chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presents to the emergency department with complaints of sudden onset of shortness of breath and chest pain just prior to arrival. She was found to be hypoxic and and tachycardic. She was subsequently admitted for management of multifocal pneumonia. At hospital admission day 20, she was transferred to the ICU for shock. She was hypotensive despite IV fluid boluses. She had extreme work of breathing, respiratory rate in the 30's and pulse was faint. She was started on vasopressors and intubated. She was found to have necrotizing pneumonia with left pneumothorax and persistent lactic acidosis and WBC in the 40-50's. She passed away 3 days later after a 23 day hospitalization.
numbness in tongue, bottom lip and chin. Lasted around 3.5 hours after taking a dose of OTC benadryl.
I awoke the day after with swollen tonsils and upper body lymph-nodes. The lymph-nodes under the arms (armpit area) were particularly sore three days after the vaccination and persisted for 6 days. My tonsils reduced in swelling after 4 days. However, my left (side of the vaccination) fingertips experienced a persistent burning sensation for 10 days. This is the fist non-single dose flu vaccination after being diagnosed with Lyme-disease.
Nausea; General Body pain; Vomiting; Muscle pain; fatigue; Headcahe; Joint pain; was freezing; then burning up; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ew0175) via an unspecified route of administration in the left arm on 14May2021 at 11:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included endometriosis. The patient had no known allergies. Concomitant medications included birth control daily (UNSPECIFIED) and hydroxyzine (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0153 ) via an unspecified route of administration in the left arm on 23Apr2021 at 11:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 the patient felt fine until about 12 hours after the second vaccine. The patient woke up at 00:30 and experienced nausea and pain all over her body, vomited for the following 12 hours and could not keep down food or liquids, no fever but she had freezing and then burning up. 29 hours since the vaccine, the patient felt moderately joint pain, muscle pain especially in the back of her neck, fatigue, nausea and severe headache. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events general body pain, nausea, vomiting, joint pain, freezing, burning up, muscle pain, fatigue and headache was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck), 0.5 ml, subcutaneous, which was improperly stored, temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports linked with the same reporter link. No additional information provided. Additional information has been requested.
Pain - edema - constantly in (Lt) deltoid muscle. Tx. VOLTAREN.
large local rxn extending from elbow to shoulder, swelling & redness;started 24hr p/2nd dose & lasted 3 days;
MODERNA-2ND  SHOT FLU SYMPTOMS, FEVER MIGRANE BODY ACH CHEST PAIN HARD TO BREATH
Covid Arm: Large red circle around vaccine site Swollen lymph nodes on right side under arm
A report has been received from a health professional concerning a female patient. No relevant history and concomitant medications of the patient were reported.  The patient who had been receiving FLUMIST Quadrivalent was started on an unknown date, indication was not reported. It was reported that a parent called in and stated their child pulled away while getting FLUMIST Quadrivalent and some went into the eye, which was considered as administration error. The outcome of the event of FLUMIST Quadrivalent went into patients eye was unknown. The report was considered to be non-serious by the reporter.
She said that night she felt as if she had the flu. Then the next day she had some swelling on her left cheek and left eye area. She also reported that it was a little tender under her left armpit. The injection site was just a little red. She called today 5/6/2018 to tell me of the event. She is better. Eye just a little puffy still.
Gave patient her 2 shots (flu and Moderna). I vaccinated her mom with 3 vaccines while patient was still sitting. She said she does not feel good. Next moment she had what looked like a seizure and was very pale and her eye rolled back in her head. I had to hold her to prevent her from slipping off the chair. She was in and out of consciousness and said she cannot hear us well. Since the fainting spells kept recurring, the Mom agreed that we call 911. The EMT's came and took her vitals. Her blood pressure was very low. They got her on the stretcher and took her to the nearest local hospital.  I checked in with the patient around 7.30pm and she was home and feeling 100%. She said they just gave her some fluids and ran some tests, but all is good.
2:00 pm very very tired, slept 45 min., 9 pm headache, very tired, muscle aches, fever 100.2, chilled, arm at shot site hurt,  hardly slept all night because muscles all over my body hurt, elbow joints hurt,  6:30 am 100 temp, still tired, rested, 10:30 am 99.3 temp. feeling less tired 3:30 pm 98.6 temp and felt much better.
Bells Palsy Symptoms started 2 days after vaccine, by day 4 entire right side of face paralyzed.
Hives began on the insides of arms.  The hives continued to appear on the full arm.   Two days later the hives began to appear on legs.  A few days after they appeared on the torso.  The hives on the arms began to subside on 10/23/2009.  The hives on legs began to subside 10/26/2009. I called the DR on 10/23/2009 however was not able to have an appt on 10/26/2009, but that was cancelled because the hives have subsided.
This spontaneous report was received from a registered nurse refers to an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were unspecified. On an unknown date, the patients were vaccinated with improperly stored M-M-R II, lot # L002242, expiry date 21-JAN-2017; K014833, expiry date 14-SEP-2016 (number of doses unspecified). No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. This is one of several reports received from the same reporter. Additional information has been requested.
The patient reported receipt of IM influenza vaccination at NMCP while working the ER in 2002 or 2003.  He denied any illness (URI) prior to this vaccination (date unknown).  Approximately 12-24 hours post vaccination, he complained of feeling tired, had a stuffy nose, sinus and chest congestion.  These symptoms worsened over the next few days to include shortness of breath and a cough which disrupted his ability to sleep.  He was evaluated by his PCP and placed on an antibiotic and TUSSINEX.  The cough medicine made him sleepy and he was unable to work for approximately one week before symptoms resolved.  He did not receive any further influenza vaccination until 12/7/2007 (AFLU #A312BA).  He again reported experiencing similar nasal, sinus and chest congestion, cough, and difficulty sleeping at night due to coughing and shortness of breath as in 2002/2003.  Early winter is a time period he experiences sinus infections.  He reported being out of work 2 weeks before symptoms eased.  However symptoms persisted for the next several months.  He was treated by his PCP with two antibiotics, FLONASE, PROVENTIL, ADVAIR, etc.  (There are no available records of evaluation by his Allergist).  In January 2009 he was referred to pulmonology where he was diagnosed with asthma and placed on SIMACORT.  One month later "all asthma medications were stopped due to worsening breathing difficulty".
Hives all over body, cough, congestion within 5 min of injection. Mom called-brought child back to office. Given Duo Neb, Benadryl, Prednisone.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 at 12:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 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), as dose 3 (booster), single (Batch/Lot number: unknown) and 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 15Jan2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2023) Positive, notes: Originally tested positive on 15Jan; (22Jan2023) Negative, notes: After testing negative for Covid on 22Jan; (24Jan2023) Positive, notes: I tested positive again on 24Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses is as follows: Originally tested positive on 15Jan. After testing Negative for Covid on Jan22, the patient tested positive again on 24Jan after waking up feeling quite sick again. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Onset of non vesicular rash 10 days after vaccination on January 30.  Rash on chest, back, bilateral flank area, and thighs. Vaccination site without satellite lesions, scabbed over. Treated with BENADRYL and ZANTAC 150 mg. Follow up today, 13 February 2017, rash resolving, almost completely gone. Back station site still scabbed over with no satellite lesions observed.
Resident became hypertensive, had fever, short of breath.  Was sent to hospital due to symptoms and admitted.
I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.; I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.; I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Dec2021 12:45 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 04Dec2021 12:00, outcome "recovering", OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Dec2021 12:45, outcome "unknown" and all described as "I do breastfeeding, my doter is 3 month. After vaccine next day I had Vaginal bleeding.". The event "i do breastfeeding, my doter is 3 month. after vaccine next day i had vaginal bleeding." was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of vaginal haemorrhage.  Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101725297 baby case
3-year-old administered incorrect Pfizer COVID-19 vaccine (orange top for 5 to 11-year-old).
This case was reported by an MA and described the occurrence of injection site abscess in a 18 month old male subject who was vaccinated with Infanrix for prophylaxis. The subject's medical history included pneumonia and sinus problems. There were no concurrent medications. On 2/21/06, the subject received 4th dose of Infanrix in the left thigh (lot AC14A007AA). On 3/1/06, 8 days after vaccination with Infanrix, the subject experienced injection site abscess, "purple color" at the injection site and injection site swelling described as "swollen, not warm, 4 by 5 diameter, nontender". The subject was seen at a physician's office and was treated with Amoxicillin trihydrate. At the time of follow-up reporting, 3/17/06, the events were improved. The MA considered the events to probably be related to vaccination with Infanrix.
Early administration of vaccine- Administration error: Patient received first dose of Pfizer COVID vaccine at another location on 28 DEC 2020. Pfizer COVID vaccine second dose to be given 21 days after first dose. Patient arrived to Bloch Arena for COVID Vaccine #2. Patient given dose number 2 on 12 Jan 2021, only 15 days after first dose.
My wife was having trouble catching her breath. I took her to the emergency room; they immediately took her back to get her put on oxygen. I know they did run several different test while she was there but I cannot remember all that they did. She was admitted into the hospital for observation and stayed a total of three nights. She was released with a diagnosis of an acute exacerbation of COPD, advised her to follow up her pulmonary doctor.
Hypotonicity, Pallor.  10/2/07 Reviewed hospital medical records which reveal patient experienced a period of unresponsiveness, pale & limpness approx 4 hrs s/p vax.  Admitted to ICU for monitored observation 8/21-8/23/2007. Temp 100.5 on admit.  ID consult done.  No further episodes while hospitalized. FINAL DX: hypotonic-hyporesponsive episode, possibly secondary to vaccinations.
The patient came in to see me at the pharmacy late Monday afternoon to see if I thought she was having an allergic reaction to the ZOSTAVAX she got on Saturday. The site was red & hard, about 2 inches diameter. We got her in to see her PCP Tuesday afternoon. He said the injection site was infected and he gave her antibiotics and she is much better now.
Woke up in middle of night feeling very achy -- like I had the flu. Sore arm & mild headache also. Great difficulty sleeping.  Felt so bad the next day that I was unable to do anything; just layed on the couch. Took 2 extra strength Tylenol every 6 hours which helped. Went to bed early & slept through the night. Felt much better in the morning; only symptom now is sore arm - red & warm.
Patient received flu vaccine at 0835 on 11/28/2018. On 11/29/2018 patient does not follow any commands. Barely able to move all the extremities. Does not withdraw to pain. All cultures remain negative. Start spiking fever up to 103. MRI was ordered and later on reviewed. It showed no acute brain abnormalities. Weakness, obtunded state resp failure raising concern for GBS with elevated CSF protein. Diagnosis of GBS confirmed with lab and EMG - with severely prolonged F waves.
Headache Chest pains/gas pains Leg cramps Foot cramps Flank pain Exhaustion Insomnia
TIA in June; dose was given prior to her stroke / spent 1 night in the hospital; This case was reported by a pharmacist via call center representative and described the occurrence of transient ischemic attack in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 4M2C7, expiry date 19th December 2021) for prophylaxis.   On 16th June 2020, the patient received the 1st dose of Shingrix. On 27th June 2020, 11 days after receiving Shingrix, the patient experienced transient ischemic attack (serious criteria hospitalization and GSK medically significant) and stroke (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the transient ischemic attack and stroke were unknown.   It was unknown if the reporter considered the transient ischemic attack and stroke to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix, the patient had transient ischemic attack/stroke and spent one night in the hospital. The patient wanted to get her 2nd dose of Shingrix on the date of reporting. The reporter was asking if this was advisable. The reporter consented to follow up.
FIRST VACCINATION: Body aches all over Fever/Chills Headache (about a 5) Tired/Fatique No appetite Fever to 103.0 Miserable and unsettled Lasted for 26-35 hours.  I did place a call to my physician, I felt I had COVID back again... tested + for Covid 10/29/20, last 3-4 days  SECOND VACCINATION: Worse then the first vaccination Came on about 7 hours later Total and complete body aches, pain, in evry joint-bone-muscle and ligament I have in my body.  I could hardly move Fever to 102.4 x 5-6 hours Migraine type headache all night no appetitie fatique/unsettled Incredibly uncomfortable  Thanks God.....(I was a previous Migraine sufferer) I had some Imitrex 50mg in my medicine chest, and some Oxycontin from previous surgery.  This is what saved me.  Put something in my stomach before taking these.  I went to bed that night about 8:30 pm, I took: 1.  2 - Advil 2.  1 - 50mg Imitrex 3.  1 - Oxycodone 5mg 4.  1 - Ambien 5mg  This and the grace of God allowed me to have a pain free and night of sleep that I needed.  Woke up aout 80% better and actually felt human.  This should be a cocktail for others who suffer needlessly.  Advil does not touch any of the pain or aches.  It also laughs at your migraine!  Those COVID headaches are migraines...trust me!
He had body aching that evening and ran fever up to 102 for the next 2 days with cough and more body aching.  Symptoms gone after 2 days but reported fatigue for another week.
Information has been received from a health professional concerning an approximately 4 year old male who was vaccinated with a 0.5 mL dose of hepatitis A virus vaccine inactivated. Subsequently the patient experienced diarrhea for 2 days. Subsequently, the patient recovered. The patient sought unspecified medical attention. There was no product quality complaint reported. There were no reported diagnostic lab tests performed. No further information is available.
Pt was sent from outlying ER due to NSTEMI and was COVID positive.  Only symptom was a cough for 7 days.
Patient is a 80-year-old male patient with a history of dementia who presents to the emergency department by ambulance from a local assisted living for increased tremors, mental status change and weakness.  Patient was diagnosed with Covid a week and a half ago and facility states over the last 3 days he has not been eating and has had increased weakness.  Patient does get agitated at baseline.  He is agitated upon arrival to the emergency department.  No fever. Associated Symptoms: agitation, weakness
Baby fussy at night 4-18-07, know Right upper thigh 2 cm x 1 cm red, knot left upper leg 1.1/2 cm x 1 cm red
Pt developed cellulitis around injection site (about 4 inch diameter), injection site area was also warm to touch.
Noticed in the evening of 8/30 small red raised rash around injection site of left arm. By the morning of 8/31 she had the red raised rash to bilateral arms. Zyrtec taken without improvement. Pt complained of itchiness to both arms but it was tolerable. No rash noted on trunk, back, legs. No other symptoms noted. Pt sent to student medicine to see a provider.
Headache  Congestion or running nose New loss of taste or smell  Dx Cough ? Shortness of Breath FATIGUE FEVER
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's relevant medical history, concurrent conditions and concomitant medications were unknown. On an unknown date, the patient was vaccinated with an expired dose of VARIVAX for prophylaxis, lot # L034369 and expiration date reported as 11-SEP-2017 (dose, strength, frequency, and route of administration were unknown). No adverse effects were reported.
Swelling in ankles/feet/calves/upper thighs, shortness of breath, fatigue. muscle soreness all over, joint pain (esp. wrists & knees). Was hospitalized for 3 days 3/20 - 3/23/2021.
Narrative: 02/24/2020 CXR impression: No significant change. No acute abnormality. COVID infection following COVID vaccine series 03/29 Pfizer, dose #1 04/19, Pfizer, dose #2 07/06 pt cc: cough, wheezing, fatigue, rhinorrhea, sore throat, 07/07-08-06 pt continue to have symptoms; cough 4-5 weeks & +COVID 08/05 COVID swab, result: detected 08/16 CXR impression: No evidence of acute cardiopulmonary process 08/18 COVID swab, result: detected 08/12 LINEAGE b.1.617.2 08/12 CLADE 21A DELTA clinically resolved
Received flu shot and it burned a lot. Then it started to hurt. Pt. stated she "babied" her arm & didn't move it much and it became stiff went to Dr and referred her to a bone specialist Dr - arm was x-rayed and physical therapy started. Is doing better but it still hurts.
Patient felt fine immediately after receiving the vaccine. She waited in the pharmacy for 15+ minutes with no reaction. Later the same day, she called informing us that she was developing hives along her panty line, and was taking Benadryl to manage symptoms. Patient says that the Benadryl was controlling her symptoms at that time. We instructed the patient to call her doctor and discuss her reaction with them. Patient  called back over the next few days to inform us that she had still been experiencing hives on and off and that they would appear at different places on her body including both arms at different times as well as the panty line again.
Site: Pain at Injection Site-Medium, Systemic: Pt leg felt heavy as if it has gone to sleep for 3 days-Medium