chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt slept 10 hours straight on 2nd night after the immunization. Screaming non-stop for 3 hours on 3rd day after the immunization (01/10/2002) from noon till 3pm and screaming off and on early of the day.
Intern working at the time forgot to inject the diluent into the Covid vial before withdrawing dose, so patient received 0.3mls of undiluted vaccine.  Talked and explained with patient about the mistake that happened about 20 minutes after dose had been given.  At that point he was not having any adverse reactions yet..  Told him he could experience more severe side effects than normal- flu symptoms or increased pain in arm or injection site.  Told him we would get back to him regarding his second dose since some sources seemed to convey in this situation a second dose shouldn't be given.
About 70 minutes after injection, heart rate shot and bp shot up.; About 70 minutes after injection, heart rate shot and bp shot up.; Dry mouth; Light headed; This is a spontaneous report from a non-contactable other healthcare professional (the patient). A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 026-596) via an unspecified route of administration in the right arm on 20Apr2021 at 09:30 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN) for unknown indications and oral birth control (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing. On 20Apr2021 at 10:45, about 70 minutes after injection, the patient's heart rate and blood pressure shot up. The patient experienced dry mouth and light headed. Requested paramedic evaluation but did not go to hospital. Could resume normal activities about an hour and a half after onset. The event resulted in emergency room/department or urgent care. Therapeutic measures were not 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 heart rate and blood pressure shot up, dry mouth and light headed was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Fever 100.9 at its highest, severe chills, sever headache, sever body aches, resting heart rate 124-130 chest pain and hard to breath.  I was unable to work or take care of my children this started 12 hours after having the vaccine.  reactions lasted about 12 hours
Burning feeling in her throat and chest at approximately  @ 9 1/2 hrs after vaccine. Tylenol given. Called pediatrician and recommended giving Motrin as well which I did. Instructed to call back if persisted. Patient woke up in the morning and only hurts to take a deep breath occasionally and has occasional wet cough.
The patient received the flublok vaccine instead of the moderna vaccine.  There was no adverse event reported by the patient.  She had gotten the flu vaccine  the previous week.
This spontaneous report as received from a certified medical assistant refers to a 50 year old male patient. No information on his medical history, concurrent conditions or concomitant drugs were provided. On 18-AUG-2014 the patient was a vaccinated with an expired dose of M-M-R II, 0.5ml, subcutaneously; lot# H014991, expiration date 10-AUG-2014, albumin status HSA, (dose number and site of injection not reported. No adverse events were noted. The patient did not seek medical attention. Additional information has been requested.
5 doses of the Moderna COVID-19 vaccine was administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna COVID-19 vaccine was administered after the expiration date) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna COVID-19 vaccine was administered after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses of the Moderna COVID-19 vaccine was administered after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. Additional information stated by the HCP was that that their facility had an error where 5 doses of the Moderna. COVID-19 vaccine was administered after the expiration date of 25-MAR-2022.
headaches, chills and fever. I had really achy joint and couldn't even pick a glass. I had a taste of metal. It lasted about 24 hours.
Approx 12 hrs after vaccine. Pt had short episode of "palpitations". Heart rate to 150 at rest. Had URI at same time. Wasn't taking medications (except OCP's)
shingrix was administered at 1 month 32 days not 2 months are required. patient had itching and a rash.
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 76-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown), 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), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "CAD" (unspecified if ongoing); "known allergies: sulphides" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as COVID 19 treatment .  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.
First vaccine resulted in  substantial  fatigue,  muscle aches and chills the following day and half of the next.  The second dose  had similar results but without the chills.
PATIENT REPORTS APPROXIMATELY 2 DAYS AFTER VARICELLA INJECTION SHE NOTICED SWELLING APPROXIMATELY 10 CM IN LENGTH AND AN APPROXIMATELY AN INCH IN THICKNESS WITH REDNESS, PAIN AND ITCHING. REPORTS THE SWELLING, REDNESS AND ITCHING LASTED APPROXIMATELY 2 WEEKS.
Patient received 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 2nd dose on 28th December 2021) and Shingrix (received 1st dose on 22nd September 2021).   On 29th September 2022, the patient received the 3rd dose of Shingrix. On 29th September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment:  This case was reported by pharmacist. Pharmacist reported a patient accidently got a 3rd dose of shingrix today on SEP 29th, 2022.  The patient was not immunocompromised. The reporter consented to follow up. Additional supportive information: As patient accidently got a 3rd dose of Shingrix which led extra dose administered.
On 1/5/00, redness area of 2cm at inject site. Cold compresses were applied by mom & Tylenol given. Low grade fever x 2 days at night. Instructed to take to Pediatrician.
Numbness in arms and hands, reduced hand strength, tingling, twitching, and strange feelings in both arms off and on all day and night. Occasionally lightheaded and feeling winded easily. Feeling irritable and just not well at times. Arms and hands are very uncomfortable with these symptoms.
Hypoxic on arrival to the ER and complaining of cough. Negative test on 11/30/2021 but CT imaging was suspicious for COVID. Recheck 12/1/2021 positive. The patient's grandson she lives with was sick last week, but no known contacts with COVID. Fully vaccinated with Pfizer x 2 in march and received a booster in 09/2021.    Symptom Onset 11/20/2021 Date of 1st Positive Test 12/1/2021 Vaccination Status Fully Vaccinated     - Admit to medical floor with continuous pulse ox, COVID-19 special precautions - Oxygen: continue current support with nasal cannula at 2 L/min; titrate to keep SpO2 between 90-96% - Imaging: no additional imaging needed at this time - Breathing treatments: no inhalers needed; avoid nebulizers in favor of MDIs  - IV fluids: not indicated at this time - Antibiotics: indicated due to concern of bacterial superinfection; azithromycin and ceftriaxone ordered  - COVID-Focused Medications: Dexamethasone 6 mg x 10 days or until hospital discharge, started on 12/1/2021 and Remdesivir x 5 days or until hospital discharge, started on 12/1/2021
Itching, rash around inject site; hot-feverish to touch; rx'd  w/cortisone preparation;
I had a sore throat, cough, lethargy, and a headache. I took an at-home COVID-19 test on 07/15/2022 that came back positive. I contacted my doctor and got a prescription for PAXLOVID and other steroid prescriptions. I began treatment the same day and started recovery the next day.
This spontaneous report as received from a physician refers to a female patient, age unknown. On an unknown date the patient was vaccinated with M-M-R II. One an unknown date the patient had "titers" drawn and showed "negative for mumps" after receiving MMR II. When further information was requested the physician placed the field representative on the line. The field representative was asked all questions in the AE report. The field representative had minimal information therefore most drop down fields are unspecified by reporter. No further information was provided. On an unknown date the patient had "titers" drawn and showed "negative for mumps" after receiving MMR II. The outcome of the "titers" drawn and showed "negative for mumps" after receiving MMR II is unknown. Additional information is not expected.
On Saturday 28th 10 pm the client cried uncontrollably for 15 min then fell asleep. She could not be awaken for 5 minutes. Then when she awakened and had a blank stare on her face and would not respond for 30 min then recovered. A rash was noted on Sunday  on face that was flat and about the size of a pencil eraser.
Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On 01-MAY-2012, at 69 years of age, the patient was administered the ZOSTAVAX vaccine at a physician's office (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from his ZOSTAVAX use: dendritic, varicella zoster. The outcome of the dendritic, varicella zoster is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Upon internal review, dendritic, varicella zoster was determined medically significant.  Additional information has been requested.
Onset of symptoms: last night very slight but worse this am and through today. Symptoms: fever, with a tmax of 102 taken orally, pain/tenderness around injection site, redness, approximately quarter size around injection site and swelling around injection site. Severity: severe. Treatment of reaction: Tylenol and Motrin for fever and pain. Past reactions to immunizations: No. Current medications: None. Protocol(s) referenced: none.
Nausea; Chills; Injection site pain; Tingling in his arm; This is a spontaneous report from a non-contactable pharmacist.   A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0140), via intramuscular, on 28Dec2020 at 13:15, at single dose for COVID-19 immunisation. Vaccine location was left arm. No relevant medical history and concomitant medications were provided. The patient was vaccinated at workplace clinic, age at vaccination was 29-year-old. No other vaccine was received in four weeks. On 29Dec2020, the patient reported normal side effects of nausea, chills, injection site pain. Patient also reported that he was experiencing tingling in his arm. No therapeutic measures were taken as result of the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
3 or 4 hours after injections start having fever of 101.0. Later that evening around 6 pm started with headache. That night I felt a rolling type feeling in my body. Next day my arm started to swell, it got red and hot. Call doctor's office, I was told to mark it. I went in on 2th and it started to stretch. I was told I had covid arm and was given antibiotic that day. Started to feel fatigued. On the 6th of March I woke up, I was on phone with friend, she asked if I had had a stroke because one side of my face was drooping. Went to ER and they told me I had bells Palsy. Fatigue just took over. Blood Pressure became high, heart rate would increase. I was going to doctor everyday or every other day. Got worse. My job modified my hours. My doctor sent me to therapy, I am doing acupuncture. Fatigue is bad. Heart still races. In October I was hospitalized because of swelling and weakness on left side. Everyday I had swelling in different places, mostly hands and legs. I developed weakness in left arm and left leg. Facial weakness as well. My tongue was numb and still is but not as bad. It made it very hard to talk. I am a case worker and my clients were asking if I was drunk.
Patient developed severe fatigue and drowsiness about 2 hrs after vaccination. She then fell asleep in the afternoon after fighting sleep for a few hours. She reports feeling "unusually drowsy" for at least 24 hours following vaccination. She was alarmed by this reaction.
Information has been received from a physician concerning a female who was vaccinated with the first two doses of the GARDASIL series (0.5 ml, intramuscular). Subsequently the patient experienced a positive prostatic acid phosphatase (PAP) test. The patient was negative before being vaccinated with GARDASIL. The patient sought medical attention. The patient's outcome was reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/8/2007.  Information has been received from a physician concerning two female patients (age not reported) who were vaccinated with the first two doses of the GARDASIL series (0.5 ml. intramuscular) (lot # not reported).  Subsequently both patients experienced a positive prostatic acid phosphatase (PAP) test.  Both patients were negative before being vaccinated with GARDASIL.  Both patients sought medical attention.  The patient's outcome was not reported.  Additional information has been requested.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: ALMOST IMMEDIATELY AFTER INJECTION PATIENT STARTED TO FLUSH AND SAY SHE WASN'T FEELING GOOD. 911 WAS CALLED. PARAMEDICS ARRIVED. PATIENT COMPLAINED OF SPIKE IN BP/HR, DIFFICULTY BREATHING, AND ABDOMINAL PAIN. ALSO HAD SOME ANXIETY WITH GETTING THE VACCINE. PATIENT ALSO HAS HEART CONDITIONS.  LEFT WITH PARAMEDICS BUT DID NOT  GO TO ER/URGENT CARE.  PATIENT CAME BACK WITHIN A COUPLE OF HOURS FOR HER CARD AND EXPLAINED SHE WAS FEELING BETTER BUT IS GOING TO FOLLOW UP WITH HER CARDIOLOGIST
RED, HOT HARD AREA ON LEFT THIGH, APPROX. 3IN DIAMETER
Pfizer-BioNTech COVID-19 Vaccine EUA. I developed night sweats with each vaccine. I also skipped my menses for three months after the covid vaccines.
1/14/21 - 1/16/21: Pain and swelling at injection site, 1/16/21: chills/fever, fatigue, headache, sore throat, congestion - took ibuprofen
This medically confirmed health authority report (initial receipt 16-Dec-2015) concerns a 38.5 year old female patient. On an unspecified date in 2014, the patient received influenza vaccine (manufacturer and batch number not reported) in the right arm. On an unspecified date, about a week after the injection, the patient experienced malaise, low grade fever, pain under her right arm, in the neck and the clavicular area. She noticed several pea sized swollen lymph nodes in the clavicular area and neck. She could hardly raise her right arm and it was painful to turn her neck. The reactions were not as severe. The symptoms lasted about 2 weeks. In Jan-2015, she did get the flu. The outcome was reported as unknown. Linked case: 2016059814 (same patient).
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date in OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L048237 and expiry date 18-MAY-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The GARDASIL 9 experienced multiple temperature excursions. Currently (unknown date) the vaccine temperature excursion was minimum of 1 degree Celsius and maximum of 5 degree Celsius for time frame of 40 hours. The vaccine had previous temperature excursions on 06-SEP-2016 exposed to 1 degree Celsius for 72 hours and on 07-SEP-2016 exposed to 1 degree Celsius for 17 hours. Data logger was not involved. No product quality complaint was involved. Additional information has been requested.
2"x2" red swollen area - 3/4/10 23:00, 102 F fever oral - 3/4/10 23:00.
Approximately two weeks after my first dose of the Moderna vaccine my left hand and wrist began to hurt. The pain varied between a constant ache to sharp  pains and a burning sensation in my wrist.  It is difficult and painful to do simple tasks like opening bottles and doors. Pain is constant. About two weeks after the second dose the same symptoms appeared in my right hand and wrist. All symptoms still exhibit themselves in both hands and wrists.
pt recv vax 21MAR96 & w/in 2-3 wk of vax, pt exp a gen rash;no further details were provided;
She had (has) a low grade fever, aches, weariness, and was sent home from school today, (12/11/2009). This has persisted now for four days. She also had a rash on her left wrist, presumably unrelated. Facility staff saw her, asked me to report to you.
I started with ringing and buzzing in my right ear which progressed to almost total deafness in the right year
This spontaneous report as received from a registered nurse refers to a 15 month old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-SEP-2017, the patient was vaccinated with improperly stored PEDVAXHIB from lot # N000236 (dose, route and expiry date were not reported) for prophylaxis. The administered vaccine underwent a temperature excursion (details not specified). This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1710USA014890.
Experienced redness, swelling and arm was warm to the touch. This occurred 60 hours after the injection. Went to the clinic at 3PM on 8-26-17 and diagnosed with cellulitis. Prescribed Cephalexin 500 mg QID x 7 days.
PT CAME TO THE PHARMACY ON 10/10/18 COMPLAINING THAT HER ARM WAS HURTING FROM THE TYPHIM VACCINE FROM 9/29/18. SHE ICED IT, BUT SHE SAID IT DID NOT LOOK SWOLLEN. SHE SAYS SHE SAW HER DR TWICE. THE FIRST TIME SHE WAS TOLD TO TAKE APAP, BUT SHE SAID IT DIDN'T HELP. THE SECOND TIME SHE SAW THE DR HE/SHE PRESCRIBED PREDNISONE.  SHE SAYS THAT IT IS STILL NOT HELPING HER AND SHE STILL HAS DISCOMFORT. I TOLD THE PT SHE SHOULD RETURN TO SEE HER DOCTOR AGAIN.
Patient says vaccine FLUZONE given too high in her shoulder and resulted in fluid accumulation. Has tried anti-inflammatories and antibiotics but no change. Trying steroids next to decrease fluid.
Patient came to ED with increasing weakness and shortness of breath.  Patient was admitted to hospital with covid and treated with remdesivir.
face swelling swollen lymp nodes, site pain, site redness, itching, headaches, sick
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Non-steroidal anti-inflammatory drugs (NSAIDS)" (unspecified if ongoing); "Known allergies: bee venom" (unspecified if ongoing); "Hypertension" (unspecified if ongoing), notes: Other medical history: (Hypertension) HTN, reflux, high cholesterol; "reflux" (unspecified if ongoing), notes: Other medical history: (Hypertension) HTN, reflux, high cholesterol; "high cholesterol" (unspecified if ongoing), notes: Other medical history: (Hypertension) HTN, reflux, high cholesterol. Concomitant medication(s) included: LOSARTAN; PROGESTERONE; HYDROCHLOROTHIAZID; ESTROGEN; PRAVASTATIN; PROTONIX [OMEPRAZOLE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I previously tested negative on day 6 of the first bout of covid; (05Aug2022) Positive, notes: I did a home rapid test today, on day 11 after contracting covid, before babysitting my grandchildren and it is positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I did a home rapid test today, on day 11 after contracting covid, before babysitting my grandchildren and it is positive. I previously tested negative on day 6 of the first bout of covid. I took a course of paxlovid from 26Jul to 30Jul. I have no symptoms. Anti-viral details : paxlovid, COVID 19 Treatment, Treatment start date=26Jul2022 Treatment stop date=30Jul2022, Lot number=2692129, Indication=Treatment of COVID-19  No follow-up attempts are possible. No further information is expected.