chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient was vaccinated for prevention of shingles. A product quality complaint was not involved. Additional information has been requested. 05/16/2008 Information has been received from a patient with no pre-existing allergies, birth defects or medical conditions, who on 17-OCT-2007 was vaccinated with a dose of VARIVAX (Oka/Merck). It was reported that the patient was vaccinated for prevention of shingles. There was no relevant diagnostic tests and laboratory data. There were no adverse events following prior vaccination. There was no illness at time of vaccination. There was no adverse experience. A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from a physician indicating that the patient called his office greatly concerned about the varicella injection he had received. He stated the shot he received was called ZOSTAVAX (Oka/Merck). He expressed his frustration about the error and wanted answers. The physician explained that the varicella vaccine he received was actually ordered for another patient who was scheduled for an appointment that day. When this patient walked in on their busiest day of the week without an appointment, wanting the shot right then, he was inadvertently confused with the other patient. The office did their best to accomodate the patient. The physician told the patient that it was not usual and customary to drop in a medical office without an appointment, for routine medical care. The patient was overly concerned that it would cause harm to him. The physician explained that "shingles" is cause by the varicella virus, the same virus that causes chickenpox. The vaccine ZOSTAVAX (Oka/Merck) is actually a boosted dose of the chickenpox vaccine currently given to children. The physician told the patient that since he had the chickenpox and the vaccines in the past, it should not cause an adverse effect on him. The physician informed the patient that he would call the manufacturer to confirm that information. He patient indicated that he already called but would do more research to find out himself. The physician indicated to the patient that he did not carry ZOSTAVAX (Oka/Merck) and that he would have to obtain it elsewhere. The patient indicated that he already scheduled an appointment with his wife's physician. The patient indicated that he was "sorry that he had to turn him into the insurance company". The patient expressed gratitude for all the previous medical care the physician rendered and requested that the physician forward the patient's medical record to the other physician. No other information was provided.
She gets sick; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 62-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date, reference case US2021AMR064841) and Shingrix with an associated reaction of pyrexia (2nd dose received on an unknown date, reference case US2021AMR064854).   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient had reported the case for herself. The age at vaccination was not reported. The patient got sick after the flu shot. The consent to follow-up was requested.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR064841:Same reporter. US-GLAXOSMITHKLINE-US2021AMR064854:Same reporter.
Pt received flu vaccine at 9:15 and was under observation for 15 minutes when Sx onset began. Pt was lethargic, lightheaded and dizzy; Upon examination pt was guided to the floor and evaluated by the NP on-site. Upon examination by NP, pt was having trouble breathing, and given one dose of epinephrine. Vitals taken and monitored while a code blue was called. Pt was monitored until hand off to EMS at approximately 0940.
Not sure if this is related to the vaccine but 6 days later I woke up drenched in sweat.; Rash like area; with raised bump on buttocks; It seems to be a shingles outbreak; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 18Mar2021 at 15:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021 (6 days after vaccination), the patient woke up drenched in sweat and had a rash like area with raised bump on buttocks, that seemed to be a shingles outbreak. The patient was not sure if that was related to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events drenched in sweat and had a rash like area with raised bump on buttocks, that seemed to be a shingles outbreak were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient was given 0.5ml instead of0.25ml. Patient was called and denies any problems since vaccination. Patient was sent a letter notifying her of dosage given also
On Friday May 28, 2021 at 10:00 I had the second/booster Covid-19 shot at the outpatient clinic. At approximately 2:00 PM that day I started vomiting. I continued to vomit until I was EXHAUSTED on Sunday 08/30/2021 when we called 911 and I was transported to hospital by ambulance. They ran tests and my kidneys and liver were failing plus my heart was in SEVERE a-fib. I was admitted and was assigned the top heart and internal medicine team. Within five days they got my kidneys and liver to an acceptable level of functioning again. But my a-fib was not under control because the Beta blockers caused me to vomit uncontrlably. After ten days there in the hospital, it was agreed by the lead doctor that I would be allowed to go home where she and I agreed that I would take a Beta blocker along with an antinausea medication.   It took me weeks to get my digestive system to settle down/  One of THEE WORST resultants from taking the Moderna second/booster shot is that my sense of taste and smell has been drastically adversely altered = certain foods TURN MY STOMACH to the point of nausea and vomiting!  EX: all specific food tastes and smells terrible!  Certain common foods smell and taste terrible such as beefy chilly, roast chicken, white bread, certain frozen entrees just to name a few.   My nose now runs almost constantly so I have to carry three soft paper towels to blow my nose and use nasal sprays to help relieve the constant flow of mucus.   Oh, by the way, when I was in hospital, I met and talked to dozens of people there that had the same or similar negative effects from the Moderna vaccine.  I also talked to a lady who had a nephew who had the Moderna booster and had to be revived three times (defibrillated) and by now in all probability be medically discharged from employer.
This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (Patient's relative) reported for a female patient of an unspecified age received BNT162B2 (PFIZER COVID 19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at unknown dose number, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received the Pfizer Covid vaccine. The patient was fine and healthy after the shot. Subsequently she fell down, hurt her hip and broke her wrist. Last Monday, she went for a steroid shot that was given in her wrist. On Tuesday, she was flushed and threw up. They took her to the hospital, and she was diagnosed with blood clots in her brain. She has been in the hospital since that Tuesday (unspecified date) due to the reported events. She has since been admitted to the hospital with a swelling of her brain, and confusion. The events happened on unspecified dates. She is scheduled for a magnetic resonance imaging (MRI). The outcome of the events was unknown.  Information on the batch number has been requested.
Arm pain, gradually increasing from day the shot was given.  One day after shot, a lump formed under skin that gradually got larger as days passed.  Larget is was was 3/4 size of ping pong ball.  Area was black, blue, green and very sensitive to touch almost immediately.  Also caused flu like symptoms approximately 12 hours after shot was administered.  Infection grew worse over next few days and sought out medical treatment 7 days after shot was given.  Was given Diclocil antibiotics.  By this time the arm was very sore to move, hot to the touch and getting worse by the hour.  It also caused slow and increasing swelling of my entire body from day one of the shot.  At one point, The area was so bad, it looked as if someone had taken a mellon ball scooper and scooped out all the tissue around the sizeable lump right down to the bone.  By this time, the rest of my arm had begun to swell to the point of making my fingers numb and I thought I was in danger of serious blood infection or arm amputation. I sought medical attention 7 days after the shot was given, I was overseas and had to go to hospital there. I was advised that this was a very serious infection and I was not to leave the Bangkok area for at least 12 days to make sure the infection was under control.  During the time after the shot was given, sweats and chills were prominent, and fever up to 101.3 were detected, with other fevers hovering at 100.00.  The swelling of my whole body progressed with time.  After I started the antibiotics, the swelling subsided about 20% and the lump gradually diminished to about 1/3 the largest size it had been.  After 7 days of anti-biotics, the infection came back rapidly, within 12 hours of the last pill, and developed rapidly. Over the course of 3 hours the arm had swollen significantly and the lump tripled in size and the discoloration began to return.  Two days after ending the first round of antibiotics, I saw urgent care at home. I was advised to take augmentin for 10 days and if it did not improve within the first three days of treatment, to go to the ER to have it drained and get stronger drugs.  So far, the augmentin has made the swelling go down, the lump has diminished but is not gone, and the over all sick feeling has subsided to some degree.  The color is improving but you can still see the marks from the worst it had been.  This has been a very scary infection for me.  It does not want to seem to go away.  I am resting and drinking fluids and eating easily digestible foods, although my appetite is zero.
Pt states that following Thursday/Friday he had headache which lasted for 2 days, then woke up unable to see out of eye. Went to Hospital ER (Dr on earlier page).
Information has been received from a registered nurse concerning a 15 month old female (41 inches, 36.3 pounds) who on 14-FEB-2003 was vaccinated subcutaneous (left arm) with Varivax (lot # 643588/0804M). Concomitant therapy that day included MMR II (lot# 642703/0629M) administered SC and Recombivax (lot# 643684/0707M) administered IM. On 31-MAR-2006 the patient developed a chickenpox (varicella) rash consisting of less than 50 lesions. She did not have a fever, and she had no reliable prior history of chickenpox. She was diagnosed with chickenpox on 03-APR-2006 by the registered nurse at her preschool. There were no relevant diagnostic or laboratory tests performed. The patient's outcome was not reported. Additional information is not expected.
I am experiencing some issue with arrhythmia; I sustained significant changes in my arrhythmia; Shoulder pain; local injection discomfort, have pain for couple of days; shoulder pain; This is a spontaneous report from a contactable physician. A 73-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 73 years old on 23Sep2021 (Batch/Lot Number: 301458A) as DOSE 3, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 01Feb2021 (lot number: EL9265) for COVID-19 immunization and second dose of BNT162B2 on 11Feb2021 (lot number: EN6700) for COVID-19 immunization. On an unspecified date, the patient experienced local injection discomfort, have pain for couple of days, shoulder pain. Also, the patient was experiencing some issue with arrhythmia. The patient sustained significant changes in my arrhythmia. The patient underwent lab tests and procedures which included EKG that showed little bit more vigorous; have a high PVC load and significant increase in the PVC load for 2 to 3 days after the injection. The patient also had BNP, CBC and pulmonary function test but results were unknown. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Arrhythmia and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101340544 Same patient and drug, different event separated in time
My arm has been getting progressively more painful. It is now 37 hours after the shot and the arm is so painful that I am completely unable to sleep. I've taken tylenol and it is still a 7/10 pain level. I was not prepared for the intense and nonstop pain.
On Wednesday, March 31, 2021 client received her second dose of  COVID vaccine at approximately 3:15pm. While in Observation Area, patient reported to EMTs on site she felt a sensation of "dizziness and some blurry vision" at 3:35pm and vitals were taken by EMT. Vitals at 3:35pm: BP: 124/82, HR: 72bpm, 02 sat: 98%. Lead PHN was alerted and client stated she experienced the same sensation of "dizziness and some blurry vision" with her first dose. Vitals were taken again at 3:47pm. Vitals: BP: 120/82, HR 90, O2 sat: 96%. Client was seated on the anti-gravity chair and given a bottle of water. Client was observed for an additional 30 minutes. At approximately 4:15pm client stated she felt "slightly better and not so dizzy." Reassessment of vitals were offered by EMT but were refused by client. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Client was educated by Lead RN & EMT on signs and symptoms of adverse reactions and when to go to the ED/call MD. Client was also encouraged to sign-up on v-safe. Client left vaccination site at approximately 4:22pm with a steady gait.
Fever of 104, severe chills for 2 hours, aches in joints, extreme fatigue for 36 hours after the adverse reaction started.  Severe mid back pain 48 hours after the adverse reaction started.
FIRST (1-3 am): vomiting (wet/dry heaving), nausea, diarrhea, chills, extreme body ache and muscle pain. LATER DURING DAY: extreme lethargy, site of shot (upper arm) remained painful and hard to lift arm.  NEXT DAY: Bruise at site of shot then developed, and I felt fine.
fever severe rash nodules possible Kawasaki syndrome - see enclosed sheet  The patient is a 15 month old male who presents for evaluation of a rash. The onset of the rash has been sudden and has been occurring in a persistent pattern for 1 week. The course has been increasing. The rash is characterized as red. The rash was first seen on the face. It spread to the upper extremity and the lower extremity. There has been associated itching (eyes), erythema and edema, while there has been no associated pain. There has been associated fever, while there has been no alopecia, anorexia, chills, malaise, nail changes or pain. Note for "Rash": Itchy eyes started on 6/19/2019. Rash started on 6/23/2019.  Mom stated he has some "hives on his legs" 6/24/2019. Itchy eyes. No other itching noticed by mom. Fever when temp was taken at home. Mom stated "feels warm to the touch." Mom thinks possible reaction to vaccines given at previous nurse visit.
Infant developed rash over body (trunk) within 20 minutes of receiving immunization. Slight fever, no difficulty breathing or other symptoms.
On 03/04/2023, around noon, I was in out of town, and I had cold symptoms. I had sore throat, congestion and cough.  We were getting ready to come home. Once home, on March 8, I took a home COVID-19 Test and it was positive. I called my doctor on Monday and he by phone, called in a prescription to prevent infection. I was too late for the viral drugs. I lost taste and smell and had brain fog.
2 hours, post vax, pt experienced seizure (shaking for 2 minutes) followed by decrease in level of consciousness. Taken to Pediatric ER at hospital. Review of systems were negative. Impression: Febrile seizure (pt was running 99F-100F) for several days. Given Motrin and released.
I was given shot on left arm, a few hours later my left side of my face became swollen, also a rash and around eye became swollen.  My primary care doctor saw me the next day.  She recommended if it got worse go to Emergency Room over the weekend.  Over the weekend my face got worse and I went to Urgent care . The Doctor prescribed predisone.  A few days later my left side got better and my right area around the eye became swollen.  It last another five days before finally going down.  Its been 10 days and I finally look 95% back to normal.
Shingles on Right Arm; This spontaneous case was reported by a nurse and describes the occurrence of Shingles on Right Arm in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Atherosclerosis. Concurrent medical conditions included Diabetes and Diabetes.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced Shingles on Right Arm. At the time of the report, Shingles on Right Arm outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from a physician concerning a 50 yr old male, with diabetes mellitus, who on 18Apr06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). On 18Apr06 the pt developed severe swelling of his injection site arm. It was reported that pt was not hospitalized, but he was seen in the ER and released. No product quality complaint was involved. Outcome was not reported. Additional information has been requested.
patient had anaphylaxis to dose #2 of Pfizer Covid Vaccine so opted to receive J&J as booster.  approximately 33 minutes after administration, patient started to have hoarse voice and felt the need to clear throat; when questioned further stated she also had a slight headache and upset stomach; patient's care was transferred to Urgent Care department in same facility as vaccine administered where she was administered an EpiPen,  diphenhydramine 50mg IM, dexamethasone 10mg IM; she was monitored for one hour with no return of symptoms, sent home with prednisone 40mg po x 5 days and instructed to take another dose of Benadryl in the evening; patient also has EpiPen prescription due to previous anaphylaxis
Developed shingles immediately after their booster shots; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient was reporter's friend. The age at vaccination was not reported. The patient developed shingles immediately after the booster shot. The reporter stated that the doctor already explained this to the reporter. The follow-up would not possible as no contact details were available. This case has been linked to US2022AMR021503, from the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR021503:Same Reporter
Patient is a 4-month-old, she developed onset of fever of 102, decreased appetite and emesis.  Parents were instructed to do symptomatic treatment with TYLENOL and PEDIALYTE. Later that afternoon she had an episode where she went limp with her eyes wide open, unresponsive, lasting 4-5 seconds. There was no associated apnea or color change. No abnormal movement movements or jerking. They called EMS after which she had 2 more episodes within 30 minutes. She was brought to the emergency room where she had a fourth brief episode of going limp. Vital signs were stable. She was transferred to hospital for admission and further workup. Hospital course included lab testing including blood work and CSF, EEG and MRI all of which was within normal limits. Ammonia level was slightly elevated thought secondary to delayed processing. Pyruvate, amino acids and organic acids were normal. Neurology was consulted and did not recommend any medication at this time. She was discharged home in stable condition.
This spontaneous report as received from a nurse referring to an unspecified female patient (age unknown) who was vaccinated with a dose of ZOSTAVAX (lot # and expiration date and dose not reported) in 2008 who developed shingles recently. At the time of this report patient's outcome was unknown. Additional information has been requested.
This literature report concerns a previously healthy 14 year-old male patient. On an unknown date the patient received H1N1 (manufacturer unknown). Two weeks after receiving the vaccine the patient developed a 7-10 day history of urinary retention, progressive sensory and gait abnormalities. T2-weighted MRI (magnetic resonance imaging) scan of the brain and spine revealed longitudinally extensive demyelinating lesions of the cervical/thoracic cord with marked cord swelling together with multiple smaller hyperintensities in the brain. Cerebrospinal fluid revealed WBC (white blood cell) 1295/mm3 and IgG index was 0.65. The event outcome was not reported. Reporter's comment: Neurologic complications of H1N1 vaccine are rare, but may occur. Further studies are needed to help clarify the incidence of demyelinating complications related to this vaccine as well as the environmental, genetic and other risk factors of acute demyelination in children.