chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The rash started at noon exactly. I had not eaten anything all day. My top lip started to swell and then my thumb started to swell. I took benedryl and the swelling started to go down. After every two hours or so my wrists and palms started itching and I started to see bumps. 11/28/2009 I woke up and my eyes were swollen and puffy and I could see more of the rash around my hands and body. I continued to take benedryl so the itching and swelling would stop. Later on in the day it continuesly got worse, my feet started to swell and it was difficult for me to walk. The rash was then on my whole body, including my neck. It itched very bad. Around 10 PM my eyes started to swell again and there were bumps around my eyes. The bottom of my eyes looked like they were blisters. I went to sleep and I woke up (11/30/2009) and the rash was all over my face and my whole body. My stomach and back were completly covered. My eyes and lips were swollen. Then I went to the doctor, he said I was obviously having an allergic reaction, but did not know to what. He prescribed the steroid Prednisone, 40 mg the first two days, 20 mg the next 7, 10 mg after that, and then 5 mg. So I would be taking this for two weeks, he also recommended Zyrtec and said it would be best to take Benedryl, two pills, four times a day. I took the Prednisone right after I purchased it along with the Zyrtec and the rash started to go away. It then came back after I ate and was still all over my face and body. Not only was this happening but everytime I ate my throat would start to swell and I could not breathe. I went to the doctor again on 12/1/2009 and he prescribed a higher dosage of Prednisone, recommended Zyrtec twice a day, Pepcid AC, and Singulair. Since I have been taking these medications I have not had a problem.
Seizure around 4 AM 1-31-08. Fever. Imm. given 1-30-08. 04/28/08-records received for DOS 1/31-2/24/08-DC DX: Febrile seizures. Comples febrile seizures. Left undescended testicle.Presented to ED with  fever 100.4 and seizure that was generalized, tonic-clonic and lasted more than 25 minutes. Intubated and admitted to PICU.
Information has been received from a registered nurse concerning a 67 year old white male with no known medical history or allergies who on 21 , Mar 2006 was vaccinated IM with a 1 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (Lot # 647982/0446R). Concomitant therapy included simvastatin (MSD). There was no illness at the time of vaccination. Approximately 24 hours later on 22, Mar 2006 (also reported as several hours later, on 21 Mar 2006 The patient experienced fatigue, shoulder pain and knee joint pain, that was described as being a 3-4 on a 10 scale of intensity. The symptoms lasted 3 days. No medical consultation or exam was performed. No laboratory diagnostic tests were performed. The patient's outcome was recovered. It was reported that on 18, Apr 2006 the patient received his second dose of hepatitis B virus vaccine rHBsAg (yeast) and he had no complains at joint pain after this dose. There were no adverse events following prior vaccination. There was o product quality complaint involved.
28 year old female complained of feeling flushed and ?foggy? at 2:06 pm. Patient was placed on stretcher in the Fowler?s position. Vital signs taken: BP 141/91, HR 71, RR 16, 02 99% on room air. PERRL. Lung sounds clear, CV- regular rate and rhythm. Was directed by MD to give patient Diphenhydramine 50 mg IM. Medication was given in the left deltoid at 2:11 am. Patient tolerated well. VS re-checked at 2:13 pm- BP 134/92, HR 72, RR 16, 02 98%. Patient stated she was feeling drowsy and dizzy after diphenhydramine injection. Patient requested water and was given water at 2:15 pm. She then complained of feeling feverish. Temperature 99.4. VS re-checked at 2:16 pm BP 134/73, HR 72, RR 16, 02 98%. Patient  continued to be monitored with improvement in her symptoms, vital signs as follows:   VS at 2:22 pm BP 133/91, HR 72, RR 16, 02 98% VS at 2:28 pm BP 129/96, HR 72, RR 16, 02 98% At 2:34 pm patient stated that she was having some difficulty taking deep breaths. Stated she was not short of breath. Denied chest pain. MD was called over to assess patient as well. MD evaluated patient and patient?s symptoms improved. Was instructed to continue to monitor patient.  VS at 2:35 pm BP 129/96, HR 73, RR 16, 02 98% VS at 2:58 pm BP 124/90, HR 70, RR 16, 02 98% At 3:04 patient stating she was feeling better, but was drowsy from the Benadryl.  VS at 3:05 pm  BP 117/80, HR 69, RR 16, 02 98% 3:10 pm Dr examined patient with ok to leave for home. Patient agreeable with plan. Educated on red flag s/sx and when to call 911. Instructed patient that provider will call her tomorrow for follow-up. Patient left clinic in stable condition with boyfriend driving her home.
Severe arm pain with large lump and rash, lump in armpit, chills, fever, headache, cough with some chest congestion, headache, runny/ stuffy nose and extreme body aches. Light headed and fuzzy headed feeling 20 minutes after shot.
Heart palpitations about a month after.  5 month later went into ER with symptoms very similar to heart attack.  Heavy chest, loss of breath and faint.  Blood pressure rise.
Patient developed a rash on her neck beginning on the right side and continued to increase around her neck. She is still experiencing redness today. She also has some itching of her scalp. She did not require intervention.
Fever of 100.3, chills and body aches, fatigue, uncomfortable soreness in right arm
This spontaneous report was received from a medical assistant refers to 8 patients (age and gender unknown). Between 01-DEC-2012 and 23-JAN-2013 (also reported as 23-JAN-2012), the patients were vaccinated with GARDASIL injection (route, dose and frequency not reported) (lot #H011350; expiration date on 21-FEB-2015). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patients may have received GARDASIL exposed to 24 F for an unspecified period of time. No adverse symptoms reported. The outcome of patients received GARDASIL exposed to 24 F for an unspecified period of time was unknown. Additional information has been requested.
Rash on torso approximately 1 hour after leaving the store. Took BENADRYL cleared reaction quickly.
transverse myelitis; On or about June 20, 2013, Plaintiff was administered the ZOSTAVAX; Information has been received from a lawyer regarding a case in litigation and refers to a 49-year-old female patient (pt). No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 20-JUN-2013, the pt was vaccinated at her primary care provider with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions (product administered to patient of inappropriate age). Subsequently, on an unknown date, the pt was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: transverse myelitis. The outcome of the event was not reported. The reporter considered the event of transverse myelitis to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of transverse myelitis was determined to be medically significant.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEPT-2013 the patient was vaccinated with M-M-R II (lot # J002502, expiration date 28-FEB-2015). The vaccine was exposed to temperature exposures of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes, 17-SEP-2013 for 35 minutes, on 19-SEP-2013 for 1 hour and 35 minutes, on 20-SEP-2013 for 40 minutes and on 25-SEP-2013 for 45 minutes. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 131USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008405, 1310USA008406, and 1310USA008407 (same reporter linked). Additional information has been requested
Patient was vaccinated with pfizer 12+ vaccine at age of 11. Pt. denies any signs of adverse reaction post vaccination.
Patient developed a fine pin point rash to her whole body. It started on the right arm, but then spread to the back and down the legs. The rash is skin colored. It is itchy.
Rash at injection site appeared 9 days after injection 1.5? x 2?
Developed erythema and swelling approx 7 cm X 3.5 cm in diameter on L thigh surrounding injection site.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. On an unknown date, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # L019835 with expiration date 23-MAR-2017, dose and route unknown). No adverse event was reported. Additional information has been requested.
a spoon and tweezers stuck to her arm at the site of the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (a spoon and tweezers stuck to her arm at the site of the injection) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE REACTION (a spoon and tweezers stuck to her arm at the site of the injection). At the time of the report, VACCINATION SITE REACTION (a spoon and tweezers stuck to her arm at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants and treatment medications were reported.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium
Large painful red cold sore on and under bottom lip. First time Ive had cold sore in the last 20years. Larger and redder than cold sores I had in the past. Larger today than yesterday Seems to be spreading across my lip.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 18Apr2021 at 14:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included essential tremor, cerebral palsy, depression and cold sores. The patient had no known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced large painful red cold sore on and under bottom lip. First time the patient had cold sore in the last 20years. Larger and redder than cold sores she had in the past. Larger on the day of report than previous day. Seemed to be spreading across her lip. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event large painful red cold sore on and under bottom lip, first time the patient had cold sore in the last 20years; larger and redder than cold sores she had in the past; larger on the day of report than previous day; seemed to be spreading across her lip was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, fever to 102 oral for 48 hours. Congestion, loose cough, muscles aches. Redness at vaccine injection site 3 1/2 x 5 inches, tender, mild swelling influenza test negative.
Bruised, sore. Can't lay on that side, swollen.  - Took Tylenol
4-5 hours after the shot, started feeling ill. Got violent chills, added clothing, turned up heat in the house and went to bed. No fever noted but did throw up about 9pm. Went back to bed and stayed there until 8 am the next morning (15 hrs total) drinking a lot of water along the way. Got up; not a lot of energy but was fine. Took it easy all day.
Injection site reaction rash, hard, raised, hot, low grade fever 100.4 on Tylenol
weakness/malaise per daughter, death on 3/14 (did have underlying medical conditions)
Information has ben received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concomitant therapy and drug reactions were not reported. On 31-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017, dose not provided) intramuscularly, which was exposed to 35 Fahrenheit (F) for 1 hour and 15 minutes as well as 47 Fahrenheit (F) for 15 minutes. No adverse effects were reported. The data logger was involved. Additional information has been requested.
Had extreme heart palpitations.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 15Feb2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included factor 5 Leiden and known allergy to strawberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) and spironolactone (MANUFACTURER UNKNOWN); both from unknown dates for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 19:45, the patient experienced extreme heart palpitations, at the time of this report the patient had them on and off throughout the day ever since. The patient never had heart palpitations prior to receiving the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 26Aug2021, the patient underwent nasal swab test and the result was negative. The clinical outcome of the event extreme heart palpitations was not resolved at the time of this report.
Fainting, quaking, extreme nausea and weakness for more than 6 hours.
This spontaneous initial report was received from a nurse referring a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The Nurse reported that on in 11-NOV-2016 the patient was vaccinated with PROQUAD lot # L032761, expiration date 24-FEB-2017 (strength, dose and route of administration were not reported) for prophylaxis. (Product use issue). The nurse also informed that the sterile diluent (MERCK) (unknown lot number and expiration date) used to reconstitute PROQUAD did not undergo a temperature excursion. No adverse effects were reported.
Chest tightness Hot flash for 1 minute  Tight throat  High heart rate 120s-130s
Patient got BEXSERO instead of MENVEO; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comment: The reporter reported that by mistake the patient received Bexsero vaccine instead of Menveo vaccine. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, mistakenly administered Bexsero instead of Menveo, which led to wrong vaccine administered.
Itchy-bumpy red rash on upper left arm. Started 9 days after injection. Getting larger every day.  Still have it 14 days after injection.
arm is very hot; they touch their arm  they feel like theirs a ball of meat or fat; arm is getting red and black; arm is getting red and black and is itching; headache; their arm got red and stated to bothering them; arm got red; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (their arm got red and stated to bothering them), FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black) and ERYTHEMA (arm got red) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058h21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced DISCOMFORT (their arm got red and stated to bothering them) and ERYTHEMA (arm got red). On 01-Dec-2021, the patient experienced FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black), PRURITUS (arm is getting red and black and is itching) and HEADACHE (headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (their arm got red and stated to bothering them), FEELING HOT (arm is very hot), MASS (they touch their arm  they feel like theirs a ball of meat or fat), SKIN DISCOLOURATION (arm is getting red and black), ERYTHEMA (arm got red), PRURITUS (arm is getting red and black and is itching) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not reported.  Few hours after the vaccination patient started experiencing the adverse events.
Pfizer Dose 1 4/1/21 (EN6198) Pfizer Dose 2 4/23/21 (EW0153) Pfizer Dose 3 10/27/21 (FF2587) COVID Positive 1/4/22  1/4/22: Patient is a pleasant 54-year-old female with past medical history of asthma, hypertension, obesity previous tobacco use comes in with chief complaint of shortness of breath, chills fever, cough.  Clinical picture started suddenly around 3:00 a.m. overnight patient reported symptoms got progressively worse so she came into the emergency department this morning for further evaluation. In ER blood work demonstrated mild lactic acid elevation of 2.1, Mag was 1.2 mild transaminitis, troponin negative EKG sinus tach CBC without significant leukocytosis or anemia. D-dimer was within normal limits.  Influenza swab was negative COVID PCR was obtained pending.  Chest x-ray reportedly without acute derangements.  Per ED provider patient was working hard to breathe tachycardic and was wheezing received antibiotics, breathing treatment Solu-Medrol and IV fluids.  Request was made to admit to medical service for further treatment evaluation.  At bedside patient is lying comfortably in bed has some lightheadedness, no vision change, mild headache no palpitations, chest pain when she gets short of breath, no abdominal pain, no paresthesia.  Has baseline swelling bilateral lower extremities.  Had 1 episode of diarrhea and, no dysuria.  She is unaware of any sick contacts, stays at home to take care of elderly father and special needs child.  Denies tobacco use, social alcohol consumption 3 times a week 1-2 drinks, no marijuana/recreational drugs, no over-the-counter medications.  She reports she has been COVID vaccinated 2 doses plus booster.  No recent travel outside the area. Does not use oxygen at baseline.  Family history otherwise noncontributory to presenting finding.  Reportedly got very dyspneic on ambulation in ED dropped to 90% otherwise was 93% room air but wheezing was working slightly hard to breathe.  1/6/22: Patient admitted for management of COPD exacerbation and COVID infection without oxygen requirement  She was on IV steroids , IV antibiotics for treatment of COPD exacerbation  She was on supportive treatment for COVID. Not qualifying for remdesivir as she is not hypoxic.  Symptoms improved and hemodynamically stable for discharge  Discharge on medrol dose pack, supportive COVID treatments, PO antibiotics and COVID safe home program
From approximately 5:00 pm on 4/9/21 - 11:00pm on 4/10/21 I experienced chills, fever (101.7 highest recorded) sweats, body aches, and headache. I've also experienced soreness at the injection site that is worse now 4/11/21 compared to the days since the vaccine was administered.
A few days after the second dose the lymph nodes under my right arm became extremely sore. Then my left (opposite) arm became sore and the pain continued moving down to my hand. It was so painful I couldn?t pick up a cell phone. Many nights my arm woke me up throbbing.  Most of the pain is centered in the elbow with throbs and occasional shooting pain above and below the elbow occasionally. My husband got his second one a few days later. He has much milder pain in his  opposite elbow. I?ve also read (and have a screenshot) of someone else with an identical reaction.  My doctor put me on two months of anti inflammatories and didn?t think it was vaccine related, but I KNOW it is...especially with others having similar experiences.
Patient presented for and received a Bivalent Moderna vaccine however had already received a Bivalent Moderna on 09/20/2022.  This was discovered when entering the injection into the system.
Had both Flu and PPSV 23 given in lf arm in 24hrs, has had swelling, warmth, redness, pain, low grade temp.