chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CAN'T RAISE ARM ABOVE SHOULDER; ARM HOT TO TOUCH; REDNESS AT INJECTION SITE; PAIN IN LEFT VACCINATED ARM; SWELLING OF ARM; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid infection, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A,  expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-APR-2021, the subject experienced can't raise arm above shoulder. On 13-APR-2021, the subject experienced arm hot to touch. On 13-APR-2021, the subject experienced redness at injection site. On 13-APR-2021, the subject experienced pain in left vaccinated arm. On 13-APR-2021, the subject experienced swelling of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left vaccinated arm, redness at injection site, swelling of arm, arm hot to touch, and can't raise arm above shoulder. This report was non-serious.
25 doses of expired Moderna Covid-19 vaccine were administered to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (25 doses of expired Moderna Covid-19 vaccine were administered to patients) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. It was reported that vial was initially stored in the refrigerator on 29 Apr 2022, 04 May 2022 and did not undergo temperature excursions.
18SEP96 Wed AM fever approx 102;rt red hot swollen rash 3-4" PM no change;19SEP96 AM area larger itchy-went to school;Thursday AM area larger;20SEP Friday PM appeared larger;
presented to ED (sent by UC) w/ SOB, found to have saddle PE, placed on heparin drip and sent emergently to main campus for intervention.
swelling, redness , warmth and itching to arm at site of injection x3 days. individual took Benadryl PO for the itching and applied ice packs to the site of injection.  Also had c/o of feeling tired/lethargic.  Denies having a temperature, SOB, difficulty breathing  or difficulty swallowing.  States she did not seek medical treatment.
Expired vaccine was given. Vaccine had been expired for four days.  Moderna has been notified and we are waiting for a response from them as to what the next steps are.
Patient fainted approx. 5 minutes after receiving vaccine then had tonic jerks. Patient was taken by ambulance to hospital emergency department.
had soreness in the injection arm; had soreness and achy symptoms in another arm; This is a spontaneous report from a contactable consumer report for self. This patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at arm on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got vaccine (Pfizer, COVID vaccine) on 20Jan2021, initial symptoms just had soreness in the injection arm. Patient woke up in the morning on an unspecified date and had soreness and achy symptoms in another arm. The outcome of event was unknown.   Information on the lot/batch number has been requested.
WHILE SLEEPING, ROLL OVER ON LEFT SIDE THE PAIN AWAKENS; LEFT ARM REMAINS WARM TO THE TOUCH; LEFT ARM SLIGHTLY SWOLLEN (AREA AFFECTED APPROXIMATELY FIVE INCHES); CONTINUAL ARM PAIN; This spontaneous report received from a patient via a company representative concerned a 60 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient had no past medical history documented. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821286, expiry: 21-OCT-2021) .5 ml, administered on 11-OCT-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin calcium for drug used for unknown indication..  On 11-OCT-2021, the patient experienced while sleeping, roll over on left side the pain awakens. On 11-OCT-2021, the patient experienced left arm remains warm to the touch. On 11-OCT-2021, the patient experienced left arm slightly swollen (area affected approximately five inches). On 11-OCT-2021, the patient experienced continual arm pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from continual arm pain, left arm remains warm to the touch, and left arm slightly swollen (area affected approximately five inches), and the outcome of while sleeping, roll over on left side the pain awakens was not reported. This report was non-serious.
Major depressive episode (lasted about 24 hours), unable to focus, wild swings from overly emotional to no emotion, crying, no enjoyment in anything, unable to complete basic tasks, generally unable to function, periods of laying in bed catatonic. This may not sound serious in clinical terms, but it felt like my brain broke and I could not function. It was terrifying. Until my doctor let me know that other people had experienced this same thing. I thought I was having major chemical imbalance issues and was worried I was having a serious mental breakdown.
At the 20 hr mark after shot Severe nausea Severe intense Vomiting  Severe Diarrhea  Very severe debilitating  stomach pain (All this lasted about 5 hrs)  Also, Spotting from period that lasted 3 days started at the 20hr post shot time.  As well as since shot. Period came a week early and was very very heavy and intense). This never ever happens.
sick; cough/coughing; body hurts/I have got to bad body ache/a lot of body pain; my nose is running; short of breath; nose is congested; This is a spontaneous report from a contactable consumer (Patient) or other non-Health Care Professional reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on 18May2021 as 2nd dose single, for COIVD-19 immunization. Patients' historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on unspecified date as 1st dose single, for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 29May2021 the patient experienced sick, cough/coughing, body hurts/I have got to bad body ache/a lot of body pain, my nose was running, short of breath, nose was congested (short of breath). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Purpura and thrombocytopenia (platelet count of 24,000).  All other cell lines normal.  Coagulation studies normal.  Platelet count recovered with a pulse of oral steroids.  Patient didn't suffer any other complications as a result of the thrombocytopenia.
Pt received vaccine stated that she didn't feel well and needed to lay down. Laid down and had an apparent seizure. Took BP and had an additional seizure EMS activate, took over care and transfered to Hospital.
23JAN98 p/(during dinner) 7PM had adverse allerg rxn, pulse rate inc, BP inc, inc in urination 4x in 1hr, chest pain  & burning under lt arm in lymph area;throat & sinuses swelling then severe thirst;numbness & tingling & shaking;h/a
4/10/21 ER HPI: 82 y.o. female who presents to the Emergency Department by paramedics from a local nursing home.  The patient is an 82-year-old female with a known history of end-stage renal disease, diabetes, and coronary artery disease.  She presented to the emergency room after being transported from a local nursing home.  Apparently, the patient was acting a little bit more confused than normal and she was looking more short of breath than normal.  The nursing home nurse stated that her oxygen saturations were in the upper 80s without oxygen and the patient looked visibly more short of breath than normal.  Because of this, the nursing home made the decision to send the patient in.  When paramedics arrived at the nursing home they placed 2 L of oxygen on her and her oxygen saturations went up into the high 90s.  The patient does dialysis on Monday, Wednesday, Friday.  She did not miss a dialysis treatment this week.  The patient has had her coronavirus (COVID-19) vaccine and several months ago did have coronavirus (COVID-19) at the local nursing home.  The patient does have mild dementia and so is somewhat of an unreliable historian.  Transferred to pleural effusion
Patient was given full dose instead of booster dose (half of dose) of Moderna vaccine. Patient experienced muscle soreness and headache symptoms.
About 30 minutes after vaccine I felt heart palpitations. 1 and 1/2 hours later I felt slight chest pressure, throat swelling (still able to breath), and an adrenaline type rush causing anxiety, shakiness, and energy burst. I did not seek medical attention. Instead I managed it at home with 50mg Benadryl. I slept through the night without any distress. When I woke up my throat still had mild swelling (felt like when you have a sore throat and a lump in your throat). This continued the whole next day along with intermittent chills, mild body aches, slight shortness of breath on exertion.  No fever. I did not take any medicine on this day.  The next day, day 3 my throat swelling was gone. I did not seek medical attention during these symptoms because the were tolerable and able to be managed at home.
Beginning on 02/26, right arm injection site developed a large red area, swollen, hard, warm to touch, itchy. Pt's mother called ER on 02/27 began icing area intermittently. More swollen today on 02/28. Seen in ER dx Benadryl, Keflex, and Tylenol.
No erection; This spontaneous case was reported by a pharmacist and describes the occurrence of ERECTILE DYSFUNCTION (No erection) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced ERECTILE DYSFUNCTION (No erection) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (No erection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported. The husband had no erection. The husband was born in 1972.  Company comment: This spontaneous  case concerns a male patient born in 1972 with no relevant medical history who experienced serious unexpected event of erectile dysfunction. The event occurred after the first dose of the Moderna COVID-19 vaccine .Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous  case concerns a male patient born in 1972 with no relevant medical history who experienced serious unexpected event of erectile dysfunction. The event occurred after the first dose of the Moderna COVID-19 vaccine .Rechallenge was not applicable since due to unknown outcome and lack of information on the second dose, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report.
15APR95 noted w/sm patches of red raised rashes to abd; spread to cover abd by 19APR95; noted sl edema to hans; 16APR95 & 17APR95 hands w/inc swelling; trace edema noted to hands & ankles; referred to clinic MD;
Incorrect product storage; No adverse effects reported; This non-valid spontaneous report was received from a nurse, concerning 3 unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions or allergies were not provided.  On an unknown date, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023501 with expiration date 16-AUG-2020; and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R008031, expiration date 18-MAR-2020 (strength, anatomical location or route of administration were not provided), both for prophylaxis;  which were concomitantly administered with a properly stored sterile diluent (MERCK STERILE DILUENT).   Regarding varicella virus vaccine live (oka/merck) (VARIVAX) the storage temperature was reported as  15 degree Fahrenheit (°F) to 46°F (-9 degree Celsius (°C) to 8°C) for 6 hours 15 minutes, 6°F to 14°F (-14°C to -10°C) for 9 hours 50 minutes and 47°F to 77°F (9°C to 25°C) for 9 hours.  Regarding rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) the storage temperature was reported as above 47°F/9°C (16.2C) time frame 9 hours.  No previous excursions were reported. The temperature excursions were detected by a data logger
Patient is a 60 y.o. male with a history of COPD, O2 dependent. COPD exacerbation about a month ago, txed, then beginning of this month had COVID, txed at home. Coughing and short of breath since but worse the past couple days. Nothing makes it better, worse with exertion. No fever but chills some. Sharp chest pain, right sided. Sent to ED by PCP."   Hospital Course:  The patient was admitted to the hospital and was evaluated and treated per below.      * COPD with acute exacerbation Description of the Problem/Progression: Plan: o COPD with acute exacerbation. Continue nebs, inhalers, and oxygen to keep pulse ox more than 92%. Patient remains at his baseline levels of oxygen at 2 L. Continue IV steroids and antibiotic therapy. Feeling back to baseline. Discharge home with oral antibiotics and steroids. Follow up outpatient. o Chronic respiratory failure with hypoxia. Remains at baseline. Continue oxygen as discussed. Continue CPAP at bedtime. o Non-ST elevation MI. Serum troponin peaked at 0.07 and trended down. CTA of the chest showed no PE or pneumonia. Currently on oral anticoagulation. Echocardiogram done showing a drop in EF to 35-40% from previous normal. Cardiology consulted. Holding oral anticoagulation for left heart catheterization today. LHC done showing CAD with not stents placed. Maximize medical treatment.  o Left ventricular systolic dysfunction. BNP is mildly elevated at 229. Started on gentle diuresis with IV Lasix. Monitor I and O's and daily weights. Monitor BNP trending down with improved symtoms. Continue PO Lasix.  o Covid 19 viral infection. Tested +19 days ago. He is outside treatment window with IV Remdesivir. Continue steroids. o Paroxysmal atrial fibrillation. Monitor on telemetry. Resume appropriate home medications including oral anticoagulation. o Hypertension. Controlled. Continue same treatment. Follow up daily labs.
Within 30 minutes, moderate pain at shot site. Over the next 4 hours pain increased in severity and expanded to encompass whole arm. Ibuprofen was given and ice applied to site. 24 hours later  fatigue, muscle pain, chills, and headache came on. Ibuprofen being given.
About 5 days after injection i felt left lower leg swelling on the lateral side of my shin with 2 areas of point tenderness and muscle pain. The area still is sore after a lot of staying off my feet and using ice packs on the area. I do an extreme amount of walking at work and am wearing brand new running shoes so the footwear shouldn't be an issue.
Pt with hx of COVID + illness x 3 months ago, received vaccine. During observation period she began to complain of burning in her right hand which then traveled up arm, lightheadedness and headache.  Monitored x 1 hour.  BP, HR, O2 sats monitored and within normal limits during period.  Orthostatic vital signs monitored.  Pt eventually felt well enough to go home and rest.
Patient called as stated the next day (evening) they got chills and got in the hot tub. Did not help with chills. Fever of about 99.5 degrees through the night. Day Oct 15, 2011 minimal eating with nausea, slept most of Thursday. Patient took TYLENOL 10/14/-10/15 for fever. 10/16/11 no sx.
This literature report has been received from the authors of a published article. In this case series, the authors described seven immunized healthy children without a history of primary varicella who presented with herpes zoster that correlated with the vaccination site of live attenuated varicella-zoster vaccine. These cases highlight the varied clinical presentations and diagnostic and therapeutic considerations for herpes zoster in healthy children. Seven vaccinated healthy children without underlying immunodeficiency presented with herpes zoster in the limb that correlated with the vaccination site. Their clinical histories are summarized. Each patient underwent varicella zoster vaccination at 12 to 14 months of age. The pediatrician's office confirmed the site of vaccination in six patients and the parents in the seventh. Median age at presentation was 3 years (range 1.5-6 years). There were no precipitating factors elicited by history in five patients; one patient developed the rash at the site of recent influenza vaccination and one patient developed the rash after surgery. The morphology of the lesions included erythematous papules, pseudovesicles, pustules, and plaques, with associated pain in two patients and pruritus in three. Systemic symptoms ranged from none to low-grade fevers, upper respiratory symptoms, and joint pain. Clinical and laboratory findings, specifically positive direct fluorescent antibody (DFA) testing, were consistent with herpes zoster in four cases; because of distinct similarities in the clinical examination, DFA testing was not conducted in the other three cases. Acyclovir was prescribed for five patients but deferred in two because of the mild or late presentation. The evaluating physician's differential diagnosis in the seven cases included viral exanthem, eczema herpeticum, atopic dermatitis, contact dermatitis, microcystic lymphatic malformation, herpes simplex infection, and herpes zoster infection. In one patient with knee pain, there was initial concern for septic hip, but inflammatory markers were not elevated, joint effusion was not seen on ultrasound, and the rash and knee pain self-resolved after several days. This report refers to a 6 year old male patient without a history of primary varicella. On an unknown date, the patient was vaccinated with varicella-zoster vaccine (code as "varicella virus vaccine live (Oka/Merck) (manufacturer unknown), Zoster Vaccine Live (manufacturer unknown) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (manufacturer unknown)") (dose and route unknown, left leg) for prophylaxis. On an unknown date (reported as 61 months later), the patient experienced herpes zoster in left leg (in L5 dermatomal distribution) with symptoms of itchy lesions. The direct fluorescent antibody (DFA) testing was positive.  The patient received acyclovir treatment for the event for 5 days. The outcome of the event was recovered without complications. The reporter considered the event of herpes zoster was related to the suspected therapies. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1802USA003640:
pt recv vax & 3min p/vax c/o not feeling well;color pale, eyes rolled back & body became rigid 20sec;A&O x 3 p/event;vs stable, PEARL, vomited x 2 w/in 5min;
Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a female patient of an unknown age 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 ILLNESS (Sickness). At the time of the report, ILLNESS (Sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not reported.
101 degrees F fever; severe headache; muscle pain; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 08:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO) of dose 10mg taken for unknown indication from an unknown date and unknown if ongoing. On 03Apr2021 at 00:00, the patient experienced 101 degrees F fever, severe headache, muscle pain and joint pain. On the same day, the patient underwent body temperature test and the result was 101 degree Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events 101 degrees F fever, severe headache, muscle pain and joint pain was unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 08:30 (at the age of 51-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Myalgia, SkinRash, Rash, see ADR narrative Narrative:  noted chills, myalgias, fatigue, rash, tingling lip and palate , symptoms improved in 2 days , saw private PCP on 1/4 and returned to work on 1/5, all symptoms resolved. H/o COVID in Sep 2020 .
03/05/2021 2 days after vaccination. I was out walking and at the bottom of the hill, which I would normally do daily. I was having to rest and when I went to my home, I found my oxygen was down to 89%. I am normally at 96%. A few months later, I came down with something like a virus and have been having major issues with shortness of breath and the enzymes I was taking weren't as effective as usual. I went to my pulmonologist for lung issues and then I went to a cardiovascular specialist however they did not find anything remarkable on test results other than a slight heart murmur. Dr. stated that it seems her COPD has been in a way activated and placed me on steroids to help with the inflammation in my lungs. Symptoms that are still going on are mainly the shortness of breath that is still causing major issues and a terrible cough.