chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While Mom was nursing patient, about 15 minutes after receiving immunizations, approximately 10:25 AM, Mom noticed that patient's face was really red and she brought him out to the nurse's station. RN noticed that patient's face was red and blotching, resembling hives with what appears to be an allergic reaction. The blotching and developing hives appeared to be spreading down to his upper chest. By the time RN got patient back in the room, the blotching had spread to his abdomen. Redness and swelling at the injection site to the right thigh was also noticed. Epinephrine 0.15 mg auto injector was administered to right vastus lateralis by RN at 10:35 AM. During this time, patient is awake, responding to Mom, and crying/breathing without difficulty. Lungs are clear to auscultation in all lobes. At 10:38, blood pressure in L leg is 106/64, respiration rate is 66/min, heart rate is 144 bpm, capillary refill is less than 2 seconds, blotching in face and trunk as well as in right thigh is diminishing. Patient continues to respond appropriately to Mom and is interacting with her; calms down and is no longer crying. Lungs remain clear to auscultation. At 10:50 lungs remain clear in all lobes, respirations are even and unlabored at 24/min, heart rate is 146 bpm, capillary refill less than 2 seconds, redness to the face and trunk as well as in right thigh is almost completely gone, patient is smiling, alert and calm in Mom's lap. RNs and office manager, discuss with Mom the options of having EMS transport patient to either his doctor's office or the ED, or Mom could transport patient directly to his doctor's office on her own as patient is much improved and has not needed any repeat doses of epinephrine. Mom decides to transport patient to her doctor's office. Patient is a patient of Dr. RN notified Dr.'s nurse of the situation and that Mom is transporting patient to their clinic to be assessed. Nurse says Dr. is out all week, but that patient will be seen by one of the other providers. RN also requested that the notes and plan from patient's visit from today at clinic be faxed so that we will know how to vaccinate patient moving forward. Mom left clinic with patient at 11:05 AM to head to his doctor's office. RN called doctor's office around 11:30 AM to check if patient made it to their clinic, which he had and was checked in.
This spontaneous report as received from a medical assistant referring to a patients of unknown age and gender. No information was reported regarding the patients' medical history, concurrent conditions, concomitant medications, drug reactions, and allergies. On an unknown date, unspecified number of patients were vaccinated with improperly stored GARDASIL 9 (lot number: N021475 and expiration date: 31-JAN-2020) and ROTATEQ (lot number: N011648 and expiration date: 01-DEC-2018) for prophylaxis. The vaccines were exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Follow-up information was received from the medical assistant on 30-JAN-2018 regarding the temperature excursions of the vaccines. On 23rd of an unspecified month in 2017, 16-DEC-2017, 02-JAN-2018, and 03-JAN-2018, the vaccines of GARDASIL 9 were administered to unspecified number of patients. On 09-DEC-2017, the vaccines of GARDASIL 9 were exposed to temperature of 33.90 Fahrenheit for 15 minutes X 8 cycles, 120 minutes. Upon receipt of follow-up information it was determined that this case is now valid because patient's identifiers were received. Follow up information has been received from a physician on 21-AUG-2018, referring to a 10 year old patient (gender not provided) who on 03-JAN-2018, was vaccinated with improperly stored dose of ROTATEQ, orally, lot number: N011648 and expiration date: 01-DEC-2018, (strength, dose and frequency were not provided). The vaccine was exposed to temperature of 32 F to 35 Fahrenheit (F), below 32 F and as low as 27 F. Time frame was reported as multiple excursions over a period of 1 month. The call was because of a digital data logger. No adverse events were reported. Sender's Comments: US-009507513-1801USA008060.
PT came into office for a 16 year well visit. For the 16 year well visit we administer the menveo A #2 was given in the L arm of the pt. vaccine administered within seconds pt fainted while sitting on table in examine room. pt came to within seconds was feeling fine at time of vaccine being given was not feeling dizzy no headache no ringing in the ears. PT also had same reaction at the age of 11  was given same vaccine by same manufacturer. lot no  M16014 on 12-08-2016  administer in R arm
no additional AE reported; improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 14-MAR-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (recombinant Human albumin (rHA)) (M-M-R II) (lot #U006488 was confirmed to be valid, expiration date: 26-FEB-2023) (dose, dose number, site and route of administration were not provided) for prophylaxis.  Before the administration, from 23-FEB-2022, the vaccine were improperly stored at 8.7 Celsius degrees (C) for 1 hour and 36 minutes (product storage error). No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA005045: US-009507513-2204USA005826: US-009507513-2204USA005827: US-009507513-2204USA005828: US-009507513-2204USA005829:
Sore throat, laryngitis, body aches,  and horrible headache.  I was actually sicker with this vaccine than with Covid infection itself in April of 2022.
Patient called the night of 10/25/09 to say that 3 days after getting the flu shot (10/20) she woke up in the middle of the night feeling warm with itchy hives/welts on her ankles, legs, buttocks, shoulders.  She did not have any Benadryl on hand at the time.  She did not have a fever, or any swelling of the lips or mouth.  After being up for a while, the hives/welts went away and were gone in the morning.  The next evening, she woke up with hives again, this time less severe and only on her ankles.  They went away again after being up for a while.  She didn't have anymore reactions after that.  She can't think of anything new she ate or did that she would have had an allergic reaction to except possibly Skelaxin she recieved from a different pharmacy.  She took one before bed the night of the first reaction, but did not take one the night of the second reaction.
Information has been received from a nurse practitioner concerning a 43 year old female clerk (same place of employment as the reporter) with seasonal allergies, an allergy to sulfa and a history of anemia, type II diabetes mellitus, hyperlipidemia, hypertension, a recent abnormal PAP test, no adverse events following prior vaccinations and no illness at the time of vaccination who on 9/30/03 at 11:00 in an outpatient clinic was vaccinated IM in the left deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot # 646320/0531N). Concomitant vaccination on 6/30/03 at 11:00 included an IM dose in the right deltoid of influenza virus split virion 3v vaccine inactivated with no adverse reaction. The patient had more than 20 previous doses of influenza virus split virion 3v vaccine inactivated with no problems. Concomitant medication included simvastatin, enalapril maleate, glyburide, and loratadine. On 6/30/03 at 11:00, immediately post vaccination, the patient experienced an injection site reaction. The area became swollen as the vaccine was being instilled. The area became huge, the size of a baseball and hard. The area was localized to the deltoid. There was progressive pain, swelling and decreased range of motion in the left shoulder/arm. Ice was applied and diphenhydramine hydrochloride 25mg was given. On 10/1/03, the patient was seen with increased swelling, pain in the arm and a limited range of motion. The patient had continued to use ice on the area. No further treatment was given by the reporting nurse practitioner and the patient planned to see the physician in the clinic later that day. The patient was treated by a medical doctor with amoxicillin (+) clavulanate potassium, an NSAID and acetaminophen (+) codeine phosphate. On approximately 10/14/03 the patient recovered from the pain, swelling, and decreased range of motion. The duration was noted to be approximately 2 weeks. A product quality complaint was not involved. The reporter also mentioned a second patient that had an experience post vaccination with pneumococcal 23v polysaccharide vaccine. Additional information is not expected.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. There was no information about the patients; concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9, (dose, route of administration, lot# and expiration date were not reported). Administered dose of GARDASIL 9 was exposed to temperature of -1 degree of Celsius for 16 hours and 35 minutes, on an unknown date. There was previous temperature excursion which took 8 hours with the temperature 14 degrees of Celsius, on an unknown date. Digital data logger was no involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
First dose I had intermittent sharp pain in left rib. Headaches when bending over  Second dose the headaches continue More importantly there is a hard bruise on bottom of right foot that started on Monday as a painful area then progressed to dark painpulf bruise
LOSS OF SMELL; LOSS OF TASTE; This spontaneous report received from a patient concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: neuropathy in legs, elevated cholesterol, alcohol use, and non smoker, and other pre-existing medical conditions included: The patient did not have any drug abuse or illicit drug use. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Concomitant medications included atorvastatin calcium for elevated cholesterol, pregabalin for neuropathy in legs, and esomeprazole magnesium.  On an unspecified date, the patient experienced loss of smell, and loss of taste. Laboratory data (dates unspecified) included: CT brain scan (NR: not provided) nothing came wrong, and X-ray of nasal sinuses (NR: not provided) nothing came wrong. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from loss of smell, and loss of taste. This report was non-serious.
This spontaneous report was received from a registered nurse referring to a 11 week old male patient. The patient had no medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 20-NOV-2018, the patient was vaccinated with the first dose of ROTATEQ lot number R002515 and expiration date of 13-SEP-2019 for prophylaxis (dose was not reported). On 05-DEC-2018, the patient experienced diarrhea and vomiting and was examined at an unspecified emergency room and seen by the physician and an unspecified stool test was performed which was positive for rotavirus. The patient did not received treatment to aforementioned events. The outcome of rotavirus test positive, vomiting and diarrhoea was reported as resolved on an unspecified date in December 2018. Additionally, the reporter did not provide causality assessment between the events and vaccination with ROTATEQ.
Moderna COVID-19 Vaccine EUA.  Around 25 min after injection I started feeling dizzy then had tachycardia, sweating, numbness and tingling in extremities. Given Oxygen and taken to the ER. Symptoms subsided 5 min after arriving in ER except numbness and tingling in hands. About 30 min later I started having dizziness and tachycardia again which lasted a few minutes. EKG, CHest X-ray and labs all normal. Just feel tired.
Patient received Fluvirin '13-'14 and had a seizure at 8:55 PM for about 5 seconds. I moved objects on the table away from him. He banged  his head on the table a few times before reviving.
pt recv vax 15SEP97 & 16SEP97 pt was tired & exp heartburn, vomiting 4x & nausea;
PLAN: This is an 86-year-old female who received her third Covid vaccine and noticed some acute swelling in her bilateral legs and ankles and some easy bruising. Symptoms for one week.  She had seen on the television concern for thrombocytosis and contacted her primary care doctor.  Primary care doctor's office advised she come over for an ultrasound and lab work. On exam she does have mild bilateral edema around her ankles, no shortness of breath or wheezing.  She also has some petechial bleeding on her forearms, minor. CBC: within normal.  No low platelet count Vascular ultrasound: No DVT Discussed with patient other causes. Agreed to CMP, BNP and ECG.  States just had other tests. Declines cxr.  Lung sounds are clear.
He got sick; Sore throat; Swelling a little bit.; He broke out with his hands, face, chest and feet but the rash and the rash is very painful/He has faced it is painful rash on his face, Neck, Ears hand really bad and feet; This is a spontaneous report from a contactable consumer (parent). A 22-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 via unspecified route on Sep2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient received historical vaccine of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1 via unspecified route on an unknown date as dose 1, single for COVID-19 immunisation. The patient after 3-4 days, got sick, sore throat, he broke out with his hands, face, chest and feet's but the rash and the rash is very painful/he has faced it is painful rash on his face, neck, ears hand really bad and feet and swelling little bit on Sep2021. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Pronounced redness, hardness, and heat at injection site. Would scream and cry in pain if touched near the shot site or any pressure applied to the leg at all while holding him.
MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, as per reporter "Your shot gave my wife myocarditis" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211033613-covid-19 vaccine ad26.cov2.s-myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
(L) deltoid approx. 4" diameter red "bullseye", swollen & very wm. to touch, c/o pain at site, h/a, tiredness, fogginess & diarrhea. Treated with ice & ibuprofen. Onset of S & S 2-23-13, no c/o fever. Temp in clinic 97.6.
dizzy, pass out, rolled back in chairblackout. Syncopy, tensed up  Staff came to evaluate. Recommended ER.  Vitals BP: 148/63  93HR 97 o2
shingles and other zoster-related conditions; shingles and other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 01-NOV-2015, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by a healthcare provider for shingles and other zoster-related conditions. As a direct and proximate result of the patient's use of the vaccine live (ZOSTAVAX) vaccine, the patient had and will continue suffer ongoing injuries, including but not limited  to: mental and physical pain and suffering; 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 cost included care for hospitalization, physician care, monitoring, treatment, medications, and supplies: diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffered such losses, and damages in the future. The outcome of the event s was not provided. Therefore, the causality for the event was related to zoster vaccine live (ZOSTAVAX).
Starting 12/29/2022, I woke up with a tight chest, raspy voice, deeper cough, sneezing fits and mild headache. My daughter tested herself that day and was positive. However, I tested negative. That evening, I started having a fever of 100.4. The next morning, I took a COVID-19 test (12/30/2022) and it was positive. At that point, I felt like I had the flu and my eyes had become sensitive to light. I went to urgent care per recommendation of the nurses line from my health plan. On 12/31/2022, I drove to the urgent care, where they tested me for flu, step and COVID-19. I tested positive for COVID-19 and was prescribed PAXLOVID. I started the medication that day. I still feel terrible to this day but I am not coughing as much. I still ache and my eyes are still sensitive to light. My headache is more intermittent and I feel more "dried" up. However, I'm still not feeling 100%. The medicine is causing some diarrhea and leaves a very poor taste in my mouth. Lately, I have been getting dizzy when I roll over in bed which is not normal. This is the most sick I have been in years.
Swelling of face with urticaria about four hours after receiving Hep B #2. To local ER with Rx of Benadryl, Epi 1:1000, Zantac.
After the first day I developed soreness at the injection site.  After about 2 days, the soreness moved to my left shoulder joint.  Currently, 8 days after the injection, my left shoulder joint remains sore and any motion to left my left arm laterally from my side is painful; like my joint is inflamed.  There is no redness or other visible external signs or discoloration.  I can not say for certain it is linked to the Modern vaccine as I've had left shoulder issues infrequently in the past.  But timing wise, my current discomfort started shortly after receiving the vaccine.
Initial report received from a registered nurse on 18 Dec 2009: This patient was vaccinated with S-OIV FLUVIRIN (batch no. 10073802) via intranasal route instead of intramuscular route. No adverse event was reported.
Cough, sore throat, slight difficulty breathing, bloodshot eyes - 2-6 hrs post vaccination. Tired, sore throat - 6 to 48 hrs post vaccination.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.