chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient consented to receive Pfizer vaccine. In about 5-7 minutes of receiving vaccine, patient started feeling nauseated, had chills and breathing difficulty. Patient is a nurse. She had epinephrine 0.3 mg pen with her which was administered in the thigh and patient had called 911 as soon as she started feeling light headed - however, her blood pressure was around 127 mm Hg.  Emergency Medical Team arrived and took over. Her symptoms were under control and one of the Emergency Medical Team member said that it might just have been an anxiety attack. She was taken to the hospital.
The patient deliberately checked that she had not received a prior vaccine- she checked "no"  on the question, " have you received previous Covid 19 vaccine". She received 2 doses of Pfizer vaccine on 12/18/2020 and 01/11/2021. On 08/25/2021 she requested Janssen vaccine as her one and only vaccine.
experiencing COVID arm after first dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (experiencing COVID arm after first dose.) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001821A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (experiencing COVID arm after first dose.). At the time of the report, VACCINATION SITE REACTION (experiencing COVID arm after first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient reported experiencing COVID arm after first dose.  No treatment information was provided.   This case was linked to MOD-2021-437153 (Patient Link).
Moderna COVID?19 Vaccine   Experiencing an Ulcerative colitis flare, i.e. abdominal cramping, rectal burning, increased stool (10 or more a day)
She said her arm a lot. I asked her if she felt the vaccine was administered properly and she said yes. I recommended she continue current meds, add ibuprofen for pain, use and ice pack, and to rest/not over exert herself until the pain has deceased significantly. She said the same reaction occurred on dose 1 of the series apparently.
administered pediatric pfizer COVID to a patient that turned 12 years old 2 weeks previously instead of adult pfizer
- second vaccine caused serious reaction - seen by UC - symptoms started first night after the vaccine with tingly hands, then itching all over, then hives, and by the next morning she was "pretty much a hive" - even in her mouth, one on head that turned into a "goose egg", joints swelled up, temperature to 101, skin fell off around her finger, blood blisters on palms that peeled off, ears swelled up, joints aching - pt states this was all very scary - was the Moderna vaccine - has been in touch with Dr. and he told her that she now has PMR, possibly triggered by the COVID vaccine - took prednisone and then felt much better - next visit is phone visit with Dr.  on 3/11, then in person visit in 3-4 weeks
Had Tdap shot 8/15, it is 8/24 area around shot red 6cm x 4cmalso had nodule 2" inside circle exists. Advised patient twice & take ADVIL & come back in 2 days. Bruised a little yellow inside red circle. No fever. Range of motion not affected.
Frequent, urgent urination with blood in urine. Started same day about 2 hours after vaccine and continued approximately 10 hours till bedtime. Cleared up on it's own the following morning. FYI: also received Pneomonia vaccine ( PRENVAR 13) at same time.
HEADACHE; FEVER; TIREDNESS; MUSCLE ACHE; This spontaneous report received from a parent concerned a 35 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced headache. On 21-MAR-2021, the subject experienced fever. On 21-MAR-2021, the subject experienced tiredness. On 21-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 100 degrees F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, tiredness, and muscle ache. This report was non-serious.
On 3/18/2021 at 11:33, patient complained of tongue swelling and slight itching in throat to EMT,. Patient carries PO Bendaryl for allergies and took 50 mg at 11:35. BP 158/P. Patient not complaining of difficulty breathing. Patient stated this reaction was similar to her seasonal allergy reaction.  11:40 patient c/o worsening of tongue swelling. EMT contacted ambulance. BP: 164/P, HR: 98, Oxygen level WNL.  No epi. needed. Ambulance took patient to ER where patient was monitored for 5 hours. Patient was then discharged to home on 3 medications. Spoke to patient 3/19/2021 - stated she was feeling much better. Will not be receiving Moderna #2 vaccine as per doctor.
CHILLS; FEVER; INJECTION SITE PAIN LEFT ARM; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol drinker, and other pre-existing medical conditions included the patient had no known allergies and did not have any history of drug abuse or illicit drug use. 's medical history patient gave tylenol 500mg (a total of 2 tablets were given in the past day, 1 at 9am and 1 at 2am).The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular) dose was not reported, administered on 12-MAY-2021 13:00 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAY-2021, the subject experienced chills. On 13-MAY-2021, the subject experienced fever. On 13-MAY-2021, the subject experienced injection site pain left arm. Laboratory data included: Body temperature (NR: not provided) 99.4 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, and injection site pain left arm. This report was non-serious.
Red itchy rash at injection site, it's an oval about 3 inches by 2 inches, warm to the touch but not raised, started lighter on 3/15 but is much darker red this morning (3/16)
Injection was given higher than normally received. It was in upper arm/shoulder area. Immediately following vaccination had trouble lifting arm. Still experiencing throbbing pain in shoulder with difficulty moving/lifting.
first dose  about 2 years ago, has not yet received second shot; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 19-APR-2022 Reporter's Comments: The pharmacist stated his patient received his first dose of SHINGRIX about 2 years ago and had not received second shot.  Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose which led to incomplete course of vaccination. This case has been linked with the case US2022066899 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066899:same reporter
On 01/23/2001 the patient's mother called the clinic and reported that the child "broke out with a bad case of chicken pox about 2 weeks after being exposed to it". At the time of the report, it was all over the patient's body including his mouth and he had a low grade fever. The child was seen in the clinic's office. The nurse reported on follow up that there was no adverse reaction to vaccine and that the child contacted chicken pox one year after vaccination. No further details were provided.
Myalgia, NauseaVomiting, per patient: "extreme soreness in my left shoulder where the vaccine was administered, and a extreme case of upset stomach"
Pt vaccinated with DTP/OPV experienced persistent crying, different from usual cry. lasted about 10hrs total; not as active; weak; poor feeding.
Patient was getting a haircut when he slumped over in the chair and passed out unconscious for 15-20 seconds. When he came to, his eyes were blood shot and he was disoriented (not sure what happened).  He said that he suddenly became dizzy before blacking out.  This is the first time patient has ever blacked out.  He had eaten a large meal roughly 2-3 hours prior to the event and was adequately hydrated (did not appear to be a blood sugar or hydration issue).    A few hours later he seemed to be running a mild fever and was given 200mg ibuprofen.  Otherwise he was fine the rest of the day.
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever), chills, headache, nausea and myalgia (muscle pain) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pyrexia (fever), chills, headache, nausea and myalgia (muscle pain). At the time of the report, pyrexia (fever), chills, headache, nausea and myalgia (muscle pain) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Rashes appeared on hands and fingers. Kept increasing and extended to hands, elbows, legs, knees, back, butt Dermatalogist first thought it is eczema but second visit he said psoraisis.
This case was reported by a consumer (patient) via a program and described the occurrence of elevated blood pressure in a currently 65-year-old female patient who received generic carvedilol for hypertension. A physician or other health care professional has not verified this report. The subject's medical history included appendectomy, coronary angiography, deep vein thrombosis, hospitalization for chest pain, malignant hypertension, migraine headache, Prinzmetal's angina, protein S deficiency, pulmonary embolism, stent, subtotal hysterectomy and transient ischemic attack. Concurrent medical conditions included allergy to TALWIN, chronic back pain, codeine allergy, coronary artery disease, degenerative disc disease, dyslipidemia, fibromyalgia, hypercholesterolemia, hypercoagulability, hypertension, peripheral arterial occlusive disease and peripheral vascular disease. Co-suspect vaccination included influenza vaccine. Co-suspect medication included COREG CR and ketorolac tromethamine. Concurrent medications included clonidine, CYMBALTA, EPIPEN, FUROSEMIDE; LIPITOR, minoxidil, MS CONTIN, NEXIUM, nitroglycerin, NITROSTAT, PHENERGAN, potassium, warfarin and ZANAFLEX. On an unknown date, the patient started generic carvedilol (unknown) (unknown manufacturer), unknown dosing. At an unknown time after starting carvedilol, the patient experienced elevated blood pressure, lack of effect, chronic headaches, concussion and hit head in fall. The patient reported that "generic COREG does not control my blood pressure/hypertension" and she is unable to take it as her blood pressure stays above 140/90. The patient also stated COREG (brand name) works for her as she is intolerant to many blood pressure medications. Since her last physician's visit the patient's blood pressure has been "slightly elevated" and the patient feels it is because she had a chronic headache caused by a concussion that occurred after a fall in which she hit her head on an end table. The patient denied any symptoms associated with elevated blood pressure. On an unknown date the patient started treatment with ketorolac trometamol (unknown), unknown dosing. The patient reported experiencing arrhythmia, bradycardia and dyspnea from ketorolac trometamol. The patient also reported receiving the flu vaccine (unknown) on an unspecified date and experienced rash and throat pain. Details regarding the vaccination and events were provided. At the time of reporting, the outcome of the events was unknown.
Information has been received from a physician concerning a 13-month-old healthy male with no pertinent medical history of allergies and known history of varicella exposure, who on 24-JAN-2006 was vaccinated intramuscularly in the left leg with a 0.5 ml dose of Varivax (lot# 652081/0942R). There was no concomitant medication. On 13-MAY-2006 the patient developed a rash with many lesions. On 17-MAY-2006, the patient was seen by a pediatric dermatologist and was diagnosed with zoster. The site of the zoster was the right groin and buttock and involved 2 dermatomes. It was reported that the physician cultured the lesions for PCR analysis but results are pending at the time of the report. The patient had not recovered. No product quality complaint was involved. Follow-up information received on 01-JUN-2006 and 06-JUN-2006 indicated that the 2 large swab specimens were inadequate; therefore, no results were reported. Additional information has been requested.
the needle assembly broke off at the hub (the glass area broke); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: GT6700) for immunisation, Device Lot Number: GT6700. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "the needle assembly broke off at the hub (the glass area broke)".  Additional information: The nurse was closing the safety device on a Prevnar 20 PFS. The needle assembly broke off at the hub (the glass area broke). They will have the nurses check for defects in the others before using. She was not injured but reporter can see where this may occur.
I felt like I had a cold but it did not get better as fast as a normal cold normally does for me. I took a home COVID-19 test on February 14, 2023, the home COVID19 test came back negative. I still was not feeling well so I tested again on February 17, 2023, again the test was negative. By February 20, 2023, I was feeling bad, so I retested, this time it was positive. I called my doctor who advised me to rest and if it got worse to go to the hospital since I am a transplant recipient.
pt recvd vax 28JUN94 & 6hrs later pt devel redness, swelling & soreness which lasted for at least 72hrs;
Jan 14: Shot #1 of Moderna at 7 am at  Hospital o Very sore at injection site for 2-3 days o Retrospectively, I recognize a subtle shift in my mood after the first shot that has persisted. I felt inexplicably sad in the afternoons and continued until March 1st anxiety event. I also found myself crying more.  o Sleep ? I woke up a handful of times with heart racing and then would fall back asleep. This is never had happened before   February 11: Shot #2  of Moderna at 7 am  at Hospital o Within 11 hours of the vaccine had fever, chills, aching and 103 fever. Next day my period started a week early. o Over the course of the next two weeks my anxiety levels heightened;  o March 1st acute event that mimicked an anxiety attack (no previous history of anxiety or attacks); followed by my first night of many nights with no sleep.  o Insomnia ? worsened each night.   o Internal thermostat dysregulation ? I would get very cold and shake uncontrollably and then feel hot after the shaking episode; shaking would often happen in the afternoon and especially after meals.  o High Blood pressure o Night sweats. o Muscle weakness; tingliness running through arms and legs. o My heart would skip a beat (several times a day). o My entire body would feel like it was pulsating uncontrollably but I wouldn?t be visibly shaking.  o Muscle stiffness. o Pain in lower right back region (ultrasound yielded nothing). o Extreme exhaustion. o Loss of appetite and dietary changes (no longer can eat rich foods; only bland small meals multiple times a day) o Weight loss (5-6 pounds) in one week (146-140) o Unable to focus; blurry vision. o Unable to partake in intense physical activity; can only walk. o Unable to participate in household work because of low energy. o Unable to participate in job duties due to inability to focus on screen for long periods of time. o.  Second week, March 8th, muscles in upper back burn and intense pins and needles in my shoulders arms to finger tips. T This sensation woke me up from sleep on Friday March 12th.   o Unable to focus; blurry vision. o Strange headaches- behind eyes, in temples, on one side of the head. (don?t? have a history of headaches)
12/08/21 presents to ED for "Cough, dyspnea, fever". PMHx of "MVP, asthma, IBS, htn"
COVID 19 INFECTION; FATIGUE; BACK PAIN (WITH RADIATION); FEVER; BACK PAIN; SORE THROAT; DYSGEUSIA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included thyroid, and allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. Concomitant medications included bupropion hydrochloride. On 10-MAR-2021, the subject experienced dysgeusia. On 11-MAR-2021, the subject experienced back pain. On 11-MAR-2021, the subject experienced sore throat. On 11-MAR-2021, the subject experienced back pain (with radiation). On 11-MAR-2021, the subject experienced fever. On an unspecified date, the subject experienced covid 19 infection, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, and Low grade fever (NR: not provided) low 99.4. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from back pain, dysgeusia, and fever on MAR-2021, had not recovered from sore throat, and the outcome of back pain (with radiation), covid 19 infection and fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Pt noticed 2 hives (red, raised area 1 1/2-2) with mild swelling of hive area only, on left bicep and very small discoloration described as appearing like a bruise on inner aspect of left elbow in evening on 12/1/04. Did not feel ill. No self treatment. Did not consult medical provider. States all discoloration, swelling/hives resolved by AM of 12/2/04.
Sore throat to swallow surrounding esophagus approximately August 23rd, about three weeks after the first vaccine.  Mild flu-like symptoms in the evenings at the onset of sore throat.  After a visit to my primary physician, an ultrasound showed multiple nodes on my thyroid gland, and was prescribed four days of prednisone to "calm it down".  Felt good for about 6 days and then the soreness returned in my throat/neck area.  I was referred to an endocrinologist to have a closer look at the largest node of 1.6 cm.  I was unable to see the endocrinologist until October 12th.    I was scheduled to take my second shot on September 11, 2021, and I took it on September 12, 2021.   I have typical second covid-19 vaccine symptoms that lasted only about 12 hours.  However, the days following my throat became more and more tender, sore and at times throbbed.  I began to have evening flu-like symptoms to the point of taking medication to mitigate fever, aches, and chills.   I began researching thyroid symptoms from the website and felt that maybe I was suffering from Subacute Thyroiditis.  The treatment was high doses of aspirin or ibuprofen.  On October 4th I began taking 600 mg of ibuprofen each day at 1:00 p.m.    I discontinued this Sunday, October 10, 2021, and was surprised that my symptoms did not return.  I saw the endocrinologist on October 12th, where I underwent blood testing and ultrasound to determine what might be going on. The endocrinologist confirmed that I indeed had Subacute Thyroiditis.  Due to the fact that I have no family history and no previous history of thyroid issues, he diagnosis was that it was related to me taking the covid-19 vaccine.
Fever 3-11-19. Fever 3-12-19. Fever and seizure 3-13-19. Febrile seizure due to vaccines.
PT  COULD NOT HEAR OR SEE AFTER VACCINE . HIS BLOOD PRESSURE WAS DROPPED . i WAS CHECKING HIS BLOOD PRESSURE EVERY 5 MINS. H E WAS REALLY HUNGRY SO GAVE HIM SOME CRAKERS AND WATER. CHECKED  AGAIN HIS BLOOD PRESSURE AND AFTER THAT HE WAS FINE . WE HAD MONITOR HIM  FOR 30 MINS .
myocarditis; This is a spontaneous report from a contactable physician and a contactable consumer.  A 19-year-old female patient (reporter's niece) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced myocarditis on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the event Myocarditis and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient can not walk, and has no appetite.  Not steady on feet.  5/16/2008 MR received for DOS 3/13-18/2008 with D/C Dx:   UTI with Klebsiella.  Sepsis resolved.  Dehydration resolved.  Hyperglycemia steroid induced. Hypertension. Generalized weakness and 4/21-27/2008 with D/C DX: Acute Renal Failure with metabolic acidosis and hyperventilation causing dyspnea, resolved.  UTI, improving.  Anemia.  General weakness. Right shoulder pain. CAD. HTN. First presented to ER 3/13/08 with c/o 4 day hx of not feeling well.  Temp 100.3'F. Found to have leukocytosis and leukocyturia.  ROS (+) for dysuria, chronic joint pain and depression. PE WNL. Admitted for IV abx. Returned to ER 4/21/08 with c/o dizziness, weakness, and SOB. Pt found to have acute renal failure with metabolic acidosis and uremia as well as hyperventilation causing dyspnea. UTI and Anemia as well.
Pt experienced neck stiffness and severe pain - shooting pain going up to her head. Headache and severe pain. Unable to turn head certain directions. Was prescribed a muscle relaxer from PCP but didn't provide relief.   Patient experienced this before with original Moderna shot.