chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Subjective Patient is a 34 y.o. male who was seen at Vaccine Clinic today for his first  dose of the COVID 19 vaccination.    He was given the Pfizer vaccination in the left deltoid muscle.   During his 15 minute waiting period after the injection, the patient began to experience difficulty breathing and throat tightness.  He denied rash, hives, welts, difficulty swallowing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and he was then assessed in the emergency area.   Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting.   Pt was given a water to drink and he reported the SOB was very mild and the water helped.  He does have a history of childhood asthma but does not use an inhaler for years.     ALLERGY REVIEW OF SYSTEMS:  Patient complains of frequent throat clearing and shortness of breath   CONT negative Eyes negative Skin negative GI negative Musculo negative Neuro negative     Previous Reactions: None    Objective    Vitals Vitals:   03/18/21 1052 03/18/21 1107 03/18/21 1114 BP: 133/86 119/80 129/82 Pulse: 50 53 (!) 49 SpO2: 100% 99% 99%      Pt is a runner and states he runs a lower pulse     Physical Exam Constitutional:      Appearance: He is well-developed.  HENT:     Head: Normocephalic and atraumatic.     Right Ear: External ear normal.     Left Ear: External ear normal.     Nose: Nose normal.  Eyes:     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds.  Musculoskeletal:        General: Normal range of motion.     Cervical back: Normal range of motion and neck supple.  Skin:    General: Skin is warm and dry.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     Mental Status: He is alert and oriented to person, place, and time.        Assessment/Plan  Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Pt was dismissed at 11:15 to return to work.  No symptoms at time of discharge.  He was told to take an antihistamine before his next appointment.
Patient reported on visit for another vaccination, the GARDASIL dose 2, on 11/28/17 that she had a little "bump" where she received the Varicella vaccine on 10/19. Was measured was 2mm under the skin; no change in color and no pain or soreness. Didn't know if it was from vaccine.
No symptoms following vaccination #1. Vaccination #2 received 1/13/21-no symptoms on 1/13/21.  On 1/14/20 pt reports fever 101.6, chills, body/muscle aches. These symptoms improved during day on 1/14/21. Pt reports evening of 1/14/2021 she began feeling like her skin hurt, burning feeling. On 1/15/2021, pt woke to hives across chest, abdomen, axillas, underside of arms and lateral torsos, scalp and posterior neck. Pt reports hives are present in area of painful skin the day prior. Pt reports hive were not initially itchy, but are at time of evaluation. Pt provided with care instructions for urticaria/hives, benadryl & OTC Allergy tablet instructions.  She was also provided for s/s to watch-worsening hives, swelling,
48 hours after vaccination, went to ER with chills, dizziness and chest pain.  Blood work and x-rays were taken.  No medications were administered.
7 days post vaccine itching, redness and hive like eruption. Using clobetasol cream twice daily.
Patient gets hives from eggs so waited 30 minutes after vaccination.  When she was about to leave, she looked down at to discover hives on her chest.  She notified the security guard who then notified nursing staff and clinic lead.  Patient was escorted into a patient room.   Patient had itching and hives on her chest, upper arms and upper back.   No signs of visible distress.  Denied SOB, throat closing, heart palpitations. Vitals taken at 2:10: 159/85 bp, 73 pulse, 99 O2.  Benedryl 25 mg administered. 2:25: 158/93 bp, 72 pulse, 98 O2. 2:50: 157/75 bp, 69 pulse, 99 O2.   Patient indicated itching was less.  Redness on back gone, lighter on chest and upper arms
Information has been received from a registered nurse, concerning her 18 year old daughter with hypersensitivity to para-amino benzoic acid (PABA) in sunblock, who at the end of November 2007, was vaccinated IM in the right buttock, with a dose of GARDASIL (lot # not reported). Concomitant therapy included ethinyl estradiol/norethindrone acetate (LOESTRIN). In December 2007 (two weeks after vaccination), her daughter, who regularly shaved her genital area, developed folliculitis of the genital area. In addition, she developed a boil at the injection site, on the right buttock that became hard, painful and red. The nurse contacted her daughter's physician, who referred her to a surgeon. The surgeon lanced the area, and prescribed trimethoprim/sulfamethoxazole (BACTRIM) as treatment. The wound continued to drain, but was less painful. A lab test was performed fro methicillin-resistant Staphylococcus aureus test (MRSA) (results not yet available). At the time of this report, the nurse reported her daughter was recovering from the events. The nurse reported her daughter had never before developed folliculitis and questioned a  relationship to GARDASIL. Additional information has been requested.
pt recv vax;exp failure to seroconvert;viral serology was VZ neg;
I started with a low fever that went up to a 102. I had a terrible headache, nausea, vomited. I had very body aches. And I didn't have an appetite. I experienced fatigue.
Administration date from Pfizer indicated that the stability of the vaccine was good for use until October 19. The manufacturer expiration date on the bottle was September 30.
The night of the shot I noticed a painful, red, swollen, arm and couldn't sleep on it. 24 hrs after shot I started to feel extreme fatigue, muscle aches, slightly sore throat, mild congestion. I had a temperature of 99.1. I went to an urgent care and my BP was elevated (very unusual for me) 140/100 and HR 110 and temp still 99.1.  They did a rapid swab on me that was negative. I continued to feel awful the rest of the day. On Sunday the next morning I awoke because I had a very swollen and sore lymph node in my left armpit. I took tylenol and did warm compresses. I had continued fatigue on Sunday and slept the whole day. I also continued with a high heart rate 110-130 with activity. My Bp was 117/70I had a pulse oximeter at home. My temp stayed 99.  Monday morning I woke up feeling better. My HR was in the 80 and temp 98.3 and fatigue is gone. I still have mild soreness in my left arm but the redness is fine and warmth is gone. My left armpit is still sore
Vaccine Not removed From Freezer at 2wk Mark - 3 wks and administered.  P consult c medical facility/manuf Notified pt offer repeat dose
Patient presented to office with a petechial rash at legs, ankles, buttock and back of neck. CBC revealed a platelet count of 2, WBC 9.1, Hgb 11.7. Patient was hospitalized and treated for ITP with IVIG.
Dose 2 of the Moderna COVID vaccine series was accidentally administered on day 21 instead of the recommended day 28 after receiving the first dose.
DTP given left deltoid 8/8/08. Mild tenderness and edema shortly after. 8/13/08 became red, warm, and indurated in about 4x4cm oval distribution. Patient often Keflex 500mg QID x 7days and told to do warm compress to area.
Night of vaccine stomach convulsions, twisting  Next day high fever (102.5) and high hear rate (105).........went to  Emergency Room for treatment....5 1/2 hours......left feeling much, much better.
8JUL96 itching & blotchy redness started which progressed to hives on trunk & upper & lower limbs;dx allerg rxn;
Died; This is a spontaneous report from a contactable consumer reporting the same event under the same suspect product for three patients. This is one of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date. It was unknown if an autopsy was performed.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101172300 Same reporter/product/event; different patient.; PFIZER INC-202101172301 Same reporter/product/event; different patient.; Reported Cause(s) of Death: Died
Fever, dehydration, muscle aches, terrible exhaustion (could not get out of bed), loss of appetite,  headache
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993, expiration date: 17-OCT-2017, and lot # L044475, expiration date: 12-MAY-2017) intramuscularly (dose and frequency were unspecified) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. It was stated that the vaccines were exposed to a temperature of 9 Celsius degrees for a timeframe of 27 hours. No digital data logger was involved. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA005167.
Monday received shot, woke up with chills, hot flashes, arm really sore could barely lift it. Getting better now.
The Bivalent Booster age 5to 11 was given as first dose. Parent notified and will monitor as any vaccine.
Pain and pulling under the right arm; This is a spontaneous report from a contactable consumer (patient herself).   A 46-Year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot/Batch number: BN6203), via an unspecified route of administration on 23Feb2021 at 05:15 pm on the right arm as a single dose for covid-19 immunisation. The patient's medical history included allergies, anxiety and depression. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 25Feb2021 at 04:00 am, the patient reported pain and pulling under the right armpit. Patient stated that she did not took any treatment medication for the events. The outcome of the events was not resolved.
pt recv vax;redness,edema,itching;sx began soon p/ inject;had been applying warm wet compresses;
Her cancer treatment center sent her to the emergency room for nonhealing wound. Patient presents with draining non healing wound requiring incision and drainage with  IV antibiotics. Pt wsa hospitalized 6 days.
Patient has rash on left arm and two little rash on left side of lower chest. He received the second dose of shingrix. First dose was administered on 3/25/19.
SUDDEN ELEVATION OF TEMPERATURE= 102, NAUSEA, BLOOD SHOT EYES, GENERALIZED JOINT PAIN. TOOK TYLENOL/ASPIRIN. LESSENED THE EFFECTS.
On the second day of my second shot of the vaccine my eyes started to feel weird. And then my upper eyelids were significantly swollen. I also  started seeing floaters in my eyes which I have never had in my life before.  I?m only 29 years old. I tried prednisone, steroid ointments, antibiotics, I still have swollen eye lids and floaters today-  months later. I have no history or facial injections. My first shot of the vaccine I got a rash on my arm.
EDD 4/11/2022. Patient had normal US on 11/17/21 with cervix long and closed. Patient went into labor starting 11/21 and delivered at 20 weeks 1 day. She had retained products and a hemorrhage, requiring 2 units of PRBCs.
HEADACHE; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included pcn allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient has no diagnostic data available. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-MAY-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.
SERIOUSNESS CRITERIA OTHER: IMPORTANT MEDICAL EVENT. Initial unsolicited report received from a nurse on 25-Oct-2017. This case involves a female patient (age not reported), who was vaccinated with FLUZONE QIV (batch number: UI847AB, expiry date: 30-Jun-2018; dose, dose in series not reported) and PNEUMOVAX (batch number, expiry date, dose, route was not reported) in same arm on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe swelling and cellulitis, warm to touch, elbow to shoulder area was swollen. Lab test and corrective treatment was not reported. Outcome of the events were not reported. Upon internal review the case was considered as serious because of important medical event: cellulitis. Documents held by sender: none. Sender's Comments: Patient experienced Cellulitis after vaccination. Time to onset is not known. Additional information on previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be evaluated.
Patient is 17 years old and Moderna is only approved for over 18 yrs. Nothing happened. Patient is fine.  She was notified and still wants to get her second shot. During check in we missed that she was under age.
ZOSTAVAX given in right arm, SC. Pt. came in 3 days later complainng of swollen, painful underarm. Angry.
48 patients received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  No Treatment medications were provided  This is a case of Expired Product Administered concerning an 89-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The re-challenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a case of Expired Product Administered concerning an 89-year-old male patient with no relevant medical history, who experienced no other associated adverse events. The event occurred on the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Pt had 2 by 3 bruise, 4 by 6 area of induration. Physician's assessment- local reaction to immunization. No treatment.
Systemic fine rash over entire body, uncomfortable feeling on skin, no fever, Still have after almost 3 weeks.
Pruritis - no rash - Prednisone taper, 3 day - 2 day. ALLEGRA 100mg, ATARAX 25mg.
Pain, swelling,  redness, large welt around injection site that lasted approx. 2 weeks. Treated with ice/heat and NSAIDs & antihistamines. Afterwards, no redness or welt, but always hot to touch, and muscle weakness & pain  that has impaired daily work functions. Second dose was given in other arm (RT) due to still experiencing  these symptoms in left arm 1 month later.
The patient is a 69 y male with a history of hypertension, chronic hepatitis, diabetes, and AAA who was admitted on 2/11/2022 because of syncope and collapse.  Patient reports that he woke up yesterday feeling dizzy.  He states that his dizziness persisted throughout yesterday morning.  He was walking down the hall to his bathroom when he had a syncopal episode.  Patient denied any chest pain, shortness of breath, or palpitations.  In the emergency department his workup was relatively unremarkable including a chest x-ray and EKG.  The patient was given a 500 cc bolus.  He was placed in the observation unit overnight.  Overnight the patient did develop a low-grade fever of 100.1 ° F and congestion.  His echocardiogram was relatively unremarkable.  His COVID test came back positive.  The patient stated that his symptoms had just started yesterday.  He was advised to quarantine at home for the next 9 days.  He denies any dizziness or lightheadedness and did not have any more syncopal episodes while in the observation unit. He was advised follow-up with his primary care provider within the next 1-2 weeks.  He was educated on concerning symptoms and told to return to the emergency department if he had any difficulty breathing, chest pain, or any other concerning symptoms.  Patient was discharged home in stable condition.
THERE WERE NO ADVERSE EVENTS.  AS STATED BY THE MANUFACTURER, THIS IS AN OFF LABEL USE BECAUSE THE PATIENT IS 15 YEARS OLD.
Patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered from an expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 04-Nov-2021 The dates of administration of vaccines were some patients had on 05-Nov-2021 and the other had doses on 12-Nov-2021. No concomitant medications were reported. The vial had not undergone any temperature excursions. HCP (health care professional) stated that no adverse event as a result of the misadministration, and patients were monitored. No treatment medications were reported.
Within 10 minutes the left side of my face went numb. In about 45 minutes my entire left side was completely numb and I wasn?t able to think clearly or speak or move my body.
Fever, aches, soreness to left arm at injection site, chills, headaches on and off for 36 hours. Treatment acetaminophen/ibuprofen. Within 48 hours complete resolution of all symptoms.
Atrial Fibrillation Was given IV with medication to stop the AFib After overnight hospital stay - Start metoprolol succinate 25 mg oral daily for heart rate control Start Apixaban 5 mg oral twice daily to reduce stroke risk  Atorvastation 20mg daily
I tested positive for COVID-19 7/8/22. I had fatigue, sore throat, runny nose, and cough. I had a slight fever for a day and a half and it is gone now. I was prescribed PAXLOVID and I take my last dose tonight.
2.5 inch x 3 inch red rash and swelling at the injection site on my left arm, feel warm and little pain.
Chronic Spontaneous Urticaria a week after Moderna booster; occurs spontaneously multiple times a day and resides with oral Zyrtec.
Allergic reaction. Patient given T.Dap.  Subsequently, large wheal and flare the length of the upper arm developed; also was warm, tender, and firum to touch.  Treatment: benadryl 25 mg Q6H PRN and Ibuprofen 400 mg TID, PRN.
Very minor sore arm the night of vaccination. Around 1200 on 1/9/2021, I developed a minor headache, fatigue, chills, and fever to 101.6 at noon.  This resolved by 1800 after I took Ibuprofen at 1700.
Severe allergic skin reaction on both arms starting within a couple of hours after being vaccinated on 8/24/2021. Reaction included swelling, hot to the touch, red/purple discoloring, blistery bumps and some weeping and intense itching and burning.   I met with a dermatologist (MD) and was prescribed the steroid Prednisone (10 day course) on 8/25/2021. I was hopeful my body would recover and begin to self-control the skin reaction, without needing the steroids. I would have preferred not to have to take them. However, over the next three days, 8/25/2021 - 8/27/2021 the allergic reaction only intensified with all symptoms getting worse each day. I started the steroids on 8/28/21 and the skin reaction is improving
Woke c/o not feeling well, aching, joint tenderness, coughing and running fever which ranged up to 103.  Was seen by physician 7/18/2012.
12/3 pt went to ED d/t SOB, sore throat, body aches, testing positive for COVID in am and one day of continuous pain radiating down the arm. PMH: CA, DM, HTN, high cholesterol. Cardiology consulted d/t STEMI and pt taken to cath lab. Pt had coronary angio, left heart cath, mechanical thrombectomy, coronary stents placed, intravascular imaging with IVS and TR band to the right radial artery by Dr.. Pt started in Brilinta. Pt admitted to ICU thereafter.  12/5 Plan transfer out of ICU, wean oxygen dc home.   12/6 around 4PM, Pt ready for dc on covid isolation, son waiting downstairs to take pt home. RN stated pt was getting dressed.   Nursing staff noticed via camera pt on the floor. Staff donned PPe and entered room where pt was on the floor by the window. Cyanotic, agonal breathing with thready pulse.  Pt without IV access. CPR initiated.  Meds given, defibrillator.   No ROSC.   Pt passed away.  pronounced on 12/6/22 at 1715 Patient's family decline autopsy I do not have information to link death to vaccine, but reporting due to proximity of dose administered and time of code. pt has received flu vaccine in the past with no reported allergies