chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; This spontaneous report received from a consumer via a company representative through media concerned a 31 year old female of an unspecified race and ethnicity. 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, and batch number were not reported, expiry: Unknown) frequency 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated that, "met a guy that lost his 31 year old daughter from your vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20221104412-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
About 30 seconds after patient got her vaccine she stated that she did not feel good and then went limp. I the vaccinator, caught her an placed her on the chair and called for backup. Patient was then assessed my EMS. It was noted that her pupils were non reactive and dilated and her eyelids were fluttering. Patient was transferred to the hospital.
On 9/19/21 I began to experience full body hives (including wheals, warmth, erythema) predominantly behind my neck and ears, my torso, and my groin area.  By 9/20/21 they covered most of my body's surface area and would last for hours at a time. I also began to have a fever between 100-102 deg F. I began to experience severe acid reflux (never had in my life), and chest tightness, expiratory wheezing with slight difficulty  in breathing. Symptoms of chills, cold sweats, malaise, fatigue, and myalgia began as well. On 9/21/21 the symptoms of the previous day worsened. New onset stabbing, burning pain and swelling of both of my fingers and palms on each hand began. A rash also appeared on both of the palms of my hands. On 9/22/21 the symptoms had not improved so I went to urgent care. I was found to be afebrile, tachycardia, hypertensive. I was COVID, Strep, and Mono negative. I received a Intramuscular steroid shot. I was prescribed a Steroid 6 day dose pack, and told to take Zyrtec and Pepcid twice a day each for one week. On 9/23/21 my hives disappeared, as well as the flu-like and reflux symptoms. My hand symptoms improved as well. The difficulty breathing slightly improved. My breathing would take another two weeks to return to normal. On 9/28 my steroids were discontinued. Later that day my hives returned but were less severe. The wheals were smaller and more pinpoint. And I mostly had red streaks of urticaria that would arise either spontaneously or in the form of dermatographia. They still would appear in any part of my body. My ears, fingers, and toes would randomly get red and warm as well. Taking Zyrtec twice a day and Pepcid AC once a day would lessen the frequency of symptoms, but there were always still breakthrough hives. Since then for the past 4 months I have had these same symptoms daily. If I do not take Zyrtec, the hives, itchiness, and dermatographia increase in frequency. The hives typically last in the affected area for 30 min to one hour. Over time, the hives and itchiness are decreasing in frequency throughout the day.
pt recv vax 28OCT;pain assoct w/flu shot has progressively worsened to shoulder aching & pain;some relief w/heat & Ibuprofen;
She had a small cough that developed that Sunday, and I gave her medicine. She was having a hard time breathing so I took her to the emergency room. They checked her oxygen which was at 98%. They gave her a breathing treatment. So, they gave prescription for steroids along albuterol inhaler. She took the albuterol inhaler for 3 days. She was diagnosed Bronchiolitis. Her symptoms improved after about a week. It took 3 days for her to be able to speak in full sentences. I do believe it is completely recovered.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 58-year-old female patient who received SHINGRIX (batch number P3777, expiry date unknown). On 18th January 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site muscle pain (serious criteria disability) and joint range of motion decreased. On an unknown date, the outcome of the injection site muscle pain was unknown and the outcome of the joint range of motion decreased was not recovered/not resolved. It was unknown if the reporter considered the injection site muscle pain and joint range of motion decreased to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that a patient who received his first dose of SHINGRIX on developed muscular twinge, 2 inches below the injection site which radiated down to right below the elbow, this had also resulted in joint range of motion decreased and was still ongoing. No further information was reported regarding the event. The reporter also reported that she called one day before the day of reporting to speak further about the adverse reaction, however she was unable to provide further details of the event. So she called back on the date of reporting to provide further details and seek recommendations from MES on how to proceed with patient's second dose in series. An initial adverse event report had not been able to be located aside from the current information in the case.
This spontaneous report was received from a pharmacist regarding a 54 year old female patient with no pertinent medical history or drug reactions or allergies. On 05-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot # J000446, expiration date 11-APR-2014) (0.65 ml, subcutaneous). No other suspect therapies were reported. Concomitant medications included unspecified eyedrops. On 07-AUG-2013 the patient experienced an injection site reaction that was red and warm. The patient also reported to the pharmacist that she had a small nodule "in her arm pit". The outcome for injection site reaction that was red and warm and small nodule in her arm pit was reported as not recovered. No treatment was given for the above mentioned events. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by calling to the pharmacy. The reporting pharmacist did not assess the causality between the above mentioned events and ZOSTAVAX. Additional information has been requested.
Arm tingling to 3rd finger. Reassurance provided tingling resolved after 20 min.
Rec'd call from mom stating that child has "blistery rash' on L leg - wondering if from Hep A vaccine given 2 weeks ago.  Reports child has had rash before and was given Benadryl.  One dose Benadryl given and child's rash decreased to fine, dry pinpoints.
I woke up the day after receiving my COVID vaccination with cold chills and nausea. Once I got to work, took temp. was 99.3. After meeting, I took my temp. again because I was having intense cold chills but felt warm and it was 102.9. I still have cold chills, nausea, headache, and 101.1 fever now.
Received smallpox in left arm. Developed axillary lymph nodes with pain. Pain radiated to beyond left anterior axillary line to almost the mid blavicular(?) line.
pt devel disseminated intravascular coagulation, fever of 106.7, rabid myalgia two & one half wk post vax;
no energy; Sick for 4/5 days after 2nd dose; House appeared yellowish green in color; Fluctuations in blood sugar level; headache; Pain in one part of body and then in other; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level), HEADACHE (headache) and MYALGIA (Pain in one part of body and then in other). At the time of the report, ASTHENIA (no energy), VACCINATION COMPLICATION (Sick for 4/5 days after 2nd dose), DYSCHROMATOPSIA (House appeared yellowish green in color), BLOOD GLUCOSE FLUCTUATION (Fluctuations in blood sugar level), HEADACHE (headache) and MYALGIA (Pain in one part of body and then in other) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication provided by the reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.     This case was linked to MOD-2021-067681 (Patient Link).
On the date of injection. My right arm was fine. Waited 15 mins. Everything was ok. Until 130 am at night. Woke up due to the heart palpitations and nausea that lasted 10-20 mins. Monitor the symptoms and it went away after 20 mins. Symptoms was mild.
little pain at the injection site of her left arm; Redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain at the injection site of her left arm) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little pain at the injection site of her left arm) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PAIN (little pain at the injection site of her left arm) outcome was unknown and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved.            Treatment and concomitant medicines were not included  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.    This case was linked to MOD-2021-070527 (Patient Link).
chicken pox like rash upper back and torso; itchy rash; This case was reported by a pharmacist via call center representative and described the occurrence of varicella-like rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number HY4GT, expiry date 21st September 2021) for prophylaxis.   On 17th June 2019, the patient received the 1st dose of Shingrix. In June 2019, 2 days after receiving Shingrix, the patient experienced varicella-like rash and itchy rash. In June 2019, the outcome of the varicella-like rash and itchy rash were recovered/resolved.   It was unknown if the reporter considered the varicella-like rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient experienced a chicken pox like rash on upper back and torso that started two days after the Shingrix vaccination, and resolved approximately 5 days later.  The rash was slightly itchy during that time.
INJECTION PAIN SITE, JOINT PAIN Narrative:  65 yo male with PMH COPD, tobacco use, polyp of colon, solitary nodule of lung reported injection site pain, joint pain after his first covid19 vaccine on 2/16/2021. Symptoms self-resolved in 2 days. ADR was reported on 3/9/2021, when he received his second dose of covid19 vaccine.
Swelling, indurated area, warm to touch approx 4 cm diameter. Treated with Cephalexin 250 mg TID x 7 days.
Redness and swelling down arm and at the injection site, fever (105), nausea, achy body, pain in arm and difficult to move arm - (Flu like symptoms) - Taken to several doctors and given Cephalexin and pain medication (Tylenol & Motrin).
Patient called to report L axilla swelling x 5 days, not improving.  VEARS completed. Advised her to see MD as this is most likely from the injection, but could also be from another cause .
injection site pain (still lasting after 9 days), itching, redness and swelling at injection site (the last two are in a two inch radius around the injection site)
Pt rec'd 2nd dose of vax experienced h/a, dizziness, muscle weakness in her legs, & frequent visual field cuts; On 6APR91 had vertical double vision which persisted for 3 to 5 min; 12APR91 MRI of brain - negative; Additional info requested;
STARTING THURSDAY EVENING 2/11 AROUND 7:30PM THRU FRIDAY MORNING 2/12 9:30AM PATIENT HAD A BLOODY NOSE.  BLED ALL EVENING.  PUT A CLAMP LIKE DEVICE ON NOSE.  KEPT A WASHCLOTH NEARBY TO WIPE NOSE ALL NIGHT.  KEPT PATIENT AWAKE MOST OF THE EVENING.    PATIENT WAS GETTING READY TO GO TO THE EMERGENCY ROOM, BUT FLOW STARTED TO SUBSIDE AND THEN EVENTUALLY STOPPED, THEREFORE RECEIVED NO MEDICAL TREATMENT.
This spontaneous report as received from a nurse via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions or allergies were not provided. On 21-OCT-2009, the patient was vaccinated with her first dose of PNEUMOVAX 23 intramuscular (dose, lot number and expiration date were not reported). No adverse effects were reported after the 1st dose. On an unknown date, the patient received her 2nd dose of PNEUMOVAX 23 (lot # J009833, expiration date: 25-JAN-2015) intramuscular, 1 single shot (exact dose was not reported). On an unknown date, the patient experienced cellulitis at the injection site after receiving the 2nd dose of PNEUMOVAX 23 and was admitted to hospital on an unspecified date. The patient sought medical attention. The patient received unspecified IV antibiotics as a treatment for the event. The outcome of cellulitis at the injection site was unknown. The relatedness between the event and PNEUMOVAX 23 was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Very bad head ache. Pain in right arm, shoulder blade and right side of lower back. Fever of 101.4. Chills.
Swelling and tenderness in the left arm pit worsening until peak swelling/pain felt through January 15th/16th. Swelling and tenderness began to decrease after the 16th. After the 16th, massaged area 2 or 3 times over next couple days.
mild fever; severe body aches; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the following side effects: severe body aches, headache and mild fever on unspecified date. The patient would like to know if she can take painkillers for the events. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Pt received shots on 8/10/01 and had red marks on shoulders Friday night but had been playing football. By 20:00, Saturday night, (away from home), had itching, circular rash on stomach and it was worse by 02:00, Sunday, over shoulders, arms and back with welts. Pt was given Benadryl and is continuing on Benadryl, Cortizone cream and Aveeno baths. Hives resolved after 4 days. Doctor wrote medical comments for future Hepatitis shots.
Back pain; Lower back swollen left side and right side; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 14Apr2021 at 10:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D3) and fish oil (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 16Apr2021 at 00:00, the patient all of a sudden started having back pain. Then the patient woke up with his lower back swollen, left side and right side. The patient was taking pain medications and was doing cold compress but pain was unbearable at times. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with unspecified pain medications. The clinical outcome of the events back pain, lower back swollen left side and right side were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Member came into clinic for "2nd dose" of Moderna COVID vaccine. Member had previously received both her first and second COVID vaccine, but did not disclose this to the healthcare team. Member did NOT have an adverse reaction to the vaccination, but did receive a 3rd dose of the COVID vaccine.
Patient returned to observation area after going to car. She is having an anxiety attack thinking what to do if she has a reaction (per patient). Patient denies chest pains, shortness of breath, trouble breathing. Panic button activated and staff including Doctor responded. No hives, rash noted. After being observed and breathing checked with stethoscope, it was determined patient didn't have a reaction. After waiting 30 minutes, patient left without any symptoms of reaction to vaccine. Patient instructed to go to ER if any problems.
pt recvd vax 5AUG93 & shaking arms & legs-having a convuls; returned to clinic, carrying pt-pt pale & conscious;  BS @ 1250PM P76, BP 110/80; cool clothes were place on neck, forehead;
Arm swelled after leaving pharmacy.  Visited physician on 12/14/15.  Instructed to go to hospital and patient was admitted.  Discharged on 12/18/15.  Diagnosed with cellulitis of left arm.
Information has been received from a health professional concerning a 15 year old female who was vaccinated with the second dose GARDASIL (lot# not provided). Subsequently the patient experienced fainted. It was unknown whether medical attention was sought. The patient's outcome is known. Additional information has been requested.
Patient is 10 years, 11 months and was given Pfizer Bivalent 12 years and up dose of 0.3 ml left arm. No direct adverse event noted. Patient monitored 15 minutes Instructed may take Tylenol for body aches, fever, or chills if occurs. Instructed to seek emergency care if developed any chest pain, SOB, or swelling of mouth or tongue. Patient left clinic with mother in no acute distress.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.  On or about 01-SEP-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-FEB-2016 the patient was treated at a medical center for a vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
The morning after (10/10/22) I had the shot I had a mild burning or irritation sensation around in the area of my heart.  A sensation I have never had before.  That sensation lasted most of the day.  By that evening that sensation stopped.  The following day (tuesday) i appeared to be fine.  I completed a very physical day of work outside, however that evening I felt more tired than usual.  Wednesday, I had a stressful experience at work, and I started to have heart palpitations, and occasional a-fib symptoms.  Thursday the palpitations where strong and continued through the night.  I went to the emergency room on friday morning to make sure it was not something more serious.  I have had a-fib symptoms a few times every year since I was 21 years old.  They gave me an iv at the hospital and the palpitations reduced quite a bit.  I was not in a-fib,  but was having a irregular heart beat.   I don't know that the issues are related, but I have never experienced the burning/irritation feeling in my chest before, and it seems possibly too coincidental for them to be separate issues.  That is why I am reporting the situation.
Eight days after receiving vaccine (today) I began to notice itching, redness, swelling at the injection site as well as it was warm to touch.  Will seek medical attention if it worsens or doesn't improve.
Developed an eczema-like rash on trunk and extremities, worsening over time. Six months later it remains. Improved twice with rounds of oral steroids; but never completely gone. Severity returns once steroids are complete.
Patient presented back to the facility after receiving vaccine earlier in the day with a swollen, red, tender arm. This ranged from the injection site down to the elbow. Patient sought treatment at urgent care and seems to be doing better since. Pt received pain medication and steroids as treatment.
Right after I received the shot, my heart started to beat very fast. Since I'm a person who has anxiety, I thought maybe I was having anxiety, and didn't say anything. My heart rate eventually felt normal and I went home. However, I woke up in the middle of the night last night feeling a fast heartbeat. Today reading the information I received about the vaccine, I saw that "fast heartbeat" is listed as a possible reaction to the vaccine, so I'm reporting it.