chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm was swollen, hot to the touch, welts from the elbow to the shoulder. This lasted for two days, I was very uncomfortable and I stayed in bed taking Advil and Benadryl. By the 4th day, I felt back to normal.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. On 05-AUG-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # 0172AE) with an expiration date of 18-APR-2013. No adverse effect reported. Additional information has been requested.
Patient stated he became aggressive, paranoid, severely depressed. Also considered suicide. Symptoms were similar but mild with the first dose. Patient stated he did not drink any alcohol or take any medications during this time. No family history of mental disorders. Symptoms lasted approximately 4 days. Patient did not contact physician or get medical treatment.
Starting mid October I had autoimmune disease symptoms, starting with face butterfly rash, rash all over body that itched, was painful, hot and felt tight. My hair started falling out, severe headaches daily, extreme fatigue, painful joints, pain in feet, knees, hips, neck, reoccurring acid reflux, depression, congestion. I have started the aip diet. I did go to the emergency room twice last week of October. I have been off work due to event. The question can be raised, if a prior autoimmune issue was flared by the vaccine?
After injected two doses of vaccine I feel left armpit lymph node always painful. Sometimes extended to low part of left breast. Until May of 2021 I found a tumor at left low part of breast. Following the 3 months to checked with clinic of OBGYN Medical Center and Cancer Center, Test with Mammogram, Ultrasound and biopsy. Finally, I was diagnosis a INVASIVE MAMMARY CARCINOMA with Metastatic cancer to axillary lymph nodes. From Sept. to now I was treated with Chemotherapy and total left breast mastectomy with near by lymph modes mastectomy. I had off work for 4 1/2 month. Over all estimate need one year treatment.
I got my period almost right after even though it wasn't due for a while. I've been bleeding and spotting since(shot on the 8 and today is 30- Nov. 2021). This is extremely abnormal for me. I've never spotted in my life, let alone for this long! And my typical cycles last 3-4 days. I hope it stops soon. Just wanted to report in case it becomes relevant. Also, the typical reaction of feeling like I had the flu and extremely tired the next day. Arm swollen badly.
pt recv vax 8SEP98;exp maculopapular rash all over body;rest PE nl;dx non specific rash;
mild reaction to moderna dose 1; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (mild reaction to moderna dose 1) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     Concurrent medical conditions included Drug allergy (Polysorbate 80) and Drug allergy (PEG (Polyethylene glycol)).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (mild reaction to moderna dose 1). At the time of the report, HYPERSENSITIVITY (mild reaction to moderna dose 1) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient Shingrix around May of 2019 and had a sore arm.  He did not know the date. He was not willing to provide any additional information and caller disconnected the call.  He did not provide his address. The reporter did not consent to follow up. This case is linked with US2019145717, reported by same reporter.
Fainted and lost all of my color within 5 mins of receiving shot.  Was drenched in sweat and browned out for a solid period of time.  EMS had to come and my fiancé had to come pick me up.  I now have a 102.1 fever and have been shaking and sweating or having the chills throughout today.  My whole body aches.  This could not have come at a worse time with work.
Adacel was administered to a 5 year old patient by mistake, with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who had adacel was administered to a 5 year old patient by mistake, with no reported adverse event after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), and family history were not provided. No concomitant vaccines were given.   On 02-Jun-2023, the patient received a 0.5 ml once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection,  unknown strength, expiration date, lot U47461AA via intramuscular route in unknown administration site for Immunization.  On 02-Jun-2023 the patient developed a non-serious adacel was administered to a 5 year old patient by mistake, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event adacel was administered to a 5 year old patient by mistake, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient starting feeling very sweaty, nauseous, light headed, dizzy almost immediately after sitting in the post vaccination chair. I had already instructed him to sit on the floor if he started feeling faint  as he stated previous fainting episodes as a kid. He sat on the floor, then laid on the floor. I brought him a garbage can in case he got sick, an ice pack, wet paper towels, and a bottle of water. After 5 minutes or so the color came back to his face and he started feeling much better. He then sat back in the chair, then stood up and stated he was feeling back to normal. I asked him to stay standing an extra minute just to make sure he was good, then he left with the woman who was with him during the vaccine.
She states that she was seen for travel here at our clinic on March 14th for pre-travel in preparation to a trip (see records).  She received yellow fever, typhoid, hep B, polio and meningitis vaccines at that time.  She states she had a sore arm for two days.  Then approximately on 03/21 she developed a "mild sore throat, stuffy nose and headache" and thought she would develop a "cold" but "never developed a full-blown cold".  On 03/23 she developed a full body rash ('somewhat raised and bright red like a sun burn and kind-of blotchy").  She felt she had "chills" like when "you have a sunburn".  She felt she developed a fever (tactile--since not documented) that "broke yesterday".  Her rash and tactile fever seem to have resolved over the last 24 hours but her myalgias and arthralgias have worsened.  They are in her hand and feet (all digits), ankles, elbows, and shoulders.  In addition, her fingers, hands and feet have swollen over the last 24 hours and her digits feel like "sausages".  On ROS she reports one day of diarrhea (03/23) which has resolved.  Some mild "chest discomfort" she gets when she has a cold and needs her inhaler.  The remainder of her complete ROS is negative. Her "boyfriend" developed "bad" diarrhea (very watery) and a tactile fever starting on ~03/23.  They were both seen last night where her boyfriend was told he had a "fever" but wasn't given the actual temperature and she recalled being told, "there is nothing I can do, take ibuprofen and call the travel clinic in the morning".  No other know exposures, no recent travel, single sexual partner (boyfriend), no recent animal exposures (bitten by a dog 1.5 years ago), sister with Crohn's disease and father with celiac.
came back later on their lower trunk; vaccination site rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (came back later on their lower trunk) and VACCINATION SITE RASH (vaccination site rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (came back later on their lower trunk) and VACCINATION SITE RASH (vaccination site rash). At the time of the report, RASH (came back later on their lower trunk) and VACCINATION SITE RASH (vaccination site rash) 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.   No Relevant concomitant medications was reported.  Treatment information included treated with a steroid.
After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye.  Patient has double vision now.
I received my first vaccine 12/22/2020 at 3:45pm. My right arm was sore like I would have expected and everything else was fine, until 12/31/2020. My left upper thigh had a burning feeling around the outer part and in the goin on that thigh a painful lymph node. That afternoon I had a burning sensation on my left butt cheek. When I looked I noticed a very small rash with blisters. I waited through the weekend because I knew the OBGYN was not open. I called first thing Monday morning and made an appointment as soon as they could see me which was the next day  (1/5/2021)at 3:30pm. The doctor took samples and sent them to the lab for testing. The test was positive for shingles. I am now taking valtrex for shingles.
Initial report was received 15 June 2011 from a health care professional. A 58-year-old female patient (age calculates to 53 years) who had a history of asthma and allergies to codeine and iodine, had received an intramuscular right deltoid injection of DECAVAC, lot number U3492BA on 28 April 2011, and within 24 hours, the injection site became hot, swollen and reddened. An unspecified amount of time later, she complained of fever, chills, and generalized achiness. Approximately one and a half months later (also reported as "now"), she had experienced asthma attacks. The patient was evaluated by her physician (date and results of doctor visit were not reported). Laboratory and diagnostic testing noted WBC 3.4 and a normal chest x-ray. The patient had no concurrent illness at the time of vaccination and she had been taking HCTZ (diuretic) concomitantly. She had not experienced any adverse events after receipt of previous vaccinations. She had received a prior dose of DECAVAC "years ago". According to the reporter, the patient remains having issues. Outcome was reported as not recovered. Follow-up information was received from a health care professional on 14 July 2011. The patient's age was confirmed as 53-years old. The patient had no additional medical history reported. The onset for the event was reported as 29 April 2011 and lasted for about one and a half weeks but the asthma signs and symptoms occurred again in May. One occurred after the vaccine and then again one few weeks later. The patient also experienced wheezing during the asthma attack. The patient was treated with inhalers but required no hospitalization. The etiology or trigger was not identified for the recent asthma attacks. The patient's doctor (MD) stated that he thought it was linked to the vaccine. The outcome was reported as recovered on 04 July 2011. The reporter for this case is the same as case number 2011-03459, 2011-03461 and 2011-03462.
Slight fever began at 11:PM on 6/6/17. Body aches and fever increased to 102-103 throughout 6/6/2017. Aspirin and Tylenol were taken. headache, low blood oxygen saturation of 91 and heart rate of 130-145 treated with Xoponex through nebulizer brought O2 saturation back to 95. Fever reduced to 101 by 5:00 PM on 6/7/17. Body aches and back pain ended 6/8/17 at noon.
Information has been received from a registered nurse concerning her 17 year old niece, who, on an unspecified date, was vaccinated with a first dose of Gardasil.  Subsequently, about an hour and a half post vaccination the patient experienced "stomach aches, nausea and dizziness."  The patient did not seek medical attention.  The patient recovered on an unspecified date within 2 hours after vaccination.  No product quality complaint was involved.  Additional information has been requested.
This case was reported in a literature article and described the occurrence of rheumatoid arthritis in a adult female subject who received Flu seasonal TIV Dresden for prophylaxis. On an unknown date, unknown after receiving Flu seasonal TIV Dresden, the subject developed rheumatoid arthritis. Serious criteria included GSK medically significant. The outcome of rheumatoid arthritis was unknown. The investigator considered that there was a reasonable possibility that the rheumatoid arthritis may have been caused by Flu seasonal TIV Dresden. Additional information updated This case was reported in a literature article and described the occurrence of rheumatoid arthritis (RA) in a middle-aged female who was vaccinated with unspecified inactivated trivalent influenza vaccine (manufacturer unknown) for prophylaxis. The patient was a part of study in which vaccine side-effects related studies were discussed. The patient was healthy. No information on patient's family history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified inactivated trivalent influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. It was reported that the patient received standard dose of vaccine. On an unspecified date, an unknown period after vaccination, the patient developed RA. Treatment was unknown. The outcome of the event was not provided. The author stated, "The vaccine-induced auto-immune disease may have atypical presentation when compared to the idiopathic origin counterpart. This might direct to-wards slightly altered pathologic mechanisms directed at vaccine-related phenomena. The incidence of autoimmune reactions to influenza vaccines is currently unknown, but it can no longer be assumed that a coincidental (i.e., un-related) association exists between immunization and the onset of RA and systemic lupus erythematosus (SLE)." The author concluded, "Although no strong evidence exists to contraindicate vaccinations, even in patients with existing autoimmune conditions, though the immune response if not as strong as in normal individuals, the benefits granted for routine vaccination. There might be a special group of the population with more predisposition to vaccine-related adverse effects, and only with more epidemiologic data and physician awareness and reporting, we might be able to find the at-risk groups and lower the incidence. Similar to analyzing HLA-B*5801 status in the high-risk population before prescribing allopurinol for gout, we might be running special panels for those at-risk communities before vaccinating." This is 1 of the 3 valid cases reported in this literature article.
Pt experienced hives. She had taken oral toradol earlier in the day stated she has had this medication and has received influenza shots in the past in without problems. She went to the hospital was admitted and observed in the ICU. Received IV fluids discharged on day 4 with an ENT eval, and referral to an allergist and pulmonologist.
Circular ball like swelling on both thighs underneath fat; This case was retrieved during the Reporting System monitoring on 12-JAN-2023. The original narrative from the sender is the following:  Circular ball like swelling on both thighs underneath fat, no redness or pain.  The reporter did not provide an assessment of causal relationship between Vaxelis and the event "injection site swelling",  No further information is expected
dose 1. Pain, redness, swelling ,heat at the injection site. Acute flu like symptoms approximately 8 hours after receiving the vaccine, fever chills, muscle joint ache, deep bone pain, etc. Severity reduced with Tylenol- but not completely masked.  Acute flu like symptoms eased to regular flu like symptoms lasting for 3 days, fatigue sissiness headache  lingered for 2 more.  Interrupted routine significantly. Symptoms dissipated and on the advice of pharmacist returned for dose 2 on 12/26/2019 same facility  Same pattern returned unfortunately. Injection site bled slightly on dose 2.
patient called almost 2 weeks after getting her vaccination saying that she has a sharp pain radiating all the way to her wrist
Bilateral upper extremity myalagia. Headache. Fever to 100.5. Overall fatigue
sweaty; left arm where the shot was given is very hot to the touch; feeling ill; fatigued/ vaccine drained me'.; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), VACCINATION SITE WARMTH (left arm where the shot was given is very hot to the touch), MALAISE (feeling ill), FATIGUE (fatigued/ vaccine drained me'.) and MYALGIA (muscle ache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015F21A, 012L20A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced HYPERHIDROSIS (sweaty), VACCINATION SITE WARMTH (left arm where the shot was given is very hot to the touch), MALAISE (feeling ill), FATIGUE (fatigued/ vaccine drained me'.) and MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 31-Oct-2021, MYALGIA (muscle ache) had resolved. At the time of the report, HYPERHIDROSIS (sweaty), VACCINATION SITE WARMTH (left arm where the shot was given is very hot to the touch), MALAISE (feeling ill) and FATIGUE (fatigued/ vaccine drained me'.) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included Fluids.
a mild headache; but she is still dragging on energy and is still fatigued.; dragging on her feet; mild pain in the left arm; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 30Apr2021 at 14:00 (at the age of 56-year-old) as a single for COVID-19 immunisation at pharmacy. The patients Medical history and concomitant medications were not reported . No investigation assessment. No family medical history relevant to adverse was reported. Vaccine Administered at Facility was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No vaccines administered on same date of the Pfizer suspect. Report not related to a study or programme. Reporter gave consent to contact. No previous immunization with the Pfizer vaccine considered as suspect. on 30Apr2021, the patient experienced mild pain in the left arm, and on 01May2021, she experienced a mild headache, but she was still dragging on energy and was still fatigued, dragging on her feet. It was reported that, a 56-year-old female patient who received her 1st dose of the Pfizer COVID Vaccine on 30Apr2021. She experienced mild pain in the left arm, a mild headache, and tiredness. It was going to be 2 weeks tomorrow, but she was still dragging on energy and is still fatigued. She mentioned that she can do her daily routine and was getting the proper amount of sleep but every morning she just feels fatigued and dragging on her feet. She texts with her doctor and they mentioned that they have also observed this in patients lasting for about 4 to 6 weeks. She was due for her 2nd dose on 21May2021. She was asking if it was normal for her to have the fatigue for this long. Patient asked, was it normal for her to still have fatigue 2 weeks later. Patient stated it kind of went away that following Monday and then it came back, and she has been dragging this week more noticeably, it will be 2 weeks tomorrow. No treatment was received for the events. No adverse event required a visit to emergency room or physician office. No relevant tests were performed. No product quality complaint was reported. The outcome of event mild pain in the left arm was resolved on 01May2021 and mild headache was resolved on 03May2021,outcome of the events but she was still dragging on energy and was still fatigued and dragging on her feet was reported as Not resolved .   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Started 10/8 in AM, itching, warm, hard to touch, no fever.
Patient received H1N1 and seasonal flu vaccines on 11/05/09. The next day on 11/06/09 patient reported having heaviness in her chest, she was wheezing severely. Patient contacted her doctor and the doctor told patient to practice breathing. Patient is now doing better.
it took about 24 hours for: oral ulcers /sores, stye in right eye, 3.5 above normal degree fever. It took 36 hours for: diarrhea
The following morning, I woke up with a flu-like symptoms - I had high temperature; my body ached; I had weakness. My arm was sore but no big deal. It lasted for 24 hours. I had the same symptoms after the first vaccine also.    I became dangerously anemia. On August 6th I had to get blood transfusion - was in the hospital for a couple of days. They did not find any internal bleeding. They didn't find a reason for it.  In my history, I had anemia when I was a child and when then about 20 or 22 years ago also. They told me to take 81 mg aspirin and stop the 325 mg aspirin. Also My heart rate was skipping - when they put me on a 30 day halter monitor. But the doctor wasn't concerned about - it skipped only periodically. I am wearing a FITBIT - plus whenever I feel like I'm short of breath - I put the oximeter on my finger - once it was 34.  I am still on Medication and go to Hematologist - Ferritin - 325 mg twice a day is what they put me on.
Multiple seizures. Unable to move for up to 6 hours during first ER visit has been on Keppra the last 2 years to keep seizures at bay.