chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admitted for COVID pna. Fully vaccinated. O2, steroids, vit-c, zinc, lovenox, Remdesivir. Was weaned to RA and able to discharge home.
11/22/2021 - Presented to ER with fever and malaise. T-103.2 and P-120 .WBC 10.3 and D-Dimer 445. BC staph aureus. AKI. Admit sepsis UTI vs port infection. Completed 2 weeks antibiotic. Port surgically removed. Cefepime and vancomycin.   12/12- New onset fever 102 with mild SOB. ABG revealed PH 7.46/PCO2 41.4/PO2 51 on rm air. Repeat ABG on 4L O2 showed PH 7.41/PCO2 7.41/PO2 69. Covid + test.. CT neg for PE. Continued Cefepime, Remdesivir, Decadron ordered and Eliquis continued. 12/15 - on 3LNC O2 to maintain saturation levels above 90%. Continue weaning. Treatment plan continued. Improving. 12/16 - Last dose of Remdesivir given. Rest of treatments continued. Discharge planned for SNF but SNF unable to accomodate bariatric case.  12/17 - placed on alternative level of care - plan SNF rehab will plan SNF rehab with Covid test to be completed on 12/22. No bed offers for SNF within 100 mile radius. 12/22 - Patient discharged to home with outpatient follow-up
3/13/2021: Red rash/hives on arms, neck, scalp, chest, back / was treated at ER with benedryl, given albuterol inhaler to take 2 puffs, 4X day for 7 days; prednisone, 40mg daily for 5 days 3/16/21: had mini stroke at home, called ambulance, they administered a series of tests and determined that all his vital signs were normal and asked if he wanted to go to hosp for addt'l testing and pt refused. 3/17/21: had 2nd mini stroke in vehicle, went straight to Hosp ER and was admitted. CT scan and MRI determined that I had suffered 2 strokes due to blood clots in the rt side of brain.  Was told to take 325 mg of aspirin a day and released on 3/19/21 with instructions to f/u with PCP and Neurologist. PCP recommends that I should NOT take the 2nd dose of the Moderna vaccine.
I had a reaction within the 15 minute observation period. I had a hot flash, increased HR, and muscle spasms near my right ankle. I was examined by the Physician and EMT on site. The following day, I experienced body and head aches. Naproxen and Tylenol
CONSTIPATION; DIARRHEA EVERY 45 MINUTES FOR 10 HOURS; STOOL FREQUENCY INCREASED; CHILLS; HEADACHE; CRAWL OUT OF SKIN IN THE MIDDLE OF NIGHT; FEVER UPTO 100 ON AND OFF; PAINFUL FEET AND RIGHT LEG; INSOMNIA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on the left arm on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the subject experienced insomnia. On 16-MAR-2021, the subject experienced painful feet and right leg. On 16-MAR-2021, the subject experienced fever up to 100 on and off. Laboratory data included: Body temperature (NR: not provided) Up to 100 F. On 17-MAR-2021, the subject experienced crawl out of skin in the middle of night. On 17-MAR-2021, the subject experienced chills. On 17-MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced diarrhea every 45 minutes for 10 hours. On 18-MAR-2021, the subject experienced stool frequency increased. On 20-MAR-2021, the subject experienced constipation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from crawl out of skin in the middle of night, insomnia, painful feet and right leg, and headache on 17-MAR-2021, constipation on 21-MAR-2021, and chills on 18-MAR-2021, was recovering from diarrhea every 45 minutes for 10 hours, and stool frequency increased, and had not recovered from fever up to 100 on and off. This report was non-serious.
Initial non-serious case received from a health care professional on 28 August 2008.  A 22-year-old female patient developed slight swelling at the left deltoid two minutes after receiving an intramuscular left deltoid injection of MENACTRA (lot number U2544AA).  Within 24 hours, the patient complained of increased swelling to 6cm at the left deltoid.  It was painful for the patient to lift her arm, but she did have good range of motion.  The injection site became tender.  The patient also complained of headache, neck pain, fatigue and difficulty concentrating.  The patient was seen by a nurse practitioner who advised taking Benadryl, Tylenol and using an ice pack.  At the time of the report, the patient had not recovered.
Got shot on a Weds Feb. 27th. Next am after vaccination (24 hours) started having pain, redness, swelling which progressed from size of a quarter to 4x4 inches in the next 24 hours. Patient took Ibuprofen thru that day. Saw her primary in the next 2 days on the 29th. At that time there was a golden look under the skin, PA didn't think it was NRSA but pt had previous MRSA, he treated pt with Keflex and Doxycycline for MRSA and cellulitis. With 8 hours, pain was decreasing. It was a painful as a surgical site. Today-redness outline is still there, hardness still there but almost gone. Pt called the consultants office the following Monday, left message for a return call and never heard back from them. She called several more times and only got voice mail, did not leave another message.
Area of left deltoid very warm to touch, and firm with redness about 3" in length and 2" in width. Mother of client reports crying and lots of coughing about 4:00 am on 10/27/2005.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (lot # K02319, expiration date 28-APR-2017; route and dose were not reported). The vaccines were exposed to 33 F for 3 hours and 49 F for 50 minutes without previous excursion. The issue was due to data logger. No symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Metallic taste starting about 3 hours post 2nd vaccine Milder condition 24 hours after 1st dose, lasting several days.
Irregular period. Menstrual cycle started the day after vaccination, week and a half early; This is a spontaneous report from a non-contactable consumer, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 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. On 16Apr2021 at 13:00, the patient experienced irregular period. Menstrual cycle started the day after vaccination, which was a week and a half early. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event irregular period, which was a week and a half early was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approx 15 min after shot, while standing at check out, dizziness to vision black out, to syncope.  BP drop to 70/50, pale, nausea, severe headache, severe pain in arm.  Hours later - spontaneous blood blister appeared on inside of leg.
Muscle ache; diarrhea; nausea; This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced myalgia, diarrhea and nausea. On an unknown date, the outcome of the myalgia, diarrhea and nausea were unknown.   It was unknown if the reporter considered the myalgia, diarrhea and nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced muscle ache, diarrhea and nausea. This case has been linked with case US2020028071, reported by same reporter.
Admitted for rt toe infection; COVID-19 +; tx w/O2 & steroids; weaned of O2 for home dc
Body aches and joint pain, swollen lymph node on right armpit, temperature of 101'F starting on 1/1
sx: felt hot, tingling at corners of mouth, dry mouth s: lungs cta b/l, upper airway cta b/l, no uvular swelling, no rash tx: benadryl 50 mg PO x 1, monitoring outcome: 911 called, pt monitored, ambulance cancelled, monitored in clinic, condition improved/resolved, discharged home with epi pen and instructions to call 911 if airway irritation develops.
FLU VACINE GIVEN ON NOV.6, 2003. PATIENT HAD TWO MECHANICAL HEART VALVES.  WAS ON AN ANTIBIOTIC AT THE TIME THE VACCINE WAS GIVEN.  FOUR DAYS LATER WENT INTO CONGESTIVE HEART FAILURE. HOSPITALIZED FOR 4 DAYS.  CONTINUED TO GET WEAKER OVER THE LAST THREE MONTHS.  LEG PAINS, WEAKNESS. PATIENT PAST AWAY MARCH 16TH 2004.  SEEMED TO BE IN GOOD HEALTH UNTIL THE VACCINE.  CARDIOLOGIST FEELS ONE OF THE VALVES FAILED.  I BELIEVE THE FLU VACCINE IS WHAT THE  PROBLEM WAS. Per death certificate, cause of death was acute MI valvular disorder.
rash emanating from the injection site and down the arm; feeling arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on unknown date).   On 5th February 2020, the patient received the 2nd dose of Shingrix. On 5th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the pain in arm and rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. After receiving the 2nd dose the patient reported feeling arm soreness after the injection.  The patient reported a rash emanating from the injection site and down the arm for about 4 and a half inches. The reporter consented to follow up.
Post vax, the pt developed headache, nausea, muscle pain in arm, temperature, swelling/knot at injection site.
Initial misuse report received from a healthcare professional on 22 November 2013. The case were received at GPV on 21 March 2014. A patient (no other information was reported) received FLUZONE on unspecified date. It was reported that FLUZONE was stored at 34F on 18 November (year not specified) and then 33F and 22 November (year not specified) and administered. No adverse event was reported. List of documents held by sender: none.
Burning at time of injection.  Redness, swelling and fever night of injection. Following morning hardness at injection, swelling and redness spreading. Back pain and heaviness of arm and swelling in lymph node under arm on side of injection. Serious fatigue.
Bruising, rash of site swelling. Hardly move my arm.  Chills, body aches, headache, stirred up my bronchitis.  It was not bothering me prior to shot.  I am on day 5.  Starting to feel better with my inhaler and cough syrup.  I will not be getting the 2nd vaccination.  I feel so much worse than getting covid vaccine, just had tiredness.
pt recv vax 5SEP97 & 11SEP97 pt exp extreme fatigue that resolved in 24hr;
Redness on arm bigger than half dollar size; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis.   On 16th July 2019, the patient received Shingrix. In July 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional information received were as follows: The pharmacist called in to question that any information on the reaction lasting this long.  The pharmacist stated that the patient received the 2nd dose of Shingrix on left arm. The patient initially had swelling but swelling had gone down and still had redness on arm bigger than a half dollar size.  The adverse event was collected. The reporter consented to follow up.
Received second Moderna in L deltoid on 2/26/2021. 6/11/2021 developed C6 dermatome shingles, exactly where c/o pain since vaccine.  Also c/o L shoulder pain since vaccination (specific date unknown) and has tendonitis L shoulder.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 04/09/21Lot#205A21A Diagnosed covid positive: Symptom onset:08/04/21 Exposure:08/04/21 Symptoms:Home
Felt dizzy after vaccine. Gave patient water and took blood pressure. Patient said they were nervous leading up tot he vaccine but felt better not long after. Had patient wait an additional 15 mintues
The patient got a flu vaccine on 10/03/2018 at a local pharmacy with no adverse effects. She then went to a flu clinic at her housing center on  the morning of 10/31/2018 not realizing she had already been vaccinated. The patient had some vomiting after eating lunch around 2pm on 10/31(the day of this report) but felt fine afterwards. I was told to report the fact that she got 2 vaccines inadvertently regardless if adverse reaction when I emailed the CDC.
Child spiked a high fever immediately following vaccinations and lost all verbal communication. Almost two years later and he still cannot communicate verbally. Prior to vaccination, the child was beginning to speak in sentences and was thriving.
It was discovered after administration that the Pfizer COVID-19 Vaccine is expired. Patient received booster dose intramuscularly on left deltoid. Patient did not exhibit any adverse reaction after administration, so no treatment was needed.
Patient is experiencing bilateral lower extremity numbness and tingling to the point where he cannot feel his feet, he cannot feel the floor, and he is almost falling.
mouth sores; slightly swollen upper lip; swelling/pain injection site; swelling/pain injection site; fatigue; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EKU176, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 18Jan2021 14:00 as single dose for covid-19 immunisation. Medical history included bronchiectasis, degen scoliosis, fibromyalgia, peptic esophogitus and swollen lymph nodes for 24 hrs, fatigue and headache for 4-5 days for first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL1284, Brand: Pfizer, Expiration date: Unknown) via an unspecified route of administration in right arm on 02Jan2021 11:00 as single dose for covid-19 immunisation. There was special history of allergies reported. Concomitant medication pantoprazole sodium diclofenac sodium 40 mg, Misoprostol (50-200) (ARTHROTEC) and lisinopril for unspecified indication. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On an unspecified date in Jan2021, the patient experienced mouth sores, slightly swollen upper lip, swelling/pain injection site, fatigue and headache. The patient hasn't been tested PCR for COVID-19 post the vaccination. Therapeutic measures were not taken as a result of events. The outcome of the events were not recovered.
DEVELOPED PAIN, FEVER, CELLULITIS TO THE SITE, WONT WALK OR STAND.
Vaccines given as instructed by MD followed by lead test at mom's request. After lead test completed and bandaid applied pt c/o dizziness and light headedness and nausea. Emesis x1. Episode resolved after approx 30-40 min.
Mild chickenpox symptoms occurred on trunk , legs and feet started 3 to 4 days after the first dose.  Symptoms are mild but prevalent after 10 days.
EXPIRED VACCINE IS ADMINISTERED DUE TO MISUNDERSTANDING WHEN STABLISHING THE EXPIRATION DATE IN THE DATABASE REPORT.
After the 2nd dose, around day 6 or 7 (approximately 02/03/2021-02/04/2021) all of a sudden my stomach started hurting, I didn't have an appetite, and felt lethargic. I think I lost some taste and that's because I had eaten some spicy food and felt that it was bland, so I do believe I lost some taste. I didn't really want to be out, I just wanted to be home. No fever. I was a little achy, but not too bad. No medical care seeked. In April, I started having shortness of breath. I did have allergy symptoms on and off for months and I kept getting tested for Covid but it kept coming back as negative. I did test positive for Covid in April.
Headache, head feeling very heavy and nausea; So far lasting for 4 days and not getting better; I took Tylenol but does not help. Last night was the worst couldn?t sleep all night
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's concurrent conditions included allergy to penicillin, codeine, tetracycline, ciprofloxacin, PROVENTIL and erythromycin. The patient's historical drug included penicillin (manufacturer unknown), codeine, tetracycline, ciprofloxacin, PROVENTIL and erythromycin. On an unknown date the patient was vaccinated with MMR II (therapy type HSA) (dose and frequency unknown) (patient was vaccinated when she was a kid). Concomitant therapies included metoprolol, mirtazapine (manufacturer unknown), duloxetine hydrochloride, benzonatate and prednisone (manufacturer unknown). On an unknown date the patient experienced an allergic reaction in which her throat swelled up. Patient sought medical attention. The outcome of events was unknown. Reporter's causality assessment was not provided. No product quality complaint was filed. This case is linked to case # 1408USA015099 (same patient link). Additional information has been requested.
The administration of the vaccine was extremely painful. Began to feel hot flashes about a half hour after the vaccine was administered, nausea and feverish symptoms. The site of injection began to swell to the size of a half dollar; the next day she could not move her arm. Describes pain from the site of injection all the way down to her wrist. The symptoms have persisted for two weeks, headache, exhaustion, and aching at the site of injection.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 38 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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: Positive, notes: COVID rebound- tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sever headache with Nausea and vomiting. Seen in the ED. improved with fluids, raglan, and benadryl
Patient reports completing her 2nd dose of the Moderna COVID-19 vaccine "three months" ago.  Seen at  ED on 4/29/21 after being referred by an outpatient provider for a positive COVID-19 test obtained yesterday (4/28/21) and concerning symptoms (at home pulse ox 86%)
Report 2001003496-1 describes joint pain in a male who received Lyme disease vaccine. The patient participated in a Lyme disease clinical trial; the protocol was not specified. The adverse event was reported spontaneously post-marketing. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The patient claims to have received placebo as part of a Lyme disease clinical trial. After the blind had been broken, the patient reportedly was offerred and accepted open-label Lyme disease vaccine. He received his first injection of Lyme disease vaccine in March 1997. No adverse experience was reported following this injection. He received his second injection of Lyme disease vaccine in 04/97. In 11/97, three months following receipt of the second injection, he began to experience slight pain in his arm joints. The patient received his third injection of Lyme disease vaccine in the spring of 1998. Within one week of receiving the third injection, his joint pain became severe and affected all of his joints. The joint pain was described as "burning and cramping". He had "the sensation of a hundred razor blades poking his knee joints, hips, ankles, wrists and elbows." The outcome of the joint pain was not provided. The adverse event of joint pain does not meet ICH serious criteria, but os being submitted as an expedited report by special FDA request per the 06/28/00 letter.
A report was recieved from a consumer on 27Nov02, concerning a 67 year old female vaccinee who experienced blisters on her body within one week of receiving 0.5ml Fluvirin vaccine 0.5ml IM on 31Oct02. Within one week the vaccinee developed a severe outbreak of blisters on the body including the face, arms, legs and trunk. On 06 or 07Nov02 the vaccinee was seen by a physician who prescribed an unk antibiotic. On 14Nov02 the vaccinee was referred to a dermatologist who suggested that thimerosal in Fluvirin vaccine might have caused the adverse event. The dermatologist prescribed prednisone 5mg six times a day. On 21Nov, a culture was taken from the blisters. The culture results were not available at the time of reporting. On 25Nov02, the vaccinee had a follow up appt with the dermatologist, who subsequently increased the dose of prednisone to 40mg daily for 1 week. The vaccinee stated that prednisone had not relieved the symptoms and that she had applied unk antibiotic cream and foam to the blisters to reduce itchiness. According to the vaccinee her face looked and felt sunburned, scabs from the blisters were deep and large leaving some scars. The vaccinee also reported petechiae on both feet, legs and inside of forearms, but no local reaction at the injection site. The vaccinee had received the flu vaccine for at least 10 years without any problem and is not allergic to any medicine except Betadine. The vaccinee has used Nerthiolate for many years without any problem.
redness swelling ,pain, heat, hard, itching to upper arm arm that began on the 7th day after the vaccine