chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Janssen COVID-19 Vaccine EUA Uncontrollable, severe itching of upper arms (both right and left) and sometimes nape of neck.  Upper arms become extremely hot.  I have to use ice packs to cool down.
got covid; got covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Jun2021 as dose 2, single (Batch/Lot number: unknown), in right arm and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 22Oct2022 at 12:30, outcome "recovering" and all described as "got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2022) Negative. Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination. No known allergies. No other medical history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had a shot for it and still got it/ suspected vaccination failure; Still got it; Very very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, had shingles twice and was very painful. The patient had shot for it and still got shingles second time. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
hot to touch; Itchy; red rash; swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (red rash) and VACCINATION SITE SWELLING (swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease, Anxiety and Arthritis. Concomitant products included ATENOLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]), POTASSIUM and VITAMINS NOS for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FEELING HOT (hot to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (red rash) and VACCINATION SITE SWELLING (swollen). At the time of the report, FEELING HOT (hot to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (red rash) and VACCINATION SITE SWELLING (swollen) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   The reporter denied to follow-up stating that she was doing fine.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Follow-up received on 09-Mar-2021, event updated from unknown to recovering.; Sender's Comments: 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.
This is a spontaneous report from a non-contactable consumer. This 74-year-old male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at 0.5 ml, single. Medical history included heart problem. Concomitant medications were not reported. The patient got all infected from the shot and he blew up like a balloon on an unspecified date. The patient mentioned that he got pneumonia shot and he got all infected from the shot, he blew up like a balloon and he had to run to the emergency room, he was there for few hours. He stated that they were going to admit him. The patient mentioned that they kept him there for about 4 hours, they put all those medications to kill the infections that he had. He was there for little while, they checked him and they drew like a road map on his arm where he had the infection and the doctor said they would release him and told him that if anything started spreading over that line he would have to come back. The patient mentioned that they told him to follow up as he had to run back to emergency room the follow one day and in meantime they gave him prescription of the medication that he had to take 4 times a day. After he got infection, he had to take whole thing for about 4 to 5 days. He mentioned that he started to get little better and improved. Therapeutic measures were taken as a result of infection. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 19-OCT-2016 the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Arthritis- large joints, feet, and back. Went to chiropractor, and doctor. Went on Vioxx, symptoms started after vaccine. Only recently did I find out the Lymerix arthritis could be related. Follow up: I went to family Dr for joint pain. He sent me to chiropracter after I was not feeling better. I then went on Vioxx and bought an inversion table to help with the pain. Chiro did not help. Now I just live with the pain.
injection site redness; injection site swelling; injection site heat; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) (batch number AMVA151A, expiry date 31st July 2020) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Menveo.  Additional details were provided as follows: The age at vaccination was not reported. Another patient expereinced redness, swelling and heat at the injection site and this patient reacted in similar fashion to the same lot number. The reporter did not agree to follow up. This case is one of 3 cases, reported by same reporter.
Pt. states her (L) arm started hurting immediately following injection. C/o pain from her elbow to her shoulder with limited mobility. States she has seen her chiropractor. States it is doing better but is still sore.
This case was reported by a healthcare professional and described the occurrence of adverse reaction in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced adverse reaction.  At the time of reporting the outcome of the event was unspecified.   The healthcare professional reported that a subject had an adverse reaction to KINRIX.
This is most likely NOT related to the vaccine but it can't be ruled out so I wanted to be thorough.  Vaccine was on 4/9/21 and I had zero reactions, arm wasn't even sore really unless I poked at it.  Later, weekend of the 24-25th, I had a sunburn on the back of my neck, neosporin burn ointment was applied (and this may have caused the reaction but no one is sure).  Reaction was rash that slowly grew, covering areas under armpits, inner arms, sides and stomach.  Multiple trips to urgent care where they couldn't diagnose the issue and kept prescribing more steroids, antibiotics and antihistamines.  Finally was referred to allergy/dermatologist specialist,  biopsy was taken, results showed extremely high concentration of a certain kind of cell that indicates an allergic reaction - they were sure it's a reaction to some kind of medicine or medical treatment but were unable to positively identify whether it would have been the neosporin, the antibiotics, or some other thing.  My bet is that it's a neosporin reaction and not related to the vaccine.  I am only reporting this to be thorough, just in case.  The rash is now pretty much gone, with just some residual itchiness.
2 weeks after flu shot client states she began with pain & tingling at her knees, progressed to arms & face. Oct 22nd hospitalized for 3 days discharged hospitalized again on Dec 3rd for 3 days - difficulty breathing not ever intubated - paralyzed arms.
1996 Pt recv 1 & 2 dose of vax. Lab eval revealed lack of seroconversion. Pt given booster dose. 20Jan98 lab eval again revealed lack of seroconversion. (VZV IgG = less than 1 EU/ml).
Information has been received from a medical assistant concerning a 65 year old male with no drug reaction/allergies and no pertinent medical history, who on 04-JAN-2011 was intramuscularly vaccinated in his left arm with a first dose of PNEUMOVAX 23 (dose not reported, lot # 667690/1158Z). Concomitant therapy included tetanus injection in the right arm. On 04-JAN-2011 the patient had a severe injection site reaction after vaccination with PNEUMOVAX 23. The patient had severe swelling and soreness of his left arm and could not lift his arm. He also had a fever of 102.1F and joint pain. The patient was applied ice to the arm and was taken TYLENOL. No diagnostic laboratory tests were performed. At the time of this report, the patient's status was not recovered. The patient sought medical attention by office visit. Follow-up information was received from a medical assistant concerning the patient who with no known drug allergy on 04-JAN-2011 was vaccinated in his left deltoid with the first dose of PNEUMOVAX 23. The patient had no illness at time of vaccination. After 10 minutes injection given, the patient experienced pain in deltoid area, redness, fever, swelling and unable to lift arm. The patient was seen for systems on 05-JAN-2011 and resolved on 07-JAN-2011 "3 days later". Additional information is not expected.
Fever, headache and body aches starting about 18 hours after the 2nd shot.  Took aspirin to attempt to mediate all issues. Temperature reached over 102 by 10:00am the morning of 4/6.  Temperature dropped to 101 by 14:00 and below 100 by 14:30.  Felt normal the morning of 4/7.
Lot of redness around the injection site; Really tired; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Lot of redness around the injection site), FATIGUE (Really tired) and NAUSEA (Nauseous) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Lot of redness around the injection site), FATIGUE (Really tired) and NAUSEA (Nauseous). At the time of the report, VACCINATION SITE ERYTHEMA (Lot of redness around the injection site), FATIGUE (Really tired) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
neck a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (neck a little swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Colon cancer (Colon cancer no problem for the past five years). Concomitant products included VITAMIN D3, EZETIMIBE (ZETIA), FENOFIBRATE (TRICOR [FENOFIBRATE]), COLESEVELAM HYDROCHLORIDE (WELCHOL), ROSUVASTATIN CALCIUM (CRESTOR), LISINOPRIL, METOPROLOL, METFORMIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (neck a little swollen). At the time of the report, SWELLING (neck a little swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-068435 (Patient Link).
Three weeks after my first Covid Vaccine, I began having irregular vaginal bleeding even though I am on Birth control pill. I have been having spotting/bleeding daily since 2/2/21.  Second vaccine was on 3/10/21.  No history of abnormal bleeding in the past.
red rash 5 cm diameter, appeared 6 day/after shot given Noticed reaction same day-not reported x 6 days
Ankylosing spondylitis affected; Aches/pain; Headaches; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No.: 21K-163-3989630-00). A contactable 55-year-old male consumer (patient) reported for himself that:  Solicited report by a consumer of a 55 year old male with events of non-serious Aches/Pain, Headaches and Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit with Humira (Adalimumab). There was no reported medical history. On an unknown date (as reported), the patient experienced Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit. In 2021, the patient experienced Aches/Pain And Headaches. On 12Jul2021, The Patient Experienced Ankylosing Spondylitis Affected By Weather/Patient thought due to biometric pressure weather been little cooler/hurt a little bit. In 2021, The Aches/Pain And Headaches Resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of Aches/Pain, Headaches, Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit unknown onset and Ankylosing Spondylitis affected by weather/patient thought due to biometric pressure weather been little cooler/hurt a little bit onset 12Jul2021 Was Not Provided.  Concomitant Drugs and dates of Administration: Concomitant Drugs Not Reported. Other relevant History: Not reported  Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB) for events pain, headache, ankylosing spondylitis/pain Causality as per reporter (Drug/Vaccine): Not Reported. Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran), for events events pain, headache, ankylosing spondylitis/pain Causality as per reporter (Drug/Vaccine): Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Ankylosing Spondylitis and the administration of the vaccine cannot be 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.
Extreme arm pain, headache, vomiting, clammy, swollen red arm at injection site.
Felt fine for a week. When I was driving, I felt the muscle in my left shoulder beneath the clavicle feel "squishy" and above the LT clavicle felt a lump of approximately 1 cm wide. No pain when touching the lump.
Vaccinated with ACAM2000 during pregnancy.  Pregnancy resulted in full term healthy delivery.
itchiness under her arm that causes a small bump; itchiness under her arm that causes a small bump; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date not reported) via an unspecified route of administration, on 03Mar2021, at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced itchiness under her arm that caused a small bump on Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient developed cellulitis after receiving SHINGRIX. The reporter stated she believed the cellulitis was physician diagnosed but was not sure. She did not see it first hand. The reporter did not consent to follow-up.
they administered the liquid part of PENTACEL (DTAP-IPV component) that was diluted with 0.5 ml sterile water but the lyophilized part (ACTHIB) was never given with no reported adverse event; they administered the liquid part of PENTACEL (DTAP-IPV component) that was diluted with 0.5 ml sterile water but the lyophilized part (ACTHIB) was never given with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves an unknown age and gender patient who was administered the liquid part of pentacel (dtap-ipv component) that was diluted with 0.5 ml sterile water but the lyophilized part (acthib) was never given with no reported adverse event , after  receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received once a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (U7311AA and expiration date: 09-Sep-2023) and a  dose of suspect HIB (PRP/T) VACCINE ( lot UJ757AA and expiration date: 09-Sep-2023) at an unknown dose via unknown route at unknown administration site for immunization.  On 01-Sep-2022 t(latency: same day), the patient developed a non-serious event" they administered the liquid part of pentacel (dtap-ipv component) that was diluted with 0.5 ml sterile water but the lyophilized part (acthib) was never given with no reported adverse event" (single component of a two-component product administered) (product preparation error) following the administration.   Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   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.
On 03/27/2023, I began to notice a feeling of tiredness and not being able to do much. I knew that I had COVID-19, because my husband had already tested positive. I went to the doctor, where I tested for COVID-19. He prescribed Paxlovid right away. I might have developed a slight fever, but I'm not certain. I did have a cough, but I didn't blow my nose or anything until 10 days later, when I think I developed the flu.
Nosebleed occurred 2 hours after vaccinated (2 dose). lasting 530-630 in varying degree. Spotting until 5-6AM 3/18/2021. Reports arm (left) sore and slight body aches. Will f/u with MD if bleeding from nose resumes. Reports using Flonase in AM (11A)