chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passing out; he was shaking when he passed out; left arm hurting; head hurting; Feeling queasy; getting sick; This case was reported by a nurse via sales rep and described the occurrence of passed out in a 10-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 25th June 2019 11:45, the patient received Bexsero and Menveo. On 25th June 2019, less than a day after receiving Bexsero and not applicable after receiving Menveo, the patient experienced injection site pain, headache, feeling queasy and sickness. On 25th June 2019 16:10, the patient experienced passed out (serious criteria GSK medically significant) and tremor. On an unknown date, the outcome of the passed out, tremor, headache and feeling queasy were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the passed out, tremor, injection site pain, headache, feeling queasy and sickness to be related to Bexsero. It was unknown if the reporter considered the passed out, tremor, headache, feeling queasy and sickness to be related to Menveo.  Additional details were provided as follows: On 25th June 2019 at 11:45 AM, the patient received Bexsero in left arm and Menveo in right arm .  The patient stayed 15 mins after vaccination with Bexsero. Then, he went home and took a nap.  Later in the day, when the patient was on the way to his father's house, started complaining of left arm hurting. He also complained of head hurting and feeling queasy. His brother pulled over and the patient got sick.  At around 4:10, the patient reached to his father's house. When he arrived he passed out and was shaking when passed out.  The patient's brother called EMT's (emergency medical technicians). The patient was fine but got sick again while EMT's were there.  The patient complained about headache for the rest of the day.  The next day he was fine. He denied headache, nausea or vomiting but his left arm was still sore. The reporter was not sure if this was a reaction to the vaccine or if patient just got sick.  The VAERS had been done.
mom said pt had cried for >3hrs @ sitter's home w/vax but then had been fine when mom arrived;irritability was not sufficient to cause parents to call or bring pt to MD;however over time the event became more worrisome to parents;
1. Cold/shivering/unable to remedy with hot water or blankets - continued 6 hours 2. Shot site red & swollen & painful - continued 5 days 3. When shivering stopped, felt like I had flu - mostly slept through next 2 days 4. Strange itching in skin of upper right abdomen (no signs of rash or bite to explain itch) corresponding with itching around injection site on left arm - at both sites, itching came and went (always together) 5. About 36 hrs after shot, outbreak of Herpes Simplex on outer nose - 1st outbreak in over a year - took Valacyclovir to keep it from worsening 6. On 7th day following shot, finally stopped feeling fluish/sluggish
Intermittent low grade fevers for 2 weeks after, extreme arm soreness (was unable to move arm) for two days
This case was reported in a literature article and described the occurrence of uveitis in a 58-year-old male subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received 3rd dose of Hepatitis B vaccine (unknown). One day after vaccination with Hepatitis B vaccine, the subject experienced uveitis and retinopathy. This case was assessed as medically serious by GSK. This is one of the 32 cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurs because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed immune complexes which initiated the ocular response of uveitis.
1) Shortly after 1st vaccine the 30 year old varicose vein (bulge) behind my right knee became very inflamed and painful. Advil helped and the pain went away.  Over the past 10 months the bulge became greatly reduced and went away.  2) one week after booster shot I developed various itchy burning locations on my extremities and torso.  Benadryl & lotion help but these areas persist.  Lots of itchy burning locations for 6 weeks now.
Lump on my arm began as a normal size.  In 48 hours, the lump covered the entire back side of my upper arm, about 7 inches long by 5 inches wide.  In 72 hours, the lump has begun to go down, but it has started to ache, sort of like growing pains used to feel.
Patient presented to the COVID vaccine clinic for first dose Pfizer today around 1:20 PM.  While reported no allergies, asked to sit in observation for 1 hour to be observed as she developed some symptoms after receiving second Hepatitis B/MMR vaccines back in May of this year.  Historical  symptoms were reported as a delayed onset, worsening and persisting over multiple days: facial swelling, diarrhea and weakness unrelieved by Benadryl at home with subsequent ED visit which resulted in a prescription for benadryl and a short course of prednisone.  Patient did not receive epinephrine in the ED; no throat or tongue swelling, stridor, wheezes, tachypnea or respiratory distress was noted.  Periorbital edema was noted.  Here in our observation area the patient did not report or develope any symptoms and left without incident after 1 hour.  Patient then returned to this clinic at approximately 4:30 PM c/o facial swelling and shortness of breath and stated "I don't feel like myself".  Symptom onset of approximately 2:30 PM.   Assessment:  A=open, no noted stridor or wheezing B=regular, unlabored, no tachypnea C=cap refill less than 2 seconds, skin pink, warm, dry.  BP 115/85.  HR 86, 02 97% on RA. D=GCS 15, RASS 0, no deficits  Patient also reported that things would get worse over time.    Epi was not indicated during her observation time. Patient was advised to go to ED via ambulance.  Patient declined.  Patient was also advised to reach out to primary care provider and allergy consult with recommendations and clearance before return to this clinic for COVID vaccine dose 2.  Also advise/reiterated to patient to present to urgent care or ED with any future urgent/emergent concerns vs presenting to a clinic.  Left clinic independedently without incident after 1 hour observation time with stable VS.
ERROR ON DATE OF BIRTH ENTERED ON SYSTEM. PATIENT VACCINATED ACCORDING TO CDC GUIDANCE REGARDING AGE AND VACCINE.
mom reported child had rash devel on arms/trunk 48hr p/vax;pt given steroid inj & discharged w/rx for clariten;told to stop typhoid pills;next morning rash gone;
Her left side of her arm  went numb; she is been evaluated for stroke and possible transient ischemic attack; This spontaneous case was reported by a patient and describes the occurrence of HEMIPARAESTHESIA (Her left side of her arm  went numb) and TRANSIENT ISCHAEMIC ATTACK (she is been evaluated for stroke and possible transient ischemic attack) in a 60-year-old female patient who received mRNA-1273 (batch no. 021b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced HEMIPARAESTHESIA (Her left side of her arm  went numb) (seriousness criterion medically significant) and TRANSIENT ISCHAEMIC ATTACK (she is been evaluated for stroke and possible transient ischemic attack) (seriousness criterion medically significant). At the time of the report, HEMIPARAESTHESIA (Her left side of her arm  went numb) and TRANSIENT ISCHAEMIC ATTACK (she is been evaluated for stroke and possible transient ischemic attack) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Coughing; runny nose; 100 fever; This is a spontaneous report from a contactable consumer (patient himself). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: Unknown), dose 1 via an unspecified route of administration, administered in left arm  on 06Feb2021 10:45 (at the age of 66-year-old) as single for covid-19 immunisation. Medical history included myeloma remission. Concomitant medications included lenalidomide (REVLIMID), ezetimibe (ZETIA), acyclovir, aspirin, amlodipine taken for an unspecified indication received within two weeks. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. On 08Feb2021 03:00, the patient experienced coughing, runny nose, 100 fever. The patient lab tests which included body temperature was 100 on 08Feb2021. The patient did not underwent COVID test post vaccination. No treatment medications was received for the adverse events. The outcome of the events was resolving.  Information about Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Received punctured vial that was left overnight in a light protective box at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received punctured vial that was left overnight in a light protective box at room temperature) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received punctured vial that was left overnight in a light protective box at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received punctured vial that was left overnight in a light protective box at room temperature) outcome was unknown.        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 medication were reported. No treatment medication was reported.
suspected  vaccination failure; Got the flu; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 9-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient received dose of Flu vaccine in the fall one year, and experienced fku in the following January. The reporter did not consent to follow up. This case has been linked with cases US2020003242 and US2020AMR003766, reported by same reporter. This case was considered as a suspected vaccination failure case as the time to onset and the lab test confirmation for influenza were unknown.
Around 5 min after injection patient became very pale, sweaty, and dizzy. She was given water and laid flat on the ground which seemed to help. Patient was accompanied by mom, dad, and brother. These symptoms seemed to last 10-15min and then she completely recovered.
sore shoulders, hands swelling, fingers tingling, nausea, achey, fever;
Myalgia, NauseaVomiting, severe right arm pain at injection site, chills, warm, very tired Narrative:
Arms falling asleep feeling tingly, and left leg too.  Heart racing at 136 at rest and 185 when doing activities in the army, hands feeling hot and pain as if needles were on my finger tips.
This study case was received from the investigator (MILVAX) in a trial on 02 May 2011. A 39 year-old male subject with a history of high blood pressure, elevated cholesterol, heart attack and asthma was found to have an acute myocardial infarction, unspecified site and a subendocardial infarction 13 and 15 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 15 September 2010. Relevant laboratory data included: an abnormal Troponin I with the highest recorded value of 09.16, a normal ECG and a normal Echocardiogram. A lumbar puncture (spinal tap), MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
On 02/16/2021 - I got very sick: fever. I was in bed for several days, chills, fever, and just felt awful. The symptoms resolved on their own after 2 or 3 days. I have had tinnitus for 7 years which was caused by Amikacin. My tinnitus was exacerbated after the vaccine, Pfizer Dose 1 & Dose 2.  The loudness increased after the vaccines. There is loud noise 24 hours a day, 7 days a week. It's unending. A shushing noise. It's always in my ears. And it has never resolved. I have not seen a doctor, the reason being is that there is nothing that can be done for it.
Immediately felt a sting when injected, within 10 minutes had a metallic taste in mouth lasted until April 30th.  As of April 14th walking was exhausting with labored breathing, felt as if my muscles were being attacked. April 21st started experiencing similiar symptoms not as intense that I experienced 3 years ago with the drugs I discovered thay I am deathly allergic to.  Since April 21st I have had a sharp pain in my right achilles and  on May 9th I popped  my right knee. These symptoms are the same symptoms I experienced within a month of taking Levaquin.
I received my vaccine at 1215 on 12/31/20.  At 1800 on 12/31/20 I began to feel mild shortness of breath. I then became dizzy at 1805. At 1815 I developed blurred vision. The dizziness and blurred vision prevented me from standing. I was able to walk with assistance at 1915. The blurred vision lasted until 1915. The dizziness lasted until 2230.  At 2000 I had muscle aches and joint pain and could not get comfortable. Muscle aches and joint pain lasted until 1-1-21 at 1930. I did not seek medical treatment. (I working in the ER and did not feel it was severe enough to check in because the shortness of breath was mild and went away shortly after the dizziness began at 1815). I took Benadryl 50 mg at 1930 and 1000mg of Tylenol.
Adverse drug reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Adverse drug reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Adverse drug reaction). At the time of the report, ADVERSE DRUG REACTION (Adverse drug reaction) had resolved.            No concomitant products were reported.  On an unknown date, the patient experienced reaction to rinvoq after med covid shot. On an unknown date, reaction to rinvoq after med covid shot resolved. Moderna covid-19 vaccine (covid-19 vaccine mrna (mrna 1273)) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 03-Mar-2021, patient received 1st dose covid-19 vaccine manufactured by moderna. On 05-Apr-2021, patient received 2nd dose covid-19 vaccine manufactured by moderna.  Causality for rinvoq (upadacitinib) The reporter's causality for the event(s) of reaction to rinvoq after med covid shot was not provided.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
unconsolable crying (not shrill non high pitched) for 6-7 hrs beginning approx 1 1/2-2hrs p/inject & lasting into evening hrs; lt leg edematous resolved in AM; pt only cried unconsolably when leg was moved
improperly stored VARIVAX were administered to patients; no additional adverse events were reported; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, an improper storage dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, anatomical location, and route of administration were not provided; lot number reported and validated as W039294 and expiration date was established as 11-DEC-2024) was administered after temperature excursion to a patient (improper storage of product in use).   The excursion occurred with a temperature of 17.4 Farenheit (F) for 2 hours and 0 minutes and 0 seconds. There was no previous temperature excursion reported. No additional adverse event provided.
Within 15 minutes of receiving the COVID19 Pfizer vaccination, I began feeling a swollen feeling near my left carotid artery, and it began radiating out through the left side of my face. My throat and tongue now feels swollen, and my eyes are burning and watery. I have a metalic taste in my mouth, and as of the last 5 minutes (2:41 pm) feel lightheaded and slightly nauseous.
Per family, patient received 2nd vaccination and began experiencing swelling and shortness of breath the following day.  This progressed over the course of 2 weeks until this today when he suffered a cardiopulmonary arrest and could not be resuscitated.  Death resulted on April 24th 2021.
Pt developed rash at injection site. Took 8 days to resolve. She said it was red, swollen & felt hot.
Vaso/vagal response with anxiety, hot/cold Encouraged laying on the floor with feet on chair but anxiety prevented a prolonged laying time Hydrated with water, spoke calmly and tried to engage patient in conversation Gave 25mg diphenhydramine at 15 minute intervals twice. Decided to call the ambulance
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient. Patient's parent reported no adverse events other than typical ones from covid vaccine. Patient's parent will consider the offer for a receive a replacement booster dose.
This spontaneous report was received from a healthcare worker regarding 10 unspecified patients of unknown age and gender. There was no information on pertinent medical history and drug reactions or allergies. On an unknown date, the 10 patients were vaccinated with VARIVAX (Merck) .5 milliliter (ml), product lot # reported as K011804, expiry date reported as 21-AUG-2016, subcutaneously after it was stored improperly. No adverse effects were reported. There was no product quality complaint involved. The outcome of the events was unknown. Additional information has been requested.
A 6 month old white female with atopic dermatitis and no known illness at the time of vaccination, was vaccinated with a second dose of hep B vaccine recombinant (yeast), IM in the right thigh, on 12-MAR-2001. Concomitant therapy, that day, included the third doses of ACT-HIB, Prevnar and Tripedia. There were no additional concomitant medications reported. The pt presented to the physicians office with a "few fine, minimally raised red patches 1-3mm in diameter" on her face and trunk. On 12-MAR-2001 the pt developed urticaria within 15 minutes of the immunization and was treated with Benadryl. The pt was sent to an allergy specialist for skin testing. The pt had tested positive for thimerosal allergy. Subsequent follow up indicated that the kin testing revealed an allergy to hep B vaccine recombinant (yeast) and Tripedia, but results were negative for allergy to Prevnar and ACT-HIB. On 12-MAR-2001, the pt recovered from her experience. Urticaria, testing positive for thimerosal and "allergy to DTaP and HBV" were determined to be other important medical events. No further information is available.
Information has been received from a registered nurse concerning an infant who on an unspecified date was vaccinated with a dose of ROTATEQ (Lot# and dose unspecified), orally. On 13-DEC-2011 the patient experienced vomited after receiving the dose of ROTATEQ and a replacement dose was administered. The patient sought medical attention in the office. At the time of reporting, the outcome was unknown. Additional information has been requested.
I read that swollen lymph nodes is a possible side effect.; It's uncomfortable its not like painful but its very uncomfortable and tender.; tender; like a ball under my arm, swollen under my arm and in my armpit and down into like my breast tissue.; I couldn't even lay that way.; That evening my arm was sore; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (Solution injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she went Tuesday afternoon and got her first covid shot. That evening her arm was sore and yesterday it continued to hurt and last night when she went to bed it was like there was something like a ball under her arm, swollen under her arm and in her armpit and down into like in her breast tissue. She couldn't even lay that way. She read that swollen lymph nodes was a possible side effect. It's uncomfortable it was not like painful but it was very uncomfortable and tender. Caller asked, is that what she was experiencing a swollen lymph node and should she get it checked out. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.