chrisvoncsefalvay/vaers-outcomes huggingface dataset:
day p/vax pt devel itchy bumps, looked like blisters under & around back of rt arm & on chest, itching growing bigger than popping & scabbing over & clearing up
Patient felt a bit numb in his arm the first day and sore but that seemed ok the next day. His main complaint was that his arm was red but not at the site of injection. Redness was located from below injection site down to elbow.
Within 5 minutes of injection felt dizzy, trouble breathing. Requested Benedryl immediately and took - pill. Over next 15 min started feeling nauseated, lips started to tingle, mouth and tongue felt heavy and I had to try harder to enunciate words. Went to ED and received prednisone. Tongue was a little swollen at this point. Airway was regularly checked and did not close.
Expired Pfizer vaccine administered past the 12 hour expiratory time. No known adverse event.
I got a fever, headache, fatigue, and nauseous for 3 days after the shot. My left arm was very sore and it went into my neck.   It is now 4 months later and I can still feel exactly where my shot was given. I have pain in my left arm and am weaker on that side. I am very fatigued all the time and get nauseous randomly.  I also get severe night sweats. Every day I take a nap at lunch and go to sleep by 8 each night. I am not sure what will happen when I have to go back to the office.  I also get random fevers where I feel bad and my fever goes to 101 degrees. Those usually last a day and then subside.
Caregiver for patient contacted mom and advised of rash on right leg and advised mom to be seen. Mom presented straight to office and was evaluated by physician. Mom denied any rash this morning; pt presented with asymmetrical redness, warmth, and induration - 5 cm x 6 cm on right thigh.
Initial unsolicited report received from a consumer (patient mother) on 15 August 2015. A female patient, whose age, medical history and concomitant medications were not reported, had received a dose of Meningococcal Vaccine (manufacture: unknown, batch number, route and site of administration were not reported) on unspecified date. On unspecified date, after vaccination as scheduled, the patient came down with less than two years and vaccine did not work. It was reported that parent will not rather expose her children to the ingredients in vaccines if they are going to have potential harm while not even preventing the infection. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Upon medical review, the case was considered as serious due to important medical event: meningococcal meningitis. Documents held by sender: none.
I was counseling patient on her prescription and she mentioned that the doctor had given her prednisone due to the reaction to the Covid vaccine she received on 01/14/22. She stated that the next day after getting the vaccine her arm became swollen and pain full. Then over the next two days it progressed to numbness and pain in both arms. The numbness and pain then shifted to one the right arm only where she had gotten the vaccine. She also mentioned that she developed little bumps under her right arm and breast. Her breast, right arm, and shoulder now feel very pain full and numb. She also added that with the first two doses she did get the bumps, but they went away. But with the third dose it seems that the bumps are not going way, and she is also experiencing numbness and pain. So she went and seen her doctor, and was prescribed prednisone. I informed patient to continue monitoring, and if she develops trouble breathing or rash to seek emergency care.
Initial report received from a consumer (the patient) on 22 OCTOBER 2014. A 75-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number and dose in series not reported) in right deltoid on 20  OCTOBER 2014. The patient was feeling tired on the day of vaccination from over activity and pre-existing physician diagnosed allergies, birth defects and medical conditions incudes allergy to shellfish, seasonal rhinitis for which patient received ZYRTEC and cough due to acid reflux. The patient's concomitant medications were not reported. The patient had been receiving yearly flu shot.  On 02 OCTOBER 2014, same day after vaccination, the patient developed weakness, dizziness, low grade fever of 99.6-100.6 degree Celsius. The patient slept the entire day and also experienced soreness at the injection site. IT was reported that the reaction was due to a week immune system but the patient states that she does not have a week immune system. Patient did not seek physician evaluation and treatment. Complimentary investigations were not reported. On 22 OCTOBER 2014, the patient had recovered from the symptoms. Documents held by sender: none.
she experienced symptoms like having water in her head; which severely affected her hearing.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team and legal division. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: HEAD DISCOMFORT (non-serious), outcome "unknown", described as "she experienced symptoms like having water in her head"; HYPOACUSIS (non-serious), outcome "unknown", described as "which severely affected her hearing.".  Additional information: She mentioned after her second dose, she experienced symptoms like having water in her head, which severely affected her hearing. She mentioned she's been contacting the legal department on her own, but that if she did not get a response, she would be contacting a lawyer. She then added that another friend of her had the same problem.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300190787 same reporter/drug/AE, different patients;
Arm was sore initially. Around 4:00 on 11/13/99, redness, warmth and itching began, progressively worsening until pt came to ER to seek treatment.
Patient had initial onset of headache which worsened to left facial droop and left sided weakness prompting his presentation and subsequent admission to the hospital.  The patient's left sided weakness has resolved, however, his left sided facial droop persists.  It includes significant left obicularis muscle weakness and tearing suggestive of LMN etiology (Bell's)
Blurry vision / Cannot focus completely; Back pain; Pain from wrist all the way up to his forearm; Nicked the nerve while taking the shot; Feels like his vision is not right; Little swollen arm; Arm is red; Sore arm; Carpel tunnel pain /  joint soreness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurry vision / Cannot focus completely), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain from wrist all the way up to his forearm), NEURALGIA (Nicked the nerve while taking the shot) and VISUAL IMPAIRMENT (Feels like his vision is not right) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ROSUVASTATIN, FINASTERIDE and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VISION BLURRED (Blurry vision / Cannot focus completely), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain from wrist all the way up to his forearm), NEURALGIA (Nicked the nerve while taking the shot), VISUAL IMPAIRMENT (Feels like his vision is not right), VACCINATION SITE SWELLING (Little swollen arm), VACCINATION SITE ERYTHEMA (Arm is red), VACCINATION SITE PAIN (Sore arm), ARTHRALGIA (Carpel tunnel pain /  joint soreness) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurry vision / Cannot focus completely), BACK PAIN (Back pain), PAIN IN EXTREMITY (Pain from wrist all the way up to his forearm), NEURALGIA (Nicked the nerve while taking the shot), VISUAL IMPAIRMENT (Feels like his vision is not right), VACCINATION SITE SWELLING (Little swollen arm), VACCINATION SITE ERYTHEMA (Arm is red), VACCINATION SITE PAIN (Sore arm), ARTHRALGIA (Carpel tunnel pain /  joint soreness) and HEADACHE (Headache) 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.
Initial report received from a consumer (the patient) through social media on 21 January 2014. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) (Manufacturer unknown, batch number, dose number, route and site of administration not reported) on an unspecified date. It was reported that the patient experienced bad reaction to tetanus. Lab investigations and corrective treatments were not reported. At the time of this report, outcome was unknown. List of documents held by sender: None Addendum on 29 Jan 2018: Upon second medical examination of case at time of internal review the following has been modified in this case: Suspect product code changed to DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED) from 015 (DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE).
Patient passed out and seized after all 4 doses given. Continued to loose consciousness and pale/sweaty. 911 was called. Laid patient on the floor with head elevated and she began to feel better/regain facial color.  EMS arrived and patients BP was around 80/50. Patient refused hospital visit, EMS stayed until BP rose about >100 systolic. Ok?d by EMS to leave with a friend as she was ok.
I administered Menactra to healthy looking 250 lb 17 yr old young man who maybe 10 seconds after removing needle slumped on his left side against me snoring. I tried to place him upright and he slumped to the opposite side. I caught him and he jerked 2 times in his upper body still snoring, after maybe 20-30 seconds sat up right with a start and was awake. I rubbed his shoulders as I called his dad in to room and then had him put his head down to his knees. He was pale and non feverish to the touch. I brought him a glass of water and asked him if he had eaten breakfast. He replies that he did not eat that day.  I asked him if he was diabetic and when he replied no, I gave him a pop-tart to help raise his sugar.  After a few minutes I asked him if he wanted to lay down, he replied that he did.  He laid on the floor of the immunization room for approximately 15 minutes.  I took his blood pressure as he was laying on floor and it was 120/90.  After the 15 minutes, I asked him if he wanted to try to stand.  His father helped him to his feet where he stood there for 10-15 seconds getting his bearings.  The left without further incident at 10:55am.  I followed up with dad at 3:15 pm and he reported that his son was fine and able to carry out his day.
The patient has cellulitis on her left arm.  It started out small (quarter size)  immediately upon injection and has expanded to a 2 inch area on her arm after 2 days    She reported today and it  has not reduced in size.
Patient had a breakthrough infection with a positive COVID -19 PCR test on 2/20/2022.
pt recv vax & 2 days later pt was found to have a positive coombs test
Initial information received on 16-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves 04 year old male patient who received HPV VACCINE, MENACTRA and 0.5 ml ADACEL frequency once, lot 54B74, expiry date 14 Sep 2020 instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, MMR VACCINE, KENDIX on 16 Aug 2018.                   It was a case of actual medication error due to Wrong vaccine administered. It was unknown if any adverse event occurred. 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 Directive and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 2-year-old patient who experienced recurrent infections and "vaccine failure". Dates of vaccine administered were not provided. Relevant medical history was not provided. Concomitant medications were not reported. A physician reported that a patient experienced recurrent infections and "vaccine failure". A "panel" performed revealed a low value of -5 of 7. The patient's outcome is unknown. No additional information was available at the time of this report.
I started feeling feverish and pain in my left arm which spread to shoulder and back. Shooting pain and swelling which was not responsive to pain Ibuprofen. For the next 2 days the symptoms worsened with chills, giddiness and nausea. No fever but just the feeling. A lot of sweating. This subsided by day 3.  I tried to handle this with Ibuprofen and Pantoprazole.
Both Pneumococcal and flu vaccine given right deltoid 1 inch apart. 2 days later right arm red, hot under arm not at site. 10/28/2005 started biaxcin 250 mg BID. Mastectomy left breast 1991. Dx Cellulitis.
Taste metallic; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Taste metallic). At the time of the report, DYSGEUSIA (Taste metallic) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Patient was not sure about the route of administration , but he was thinking it was subcutaneous.
Shingles outbreak on right side on face and jawline, and in vaccination arm, five days after second dose of Pfizer Covid Vaccine.
Cellulitis of left deltoid area. The follow up states that the pt received the "smallpox" vaccine on 2/8/03. More info about the vaccine provider is unknown. Pt was in ER for three hours and wa not hospitalized. He was treated with Ancef and discharged home on Keflex. There is no contact info on record for the pt other than the APO address on the VAERS report. Per 60 day follow up: It is unknown if pt has recovered. Pt was to F/U with his primary physician. The 60 day follow up states pt was to f/u with his doctor. I am an ER doctor and only saw him that night.
My adverse event started in the morning at 08:00AM on 12/28/2022. I had hives and dermographia it was all over my body. It was red, itchy, and inflamed. On 01/05/2022 after 8 days later I went to my doctor's office to inform her about  the hives I was experiencing. The hives comes and goes at different times. She did few blood tests. I got the results yesterday over the phone from my doctor's office they said everything was normal and no further treatments were needed. My doctor advised me to take CLARITIN if the itching gets out of control and she also told me to wait 6-8 weeks to see if the hives disappears by itself.
Vaccine site became red and itchy, redness spread to 2/3 of upper arm and receded after 24-48 hours. The evening of 07/18/23 pt also had vomiting, chills, 101+F temp and could not sleep. Pt took tylenol for the fever. All symptoms subsided after 24- 48hours.
2 days p/vax pt devel erythema, warmth, swelling & induration;general malaise rt deltoid where pneumonia was given;
around 1730 Patient was given vaccine and d/t allergy history was brought in the 15 minute observation. Patient stated that she was feeling dizzy and throat feeling funny also the same way when gets the flu shot. Patient was kept in observation while being monitored and Code Blue Team arrived d/t the possibility of an anaphylactic reaction.
worsening sinus/migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (worsening sinus/migraine headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001421A) for COVID-19 vaccination.     The patient's past medical history included Sinusitis.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (worsening sinus/migraine headache). At the time of the report, MIGRAINE (worsening sinus/migraine headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported by the reporter. Treatment medication was not reported by the reporter.
Pfizer-BioNTech COVID-19 Vaccine EUA  I have experienced pain and tingling in my left arm, where I was injected with the vaccine, since the night (early next morning) I received the vaccination.  The pain and tingling runs from right below the point of injection down through my forearm.  Just within the last few days (3-5 day) I am experiencing tingling in my hand/fingers.
Ringing in left ear; Hearing loss in right ear; Ear ringing in right ear; Mild soreness at the site of injection; A spontaneous report was received from a consumer, a 71 year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain.  The patient's medical history included a kidney transplant. Concomitant product use was not provided.   On 19 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch number: 029L20A) in the left arm for COVID-19 infection prophylaxis.   The patient had some mild soreness at the site of the injection which lasted one to two days. On 21 Jan 2021, he experienced some ear ringing in his right ear which was followed by hearing loss that lasted six hours. Both the ear ringing and hearing loss resolved by the next morning.   On 24 Jan 2021, the patient had ringing in his left ear, but it was not associated with hearing loss. The patient stated he thinks the tromethamine hydrochloride in the vaccine may have induced his hearing loss. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The events, hearing loss in right ear and ear ringing in right ear, were considered resolved on 22 Jan 2021. The event, mild soreness at the site of injection, was considered resolved on an unknown date Jan 2021. The outcome for the event, ringing in left ear, was unknown.; Reporter's Comments: This case concerns a 71- year old male patient who experienced hearing loss in right ear/deafness unilateral, ear ringing in right ear/tinnitus, ringing in left ear/tinnitus, and mild soreness at the site of injection/injection site pain, all within 4 days after administration of Moderna's COVID-19 Vaccine (mRNA-1273). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
PATIENT WAS ADMINISTERED HIS PFIZER BOOSTER DOSE TODAY,WHICH IS ABOUT TWENTY FIVE DAYS EARLY.PATIENT HAD SCHEDULED HIS APPOINTMENT THROUGH THE local DOH.
5 hours after shot, soreness in upper arm, noticeable with any arm movement. Next day, redness and swelling, soreness continued. Third day, redness and swelling pronounced. Area felt warm. Fourth day, redness and swelling persist, but reduced. Area feels somewhat itchy and warm.
Severe pain in left deltoid, up into neck and down into elbow and forearm. Patient has seen a physician who has diagnosed him with tendonitis, and is currently treating him for such.
35 minutes after receiving the vaccine, hives covered both arms from wrist to elbow.  Itching began over the whole body, from hair to feet, and hives very quickly spread to right leg from ankle to knee, chest, and neck.  I called vaccine provider and they said to take Benadryl and call my primary doctor.  I took 1 dose of liquid Benadryl and got a 2:15 virtual appointment.  Hives continued and itching worsened while I waited for appointment- Benadryl had no effect. Held virtual appointment and recommended I take my own Singulair, and obtain and take Cimetidine, and Zyrtec.  I took a dose of all three, and around 5-6pm started to see a reduction in itching and hives.  By the time I woke up the next morning all hives and itching had resolved, and did not return.
Approximately 18 to 24 hours post-injection, patient experienced a fever of 102 degrees, a corneal guttata of the left eye, and pain and impaired movement in the left arm. The fever and eye symptoms resolved within 24 hours, and the symptoms in the arm resolved within 48 hours. All symptoms have completely resolved.
Slight sorness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slight sorness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Slight sorness). On 14-Mar-2021, PAIN IN EXTREMITY (Slight sorness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported    This case was linked to MOD-2021-044324 (Patient Link).
3 hrs post inject pt devel red rash w/raised white bumps; regular in shape & size; itchy on all body parts; blanched on touching; afebrile; no resp distress;
Patient had his first pfizer vaccine 2/23/23, provider wrote on patients labels that he needed "Covid #3 and HPV #2". CMA prepared a covid bivalent injection for the patient as the provider had written "Covid #3". After administering the bivalent Covid, she realized that patient had only had one other dose and this would have been his second dose-not the bivalent.
Patient received Janssen Booster dose earlier than is required.  Received 2nd shot at 23 days rather than at least 60 days.  Has had no true adverse events to report to date.  Reporting is being done same day as receiving this vaccine, so we will be following up with patient later in the week to see how he is doing since he received it too early.  I am putting in Item 20 that as "unknown" due to not knowing if he will have any adverse events or anything from receiving early. Truly right now, he is not reporting any adverse events.
MMR vaccine (& Hep A and Varicella) on 8/16/11 then 3 seizures 8/25/11 - 8/26/11.