chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Syringe started leaking out the side as a result of device malfunction.  Vaccine ran onto patients arm. Retracting needle shot off instead of retracted.  Revaccinated per instructions of Clinical Pharmacy Specialist.
patient are mistaken the shot had made patient ill many times, doctor's said cant help you; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.    This case involves a female patient of unknown age who was mistaken the shot had made patient ill many times, doctor's said can't help you (illness), while patient was treated with influenza vaccine.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was mistaken the shot had made patient ill many times, doctor's said can't help you (illness).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Information has been received from a registered nurse concerning a 7 year old male who on 4/28/98 was vaccinated SC in the left arm with a 0.5cc first dose of varicella virus vaccine live (lot # 625127/1581E). The patient was not ill at the time of vaccination. On 4/28/04 the patient started breaking out with blister-like spots on red base over torso, face, and neck. The patient was seen in the physician office on 5/3/04 and varicella was confirmed. The patient recovered from varicella on an unknown date. No additional information is expected.
Nausea, fatigue, unable to sleep, arm pain, body aches, headache
Injection was given @4:29PM & immediately broke out in a sweat. Patient was given water & taken to a room to lay down. EMSA was called & arrived at 5:40PM. They assessed him & determined he was fine. His girlfriend took him home. The next day the pharmacist who administered the shot called and he was feeling good.
Delayed reaction  5 days latter swelling, redness, heat, and hives surrounding vaccine site.  3 inches across and 6 inches down my arm.  Also it hurts, stings and extremely itchy.
Body aches; difficulty breathing; Chest pressure; Chills; This spontaneous case was reported by a consumer and describes the occurrence of   in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
pt recv vax; devel swelling of harm, eye, wrist & joints & was felt to have a "lupoid-type rxn;
The injection site on the back of my right arm became very red, very hard and very hot.  I started getting a reaction late Monday, 4/21.  By Wednesday afternoon, the reaction had gotten the size of a grapefruit, was extremely warm and beet red.  I applied a hydrocortisone cream & started taking Benadryl.  Continued treatment for three days.  I still have a slightly red area that itches.
This report describes a female in her 30's who did not respond (therapy non-responder) to 3 injections of Hep B vaccine recombinant (Engerix-B). This report was received from the subject who is a nurse and has been medically confirmed. The subject's medical history included an allergy to sulfa and airborne allergy. 2 yrs ago, the subject had an allergic reaction to a flu vaccine (NOS) that contained sulfur component/base. There was no concomitant medication. In the early 90's, the subject received 3 injections of Hep B vaccine (Engerix-B). Approximately 2 to 3 yrs after completion of the vaccination series, the subject's titer tests were checked and came back negative. It was determined that the subject did not seroconvert. A 4th injection of Engerix-B was administered. The PT had repeat titers drawn which were positive nothing seroconversion. The reporter considered the lack of seroconversion following the 3rd injection of Engerix-B to be probably related to the Engerix-B administered.
Pt states about 2 hours after receiving vaccine he started seeing spots and losing vision in both eyes. He reported this to me 6 days later.  Stated it had improved about 90% but still had some vision disturbances.  He did not contact his family physician or ophthalmologist.  I encouraged him to do so.
This spontaneous report was received from a health professional (medical assistant) regarding a multiple unknown patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unknown dates multiple unknown patients were vaccinated with improperly stored GARDASIL 9 (lot, expiry date, dose and frequency unknown by the reporter) and PEDVAXHIB (lot, expiry date, dose and frequency unknown by the reporter). The administered vaccines experienced a temperature excursion of 32.8 Fahrenheit for 20 hours and no previous temperature excursion was reported. No adverse effects reported. No product quality complaint (PQC) filed. Additional information has been requested.
Given a 0.25 mL dosage as their first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Given a 0.25 mL dosage as their first dose) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 05-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (Given a 0.25 mL dosage as their first dose). At the time of the report, ACCIDENTAL UNDERDOSE (Given a 0.25 mL dosage as their first dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that the patient has not reported any symptoms. No additional doses or treatments had been administered to the patient till the time of report.
Patient was administered vaccine after expiration date but the manufacture had approved stability and efficacy for date past the administered date. patient has not reported any symptoms, monitoring
Started with bruising and pain at injection site (left deltoid). By 10hrs post injection, fever (103-103.5). body aches, chills, headache, sinus congestion, sore throat, n/v/d and abdominal pain. Left arm (site of injection) still has significant bruising, pain with movement, numbness and tingling going all the way from deltoid to hand. Taking Zinc, Vit D, Vit C, Tylenol, Motrin. Today, NP prescribed Tessalon perles and Flonase, ASA.
A week after both doses of the moderna vaccine,  I received rashes on both arms, armpits, and around the eyes.
This is a spontaneous report from a non-contactable consumer, reporting for husband. A male patient of an unspecified age received the PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling, redness, and pain. The clinical outcome of the events, swelling, redness, and pain, was unknown. No follow-up attempts are possible. No further information is expected.
pt recv vax 27JUN95 & reported following rxn ER visit on 9JUN95 for hives all over body; itchiness on arms, elbows few days prior to breaking out in hives; rxn DPH, Epi felt better next day;
Day 11 after vaccines rash started on face as small red bumps, spread to chest and arms. No fever. Some loose stools. Rash gone by 06/28/04.
This is a spontaneous report from a contactable other hcp.  A patient of unspecified age race and gender received PREVNAR 13, at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hives on an unspecified date with outcome of unknown.
Child received flu vaccine #1 on 1/4/08.  On 1/7 pm developed fever, on 1/8 pm had generalized tonic-clonic seizure with fever up to 103.6 degrees.  Lasted about 15 l/q.  EMS called.  Seen at ER-nl exam & discharged without meds, Tylenol/Motrin.
Patient reported severe shoulder pain 3 days after receiving vaccine. Went to the doctor after 7 days and received steroid injection. MRI revealed tendonitis in shoulder and is still currently receiving corticosteroid injections for inflammation.
Patient requested flu vaccine, completed flu vaccine admin form, technician verified flu vaccine with patient and pharmacist verified flu vaccine with patient.  After administration, patient inquired about Covid vaccine and thought that she was getting Covid vaccine.
feverish at the spot; Right arm swelled up, it is about 2.5 inches in diameter, is hard; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (feverish at the spot), VACCINATION SITE SWELLING (Right arm swelled up, it is about 2.5 inches in diameter, is hard) and VACCINATION SITE ERYTHEMA (red at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE WARMTH (feverish at the spot), VACCINATION SITE SWELLING (Right arm swelled up, it is about 2.5 inches in diameter, is hard) and VACCINATION SITE ERYTHEMA (red at the injection site). At the time of the report, INJECTION SITE WARMTH (feverish at the spot), VACCINATION SITE SWELLING (Right arm swelled up, it is about 2.5 inches in diameter, is hard) and VACCINATION SITE ERYTHEMA (red at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Rash on left forearm/itching/throat itching/ heart rate fast/left hand itching
Information has been received from a health professional concerning a 14 month old white male, with no medical history and no allergies, who on 11/11/2005 was vaccinated with a 0.5 ml subcutaneous first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot #646669/0626R). Concomitant vaccine administered on the same day included a third intramuscular dose in the right conj-hepatitis B vaccine (MSD) (Lot #652498/0643R), and a first intramuscular dose in the left thigh of influenza virus split virion 3v vaccine inactivated (Fluzone) (Lot #U1767CA). There was no illness at the time of vaccination. It was reported that, on 11/15/2005, the patient's mother notified the reporter that on 11/13/2005 (previously reported on 11/14/2005) the child developed a fever of 103.4 F and extreme pain when the child tried to us the leg in which the vaccine was given. The mother was advised to give the child over-the-counter ibuprofen. The patient was seen in the office on 11/16/2005 and the fever was down to 99.6. On 11/18/2005, the fever and leg pain had resolved, but the child did develop a mild red rash on his trunk. At the time of the report the patient was recovering. The reporter assumed that the child had since recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that no treatment was provided except for ibuprofen and warm compresses. It was reported that the patient recovered. Additional information is not expected.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients of unknown age. Current conditions and medical history were not reported. On an unknown date in 2014 (reported as since August 2014) the patients were vaccinated with improperly stored PROQUAD (Merck) (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
"Covid Arm" about a week after the shot, a red, itchy, welt has risen on my arm and it is painful to touch. No medical assistance needed.
Oval shaped 4 inches long by 2 inches wide red, not hot to touch and site is itchy.
Extreme arm soreness. Eye redness/swelling (right eye -> same side as injection).
Information has been received from a licensed practical nurse concerning a 40 year old male with an allergy to penicillin who on Oct 29 2004 at 2:20 was vaccinated in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N). Concomitant vaccine therapy given in the left deltoid included a first dose of influenza virus vaccine (unspecified0 (lot U1449AA). There was no illness at the time of vaccination. On Oct 30 2004 at 2:30 the patient woke up with nausea and vomiting. He had a red, swollen, painful area where the injection was given. His had a temperature of 100.1 and he had pain in his neck that radiated across to his right shoulder. Unspecified medical attention was sought. No treatment or diagnostic lab tests were performed. On Nov 01 2004 the patients aches and temperature decreased and the redness and swelling went down. Subsequently, the patient recovered. No product quality complaint was involved. No further information expected. No further information is expected. It was also reported that another patient was vaccinated with dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA00295).
Received liquid portion only; Received liquid portion only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2023) for prophylaxis.   On 12th December 2022, the patient received Menveo. On 12th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Dec-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received the liquid portion only of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
After second dose around 9pm I had continuous excruciating electrical shock sensation from head to toe with feeling of burning pain for several hours.  All of this recited by next morning, months went by with no additional side effects until July 2021.  Where I experience only in evening time reoccurring excruciating electrical shocks again.  This has continued off and on up to date (date of this report 10/30/2021)
My face began to feel like it was burning, my cheeks and up to my eyes, including my eye lids were red and began to swell. It continued to burn for about 4 days. It looked like I had a sunburn but I have not been on the sun. At that point I went to Urgent care, they prescribed prednisone for 2 weeks. I went to a dermatologist and she also put me on prednisone for only for 1 week. Then I saw my internist and at this point I had some burning  in my chest and it felt like bacon popping it was completely different. It never met my face. When I saw my internist she ordered a lot of lab panels and an ultrasound and it looked like lupus maybe. I went to the dermatologist she did 3 tests on my chest they came back negative for cancer. We do not know what it is and they took me out of all the other medications They got me on a vegan diet and no change at all. My face was feeling the same but my chest cleared up. Last time I had a flare up was two weeks ago.
09/10/22 presents to ED for "altered mental status". PMHx of "CAD, HTN, HLP, previous CVA Seizure disorder"
Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (also the age at vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Aug2021 11:00 (Lot Number: FD8448) as single for COVID-19 immunization. Medical history included B12 deficiency, mild asthma, the patient also has several allergies; all from an unknown date and unknown if ongoing. The patient is not pregnant. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. The patient experienced anaphylactic reaction on 19Aug2021 11:00 with outcome of not recovered. Event assessed as serious due to life threatening. The event was described as follows: anaphylactic reaction that needed epinephrine then to ER. The patient was also given steroids and Benadryl. Adverse reactions continues to present date. Symptoms were facial/ chest redness/facial numbness, similar to a mega dose of Novocaine. Jaw numbness/pain. Numb and sore lips and tongue/poor taste buds. Body weakness. Shortness of breath. Body feels like a foreign monster has entered it. Attacks of the body leads to weakness, shortness of breath. The attacked was severe to point of taking off feet for bed rest as it attacked back area, which caused shortness of breath, substantial body weakness. Event anaphylactic reaction resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and was assessed as life threatening illness (immediate risk of death from the event). The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.
left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at; injection site blue and purple; swollen Lymph nodes; injection site is swollen; headaches; nausea; fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue), LYMPHADENOPATHY (swollen Lymph nodes) and PAIN IN EXTREMITY (left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at). At the time of the report, VACCINATION SITE SWELLING (injection site is swollen), VACCINATION SITE BRUISING (injection site blue and purple), HEADACHE (headaches), NAUSEA (nausea), FATIGUE (fatigue), LYMPHADENOPATHY (swollen Lymph nodes) and PAIN IN EXTREMITY (left arm painful/arm pain was so bad I went to the Emergency Room to have this looked at) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medication provided by the reporter.
Client was a walk-in on COVID19 vaccine event. The electronic LINKS system was down and not working properly. The client verbalized that she was here for first dose of COVID19 vaccine and requested Pfizer brand. Pre-vaccine check list reviewed with client and denied receiving previous dose of COVID19 vaccine. Pfizer 0.3ml given IM left deltoid IM, client tolerated well later has nursing supervision noted that the client had previously received two doses of Moderna, COVID10 vaccine at another facility. The Pfizer dose given on 10/28/2021 was 3 months from the last dose of Moderna according to the LINKS record. It was .... the last COVID19 vaccine given on 7/7/2021. Client also had the first dose on 6/3/2021. The medication error was realized after the client left the health unit. Client did not qualify to receive a booster dose since it was less than six months from last COVID19 vaccine.
This 12 month old white female went to ER with systemic rash, resembling mumps, over entire body with a fever of 102F, malaise, fatigue, 10 days, post vax of MMR.
Hives and angioedema. Treatment: Benadryl and prednisone (corticosteroid).
Severe shaking/shriving; Severe Coldness; Severe Muscle aches; Severe Increased temperature/fever; Severe Headache; severe weakness; This case was reported by a consumer and described the occurrence of tremor in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 9 hrs after receiving Shingrix, the patient experienced tremor, coldness, muscle pain, fever, headache and weakness. On an unknown date, the outcome of the tremor, coldness, muscle pain, fever, headache and weakness were not recovered/not resolved.   It was unknown if the reporter considered the tremor, coldness, muscle pain, fever, headache and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-JUL-2022 Reporter's Comment: This case was self-reported by patient. The patient received second dose of Shingrix and experienced the side effects that were severe as per reporter that included shaking or shriving, coldness, muscle aches, increased temperature or fever, headache, and weakness. These symptoms began after nine hours of receiving the shot.  The patient talked to PCP (primary care physician) on the day of reporting (24 hours) after the shot and she said that these were common, and the patient would feel better in a couple of days.