chrisvoncsefalvay/vaers-outcomes huggingface dataset:
31 y/o male came in for first dose of COVID-19 Vaccine-Moderna Lot# 013A21A exp:04/04/2021. After patient completed his 15 minutes in the  observation he verbalized to check out OA he wished to speak to a Nurse. Upon arrival to patient, he was complaining of itchiness to his neck and back. Redness to his forehead and neck noted. Initial vitals O2sat-100%, P-102, Bp-132/86. 1533- One 50mg capsule given with water.  1539-V/S130/86 99% P-98. No SOB noted nor reported by patient, A/O, No compliant of breathing by patient. Redness noted to be less to forehead and neck. 1543-bp-126/80, p-70 O2-100%. Patient verbalized feeling better, slight redness noted to neck only. 1550-118/70 P-76, O2 99%. Patient called his mom who gave him a ride home.
Patient was 3 months older than the pediatric dosing age requirements. Patient received the pediatric Pfizer dose, when she should have received the adult Pfizer dose. She was 12 years old at time of vaccination and received the vaccine for ages 5-11 years old.
By evening of day of vaccination, left lateral upper arm swollen and red from axilla to elbow. This resolved by 4/26/03.
Information has been received from a registered nurse referring to the patients of unknown ages and genders. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates in 2016 (reported as "after May 2016), the patient were vaccinated with improperly stored dose of VARIVAX (lot# L042266, expiration date 27-OCT-2017, dose and route not reported). The vaccine was improperly stored at 9.36 degree Fahrenheit for 10 hours. There was no data logger. Central monitoring was used. This is one of several reports received from the same reporter. Additional information is not expected as there is no permission to contact the physician.
I saw her result on Nov 27, 2018 for pain in the right shoulder and arm. She indicated at that time that the injection was placed high on the right arm, suggestive of an improper placement of an IM injection. She did not have pain at the time of the injection the pain started later that night. She reported the pain at that time was 10 out of 10 and she wore a sling and rested the arm for a few days and the pain became mild but did not go away completely. On November 23 she reports the pain became severe again and she scheduled the appointment with me on the 27th. She had called the nurse advice line and they suggested there could possibly be a bursitis or infection. There was no acute erythema or warmth the patient completed a 7 day course of dicloxacillin empirically, 500 mg 4 times a day. She was last evaluated on Dec 3, 2018 by her primary provider and the pain was improving though not gone completely. The plan is to have her follow-up in the next few weeks and if she is still having significant pain additional imaging such as an MRI may be ordered by her primary.
Immunizations given 11/22/06 PM. Grandmother reports beginning 11/23/06, patient experienced increased anxiety, irritability, fidgety hands through weekend. Back in school 11/27/2006.
Complained feeling "like I'm going to pass out." Pale, clammy, rested for several minutes and drank water. Feeling better; attempted to walk to restroom and was unable to stand straight and said "I'm gonna pass out." Lowered to chair. Assisted to cot where she rested approx 30 min. Drank H2o and had a snack. Felt better. Left with mother. Called that eve and pt was feeling fine.
Stiffness/sorness all over body  stabbing pain thru right eye  shortness of breath
8 pts recvd a series of 3 doses of Engerix-B & are reported to have not responded; titers ranged fr 0.6 to 6.0; booster dose is planned;
All of the sudden at 10 pm i became super tired. Like druggie tired. Got up to just go to bed and had the shills, to the point my teeth were clacking. It lasted till 5 am. Could not sleep through it at all. Slept that day and was fine afterwards. Had severe headache for about two weeks. Not sure if that was side effect or all the smoke, but servre weird headaches.
Full body erythema multiforme appearing on day 2 post vaccination lasting for 1.5 weeks. Had a second incident shortly after vaccines given at 6 months
ERYTHEMATOUS; LOCALIZED INFLAMMATION; Arm is sensitive; hot; hives; red ring going around; arm was red; arm was tender; slight headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (ERYTHEMATOUS), INFLAMMATION (LOCALIZED INFLAMMATION), SENSITIVE SKIN (Arm is sensitive), VACCINATION SITE WARMTH (hot) and VACCINATION SITE URTICARIA (hives) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZU(orV)7) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Diabetes, High cholesterol, Drug allergy (Most cholesterol medicines, hydrocodone allergy), Food allergy (scallops, clams, bass, fish) and Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.  On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 25-Feb-2021, the patient experienced SENSITIVE SKIN (Arm is sensitive), VACCINATION SITE WARMTH (hot), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (red ring going around), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PAIN (arm was tender) and HEADACHE (slight headache). On 26-Feb-2021, the patient experienced RASH ERYTHEMATOUS (ERYTHEMATOUS) and INFLAMMATION (LOCALIZED INFLAMMATION). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; HYDROCORTISONE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (ERYTHEMATOUS), INFLAMMATION (LOCALIZED INFLAMMATION), SENSITIVE SKIN (Arm is sensitive), VACCINATION SITE WARMTH (hot), VACCINATION SITE URTICARIA (hives), VACCINATION SITE RASH (red ring going around), VACCINATION SITE ERYTHEMA (arm was red), VACCINATION SITE PAIN (sore arm), VACCINATION SITE PAIN (arm was tender) and HEADACHE (slight headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt became ill, acted lethargic & started running fever about 1hr p/vax;was taken to ER, T105 R MD on call found no evidence of ear, throat, chest or other infect;site of inj (lt thigh) sore & swollen;mom was told fever probably d/t immun
Pfizer 5/4/21 and 5/25/21. Positive on 1/17/22
Moderna COVID?19 Vaccine EUA Developed multiple painful ulcerations on roof of mouth with no apparent cause (no trauma, no burn, etc)
I noticed the following day of the booster shot it felt as though there was a lump in my throat. I noticed it when I was swallowing or eating. I went to an Urgent Care and they diagnosed me with uvulitis I was prescribed amoxicillin 500mg  to take for 10 days. If it got worse they recommended I see an ENT. It hasn't gotten any worse, but has now last about 30 days. The feeling in the back of my throat has subsided in the past couple of days, but I still feel it in my sinus.
PATIENT'S WIFE CALLED PHARMACY 10/7/23 AND SAID HUSBAND IS VERY CONFUSED THIS AM...HE RECEIVED HD FLU AND AREXVY ON 10/6/23.  PATIENT IS 75 YEARS OLD, HISTORY OF BRAIN SURGERY AND STROKE.  TAKES MEDS FOR SEIZURES AND SHE IS NOT EVEN SURE IF HE TOOK HIS MEDICATION OR NOT.  CONTACTED HIS PROVIDER AND HE RECOMMENDED FOR HER TO GIVE ADDITIONAL DOSE OF SEIZURE MEDS THIS AFTERNOON IF PATIENT IS STILL CONFUSED.  IF HE GETS WORSE, SHE HAS BEEN INSTRUCTED TO GO TO ER TO HAVE HUSBAND CHECKED OUT.
Pt has dark, baseball size lump, arm senstive to lift starting 2 days after at injection site.
LIGHT HEADEDNESS; DIZZINESS; BLURRED VISION; NAUSEA; FATIGUES; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 239 pounds, and height was 66 inches. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180978, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced light headedness. On 09-JUN-2021, the subject experienced dizziness. On 09-JUN-2021, the subject experienced blurred vision. On 09-JUN-2021, the subject experienced nausea. On 09-JUN-2021, the subject experienced fatigues. On 09-JUN-2021, the subject experienced muscle aches. On 09-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, light headedness, dizziness, blurred vision, fatigues, muscle aches, and fever. This report was non-serious.
Begin having pain in my abdominal area one week after my second injection. Was diagnosed as bacterial vaginitis two times with subsequent antibiotic therapy. This offered some relief but the pain continued until I had to be seen on January 31st 2022 at hospital where a CT showed an epigastric appendigitis. I am now set up to see the gastroenterologist tomorrow morning.
she lost her sense of taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AGEUSIA (non-serious), outcome "not recovered", described as "she lost her sense of taste". Additional information Reporter verifies that she is talking about the Pfizer Covid Vaccine. Reporter said that she had all the Pfizer covid-19 vaccines, including the booster. She stated that after her first dose, which is 2 years ago, she lost her sense of taste after the first vaccination. Says she has never gotten her sense of taste back.  Asks will her sense of taste ever come back, She wanted to know if this has been reported before, when will it comeback or how long it will last. She added that she already contacted her HCP and said that this is a vaccine related since it only happened after that.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sudden stomach abdominal pain.  Several dr visits, specialist appointment, endoscopy done. No one could find any reason.   After 2nd vaccine 8/7/2012. Brain fog, tingling in extremities, headaches.   After 3rd vaccine 12/27/2012. All symptoms immediately worsened. Also sinus issues, more severe head pain, vision issues worsened, and anxiety and panic attacks. Also chronic fatigue from first vaccine worsening over the months.  Appointment with neurologist brain MRI all normal.
SWOLLEN FACE; BAD RASH ALL OVER BODY; PASSED OUT; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-APR-2021, the patient passed out and had no symptoms until seven days. On 07-APR-2021, the patient experienced pretty bad rash. On 08-APR-2021, the patient experienced swollen face and rash all over body which made him to visit an urgency clinic where he was prescribed with prednisone for rash. The patient visited doctor or healthcare professional office for events passed out, swollen face, and bad rash all over body and emergency room or department or urgent care for events swollen face, and bad rash all over body. It was reported that, the medication had not eradicated the symptoms but only calmed them down. According to the patient, if he had stop taking the medications the symptoms would go back to the same intensity as before.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out on 01-APR-2021, and had not recovered from swollen face, and bad rash all over body. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210422310-covid-19 vaccine ad26.cov2.s -Passed out. This event is considered unassessable. The event 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.
The site of injection was extremely sore--to the point where I couldn't lift my arm without severe pain. I developed a fever of 102 degrees, a very bad headache, muscle ache and extreme fatigue.
pt recv vax 12AUG93 in preparation for trip to China; tolerated 1st 3 pills fine but devel facial swelling p/last pill; seen in ER & was told this was a definite react to vax;
Left arm deltoid area where DTaP was given noted to be erythematous and swollen the day after. Warm compress and Motrin/Tylenol was given as well as Benadryl.
Patient is fully vaccinated and boosted.  Covid positive on 5/14 on admission to hospital. 85y.o. male who came to the ER with shortness of breath fatigue and increasing hypoxia. + anemia <6.0. He denies chest pain. ECG/troponin were not concerning for ACS.  He has been afebrile. CT ruled out PE but did show pulmonary nodules. Dx: acut repsiratory failure, NSTEMI, anemia, CHF and COVID. CT PE no PE, pulmonary nodules, Chest x-ray no acute cardiopulmonary process. On 4 L nasal cannula, same as home regimen. Chest x-ray stable. Recent echocardiogram with ejection fraction of 60% Continue with diuresis. Pulmonary nodules suspicious for malignancy.  For oncology follow up. Leudocytosis. Elevated troponin. CAD. AKI. D dimer 870.  Patient discharged home.
This spontaneous case was reported by a consumer and describes the occurrence of ALTERED STATE OF CONSCIOUSNESS (felt out of it) and ANAPHYLACTIC REACTION (anaphylactic reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker and Detergent sensitivity (Thirteen years ago, contact allergies with Woolite and Tide laundry detergent) since 2008. Concomitant products included AMFETAMINE ASPARTATE, AMPHETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 30-Apr-2021 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ALTERED STATE OF CONSCIOUSNESS (felt out of it) (seriousness criteria medically significant), ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DIZZINESS (felt dizzy), FEEDING DISORDER (unable to eat until 4pm) and DYSPNOEA (hard time breathing). On 30-Apr-2021 at 1:00 PM, the patient experienced OROPHARYNGEAL DISCOMFORT (throat started to clamp up). On 01-May-2021, the patient experienced PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat). On 30-Apr-2021 at 4:00 PM, FEEDING DISORDER (unable to eat until 4pm) had resolved. At the time of the report, ALTERED STATE OF CONSCIOUSNESS (felt out of it), ANAPHYLACTIC REACTION (anaphylactic reaction), DIZZINESS (felt dizzy) and OROPHARYNGEAL DISCOMFORT (throat started to clamp up) was resolving and DYSPNOEA (hard time breathing), PHARYNGEAL SWELLING (throat started to get a little swollen), THROAT IRRITATION (throat started to get a little itchy) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient has never had a reaction to vaccines or latex.  After waiting in the vaccinating provider's observation area, she felt fine. On the drive home she felt dizzy and a little out of it. Her Epi-Pen had expired. She took Claritin and laid down to see if the reaction would get better or worse. The symptoms got better 2.5-3 hours (3:30-4pm) later. Things were better and she felt fine. She took Claritin for a total of 4 days following the injection. She did contact her healthcare professional, who referred her to an allergist and her appointment with the allergist is pending. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Anaphylactic reaction is consistent with the product safety profile.
Patient is a 91-year-old female who presents today for evaluation of having a sore throat for the last 2-3 days with voice becoming more hoarse.  No drooling.  No dyspnea.  She has rhinorrhea, congestion and a dry cough.  No known ill contacts.  Patient has been fully vaccinated for COVID-19 (Pfizer, 2nd dose 2/19/21.  Patient denies fevers, chills, nausea, vomiting, chest pain, abdominal pain or urinary changes.  She has noticed some diarrhea.  No analgesics taken prior to arrival.  Oxygenation is 92-93% RA on arrival.  Speaking in full and non-labored sentences.  Occasional coughing.  ASSESSMENT  &  PLAN: Patient's condition remained stable during ED monitoring.  Available old records were reviewed.  Data available relating to medications and allergies were also reviewed in charting system.  Patient treated with tylenol PO and Dexamethasone PO  On reassessments, tolerating oral.  Oxygenation 92-98% RA.  Multiple potential diagnoses were considered in this patient.  Patient placed in both airborne with eye protection and contact isolation status.  Patient tested for COVID-19 with COVID-19 PCR testing PENDING.  Rapid strep testing is negative.  I offered CXR and/or CT soft tissue neck along with laboratory assessment after initial rapid strep is negative however patient declines this testing at this time.  She is afebrile and otherwise non-toxic appearing.  No respiratory distress or drooling.  No neck rigidity or mass on palpation.  No erythema or bruising of skin.  No clear evidence for retropharyngeal abscess, epiglottis, tracheitis among other considerations.  Overall patient with likely viral pharyngitis with URI/cough.  COVID-19 infection is possible although she is fully vaccinated, consideration of breakthrough infection.     Patient should follow-up closely with PCP however can return to ER for any worsening symptoms and/or for any further concerns.       After evaluation in the Emergency Department, my clinical impression is:       CT(R) 1. Viral pharyngitis  VIRAL PHARYNGITIS 2. URI (upper respiratory infection)  UPPER RESPIRATORY INFECTION         Script:     NONE                 MD 08/19/21 0429
3 days p/vax, brusing & lump appeared; skin over burised area started to peal 14 days p/vax; sx occurred in lt thigh;
Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 12/22/2020    Date:  12/22/2020                                                                                              Subjective Patient is a 23 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience Headache and felling warm.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis.       Review of Systems  Neurological: Positive for headaches.  All other systems reviewed and are negative.        Objective    Vitals Vitals:   12/22/20 1554 12/22/20 1623 BP: 132/73 121/73 BP Location: Right arm Right arm Patient Position: Sitting Sitting Pulse: 94 85 Temp: (!) 96.7 °F (35.9 °C)   SpO2: 99% 99%     Physical Exam Vitals signs reviewed.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate.     Pulses: Normal pulses.  Pulmonary:     Effort: Pulmonary effort is normal.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was told to take Tylenol for HA.  Continue to monitor symptoms.       APRN Electronically Signed 12/22/2020 4:27 PM
Patient was administered the Pfizer Bivalent booster that was past its beyond use date.  The vaccine he received was 7 days past its BUD of 2/10/23. Patient was contacted and made aware of this mistake on 3/17/23 and has rescheduled a time at the end of April to get re-vaccinated.
Day after immunization, was painful, redness, warm to touch. Increased redness and temperature migrating down arm over next several days. APAP helped somewhat, but still some pain 5 days later.
Death; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient was died.  The patient's medical history was not provided. Concomitant product use was not provided.  On an unknown date, the patient received his first dose of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was died.  Treatment of this event was not provided.  The patient was died. The cause of death was not provided. Autopsy details were not provided.; Reporter's Comments: This case concerns a male patient (unknown age), who experienced event of death (cause unknown). The event occurred on an unknown date after the first and last dose of mRNA-1273 vaccine administration. Autopsy and cause of death were not reported.  Based on the current available limited information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.; Reported Cause(s) of Death: Death