was discharged on dual anti-platelet therapy and a recommendation to start a PCSK9 inhibitor.
Patient reporting the following symptoms which started 4 days after vaccination and have continued. we have ruled out lupus flair, she went to ED 12/31/21 for sensation of worsening neck swelling and CT was negative for lymphadenopathy or other significant abnormality. Symptoms ongoing and not yet controlled. -headache daily  -sweating constantly -intermittent fevers -achy & stiff fingers/hands -lymph node swelling, pain (neck, underarm, and groin) and lymph fluid build up on left side of neck/face - chronic extreme fatigue -occasional shortness of breath -rapid heart rate -off and on sore throat -pain in jaw/teeth -constant breast tenderness - increase in number and length of periods plus unusually painful cramps - flu like ache in body -chronic poor sleep -restless legs at night -occasional pins/needles in arms and legs -severe brain fog (worse than before) -weight gain
Began with chills and muscle aches. Got worse over the course of an hour until I was unable to get out of bed. Pain in my muscles all over from hours of full body chills. The chills stopped after two hours at which point an uncontrolled fever set in. Highest temp recorded was 103. Severe full body muscle pain prevented me from getting up or drinking water on my own. Small movements like sitting up or rolling over to relieve muscle pain resulted in sudden and severe nausea. Considered going to a hospital to bring down the fever and hydrate. After two more hours of applying cold compresses, the fever decreased to 100 at which point I slept it off for six hours.  Prolonged bouts of dizziness, dehydration and nausea over the following two days.
Headache, fever 102, diarrhea, muscle aches, joint pain. Regular flu treatment at home, fluids, rest, popsicles, cool compress. Lasted for 3 days.
Reason for Admission  Patient 22-year-old male with a history of seasonal allergic asthma who presented to ER with a chief complaint of chest pain.  He said he started having multiple episodes of vomiting/fever on Saturday morning, went to urgent care and diagnosed with sinus infection,  prescribed amoxicillin, then  he started having chest pain on Sunday at 4 PM, mid sternum, constant, pressure type of pain, 5 out of 10 in severity, worse with cough and deep breathing/lying down flat a lateral position, better with sitting up/ leaning forward.  No radiation.  Denies lifting any heavy weight or any heavy exercise.  Never had similar symptoms in the past.  He had his second dose Pfizer COVID-19 vaccine on May 12.  He denies leg pain or swelling.  His vomiting and fever resolved.   ED: He was found to have troponin of more than 12,000, EKG showed diffuse ST segment elevation with possible repolarization.   Transferred for possible cardiac cath/cardiac MRI.  CT angio chest no PE, normal aorta, no infiltration.  Pending second set of troponin, stat echo, aspirin po  given in the ER.   In addition to the above HPI, he reports having 2 days of fevers, chills, nausea, vomiting, diarrhea.  T-max 103F.  His chest pain began around 4 PM yesterday and he felt like it was initially consistent with his asthma, however it did not improve so around 1:30 AM he states they went to the ER.  He states that the chest pain gets better with exertion, and is worse with deep breaths and lying on his side, or leaning forward. He did take Nyquil decongestant which contains phenylephrine.     Hospital Course   22 yo M w/PMH exercise induced asthma admitted for evaluation of CP, elevated troponin to 21,292 with negative LHC. UDS Negative. EKG w/diffuse ST changes so consistent with Myopericarditis I31.9 given Recent Viral Illness resulting in first time myopericarditis, will treat per pericarditis algorithm, ASA+Colchicine w/90% response rate by 1 week.     -ASA 650 to 1000 mg TID, weekly tapers if CRP normalized and sx free; will start at 650 mg dose   -Colchicine 0.6 mg BID for 3 months, no taper (lowers recurrence rate, NNT = 5)   -Glucocorticoid generally not indicated in first-time acute myopericarditis as observational studies suggest increased recurrence rate, but can consider if he does not adequately respond to aspirin and colchicine   -Trend troponin to ensure downtrend continues   -No strenuous exercise during recovery period
Within 2 minutes of administration, patient started coughing and wheezing, became flushed, developed urticaria on arms and legs - administration site affected, complained of itching and was diaphoretic. Tx: epinephrine, O2, BENADRYL, albuterol, admit to PICU.
19JUL95 2PM hives, fussiness, t102.8 which dec w/APAP; 19JUL95 11PM-1AM hosp ER mom states pt had urticaria & was given DPH; p/1 dose of DPH no further sx;
mild diarrhea; increased blood pressure; sore throat; some difficulty keeping food down; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-098174), for bnt162b2 (COMIRNATY).  A male patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as BOOSTER DOSE (INITIAL PFIZER DOSE), SINGLE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 17Aug2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for thyroid cancer. Medical history included thyroid cancer from an unknown date and unknown if ongoing Medical History. Started Lenvima 24mg on 8/17/2021. The patient's concomitant medications were not reported. On an unspecified date the patient experienced mild diarrhea increased blood pressure, sore throat, some difficulty keeping food down. The patient underwent lab tests and procedures which included blood pressure measurement: increased on.  The action taken in response to the event for lenvatinib mesilate was unknown.  Therapeutic measures were taken as a result of increased blood pressure blood pressure increased. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The morning after the second vaccine I had throbbing and stabbing pain in my feet.  The pain shot up my legs which made it almost impossible to stand or walk.  The pain has not subsided since then.  I have a lot of muscle weakness in my calves and legs.   The pain makes it very hard to sleep which is leading to exhaustion.  I also have numb fingertips.
Mother states patient developed Redness to area of vaccine injection site on Left upper thigh Within 24 hrs of the vaccine being given. She applied warm compresses to area and redness has almost completely resolved. No further treatment necessary.
side effects appeared a week after (1/11/21)  from getting the vaccine. Left arm injection site develops redness, swelling (hardness), itchiness and warmth. It continues to spread until 01/15/21 but redness and swelling subsides and it appears to look like phlebitis.
Breakthrough menstrual bleeding started Wednesday night. It stopped overnight, but restarted this morning. Very mild cramping and light bleeding.
headache,  pain at injection site, painful/swollen axial lymph nodes x 2day
On 02/20/21 patient had hives on body from head to toe. Patient reports sore left arm and chills for 3 days.
I was diagnosed with oral shingles on april 17th, symptoms started on April 13th
After the injection , I had the usual sore arm for several days and was tired.  On day 3 (Jan 6), I felt very dizzy while teaching at school. I did not pass out, but I had to sit down. My blood pressure was elevated. This feeling continued on and off for several weeks after the vaccine. The main adverse event was the vaccine red arm. On day 8, (Jan. 12), my vaccine site got red and swollen again. It was 5 cm by 8 cm. It became hot and swollen and itchy. My primary care doctor did not know what caused it. My school nurse did not know. I was able to contact the father of one of my students who worked in the Medical Center who advised me that it was just an allergic reaction. Days 8-10 had the most symptoms. It slowly went away after that.  I treated it with topical hydrocortisone cream several times a day. It helped soothe the redness and itch. By Day 15, it was gone.
New onset rash around day 3 post vaccination; progressively worse over past week; now w/fever