chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EMPLOYEE REPORTED FEELING CHEST PAIN, RESTLESSNESS, PALPITATIONS AND HE SHOWED CONSISTENT DRY COUGH AT 11:55 AM. NO HIVES,WHEEZING, REDNESS SHORTNESS OF BREATH OR SWELLING OF THE FACE WERE NOTED.HIS INITIAL VITAL SIGNS BEFORE THE VACCINE WERE B/P 138/90, PULSE 76, T-96.8F,R-20. VITAL SIGNS AFTER THE ADVERSE REACTION WERE @11:55AM BP 150/100, P-107, T-99.1F,R-18. MEDICAL DIRECTOR, NOTIFIED ABOUT THE REACTION VIA PHONE AND SUGGESTED TO CALL EMS. EMS WAS CALLED @ 11:59AM.VITAL SIGNS @12:00PM WERE BP-165/109, P-126, T-99.6,R-18. EMPLOYEE PLACED ON OXYGEN VIA NASAL CANNULA @ 5L/MIN.EMS PUMPER 12 AND RESCUE 12 ARRIVED @ THE SCENE MONITORING THE OXYGEN SATURATION BEING 98%, AND THE BLOOD GLUCOSE LEVEL BEING @137 MG/DL. VITAL SIGNS @12:05PM BP-148/84, P-156,R-18. EMPLOYEE WAS TRANSPORTED TO THE HOSPITAL VIA STRETCHER BY EMS @12:06PM.  EMPLOYEE CONTACTED AT HIS CELL PHONE VERBALIZING THAT THE DOCTOR FROM THE HOSPITAL DIAGNOSED HIM WITH AN ALLERGIC REACTION TO INFLUENZA VACCINE. HE STATED THAT HE WAS DISCHARGED @ 3:30PM UNDER STABLE CONDITION FROM THE EMERGENCY ROOM,AND THAT THE DOCTOR TOLD HIM TO BE BACK TO WORK UNTLI 11/30/07.   12/7/07 Reviewed ER medical records which reveal patient transported by EMS 11/28/07 after experienced anxiety, sore throat w/swelling, nonproductive cough, red facial rash & mild SOB immediately s/p flu vax.  Tx w/IV benadryl, O2 & steroids.  Improved & d/c to home FINAL DX: acute allergic reaction.
Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 09-Apr-2022; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 09-Apr-2022) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 09-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, stored in refrigerator on 04-Apr-2022 and administered on 09-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. The vial was initially stored in refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. Treatment information was not provided.
Pt experienced flushing, hypotension and seizure 10-15 minute after injection. She was treated with epinephrine, Decadron IM and Benadryl IM. She improved, was taken to the ER and admitted for continued steroids (IV) and IV fluids.  11/14/08 Reviewed hosptial medical records of 10/23-10/24/2008. FINAL DX: anaphylaxis, reaction to vaccines. Records reveal patient experienced hypotension, flushing, seizure activity of unresponsiveness & incontinence after vaccination in office.  Tx w/epi, steroids & antihistamine.  Improved but admitted overnight for observation & treatment for possible biphasic reaction.  D/C to home on continued steroid taper & epipen.  Leaving for foreign travel.  Referred to allergist on return.  Had received hep A vaccine previously w/o reaction.
my arm is still sore from that shot and cannot even sleep on that side it hurts; it is bothersome because sometimes I can't even raise my arm. I can't even sleep on that side, it hurts.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "my arm is still sore from that shot and cannot even sleep on that side it hurts"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "not recovered", described as "it is bothersome because sometimes I can't even raise my arm. I can't even sleep on that side, it hurts.".  Additional Information: The patient reported that she had some issues with the adverse reaction to the booster shot. The patient stated that she had the booster dose in February later corrected to October of last year (2021) and experienced arm sore from that shot and she don't know if anybody else had the same reaction or what. The patient just wanted to know because it was bothersome because sometimes she cannot even raise arm. The patient cannot even sleep on that side as it hurts. The patient still have the arm sore.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness to chest and left upper arm and face. Saw spots when felt lightheaded. 12/1/2009 ED record for 10/6/2009, patient with c/o's dizziness, numbness lt arm and red rash over face and neck. Rx'd benadryl BP was elevated, to f/up with PCP  Dx flu-like syndrome
Dizzy, shook, fainted. Laid patient down, raised feet, cool cloth patient recovered and patient reevaluated by doctor.
COVID Breakthrough case Dose 1: Pfizer, EW0164, 04/17/2021 Dose 2: Pfizer, EW0179, 05/08/2021 Booster: Pfizer, FD0809, 01/12/2022
had the same rash that he got; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (had the same rash that he got) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (had the same rash that he got). At the time of the report, RASH (had the same rash that he got) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  Treatment medication was not provided by the reporter    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Non Significant follow-up received on 16-JUN-2021. Mailing address was updated
I had my first Moderna COVID vaccine on Friday January 29, 2021. On Thursday February 11, 2021 the vaccination site started to itch. Today on February 12 it continues to itch and is also achy. There is a large red splotchy, rash about 3 inches in diameter at the injection site.
choke; Throat sounds scratchy when talking; cough; This spontaneous case was reported by a patient and describes the occurrence of CHOKING (choke) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 50 microgram. On an unknown date, the patient experienced CHOKING (choke) (seriousness criterion medically significant), THROAT IRRITATION (Throat sounds scratchy when talking) and COUGH (cough). At the time of the report, CHOKING (choke), THROAT IRRITATION (Throat sounds scratchy when talking) and COUGH (cough) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.  Company comment: This spontaneous case concerns an elderly female patient with no medical history reported who experienced the serious (medically significant) unexpected event of choking among other non-serious events. A dose of mRNA-1273 Bivalent vaccine was administered on an unknown date. Temporal association cannot be assessed due to lack of information on vaccination date and onset date of the event. The patient reported that her throat sounded scratchy when talking and caused to cough/choke. At the time of the latest report, the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Bivalent vaccine is not affected by this report.
VOMITING; HEART RATE LOW; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. 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 APR-2021, Laboratory data included: Pulse oximetry (NR: not provided) 97 (not reported). On 07-APR-2021, the subject experienced vomiting. On 07-APR-2021, the subject experienced heart rate low. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, chills and heart rate low was not reported. This report was non-serious.
Patient developed inflammatory arthritis and pedal edema 3 weeks after 2nd moderna vaccine.
numbness in her cheek and in her pinky; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on unspecified date at single dose (Lot: 8730, expiration date: 31Jul2021) for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that an hour and a half later after first dose, patient started experiencing numbness in her cheek and in her pinky on the same side that she got the vaccine, which was the left arm. This numbness had not gone away and had been on and off for 3 weeks, describing it as "very slight." She stated that when patient smiled she felt the numbness. She reported that the only health issues patient had was that 3 to 4 years ago she had a scan done to watch her lymph nodes. She already spoke with one of patient's physicians, who was a doctor of osteopathic, who told her that she should not get the second dose. The outcome of event was unknown.   No follow-up attempts are needed. No further information is expected.
Shot #1 turned out to have severe side-effects. The very next day, I did not expect it, could barely move. And I am tough but it kicked my butt the next day. Any movement what-so-ever caused me to feel like I was going to vomit and any movement at all caused my head to pound harder. I literally ate 2 crackers that day and tried to sip. I felt miserable. I also remember my left foot itching over night so much so that I had to scratch it often, kind of keeping me awake. The next day after this one I felt a ton better. I received my 2nd shot earlier today. No report on that since it was today.
Pain in right leg that lasted for 2 days, that started 2 weeks after injection. Also had 5 minutes of dizziness the morning after the injection. I?m going to report this info to my personal physician today.
Patient reported having a fever of 101.7 degrees with chills, abdominal cramps, pruritus (itching), vomiting, blurred vision, dizziness, laryngitis/hoarseness of voice, and headache. She described being awake intermittently throughout the night with these symptoms which continued into the next morning. She was seen at urgent care facility late that afternoon (on 11/12/20) for these symptoms and also to be tested for COVID-19 because of her fever. Rapid COVID antigen test was negative. Her fever resolved earlier that day & temperature measured 97.5 at Urgent Care. She reports Urgent Care told her to take Benedryl, which she did that evening upon reaching home. She reports feeling better a few hours after one dose of Benedryl. The following morning, 11/13/20, she reports feeling completely better with complete resolution of symptoms.
Client given 0.5ml  of Moderna for a booster, instead of 0.25ml.
Arm pain surrounding injection site (from about an hour after injection though 48 hours); headache (from about an hour after injection through about 48 hours); Arm pain surrounding injection site (from about an hour after injection though 48 hours), headache (from about an hour after injection through about 48 hours), nausea (day after injection), diarrhea (; Arm pain surrounding injection site (from about an hour after injection though 48 hours), headache (from about an hour after injection through about 48 hours), nausea (day after injection), diarrhea; chills (day after injection); heart palpitations (for a few hours ~27); This is a spontaneous report from a contactable consumer or other non hcp. A 43-years-old female (non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 2, via an unspecified route of administration, administered in Arm Left on 16Feb2021, 04:45 PM (at the age of 43-years-old) as single dose for covid-19 immunization. Medical history included coeliac disease, rheumatoid arthritis , sinusitis , drug hypersensitivity , gluten sensitivity. Concomitant medication(s) included drospirenone, ethinylestradiol betadex clathrate (YAZ); cetirizine hydrochloride (ACER [CETIRIZINE HYDROCHLORIDE]) medications in two weeks. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318), dose 1, via an unspecified route of administration, administered in Arm Right on 26Jan2021, 05:00 PM as single dose for covid-19 immunization. Also, patient had previously taken metaxalone and experienced drug hypersensitivity. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid. On 16Feb2021, 06:00 PM the patient experienced arm pain surrounding injection site (from about an hour after injection though 48 hours), headache (from about an hour after injection through about 48 hours), nausea (day after injection), diarrhea , chills (day after injection) and heart palpitations (for a few hours 27). There was no other vaccine received in four week. The patient did not receive treatment for adverse events. The reporter considered the case as non serious. The outcome of event was recovered on an unspecified date in 2021 .
Headache; Fatigue; Large swollen painful lymph nodes in right armpit; Large swollen painful lymph nodes in right armpit; Fever 102 for 2.5 days; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0178) via an unspecified route of administration in the right arm on 08Jul2021 at 14:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, depression and anxiety. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC), buspirone hydrochloride (BUSPAR), pantoprazole sodium sesquihydrate (PROTONIX) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the right arm on 17Jun2021 at 18:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jul2021 at 22:00, the patient experienced fever 102 for 2.5 days, large swollen painful lymph nodes in right armpit and fatigue. On 08Jul2021 at 22:00, the patient underwent Body temperature and the result was 102 (unit unspecified). On 10Jul2021, on day 3, the patient experienced headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events large swollen painful lymph nodes in right arm pit, fatigue and headache was resolved with sequelae on an unknown date in Jul2021; while that of the fever 102 was resolved on 11Jul2021, after the duration of 2.5 days.
Urticarial rash on distal legs only. Started as urticarial bumps on Day 4 after Varicella and Comvax given (no fever).
The pt developed 10-15 scattered small vesicles on a red base. Pt was diagnosed with probable breakthrough chickenpox. 3 days later the pt recovered.
Skin rash after receiving H1N1 shot.  Pt. received steroids from the doctor.
one week following the injection, pruritis occured along with inflammation, reddness, swelling at site.  This was accompanied by slight headache, low grade fever of 99, & fatigue.
Bronchitis, headaches, rapid heartbeat, low grade fever, tremors, anxiety attacks, exhaustion, blurred vision-night blindness, tongue sensitivity, heat intolerance, diarrhea, burping, gagging, vomiting bile, urinary incontinence, numbness in arms and legs, brain fog, hernia.
pt recv vax 8MAY96 & began w/green, mucousy stool on 13MAY or 14MAY96;about 10AM t102.4 by ear canal;seen by ARNP on 14MAY96 temp 100 R,w/no antipyretic administered;no test, no tx;pt breast fed;sibling w/diarrhea
Pt got shots on Thursday evening on 8/3/17. She stopped by at the pharmacy today on Wednesday 8/9/2017. She informed me she has redness on her left arm that appeared on Thursday evening and still present. Not itching/ not spreading just moved down a little. Her main concern however was itching and rash all over torso and chest that started on Monday and still continued. I advised her to try BENADRYL oral tab and Hydrocortisone spray for management of symptoms tonight and address this issue with her doctor tomorrow, 8/10/2017 to see if she needs further assessment - she stated she will be seeing him anyway and therefore I advised her to bring this issue to him as well.
Information has been received from a pharmacist concerning a 70 year old female patient with niacin, cephalosporin and CODEINE allergies, who about six years (approximately 2002) was vaccinated with the first dose of PNEUMOVAX.  There was no concomitant medication.  In approximately 2002, 507 days after vaccination, the patient experienced swelling and inflammation from her right upper arm to her wrist.  The patient no  had any laboratory test done.  Two weeks after the onset date in approximately 2002, the patient recovered.  The patient was seen.  Follow-up information was received from the pharmacist who reported that she had no further information.  She reported that the incident was 6 + years ago and not at her facility.  No further information is available.
Generalized large red macules of varying sizes on trunk 1cm-10cm in diameter with 3mm papules and welts scattered over body. Benadryl 1/2 tsp now and every 6 hrs. Pt to follow-up in 1-2 days. Go to E.R if worse.
Patient received Covid vaccine while sitting without issue. Within minutes of receipt of the vaccine he had a vagal reaction (fell off his chair). Initial eval was notable for supine position, pale face, HR in 30's, clammy skin, small lac to L forehead (not actively bleeding). Pt was alert and oriented initially then was noted to slow  his speech/had decreased responsiveness <1 minute. He was then alert and able to answer all questions. Denies any past medical history, not on any meds, NKDA, no hx of reaction to vaccines. He denies any itching, rash, swelling, difficulty breathing/SOB/Wheezing, or GI sx. Exam remained unchanged with no objective signs of allergic reaction. His color improved as well and he reported feeling better, was able to sit up. He reports eating minimal breakfast this morning. Has a history vasaovagal reactions with blood draws. Decision made to call EMS for transfer for additional observation. EMS arrived at 1115 and transported patient to ER for observation.
Local reaction initially immediately after injection with mild red erythematous surrounding.  After 1 week the location reaction appears to harden and a month later it was noted to have cystic like mass deep seed nearby the injection site.  Patient is other wise well and not in acute distress.  No further work up performed at this point.  Patient was referred to peds surgery for evaluation of mass and removal.
Very intense flu like symptoms; Severe Joint Pain; Neurological tingling and buzzing in feet and toes; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very intense flu like symptoms), ARTHRALGIA (Severe Joint Pain) and PARAESTHESIA (Neurological tingling and buzzing in feet and toes) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AZILSARTAN KAMEDOXOMIL (EDARBI) and CHLORTHALIDONE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Very intense flu like symptoms), ARTHRALGIA (Severe Joint Pain) and PARAESTHESIA (Neurological tingling and buzzing in feet and toes). On 14-Mar-2021, INFLUENZA LIKE ILLNESS (Very intense flu like symptoms), ARTHRALGIA (Severe Joint Pain) and PARAESTHESIA (Neurological tingling and buzzing in feet and toes) outcome was unknown. Not Provided          No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD21-053474 (Patient Link).
Induration at injection site (RL): 3pm 12/18. No treatment. Irritability, Decreased appetite, Fever noted at 8am 12/18. Treatment provided 80ml Tylenol every 4 hours.
This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired vaccine used) in a 69-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006C21A) for COVID-19 vaccination. No medical history reported. On Aug 20, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 20, 2021, the patient red product (expired vaccine used). On Aug 20, 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received included no new information.
Low grade fever, inability to walk for 24 hrs; mod redness/swelling @ inject site; cranky, wanted to be held all the time;