chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the first dose yesterday and all he had was a little soreness like with the Flu shot/clarified that his left arm is sore, and his left arm is where he got the injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: Unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included HIV (unspecified if ongoing), he is immune deficient; Chronic COPD (unspecified if ongoing); Type II Diabetes (unspecified if ongoing); Fibromyalgia (unspecified if ongoing); Asthma (unspecified if ongoing). There were no concomitant medications. Vaccination history included Flu shot (clarified that his left arm is sore, and his left arm is where he got the injection), administration date: Sep2020, when the patient was 55 years old, reaction(s) little soreness. The following information was reported VACCINATION SITE PAIN (non-serious) with onset 15Mar2021, outcome unknown.   He received the first dose yesterday and all he had was a little soreness like with the Flu shot. The soreness started 3 hours after the vaccine. His first dose was on 15Mar2021. Second dose is on 04Apr2021. It was recommended and he has no problems taking vaccines. Flu shot: Reporter doesn't have NDC, lot, and expiry to provide for Flu shots that caused a little soreness. His most recent flu shot was Sep2020. Reporter clarified that his left arm is sore and his left arm is where he got the injection.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
NUMBNESS IN RIGHT ARM, HAND AND LEG; TINGLING IN RIGHT ARM, HAND AND LEG; 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: UNKNWON, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced numbness in right arm, hand and leg. On 10-APR-2021, the subject experienced tingling in right arm, hand and leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in right arm, hand and leg and tingling in right arm, hand and leg was not reported. This report was non-serious.
PT is a 53 y.o. female who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 016B21A on 3/30/2021. The patient experienced the following reaction(s) during the immediate  of observation: 10:48am Patient sitting in observation and c/o "feeling faint and heart racing." Patient was treated/managed as follows:  10:49am VS BP 132/78, HR 84, RR 18, O2 sat 99% on room air. Patient instructed to take deep breaths and water offered. Patient reports symptoms resolving. 10:59am VS BP 118/82, HR 68, RR 18, O2 sat 100% on room air. Patient reports feeling better and symptoms subsided. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 11:03am Patient escorted to car by significant other and. RN.
Received 2nd Moderna vaccine in the morning of the 5th, got typical reactions starting around 9pm that night such as fever, fatigue, headache which lasted until 9pm the following day, the 6th.  At about 7pm on the 6th I felt a constricting feeling around my chest, something I'd never felt before.  The constricting feeling grew very painful and was centered under my sternum.  Very shallow breathing but not gasping or needing air just didn't want to take a deep breath/hurt too much to do so.  I was a bit panicked and was thinking that if the feeling didn't go away I'd have to ask my son to call the ambulance.  I'm not given to alarm typically.  The intense pain last for about 1/2 hr before slowly/gradually going away.  I did ask my son to call my PCP but she was away on a vacation so we waited.  A soreness persisted for a few days afterward but that was it, it didn't return.  I rested and got back to normal way of life.
Overnight after the injection woke every 30 minutes to urinate in extremely large volumes. Resolved by next morning. Significant amount of urination never previously experienced. Glucose was 118 at the time.  Also had headache, fever, aches.
Lethargic, unable to focus mentally, widespread pain, Dizziness, loss of balance , blurred vision, nausea. Has now been diagnosed by cardiologist with Orthostatic Hypotension.  Vision changed in less then 5 months ( her last appt prior was in April) and now developed astigmatism in both eyes confirmed by eye doctor. And Primary is now treating for Mast Cell Activation. She is also having very heavy  and painful menstrual cycles now. She has missed  ton of school due to illness since her 2nd dose.
I have had long time COVID-19 symptoms since 01/2021 with tremendous pain in my legs and back. After my 4th vaccine, my symptoms got worse. My back pain also got worse. Blood thinners seem to instigate more pain in my back. My hips and legs really got bad, knees all the way down. I also got nausea. It magnified my conditions, fatigued and brain fog. My calves really hurt and could not really move. I also had problems with headaches and fatigue, loss of appetite. I am not sure if my symptoms are related to the vaccine or my COVID-19 symptoms. I also walked today 5.6 miles but had a lot of pain when walking. I am going to ER today because my body chemistry is out of whack.
since the shot, I had some chills and fever for one day, and now I have constant fatigue, and muscle aches and headache for 14 days.
Information has been received from a physician concerning an 10 yr old Asian male with a history of wild type varicella exposure on 06Mar05 and no other medical history or allergies who on 10Mar05 was vaccinated SC in the right upper arm with a first 0.5mL dose of varicella virus vaccine live (lot 648084/0081P). There was no concomitant medication. There was no illness at the time of vaccination. On 21Mar05, the pt was diagnosed with mild varicella. Unspecified medical attention was sought and no treatment was given to the pt. It was noted that the varicella resolved on its own and the pt recovered on an unspecified date. A product quality complaint was not involved. Additional information was received from a health professional at the physician's office who indicated that in the AM of 28Apr05, the pt was seen in the physician's office because of a rash on his face and abdomen that had started that morning. In the family, two of his brothers had chickenpox recently and also, according to his sister, he had been up to date with all his immunizations. He was noted to be afebrile and his vital signs were stable. A rapid strep test was done and was negative. A head, ears, eyes, nose and throat exam revealed that his ears were TMI, his nose was clear, his throat was injected with no white exudate, and his neck was supple with no adenopathy. His lungs were clear bilaterally, his heart was in normal sinus rhythm, his skin had some macular papular rash on his face and upper chest and abdomen but had no vesicular lesions at that time. The assessment/plan included fever, tonsillitis and a throat culture. Also noted was skin rash, question of viral rash, question of chickenpox varicella. A chickenpox titer, IGM, and IGG test were planned. A throat culture was also planned and if positive, they planned on treating the pt symptomatically with hydroxyzine hydrochloride (ATARAX) one to two teaspoons every six hrs for itching, topical calamine lotion Tid, and topical desoximetasone (Topicort) 0.25% cream BID. He was to stay home the rest of the day and the following day to see if he developed chickenpox. If the pt did not, he would be able to return to school on 02May05. A follow up appt was to be scheduled in two weeks. The pt recovered from mild varicella on 10May05. It was reported that no diagnostic lab tests were performed. It was noted that neither the pt or his siblings had any adverse events following prior vaccination. No further information is expected.
4 hours after vaccine felt tingling in legs, chills, very sore arm at injection site and couldn?t life it at all. Came on rapidly. Took temp 6 hours in, 102 F. Nauseous and sweaty. Felt very weak and could not eat anything. Felt better by next day at 9am, maybe 21-22 hours from vaccine.
She got the vaccine on 12/10/09. She awoke with itching and hives on Dec. 13, 14, 15, & 16. Each morning she took a Benadryl which relieved it. On 12/17 she took a Benadryl early and never had any itching or hives. She never had any more problems.
12/29 vaccination 12/31 woke up with HA; lasted 1 week. I do get headaches. I didnt know if this was related to the vaccine or the pregnancy. Stomach pains but PCP  stated it was ligament pain.
Sudden development of burning sensation weakness and tingling at site of injection (posterolateral aspect left arm)and roundish red raised papular rash, warm to touch and tender to palpation. She also c/o hoarsenss in voice, productive cough and some wheezing that occurred in am of same day. Wsa evaluated by Dr., who advised about symptomatic treatment at home, any any signs/symptoms that she should seek urgent treatment for. No specific treatment given at this time. To F/U with client in a few days.
shingles on her right knee; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in September of 2007 on right side of ribs) and shingles (had another case of shingles in May 2023 on right leg outside of knee).   On 25-SEP-2023, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles on her right knee). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter was a patient. The reporter stated that after her vaccination with Shingrix, she developed shingles on her right knee. When she developed shingles after the vaccine, the shingles was on the same site as her last episode (right leg) The reporter did not consent to follow up.
Patient had more than typical bleeding after injection and slight swelling at injection site. He denied any burning, itching, dizziness, or malaise when questioned. He was told what to do in case any other symptoms occurred and redressed with new bandages. Left with no assistance.
feel something different in her neck; pain in her neck; she can actually feel the injection go into the right of her neck, the middle of the back of her neck into her right breast and then into her right leg; feeling as discomfort and thinks it might be inflammation; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot Number: EN6207) dose 1 via an unspecified route of administration, administered in Deltoid Right on 19Mar2021 (at the age of 60 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced feel something different in her neck , pain in her neck, she can actually feel the injection go into the right of her neck, the middle of the back of her neck into her right breast and then into her right leg feeling as discomfort and thinks it might be inflammation. The outcome of events was unknown.   No follow-up attempts are needed. No further information is expected.
Tested NAAT positive for COVID 10/29/21 after being fully vaccinated.
Contraindication of yeast for this patient; The patient got a rash/ The rash has spread to his chest; This spontaneous report was received from a nurse via company representative refers to a male patient of unknown age. The patient was allergic to unspecified allergies, anaphylactic reaction to unspecified allergy shots (drug hypersensitivity). The patient's concomitant medication was not reported. On 29-JUL-2019, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milligram, lot # R032766 with an expiration date of 31-AUG-20121 (strength, route was not reported) for protection against HPV (prophylaxis).  On an unspecified date in 2019, the patient got a rash on his right upper arm after receiving the vaccine. The rash had spread to his chest. The representative assumes that the rash was in the arm that the vaccine was received. The nurse stated that they were concerned of the contraindication of yeast for the patient (contraindicated product administered). The patient sought medical attention by calling the physician. No product quality complaint was involved.  The outcome of event was unknown. The reporter's causality assessment was not reported.
DIARRHEA; FELT A LITTLE NAUSEOUS; EXTREME WEAKNESS; DIZZINESS(COULD NOT WALK); WIPED OUT; MUSCLE PAIN; This spontaneous report received from a patient concerned a 64 year old female. The patient's weight was 120 pounds, and height was 70 inches. The patient's concurrent conditions included menopause. The patient was previously treated with vitamins nos. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 16:55 for prophylactic vaccination. Concomitant medications included . On 14-MAY-2021, the subject experienced muscle pain. On 16-MAY-2021, the subject experienced dizziness (could not walk). On 16-MAY-2021, the subject experienced extreme weakness. On 16-MAY-2021, the subject experienced wiped out. On 17-MAY-2021, the subject experienced diarrhea. On 17-MAY-2021, the subject experienced felt a little nauseous. Treatment medications (dates unspecified) included: bismuth subsalicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little nauseous on 17-MAY-2021, and muscle pain, was recovering from diarrhea, had not recovered from extreme weakness, and the outcome of dizziness(could not walk) and wiped out was not reported. This report was non-serious.
Beginning 5 days after injection on March 16, I started experiencing back pain. The next day, the 17th, a small red rash started near my navel with itching and started with headache and malaise.  Later that same day I looked on my abdomen and right torso and notice an additional red rash on my right torso, under my arm, leading from my navel.  Itching became intense and the pain started. Vesicles stared on the 18th and I was unable to get an appointment until the 19 the where the MD confirmed Shingles. I was started on Valtrex (generic) 1 tab bid for 7 days. The pain was so intense, I was unable to have any clothing, bedding touch the area. I had a fever, chills, intense pain, with inability to raise right arm due to pain.  There was also a lymph node that was tender and swollen under my right arm.  Treatments included Calamine lotion and OTC Lidocaine applied topically and the fever and headache were managed with Tylenol 500 mg every 3-4 hours until it became unbearable and I requested additional pain meds.  The MD gave me Oxycodone which helped some. The lymph node were no longer tender and sore by day the 28th or so.  The lesions/vesicles started to dry up by 04/02/21 but the  itching persisted and remained very painful. The back pain persisted throughout with difficulty sleeping due to the pain.  By the 4th of April, the lesions had dried completly and all the scabs had fallen off. Some of the nerve pain persisted but clothing was more bearable by this time.  As of today, there is some itching that remains and some back pain with some tenderness on my right torso.
Hives showed 10 days after receiving vaccine. Have continued to show for 3 days since
Dizziness, Nausea, Body Aches, Fever, Chills, Chest Pain, Extreme Fatigue
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX by a physician for routine adult health maintenance and the intended purpose for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus that ZOSTAVAX is intended to prevent. On or about 23-JUN-2010, the patient was treated by a physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Legs and arms were completely paralyzed; Could not walk; Using the walker to move; This spontaneous case was reported by a consumer and describes the occurrence of QUADRIPLEGIA (Legs and arms were completely paralyzed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A, 010M20A and 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020 and Pneumonia (mild case.). Concurrent medical conditions included Adrenoleukodystrophy (Defined as long fatty acids attacking myeloid sheath, damaging it similar to what happens in sclerosis).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced QUADRIPLEGIA (Legs and arms were completely paralyzed) (seriousness criterion medically significant), GAIT INABILITY (Could not walk) and WALKING AID USER (Using the walker to move). At the time of the report, QUADRIPLEGIA (Legs and arms were completely paralyzed), GAIT INABILITY (Could not walk) and WALKING AID USER (Using the walker to move) outcome was unknown.            No Concomitants and Treatment medication were reported.  Company comment: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Quadriplegia. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-370528, MOD-2021-370729 (Patient Link).; Sender's Comments: This case concerns a 69 year-old male patient with relevant medical history of Leukodystrophy adrenomyeloneuropathy (AMN), who experienced the unexpected serious event of Quadriplegia. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The patient's history of AMN remains a confounder considering the progressive nature of the neurologic symptoms associated with the condition. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rash on both hips and lower back along the spine. Other small rashes at various spots. Mild irritation at rash sites.
Pt had fever of 101.7 12 hours after vaccine given. Take to ER, blood, urine, CXR done. IM antibiotics given. Pt. seen in follow-up next day - fine.
Symptoms of heart beating faster, louder and harder with mild pleuritic chest discomfort starting about 5 days after second COVID vaccine, ongoing but improving.  Got his second COVID vaccine on 5.13.2021. Feels like heart is beating out of his chest, constant throughout the day, worst when laying down. Heart rate up to 100 at home. intermittent shortness of breath. No chest pain. After the vaccine, he developed a high fever for 2 days, a sore arm and tiredness.  vitals normal at time of clinic exam today, May 24, 2021  RX: slow breathing, albuterol inhaler, reading recommendation: Breathe by hcp
The person who administered the vaccine was a student and injected it directly into my acromion process.  As a result I can barely move the left arm outward and upward. I have nerve pain up and down the entire arm into my fingers. The entire arm is stiff and rigid when I wake up in the morning.
About 12 hours, post vax, infant developed a temperature of 102F with extreme irritability. Temperature lasted 48 hours and irritability lasted 72 hours.
Significant increase in heart palpitations, arrhythmias, and strong beat. Gray-outs when exerting, like hiking in mountains. Shortness of breath has increased. Started a week or two after the second vaccination
death(month died: Feb2022); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ5342) 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: DEATH (death, medically significant) with onset Feb2022, outcome "fatal", described as "death(month died: Feb2022)". The patient date of death was Feb2022. The reported cause of death was unknown. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death(month died: Feb2022)