chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Congestion; fatigue; fever; This is a spontaneous report from a contactable consumer (patient's wife). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection; lot number: 301308A), via an unspecified route of administration on 06Sep2021 at 11:00 (at the age of 62-years-old) at dose 1, single in the left arm for COVID-19 immunization. Medical history included A-fib, hyperlipidemia, bradycardia, obstructive sleep apnea, mitral regurgitation, tricuspid regurgitation, and COVID-19. The patient has no known allergies. The patient was not tested for COVID-19 post vaccination. Concomitant medications included apixaban (ELIQUIS), atorvastatin calcium (LIPITOR), digoxin (DIGOXIN), flecainide (FLECAINIDE), and tadalafil (CIALIS). The patient did not receive any other vaccines in four weeks. On Sep2021, after the first vaccination, the patient experienced congestion, fatigue, and fever. No treatment received for the events. Outcome of the events was unknown.
C/O NUMBNESS ON LEFT SIDE OF BODY, FOGGY FEELING, CHILLS, FATIGUE, ITCHY THROAT, BURNING GUMS, BLURRED VISION, "FEELS LIKE SHE HAD A CONCUSSION" SAW AT ER AND GIVEN BENADRYL AND ADVISED THIS WAS A REACTION TO THE VACCINE
Patient received Moderna COVID vaccine in the immunization room. There were no apparent immediate adverse effects following the injection, and the patient was instructed to wait in the lobby for 15 minutes to monitor for adverse effects or allergic reactions. Approximately 5 minutes after the injection, the patient lost consciousness and exhibited a stiff posture in the waiting lobby and EMS was called. Patient appeared to be not breathing for approximately 10-15 seconds and was carefully laid on the floor where she started breathing again. At no time was there no pulse. Patient regained consciousness after about 1 minute and expressed feeling confusion with the situation and numbness in the mouth but no other symptoms. EMS arrived on the scene promptly 2 minutes after being contacted and took over care of the patient. After the situation resolved, the patient was contacted on the phone and seemed to be feeling much better.
magnet sticks to the place she got the shot; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (reporter's daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number; Expiry Date; NDC number: Unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that a magnet sticks to patient's injection site/magnet sticks to the place she got the shot on an unspecified date. Her daughter could put a large or small magnet for it to hold on, and it sticks. She can feel it pulling. The outcome of event was unknown.  Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021611456 same reporter/drug/AE, different patient
p15,16, & 17APR devel fever;18APR devel painful enlarged lymph node behind ears, exp rt side;20APR went to MD & was given ATB tx;22APR h/a, burning to eyes & rash;went back to MD;
body aches, chills, rigors, headache, fatigue, lymphadenopathy on the side of the injection
Information has been received from a nurse Concerning a female who was vaccinated with the third dose of GARDASIL vaccine.  The nurse reported that "the patient received the third dose of GARDASIL and then 24 hours later the patient's mom called the nurse and told her the patient had a headache".  The nurse stated that she advised the patient's mother to speak to the patient's physician.  The patient did not seek medical attention.  Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-AUG-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 13-OCT-2014, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Hospitalized 12/29/2021; COVID-19 positive 12/29/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider: PA-C Admission Date: 12/29/2021 Discharge Date: Jan 7, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COPD exacerbation [J44.1] COVID [U07.1]   HOSPITAL COURSE: Patient is a 79 y.o. female with pmhx of tobacco use, COPD not on oxygen at baseline, afib s/p watchman, SSS s/p DCPPM, ESRD on peritoneal dialysis, OSA, frequent falls, and diverticulosis who presented with a chief complaint of SOB from senior living.  During her stay, she became leukopenic, neutropenic and developed hypothermia, otherwise hemodynamically stable and on room air. Precautions taken and started on cefepime. Warming device used to maintain normothermia. Blood cultures remained negative at 48 hours and once 24 hours with normothermia without warming device, antibiotics were discontinued. Neutropenia resolved.  She was treated for a COPD exacerbation, suspected related to COVID, she did not require oxygen. She had an episode of desat to 87% in the ED but recoved without oxygen. She was treated with steroids, switched from prednisone to decadron in light of COVID infection. She was previously vaccinated with two doses of Moderna. She persistently refused chemical DVT prophylaxis due to history of GI bleed. She accepted risk of PE.  Hematology performed dialysis on patient while at the hospital. She was medically stable for discharge, but due to Covid protocols, was not able to obtain transportation from her facility to her dialysis clinic. Thus she remained in hospital until 1/7/22 and discharged back to her facility with nursing, PT and OT home health care.
Patient began to have a hot flash / dizzy / lightheaded about 10 minutes after her vaccine.  I went to check on her and offered her a cold compress for the back of her neck to help her cool down.  After another 5 minutes I went to check on her and the patients mother said she still did not feel good and she would like to have her checked out.  I explained that what she was experience were normal side effects of the vaccine, and she still wanted me to call EMS.  I called 911 and spoke to the dispatcher about her symptoms.  EMS came and checked her blood sugar, and blood pressure which were fine.  They instructed her to rest and explained those were normal symptoms.  She was able to leave about another 10 minutes of resting.
Fever 101 stiff neck, cold like symptoms, 10 days after Flumist. No treatment 48hrs.
I began itching at the injection site around 10 am. It then began to spread down my arm and into both sides of my rib cage.  It kept spreading up my throat, across my chest and neck and down to my legs. I could not stop scratching. About the time my neck started itching, my throat started feeling weird and tight. I could not swallow easily. I was given Benadryl, famotidine, Solu-Medrol, Zyrtec and epinephrine. My symptoms would slow for a moment and then continue. I was sent to Holy Family Emergency room from urgent care due to my severe allergic reaction to the vaccine. I was given some of the same medications but they also eventually added Vistaril. I was eventually discharged late that night. I did have a rebound reaction between 2-3 am the next morning with new hives developing and a feeling of tightness/inability to swallow returning. I have had the itching and hives return several times this past week and still have visible hives. I feel weak and tire easily. I have missed some work because of this. With times being hard as it is, that isn't good. I was trying to be a good citizen.
Patient was at clinic for his 4th DTaP. He was inadvertently administered Kinrix DTaP+IPV. No adverse effects of the event have been reported.
On 4/12/2021 I received my second dose of the Pfizer COVID-19 vaccine at approximately 9:45am at the Medical Center. Already have a serious adverse reaction to the first dose, a nurse from my primary care team told me I was safe to receive the second dose and assumed I would not have any symptoms from this second dose. Around 11:30am I began to notice my shoulder being sore at the shot injection site. This was a symptom I did not experience during my first dose of the vaccine. Around 3:00pm I began to feel extremely fatigued. Around 7:00pm my head began to feel congested, I had trouble staying warm, and I began to start a fever. After lying in bed I began to have chills, body aches, and shaking with a fever of 101.4°F. I also developed a light cough. I stayed home and laid in bed for the next two days with periodic chills, periodic fevers, and extreme fatigue. The second night (4/13/2021) I began to have uncontrollable coughing fits to the point of dry-heaving, but had no vomiting. From 4/15/2021 until 4/25/2021 I continued to have a deep lingering cough. But no other symptoms.
NO issue with injection site except for soreness at site.  Then 8 days after vaccination, red rash at injection site, itching, hot and pain to the touch, following 9th day chills, diarrhea.
Sister with chickenpox 10/24/2005.  On 11/03/2005 broke out with a few spots on face and back.
Pt complaining of reaction at site of injection. Red, rash, swollen. Itching at site as well as up through neck area. Pt feeling feverish.
brachial neuritis; axillary numbness on opposite arm;no clear weakness; EMG neg;
4 inches by 3 inches urticial rash at injection site. Warm to touch
after giving janssen shot pt experienced fainting, reported from fellow customer. upon checking with patient seemed to have tremor/seizure condition. Call 911 but patient had already recovered from the symptoms. pt denied the service for 911. and 20 minutes later patient was left by family member, techician escorted to exit the store.
This spontaneous report received from a registered nurse referred to a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-MAR-2017, the patient was vaccinated with VARIVAX (dose, frequency not reported, lot:M028546, expiry date not reported) for an unspecified indication. The nurse reported that the vaccines were stored in a freezer with defrost cycles, but full excursion details were not provided (incorrect product storage). The reason for the temperature excursion occurred was due to the defrost cycle of the freezer. The nurse was unable to provide the lot number and expiration date for the properly stored sterile diluent that may have been used to reconstitute the vaccine. No adverse effects reported. The temperature for the vaccine stored and time frame was unspecified. Previous temperature excursion was unspecified. Data logger was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP. A 10-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FJ1620),  Dec 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pyrexia (slight fever), peripheral swelling (arm is kind of swollen), and burning sensation (kind of burning-up), with outcome of unknown. Additional information: Reporter stated, "I am calling because my granddaughter said she was having a slight fever. She just got the Pfizer COVID-19 vaccine yesterday. She was kind of burning-up but her arm was kind of swollen." When paraphrased the concern, reporter stated, "Yes, her arm is kind of swollen." No follow-up attempts possible. No further information expected.
Muscle soreness at injection site starting immediately after.  Within 8 hours: headache, fever, chills, tiredness, and inability to sleep
Info has been received from a HP concerning a 41 year old male who on 7/22/05 was vaccinated, SC with an 0.5ml dose of MMRII. On 7/26/05, the pt experienced general red rash consisting of small red spots which were slightly raised and itchy. The pt reported that on occasions, it clears up and then comes back. As of 7/28/05, it had been getting a little worse and the pt presented to the ER. At the time of the report, the ER did not yet treat the pt. The pt was not recovered. No product quality complaint was involved. Additional info has been requested.
Swollen & tender glands in armpit near injection site; itchy/tingly rash all over trunk, neck; chills
Started itching back arms and head within 15 min of vaccine.  Increase redness noted of arms and face. benadryl 25mg given at 15 min by 30 min itching had improved by 75% No lip or tongue or respiratory issue
Dizziness, Headache, Sedation, chills Narrative:  Other Relevant History:
Sore deltoid muscle starting 10 hrs after injection lasting 24 hrs.  No treatment required.   Menstrual cycle 3 days late as of today. Negative home pregnancy test. Menstrual cycle is normally very regular.
I started feeling shortness of breath and thought it was a cold. Right after I started having pain in my knee and hip joints, dry mouth and dry eyes, extreme fatigue I can barely get out of bed. I have been taking ibuprofen for my joint pain as needed. I have an appointment with my PCP next month. I am assuming that this is due to a flare up of Sjogren's syndrome. I was diagnosed with Sjogren's syndrome and Lupus a few years ago.
The patient's pediatrician believes the shot was given to high in the deltoid cause shoulder pain.  The doctor believes the patient has sirva shoulder.
Baby did not appear to notice vaccine administration. Within approximately 2 minutes his eyes rolled back and he appeared to "pass out". We took this for sleeping, although it seemed very odd at the time. Approximately 30-45 minutes later baby awoke with an inconsolable, frightening high-pitched scream which went on for 30 minutes. Baby appeared to be experience horrible head and neck pain. Pediatrician was immediately called and advised to give Tylenol. Baby slept after 45 minutes until the following day, waking only for occasional nursing. Pediatrician refused to document any unusual reaction. Likely unrelated, but three months later child diagnosed with multiple very severe food allergies and otherwise normal development.
Patient Became Faint and started to Fall. Her mom caught her as she was falling. Slight abrasion above Right eye From hitting wall Dizzy, unresponsive, now when sitting says her hands are still tingly
Moderate to severe: Fever, headache, nausea, chills, neck and back aches/burn, deep arm soreness, weakness, fatigue for 18 hours  Mild arm soreness and body aches for 2-3 days
Became ill with what I was told were COVID-like signs and symptoms as reported in the health check-in. Persistent cough, severe sore throat, upper respiratory discomfort, laryngitis, conjunctivitis, middle ear infection, intermittently febrile and diaphoretic, sinus drainage, low energy.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 57-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX and ENBREL. On 15th November 2018, the patient received the 2nd dose of SHINGRIX. On 15th November 2018, less than a day after receiving SHINGRIX, the patient experienced rash, facial swelling, neck swelling, red face, feeling of warmth facial and muscle pain. On an unknown date, the outcome of the rash, facial swelling, red face, feeling of warmth facial and muscle pain were not recovered/not resolved and the outcome of the neck swelling was unknown. It was unknown if the reporter considered the rash, facial swelling, neck swelling, red face, feeling of warmth facial and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient reported that she experienced rash, swelling, redness, and hotness on her face and neck. The patient reported that she went to the emergency room twice in December 2018. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up. For the tolerability of 1st dose, refer case US2019015781, reported for same patient.
This spontaneous report was received from a 65 year old female patient, reporting on herself. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, in May 2018,  the patient was vaccinated with the first dose of GARDASIL 9, then, the second dose in approximately July 2018, reported a 2 months later and finally, the third dose on 06-NOV-2018, intramuscularly for prophylaxis (lot number and expiration date were not reported). However, no adverse effects were reported.
Vaccines given 6/20/01, the night of 6/20/01 pt screamed inconsolable for 3-4 hrs, temp 102.9F. In office next day for evaluation exam was negative temp 99.9F (ear). CBC all WNL
Noticed swollen lymph node in same arm as injection when performing breast self examine on Feb 13 - first vaccine Jan 27 and 2nd Feb 17.  As of Feb 25 still swollen
Nausea, tremors, lightheaded/dizzy, wheezes, shortness of breath, fullness in throat/neck area, warmth to the site of injection within minutes of the vaccine.  Developed vomiting and diarrhea around 16 to 17 hours post injection.
8 hrs after flu vaccine administered, I had high fever, chills and aches everywhere.  I have had the flu in years past and I can only describe this has having a severe case of the flu for 8 hours.  This is the 2nd year I have taken the county vaccine and had this reaction.  I can only conclude that serum from some manufacturers does not agree with me.
Fever, body aches, joint pain, severe fatigue, loss of appetite, inflammation of mouth and around right eye.  In bed for two days after vaccine.  Facial/oral inflammation began after 24 hours of vaccination.
Heart palpitations, chest pain approximately one week from receiving booster. Made worse when laying down. Sent to ER by Urgent Care clinic
large local reaction. Erythema warmth located 2-3 inch diameter surrounding where shot was given left deltoid. Started several hours after the vaccination and has continued now almost 2 months. Still pruritic.  She has some dyspnea and tachycardia associated.  Some response to topical steroids.  This was after the first injection, she tolerated second injection no problem.
Hives on left arm with in 5 minutes of shot. Was told it was fine. Head to toe hives writhing 2 days of shot.
extreme headache pain at 4 hours after injection, severe arm pain through the night.  next day/evening  noted swollen lymph node on collarbone on effected side, painful to touch.  >24 hours later, pain increasing in lymph node which now radiates up into jaw and ear on effected side.
Worsening pain, soreness, red raised warm welt 3cm diameter, malaise worsening getting into hours 20-24 post injection.
Chills; Fatigue; This is a spontaneous report from a contactable consumer (Patient) via Regulatory Authority  A 77-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot number: Not reported) via an unspecified route of administration on 01Feb2021 (at the age of 77-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included thyroid disease, high cholesterol and (COPD) chronic obstructive pulmonary disease). No known allergies to medications, food, or other products. Concomitant medication included rosuvastatin and levothyroxine (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced chills and fatigue on 01Feb2021. Patient did not receive any treatment as a result of events. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are needed. Information about lot/batch numbers cannot obtained.
Initial report received from a health care professional on 26 May 2010: This patient was vaccinated with MENVEO (batch no: CWY lot: 091991, A lot: 100001), (dose: unknown) intramuscularly on 25 May 2010. The patient was administered only the diluent portion of the MENVEO. No adverse event had occurred due to this inadvertent administration. Follow up report received from a physician on 23 Jun 2010: The patient was vaccinated with MENVEO on 24 May 2010. The patient will return for full vaccination.
Child presenting to ER with possible reaction to MMR vaccine. Complained of fevers and sleeping more. No history of previous illness. Received injection 4PM Monday resulting in fever all night. Left deltoid with some red and indurated area with few very small vesicles. No other reaction to vaccine.
red, puffy, painful itchiness at injection site; red, puffy, painful itchiness at injection site; red, puffy, painful itchiness at injection site; red, puffy, painful itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (red, puffy, painful itchiness at injection site), VACCINATION SITE ERYTHEMA (red, puffy, painful itchiness at injection site), VACCINATION SITE PRURITUS (red, puffy, painful itchiness at injection site) and VACCINATION SITE SWELLING (red, puffy, painful itchiness at injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (red, puffy, painful itchiness at injection site), VACCINATION SITE ERYTHEMA (red, puffy, painful itchiness at injection site) and VACCINATION SITE PRURITUS (red, puffy, painful itchiness at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (red, puffy, painful itchiness at injection site). At the time of the report, VACCINATION SITE PAIN (red, puffy, painful itchiness at injection site), VACCINATION SITE ERYTHEMA (red, puffy, painful itchiness at injection site), VACCINATION SITE PRURITUS (red, puffy, painful itchiness at injection site) and VACCINATION SITE SWELLING (red, puffy, painful itchiness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include birth control