chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist administered SHINGRIX vaccine. Mixed the vials; first attempted-he had not pulled the liquid from the vial into the syringe. Second attempt, administered in subcutaneous area on back of left arm. Asked why he wasn't injecting into muscle. He said this goes in subcutaneous. Next day, arm are very sore, hard and red size of tennis ball. Also had chills. Second day, still very red, size of tennis ball and very tender. Was going to go back to Pharmacy and have them look at arm. Later learned CDC says subcutaneous injection is an error. This pharmacist needs training!
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol consumption, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies and drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 19-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-AUG-2021, the subject experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non-serious.
erythematous patches w/hives on thorax & extremities; swelling of lt side of tongue & tingling of lt side of face; DPH given;
Extreme joint and muscle pain and unable to flex joints starting 15 days after innoculation.  Different joints affected on subsequent days.  General feeling of malaise and tiredness.  Soft bowel movements.
Starting 01/01/2022, I felt like I had a cold. My head was congested and felt like I had a head cold. No fever, slight body aches and I went to the doctor because my ears were hurting at the same time. I took a COVID test, and they gave me an antibiotic because my ears were hurting (amoxicillin). After about 2 days, the results came back positive. I stayed home for 2 weeks, and had to sleep sitting up due to ear pressure (mostly right ear). To this day, I am unable to sleep on my right side due to the right ear pain, which is constant and annoying. Since I have had COVID, I have been having intermittent episodes of vertigo, and I am still sleeping sitting up.
Acute non ST elevation myocardial infarction in a previously healthy 25 year old man
Started as just itching, then painful rash on back extending towards the anterior trunk. Patient was treated with FAMVIR 500mg BID x 7days.
After pt. received shot, she stood up started moving around and proceeded to collapse mother caught her and laid her on the ground and pt bumped her head and went into a seizure lasting aprox 20-30 seconds, signs of breathing and pulse pt was turned to her side. Ambulance was called and pt was taken to Hosp.
Fever; Chills; Swelling; Fatigue; Itching left arm; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching left arm), VACCINATION SITE ERYTHEMA (REDNESS), PYREXIA (Fever), FATIGUE (Fatigue) and CHILLS (Chills) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seasonal allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching left arm), VACCINATION SITE ERYTHEMA (REDNESS) and FATIGUE (Fatigue). On 12-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE SWELLING (Swelling). On 12-Jan-2021, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. On 13-Jan-2021, FATIGUE (Fatigue) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (Itching left arm), VACCINATION SITE ERYTHEMA (REDNESS) and VACCINATION SITE SWELLING (Swelling) 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 details was not reported by the reporter.
episode of pericarditis; episode of pericarditis; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included pericarditis. The patient's concomitant medications were not reported. Patient who had medical history of pericarditis had another episode of pericarditis and was brought to the hospital after receiving the COVID vaccine. He received ketorolac (TORADOL) and was discharged. Outcome of the event was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported event pericarditis and BNT162B2 cannot be fully 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 RAs, Ethics Committees, and investigators, as appropriate.
This literature report (initial receipt: 13-Nov-2012) concerns a 28-year-old male patient, who had a history of varicella as a child. The patient was in excellent health until about 2 weeks prior when he received an influenza vaccine (manufacturer, brand name and batch number were not provided). The following day (after vaccination), the patient noted the development of a cold sore on his lip. He was treated with over the counter medications. About 1 week later, he developed a burning-like pain across the mid-back and then noted a rash. The patient was referred for a painful rash. Examination revealed a rash consistent with herpes zoster, just lateral to the midline of the back, at the level of T9. The remained of the examination was normal. The rash had subsequently resolved. However, the patient continued to have pain and was started on gabapentin and provided with a TENs unit, which helped to resolve the pain. Reporter's comment: There is no known case in the literature of the influenza vaccine leading to shingles. In this patient, the influenza vaccine appears to have reactivated the latent HSV-1 & HSV-3 viruses.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], DOCOSAHEXAENOIC ACID (DHA), SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUDESONIDE (PULMICORT) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Around 8:30 pt started with vomiting and c/o severe headache and what felt like "buzzing bees" in his head. Mom said his eyes were "funny looking" and was taken to ER where doctors had a hard time waking him up. Pt was then admitted. Per annual report-Reporter states possible diagnosis is pediatric migraine. No 2nd dose of flu vaccination will be administered.  Hospital report requested from Medical Center.  2/1/06 Review of medical records (neuro consult) Final impression: probable pediatric migraine, nothing suspicious for seizure.
sx occurred @ 2mo shots consisted of shrill cry for 24hr;pt recv 4mo shots w/o any side effect
Unprovoked seizure (clonic tonic) 13 days later, requiring hospitalization and testing
Since I've gotten my second shot, I keep getting numbness in my right arm. It goes all the way down along, mainly in my fingers and my arm will be colder to the touch than my other arm, even more so my fingers. They don't look discolored, but they lose all feeling and become very numb as if my hand is sleeping. I've also been having joint pains and muscle pains, no fever but getting chills or feeling feverish. The shot was very painful for the first day and second day; it was hard to move because of the pain but eventually; it stopped and now I just have this numbness and chilly feeling that keeps coming and going since the second shot. The only other noticeable symptoms I had were feeling extra thirsty, fatigued, and since the first shot, I've been itchy and having inflammation but had no rash. I also was feeling short of breath, which might be because of my asthma I already have prior to the shot and could be unrelated.
Shooting pain in ear; Cough; Colds; Lightheaded; 2 distinct tender lumps above left collarbone; Redness in the injection site; Head really hurt; Fever (100.6 F); Fatigue; A spontaneous report was received from a consumer who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of fatigue, shooting pain in the ear, head really hurt, redness in the injection site, 2 distinct tender lumps above her left collarbone, fever (100.6 F), cough, colds and lightheaded.  The patient's medical history was not provided. No concomitant medications were reported   On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 206L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced fatigue that continued for two more days.   On the early morning of 04 Jan 2020, the patient experienced shooting pain in the ear, head really hurt, redness in the injection site which she noticed was an oval shaped measuring bout 3-3.5x4 inches, 2 distinct tender lumps above her left collarbone, fever (100.6 F), cough, colds and lightheaded. Treatment for the events included paracetamol for the ear pain and headache.  On 05 Jan 2020, the patient reported that the redness in the injection site got bigger and was the size of her palm. She still had cough and colds. It was also noted that she might be scheduled for a Covid-19 test.  Action taken with mRNA-1273 in response to the events was not provided.  The event, fatigue, was considered resolved on 31 Dec 2020.  The events, shooting pain in the ear, head really hurt and fever (100.6 F) and lightheaded was considered resolved on 04 Jan 2020.  The outcome for the events, redness in the injection site, 2 distinct tender lumps above her left collarbone, cough and  colds was not resolved.; Reporter'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.
Large red rash appeared on second day and continued to grow and get larger. Today is the 12th day since vaccine and it continues even with medicine.
RECVD ENGERIX-B FOR 3RD DOSE IN SERIES OF HEP B VAXS, DEVLPD HIVES.TREATMENT/OUTCOME UNKNOWN.TREATED WITH BENADRYL 50 MG AT ONSET OF HIVES ON ARM OF INJECT,NECK,CHEST,UPPER TRUNK. HIVES RESOLVED.POSS LIFE THREATENIN DET BY REPORTING NURSE.
A week after my shot, I developed a rash/welts at the injection site (no irritation other than if press on it), the next day the welts were gone and I had a round ring like rash around the area where the welts were the previous day. This was my first reaction since the vaccine , nothing occurred immediately. I have not had any other symptoms aside from the expected soreness and tiredness on days 1/2. As of now I have no other symptoms but  felt that I should report this due to not seeing it being a common reaction (delayed) so far from what I have read. I also normally do not ever get a rash or anything from shots.
The pt complained of edema, redness to the right thigh the same day of vax. The redness resolved on 3/15. No fever was noted.
Patient had Covid vaccine this am, with no problems noted during his 15 min observation post vaccine.  Patient returned to Employee Health approximately 4.5 hrs following vaccine stating he has had a "tingling feeling " in his chest for the past few hrs.  Tingling has not changed in intensity.  Patient does not have dyspnea or lightheadedness.  Patient escorted to ED for evaluation.
within 3 to 4 minutes after the vaccine was given the patient started Itching his face and developed urticaria on his face Benedryl 1.25 ml was given the patient responded to the benedryl  and the urticaria on his face went away he was still itching on his left thigh waited 15 more mins then that stopped there was no lip swelling and lungs were clear
Signs/Symptoms: Tingling in lips and legs; Slightly light headed; Blurry vision.  Treatment: Benadryl PO at 13:42.
10 days post vax, the pt came in with red raised papules with central yellow area.
Rash, sore arm, chills, low grade fever lasting about 4 days. I had a head cold and cough when I was given the shots.
Patient described episodes of fainting after medical procedures.  After initially appearing fine after the vaccination, the patient fainted about 10-15 minutes after the vaccine was administered.  Patient was let to lay on the floor as he almost fell out of the chair he was sitting.  No injuries reported from falling or being moved to the floor.  Patient spent approximately 10 minutes on the floor until feeling well enough to stand and move about.  Once standing the patient was able to get move freely and did not have any more episodes while on site.  Patients family was supportive and well educated on how to handle his situation.
Full fledged case of shingles, lots of pain and a rash from front to back at chest level, right side.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 08Jul2022 at 11:00, outcome "recovering", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: anti viral details product: COVID 19 Treatment, brand: Paxlovid (from 29Jun2022 to 04Jul2022).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Per MD note, area of the shot looks mildly swollen and red. Not significantly warm or tender at this point. Full ROM and N/V status is intact.
Patient received zoster vaccine Lot J011828 on 5/16/14 (manufactured by Merck - exp date 12-26-14). Five days after administration patient developed generalized rash pruritic in nature and few blisters in arms. No fever, no SOB, no DOA, no swelling, no desquamation.
Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (She is immunocompromised) and Ulcerative colitis (Pre-existing ulcerative colitis). Concomitant products included INFLIXIMAB (REMICADE) for Colitis ulcerative aggravated, PREDNISONE for an unknown indication.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLITIS ULCERATIVE (Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use). At the time of the report, COLITIS ULCERATIVE (Pre-existing ulcerative colitis flare up/pre-existing ulcerative colitis flare up and Remicade use) outcome was unknown.            On 16-Mar-2022, the patient called and stated that she was immunocompromised due to pre-existing ulcerative colitis and was taking Remicade for a recent flare up. She also states she takes the steroid prednisone and asked if there was any interaction with the Moderna vaccine.  She states that she had two primary series Moderna doses and a third dose but she was not sure if it was 0.5mL or 0.25 mL.  No treatment medications were reported.  The caller asked if she could get an additional booster due to being immunocompromised.   Caller declined she was reporting side effects after Moderna vaccine.
Patient reported feeling okay after getting the vaccination, went to bed, didn't sleep well, awoke for on 08/25/21 at 0600, felt "strange", went to work then had to come home early because he was extremely tired. Patient developed Temp of 103 F, took fever reducer with no change in Temp until today, Temp = 101.3, chills of f and on, diarrhea began today 08/26/21 with patient having several very loos stools prior to calling our office at 4:21 PM.
i have a rash on my body that started in july 2021 and i still have the rash on 1-17-22 do you have any others like this and what did they do to cure the problem
Persistent shoulder pain post immunization-failed NSAID, TYLENOL #3. Imaging (x-ray) WNL-referred to Ortho for steroid injection.
Information has been received from a registered nurse concerning a 28 year old female certified medical assistant (CMA) who on 21-APR-2009 had ROTATEQ spit in her eye by a child who received the vaccine (WAES #0904USA03828).  The CMA's eye teared up and was watering.  The eye was flushed with water and the CMA was advised to see an eye doctor for follow-up.  It was reported that the CMA was not wearing contact lens.  This is one of two reports received from the same source.  Additional information has been requested.
Patient experienced a BRUE manifest as stiffening followed by apnea and central cyanosis
12/17/2020 INJECTION. 12 HOURS LATER, NAUSEA W/ TACCYCARDIA, PROXIMAL. HEARTRATE 150. WENT TO ER.  HAD TESTS DONE. NO HISTORY OF ANXIETY; HAD PRETTY ANXIETY. LASTED ABOUT 45 MINUTES. ATIVAN PRESCRIBED BY ER DOCTOR.  DIAPHORETIC.  I AM WORKING BUT STILL DIAPHORETIC AND STILL FEEL A LITTLE FATIGUED. DON'T KNOW IF RELATED TO VACCINE.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included shingles (in June 2018 at the age of 72) and blood cholesterol increased. On 11th September 2018, the patient received Shingrix (intramuscular). On 11th September 2018, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal. On an unknown date, the outcome of the influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal were unknown. It was unknown if the reporter considered the influenza-like symptoms, chills, local swelling, pain in arm, erythema of extremities, headache, fever, weakness and feeling abnormal to be related to Shingrix. Additional details were provided as follows: The patient was receiving unspecified cholesterol medication as concomitant product. In the evening after receiving Shingrix, the patient experienced flu like symptoms of headache, chills, fever, weakness and feeling out of it. The patient also reported arm soreness, redness and a bulge below the arm and below the injection site.
citrus taste" in her mouth; This is a spontaneous report from a contactable consumer (patient). A 77-old female patient (Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 25Jan2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. She stated that she received her second dose of the Pfizer BioNTech COVID-19 vaccine on 25Jan2021 and was calling to report a "citrus taste" in her mouth. She would like to know what to do about this side effect. Informed caller that the reported "citrus taste" was not listed as a commonly reported side effect and referred her back to her Health Care Professional for guidance. The reporter considered events as non-serious. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Erythema and slight induration surrounding vaccination sites on left arm (IPV and DTap).  Right arm (MMR) was normal.
From initial info received on 6/13/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a female pt received a dose of Menactra vaccine, lot U1575AA, SC instead of IM, in the left upper arm on an unspecified date. An unspecified amount of time later, the pt developed large redness of her left upper arm. At the time of this report, the pt recovered from these events.