chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID VACCINE MODERNA UNDER EUA  During her 15 minute post-vaccination observation period, patient reported feeling lightheaded and very warm. She had flushing on her face and neck. No rash, hives, angioedema, or breathing difficulty. No fall, no loss of consciousness. The client denied allergy history but did say the same thing happened to her during a root canal when the local anesthetic was injected in to her gums.   This RN along with another RN observed the client for approximately 25 minutes total then discharged her home. Approximately 15 minutes in to this observation period, the client reported improvement in her symptoms and the flushing appeared to be improving. The patient did not wish to call for a ride or seek EMS. At time of discharge, patient agreed to pull her vehicle to the side of the road and call for assistance if, at any time, she did not feel well on her drive home. Interventions implemented were lying down with feet elevated, smelling ammonia salts, application of cool compress to head and neck, drinking juice, and eating snack bar. I called the client two hours later to confirm she arrived home safely. The patient confirmed save arrival home and reported feeling much better. She said she was planning to follow up with her PCP about her response and also had a partner at home to observe her. Associate program manager notified of event details.
pt adm to hosp 14NOV92 due to pancytopenia & sepsis; pt was thought to have recvd flu vax prior to this event; Ceftazidime therapy was inititated; Bone marrow biopsy is planned;
KNEE PAIN; LEG PAIN AND PAIN IN THIGHS; PAIN IN CALVES; EXHAUSTED; CHILLS; JOINT PAIN; MUSCLE  PAIN; EXTREME FATIGUE; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included no health issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced joint pain. On 08-APR-2021, the subject experienced muscle pain. On 08-APR-2021, the subject experienced extreme fatigue. On 08-APR-2021 19:00, the subject experienced exhausted. On 11-APR-2021, the subject experienced pain in calves. On 11-APR-2021, the subject experienced knee pain. On 11-APR-2021, the subject experienced leg pain and pain in thighs. On 12-APR-2021, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 08-APR-2021, and extreme fatigue, and exhausted on 10-APR-2021, and had not recovered from muscle pain, knee pain, leg pain and pain in thighs, pain in calves, and joint pain. This report was non-serious.
About 24 hours after immunizations listed below, patient developed petechiae/purpura, temperature 100-101 and WBC 26,000. Blood Culture negative. Latex agglut negative. Discharge diagnosis viral syndrome. The follow up received on 11/25/02 states, "latex agglut (-) for N. meningitidas."
Patient left office, had some sneezing and coughing. Was in parking lot became pale - returned to office was pale, started vomiting, alert, lungs CTA, heart reg. Pt then fainted, O2 applied, pulse Ox 98 HR 128 BP 66/38. Pt arousable, answers questions, follows commands. Then slept and transported to ER via ambulance.
Inadvertently given expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (Allergic to Influenza vaccine).    On 10-Nov-2021 at 11:20 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Inadvertently given expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  No adverse reaction was reported.
c/o vertigo, coordination problem, laryngitis & URI;18SEP98 strange sensation in arms;numbness of arms, legs & face;unable to r/o GBS @ this time;poss sensory neuropathy;flu;problems starting urine;arterial insufficiency;
Belly pain, involuntary leg movements, tingling and numbness in legs, insomnia.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL lot # L040459, expiry date 06-APR-2017 and lot # K010215, expiry dates 05-MAY-2017. Temperature excursion of 52 Fahrenheit for 182 days, no data logger and there was no previous excursion. There was no adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
I had a sore arm for a couple of days, 3 days later I felt very nauseous, and I've been throwing up a lot. I went to go see Dr. on Nov 19th. It could've not been the vaccine. No medication was provided but she would like for me to go back in two months. I'm still pretty nauseous as of now.
Vomiting, diarrhea, mild x3 days; seen at E.R 5/28/08
only received the first dose,several months later are coming for the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (only received the first dose,several months later are coming for the second dose) 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.
07May07 Body covered with hives. Went to ER. received steroids, Benadryl at 2200 released at 0500 08May07. Member still has hives and was given script for Prednisone
Vaccine received 5/21/07 in the morning.  Patient called clinic 5/23/07 am to report arm that was vaccinated had reddness extending to anticubital area.  "Hot" yesterday, "warm" today.  Taking Tylenol.  Pain level 4.
Information has been received from a registered nurse concerning a 79 year old female with no known drug allergies who at 9:10 am on 21-MAY-2007 was vaccinated IM in the left deltoid with a second dose (date of first dose not reported) of PNEUMOVAX 23 (Lot#655588/0883F). Post vaccination with in 24 hours on approximately 22-MAY-2007 the patient developed redness, tenderness and swelling at the injection site down to her elbow. On 23-May-2007 the patient was seen in the physicians office, no edema or warmth were noted. Redness was noted from the elbow to the shoulder and the area was tender to the touch. Subsequently, approximately one week later the patient recovered from the events. Additional information has been requested.
Mother states child developed swelling to the left deltoid area approximately 8-12 hours after receiving flu vaccine. Also he complained of itching at the site and itching to his tongue. Mother states that both cold and hot compresses were applied as well as vicks vapor rub. Violet was applied to the tongue by mother. Child returned to Health Center after 24 hours was examined and instructed to use cool compresses only and to give 1 TSP Benadryl every 6 hours as needed.
Localized erythema and swelling and possible generalized pruritus and urticaria - 31 hrs after vaccine. Treated with antihistamines and Prelone. A 6 year male patient, with a history of chronic idiopathic urticaria and food allergies, received on 10 November 2010 a right deltoid intramuscular injection of FLUZONE No Preservative 2010-2011, lot number U3777BA. The patient had no concomitant medications and denied any illness at the time of vaccination. On 15 November 2010, 5 days after the vaccine, the patient reported that he had an area the size of a 25 cent piece at the injection site which was ulcerated and painful. The patient was evaluated by an infectious disease specialist. The outcome was unknown. Additional information was received from the health care professional on 16 and 19 November 2010. The patient was vaccinated from a single-dose vial and developed a skin ulcer within 1 to 2 days of vaccination (previously reported as 5 days post-vaccination). He had "multiple medical problems", and had received influenza vaccines in the past. At the time of the report, the ulcer was healing on its own.
Pt admitted with acute hypoxic respiratory failure secondary to COVID-19 pneumonia and decompensated systolic CHF.
rash to arms, palms 4hr p/vax +swollen eyelids;DPH given;
Beginning on 4/19/22 I experienced abdominal pain, fever, and I had a telemedicine visit and was prescribed an antibiotic for a UTI. Four days later I had fever of 102, tachycardia, and went to the urgent care where I was sent to the ER where I was diagnosed with an acute UTI with liver enzymes elevated, CRP elevated, sepsis, and hypokalemia. At the ER, I was given IV fluids and antibiotics. I am waiting for a follow up with GI doctor for elevated liver enzymes and CRP levels. I am still experiencing the symptoms ongoing at this point in time and am on 2 antibiotics and a potassium replacement.
Pediatric COVID-19 vaccine was not diluted, drawn up to 0.2mL and administered IM to pediatric patient. Patient's doctor's office called and message to call pharmacy back left. Patient's mom was called and advised about the event.
01/07/2021-  1ST DOSE OF MODERNA COVID 19 VACCINE 02/03/2021- 2ND DOSE OF MODERNA COVID 19 VACCINE 08/06/2021 - SYMPTOM ONSET  OF COVID. SYMPTOMS: HEADACHE, CHILLS, AND NASAL DISCHARGE. 08/13/2021 - PT TESTED POSITIVE FOR COVID-19 via RAPID PCR TEST.
Evening of 07/25 - noted redness, soreness, very warm to touch - redness down to elbow, continues today (07/28).  Temperature 100.8.  Cellulitis questionable- treated with Cephalexin.
This spontaneous report as received from a certified medical assistant/healthcare worker refers to multiple patients of unknown demographics. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot # reported as 1013824, expiry date: 21-APR-2017) (incorrect product storage). No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This report is one of several reports from the same reporter. Additional information has been requested.
Patient is a 93 y.o. male who presented to Hospital 3/22/2023 with SOB   1. Covid pneumonia               - positive 3/23 at hospital; family reports was + one week prior at ECF               - vaccination status: 2 plus booster              - blood cultures NGTD              - lactic acidosis resolved               - CXR with central bronchial wall cuffing; superimposed mixed intersititial and alveolar opacities; small bilateral pleural effusions               - ID initially recommended Paxlovid- but patient would have had to stop statin and Plavix for 5 days. Remdesivir started 3/25/23 per ID.    - CTPA shows pleural effusion and multifocal pneumonia -Pulmonary consult placed - note reviewed - appreciate recommendations -patient was initially started on IV Zosyn but was discontinued per pulmonary recommendations  -ABGs reviewed  -requiring 3 L oxygen on discharge day. Was discharged with Home O2 and oxygen concentrator pt completed remdesevir course last dose being 3/29.  2. HTN 3. HLD  4. History of CVA               - History of right internal capsule stroke with residual spastic left hemiplegia (11/22/2016)  5. CAD; history of CABG 6. Hypocalcemia - started on po supplementation 7. Hyperglycemia - A1C 5.9 - prediabetes - will need OP follow up and monitoring 8. Acute hypoxic respiratory failure  9. Severe protein calorie malnutrition
About 1" away from injection site arm is red, swollen, hot, itchy...this covers an area 3" x2".  It's been two days and it doesn't seem to be waning.  I went online and "Covid Arm" popped up...the pictures look exactly like what I have.  Not life threatening,  a minor inconvenience but online it says its a side effect of Moderna and I received Pfizer so I thought I would report it. I'm using cold compresses and Bactine which helps.
Patient states 2 weeks after shot pain in back of arm  to elbow. Patient states not rotator cuff. Patient also states immunizing pharmacist gave immunization correctly and received seveal immunization from that pharmacist. Patient had MRI 7-25-23. Doctor recommended physical therapy and voltaren gel. Patient states she thinks Fluad was too strong for her even though she received Fluad since 2019 and age appropriate.
Rapid Heartbeat, panic, dizzy- taken by ambulance to the emergency room less than one hour after vaccine.
Swelling of right deltoid area (right deltoid). Started Saturday 7/10/04. Tender to touch. Temp 105 oral.
Kidney stones began approximately 1 month after first vaccine dosage received.  Liver cysts discovered in a CAT scan along with kidney stones.  Follow-up ultrasound scheduled for 9/7/21. Menstrual cycle was also inconsistent for 6 months after first injection, although I did not seek medical treatment for this.
PATIENT FELL TO FLOOR AFTER GETTING MODERNA DOSE 1. HE TOOK A FEW STEPS FROM THE SHOT BOOTH, THEN FELL TO HIS KNEES. PATIENT CITED DIZINESS AND ANXIETY AS CAUSE OF THE FALL. HE SAT IN MY VIEW FOR 30 MINUTES, AND SIGNIFICANTLY IMPROVED IN THAT TIME. NO MEDICATION WAS GIVEN.
Major fatigue the next day. It kept me from working. I slept majority of the day. Pain and swelling at injection site lasting for 2 days. Bad headache lasting two days.
nocturnal, bilateral paresthesia (has happened to both feet/legs, hands?whichever is lowest if on the side, or hand if in a bent position on back). Also persistent severe knee and foot joint subluxation.
my toes began tingling, getting numb, and then turning white and purple several times a day since I received the first dose of the vaccine. I have worn socks and slippers, I maintain an active lifestyle, and I am not sedentary during the work day. There were no changes in my lifestyle after receiving the vaccine. I have never gotten Covid-19, as far as I know. I contacted my doctor over the phone about my toe numbness and color changes, due to concerns about circulation, and she informed me that my most recent comprehensive bloodwork taken in January of this year showed me in excellent health. No concerns noted for anything such as lupus, hypo or hyperglycermia, or poor circulation. I am concerned about this ongoing.
The patient received dose 1 of the Pfizer COVID vaccine (lot FK5127) at 1212. At 1220, the patient's body went limp and his head slumped forwards while sitting in his father's arms. The patient's father called for help. Patient's mother reported the patient was not responding to verbal stimuli. PHN and PHN approached to assess patient. Patient appeared pale and diaphoretic. Patient started responding to verbal stimuli asking "what's going on?" PHN and father assisted patient to the ground. Vital signs: blood pressure 90/58, O2 99%, pulse 84, respirations 24. At 1225, patient reported he saw black and felt sleepy but currently symptoms improved. Patient's mother reported patient had allergies to ibuprofen and bandage adhesive, no medical conditions, and takes no medication. PHN offered Benadryl but patient's mother declined. PHN educated on remaining for 30min monitoring from time symptoms started, to follow up with provider, and ER precautions. Patient's mother reported that patient had no prior history of syncope. PHN offered patient water and applesauce but patient declined. At 1228, patient reported symptoms had resolved. Vital signs: blood pressure 94/62, O2 99%, pulse 78, respirations 20. At 1245, patient sat up, continued reporting no symptoms. Vital signs: blood pressure 92/60, O2 99%, pulse 80, respirations 18. At 1248, patient stood up, continued reporting no symptoms. Patient left walking with steady gait at 1250 accompanied by parents and sibling.
Within 1 minute of receiving DTaP, pt had an urticaric induration on right shoulder and right cheek and left shoulder below injection site. There was no wheal. He was given Benadryl 12.5mg po.
SkinRash, Rash & RASH; BURNING SNSATION; INJECTION SITE PAIN
body aches, lightheadedness, headache, nausea, injection site pain and stiffness
This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site cellulitis, injection site pain, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site cellulitis, injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site cellulitis, injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced pain, swelling and redness at the injection site, which progressed into cellulitis and lasted for more than 3 days. This was the only information reported to the field representative. No additional details were provided.
improperly stored vaccine adminsitered; This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent condition were not reported. Concomitant therapies included sterile diluent. The nurse described that on 02-JAN-2020, the patient was vaccinated a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) 0.5 millileter (product storage error), lot # S013712 with expiry date 01-NOV-2020, (strength, route were not reported) for prophylaxis. It was reported that sterile diluent was used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was properly stored. It was reported product was stored temperature at -12.2C, for 25 minutes and there was no previous temperature excursion and digital data logger was present.
Rash and itching at injection site given Diphenhyramine 50 mg monitor for 30 minutes symptom improved.
local induration with redness 2.5cm x 4cm (SL local reaction).
Just SLight, immediate swelling at injection side, like a large mosquito bite, clearly swollen though
itchy throat, nausea, vomiting, SOB, coughing, gave oral benadryl, pt vomited it up, throat swelling. Benadryl IM 50mg given in right deltoid and epi injection, EMS called, pt went to ER.
A report has been received from a Health Professional via Medical Representative concerning a patient of unknown gender, who had been receiving FLUMIST (Intranasal) started on an unknown date. The patient experienced fever. The outcome of the event of fever is unknown. The reporter was considered to be non-serious by the reporter.
is a 50-50 chance that he may receive either vials.; pain on his arm; swelling; redness; anxious; This is a spontaneous report from a contactable nurse. A male patient of an unspecified age received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a 50-50 chance that he may receive either vial, pain on his arm, swelling, redness (It was about 2cm of redness. On the third day, it got bigger), anxious. It was reported that something happened during vaccination. There were 2 nurses, the first one is the one administering the Pfizer COVID-19 vaccine to him while the second nurse asked the first nurse which vaccine vial did she use on the caller. The second nurse explained that only 1 vial contained the vaccine while the other one was used for training purposes and only contained the diluent (saline). The first nurse was confused on which vial she had used. Caller is anxious since there is a 50-50 chance that he may receive either vials. He wanted Pfizer to have an opinion on whether he had he vaccine vial or the vial that only contained diluent. The outcomes of events (is a 50-50 chance that he may receive either vial, anxious) were unknown, and the outcomes of events (pain on his arm, swelling, redness) were recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Two days after he got his second Pfizer vaccination, he developed fasciculations in his left arm early April 2021. He sought a neurological exam, who sent him for a second opinion,  and he was diagnosed with motor neuron disease. Diagnosed with early onset ALS.  has developed anxiety and depression and cognitive issues.
Overall Aches, Injection site soreness, later in evening Fever (100), Chills, Restless Sleep and Fever Dreams. I was contemplating going to ER.  Next day was overall lethargic and achey. Next evening felt better but woke up drenched in sweat during the night (unusual for me).
CHRONIC AND PERSISTENT DIARRHEA (PASSES DARK BROWN LIQUID 15 TIMES A DAY); NAUSEA; BELCHING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 254 pounds, and height was 73.5 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JAN-2022, the patient experienced belching, and nausea. Treatment medications included: loperamide hydrochloride. On 07-JAN-2022, the patient experienced chronic and persistent diarrhea (passes dark brown liquid 15 times a day). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic and persistent diarrhea (passes dark brown liquid 15 times a day), and the outcome of belching and nausea was not reported. This report was non-serious.