chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rarely leaving bed.; Checked oral temp: 100.6 F.; Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding.; 5/20-Woke in AM drenched in sweat, blankets wet, and freezing.; Fatigued; Muscle aches; Feeling extremely cold and always waking drenched in sweat with wet blankets. 5/21- rarely leaving bed; Woke up during night freezing; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in Arm Left on 19May2021 at 16:00 (at the age of 37 year) as DOSE 2, SINGLE for COVID-19 immunization at School or Health Clinic. Medical history included idiopathic hypersomnolence, anxiety, depression, excessive daytime sleepiness, chronic fatigue, constipation, internal and external bleeding haemorrhoids and non-celiac gluten enteropathy. Patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate and dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccine within four weeks of vaccination. Patient received Adderall XR 40 mg twice per day within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW 0172), via an unspecified route of administration, administered in Right arm on 28Apr2021at 15:00 as single dose for covid-19 immunization. On 19May2021 at 08 PM, patient woke up during night freezing. Applied more blankets and fell back asleep. On 20May2021, woke in AM drenched in sweat, blankets wet and freezing. Able to sit up for about 2 hours total throughout day watching TV. Otherwise in bed, fatigued, muscle aches, feeling extremely cold and always waking drenched in sweat with wet blankets. On 21May2021, rarely leaving bed. Checked oral temp: 100.6 F. Seemingly constant cycle of waking freezing, drenched in sweat with wet blankets. Not showering, brushing teeth or hair, not taking prescription meds, not changing clothing or bedding. Last day of symptoms was on 03Jun2021. Patient tested for COVID-19 after vaccination. The patient underwent lab tests and procedures which included body temperature: 100.6 Fahrenheit in May2021 and SARS-COV-2 test/ Nasal Swab: negative on 25May2021. This case assessed as non-serious by reporter. Patient visited to doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The outcome of the events was reported as recovering.
1. Ringing in both ears. Note: I have had very mild tinnitus for the past 20 years that comes and goes, but after receiving the vaccine, the sound became louder and as of this writing it has not stopped in both ears since 11:15, 31 March, 2021 2. Fiery nerve pain thought my entire body that reached pain levels of 8-9 that I have not experienced since 2016. Note: I have been diagnosed with Immune-Mediated-Neuropathy since 2016.  Prior to the vaccine, I had pain levels 1-3, and only on parts of my body at times; mainly legs. However, about 45 minutes after the vaccine, my entire body lite up with fiery nerve pain thought my entire body.
Complained of generalized  warm and cold flash like  sensation, scratchy throat immediately 5 minutes after J&J vaccination. Symptoms resolved 30 minutes  after the event. Cleared by NP. No EMS needed at this time.
Narrative: Headache, NauseaVomiting, CHILLS, NAUSEA, WEAK, THROWN UP, LOSS OF VISION
This was an administration error.  Vaccine was given on 9/6/22 that had an expiration date of 8/31/22.
Bodyache; Light headed; Chills; Headache; Fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female 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 12May2021 at 15:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 14:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. On 13May2021 at 06:00, the patient experienced chills, headache, body ache, light headed, fever and nausea. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, headache, body ache, light headed, fever and nausea was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had mild fever 101 body aches and pains all over and difficulty sleeping as well as reported a very sore arm. Patient said symptoms lasted 24 hours before they subsided.
This is a spontaneous report from a contactable nurse. A female patient of an unspecified age and ethnicity received the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first injection of TRUMENBA on an unspecified date, reported as 3Oct, for immunization. Two months later, the patient got the second dose and got the rash at the site, 8-10 cm, little swelling, mild tenderness, no difficulty swallowing or breathing. Therapeutic measures were taken as a result of got rash at the site, 8-10 cm, little swelling, mild tenderness and included treatment with BENADRYL and applied BENADRYL cream. A couple of days later, the patient felt it was getting worse, came in, but MD said it didn't look worse. It had resolved. NP states that he did not intend for the patient to get the 3 dose series, she was only supposed to get doses at 0 and 6 months. The information on the batch number and expiration date have been requested.
I was on mensuration during time and have been bleeding and clotting ever since. Bleeding is still happening.  I have very regular periods. So this is very new to me .
Information has been received from a wife concerning her 47 year old husband who was vaccinated on 11/28/00. 5 minutes after the vaccination, the pt experienced hot and cold sweat, nausea, and was dizzy. The physician's  office also noted that the pt's blood pressure dropped. The wife states the the physician felt that the pt's experiences were related to the vaccination.
Sx onset 7/21 cough, runny nose, chills, muscle aches, sore throat, nasal congestion, headache, fatigue, loss of smell & loss of taste. Presented to provider for symptoms as well as post-surgical concerns and rectal bleeding. Tested positive on 7/23/21.
Patient was given a dose of Pfizer BioNTech that was past its beyond use date. No adverse reaction noted.
Near syncope episode after second vaccine administered.  Never lost vital signs or consciousness.  Recovered quickly with recumbent position.  Sent home after brief period of rest.
first ever non febrile seizure on 11/29/21 and second seizure, also without fever, on 12/9/21
Pericarditis, Rapid Atrial Fibrillation, Psoriasis
48h after injection developed diffuse itching.  Then developed red macules on lower back & hip.  Responding to oral steroids, but itching returns when off steroids.  Saw me 6/23/08-has F/U 7/11/08.  No rxn. at injection site.
Information has been received from a health professional concerning a child who was vaccinated with hep B vaccine recombinant (manuf unk). It was reported that the child is involved in a formula study and therefore has multiple liver enzymes drawn. One month into the study, serum aspartate aminotransferase test (SGOT)=47; four months into the study, SGOT=50, serum alanine aminotransferase test (SGPT)=31; twelve months into the study and six hours after hep B vaccine (manuf unk), SGOP=427, SGPT=534, 15 months into the study, SGOT=5 units higher than nomral, normal for this lab=0-45. Upon internal review, increased SGOT and SGPT was determined to be other important medical events (OMIC). No further info is available.
HAVING ISSUES SPEAKING; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 24 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100/101 F, CT scan (NR: not provided) No blood clots, and MRI (NR: not provided) No blood clots. On 21-MAY-2021, the subject experienced having issues speaking. The action taken with covid-19 vaccine  was not applicable. The outcome of the having issues speaking, fever and headache was not reported. This report was non-serious.
The patient arrived for his booster vaccination which was given at 3:40pm 2/25/22. 15 min. after vaccine administration pt c/o chest pain, radiating to his left arm, nausea and headache. Vitals HR-107, sat.O2 96, BP 160/100. Ambulance was called and arrived at 4pm. The patient was given aspirin 324 mg at 4.03 pm and nitroglycerin 1tb. at 4.15pm.  Patient has been taken to the ER.His wife and daughter are present. Patient reported that he had cardiac ablation done in November, 2021 and he had a lot of commorbidities. Vitals at 4.25pm BP 165/100, Sat.02 -98, HR -98.
mom states when pt awoke from PM nap had red spots on face, arms, legs, trunk of body;
Patient with PMH of depression and GERD who presented 1/8 with constipation, abdominal discomfort and worsening dyspnea. Symptoms began around 12/29. COVID vaccine 12/19. Previously quite active, marathon runner, gained some weight over last couple years but was still in good enough shape to complete 10K in New Orleans in early February. In late February, had a flu-like illness, as did one of his friends from church. 2020 was hard on him - weight gain, decreased activity, stress, overall deconditioning. No issues apart from sore arm after COVID vaccine 12/19 but then starting getting abdominal fullness/discomfort around 12/29, which steadily worsened, also develop worsening dyspnea on slight exertion. No known sick contacts.. Work-up notable for pericardial effusion, pleural effusions. Echo with severe diffuse LV hypokinesis, concern raised for myocarditis. COVID PCR negative, serology negative. RVP negative. . Concern raised that COVID vaccine may have played a role in myocarditis. He was found to have the following conditions Acute heart failure with reduced EF NYHA FC II,  non-ischemic cardiomyopathy. Myocarditis appears subacute per MRI hypertension obesity small pericardial effusion- asysmptomatic no pericarditis suspected obstructive sleep apnea.   .Started on the following medications. Continue Carvedilol 12.5mg BID, Farxiga 5mg daily, Digoxin 0.125mg daily, Entresto 97-103mg BID, and Spironolactone 25mg daily.   Per MD note.  While it remains uncertain, team is doubtful COVID vaccine played a role in his cardiac issues. Given the MRI findings are not acute, more likely that the cardiac insult occurred weeks to months ago - potentially in the setting of the February 2020 illness. Perhaps his "deconditioning" in 2020 was related to worsening cardiac function. Nevertheless, will hold on 2nd COVID vaccine dose given absence of a clear explanation for his myocarditis. conversation with team will continue to determine if candidate for second covid vaccine. If consensus is that myocarditis pre-dated vaccine, might be able to proceed with dose 2 of vaccine.
PT went to the ER with Flu symptoms 2 days after vaccine. Found to have elevated cardiac enzymes and mild leukocytosis. Admitted to cardiac icu for monitories with presumed myocarditis.
Approximately 2 hours after Pt was immunized mom noticed child spitting up alot, gagging on secretions, staring at mom. Lasted about 15 minutes. Child then breathing normally. No loss of consciousness. No jerking movements, No fever. Child seemed sleepy after this episode. No further symptoms over last 4 days. Child acting normally. At time of episode 911 called. Paramedics evaluated pt, no seizure, noted on exam vital signs were normal. Child not taken to Emergency Dept. Told no action needed by paramedics.
Musculoskeletal stiffness; Skin warm; Rash; Chills; Feeling hot; Disorientation; Limb discomfort; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Feeling hot), LIMB DISCOMFORT (Limb discomfort), DISORIENTATION (Disorientation), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness) and SKIN WARM (Skin warm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced LIMB DISCOMFORT (Limb discomfort). On 13-Mar-2021, the patient experienced FEELING HOT (Feeling hot), DISORIENTATION (Disorientation) and CHILLS (Chills). On 16-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), SKIN WARM (Skin warm) and RASH (Rash). At the time of the report, FEELING HOT (Feeling hot), LIMB DISCOMFORT (Limb discomfort), DISORIENTATION (Disorientation), MUSCULOSKELETAL STIFFNESS (Musculoskeletal stiffness), SKIN WARM (Skin warm), RASH (Rash) and CHILLS (Chills) outcome was unknown.            Treatment of the events included Benadryl total of 4 tablets and Claritin - 1 pill
fever; This case was reported by a consumer via (facebook) interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2021, less than a month after receiving Shingles vaccine, the patient experienced fever. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient just received dose of Shingles vaccine and experienced fever from the last three days. The patient was taking Tylenol as a treatment medication. The reporter wanted GlaxoSmithKline comment. The follow-up would not possible as no contact details were available.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: ew0150), on 23Apr2021 as dose 2, single (Lot number: ew0164) and on 27Aug2021 as dose 3 (booster), single (Lot number: FC3182) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Jul2022) Positive, notes: had a positive covid-19 test +9 days after finishing Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient developed covid-19 symptoms plus 9 days after finishing Paxlovid and had a positive covid-19 test plus 9 days after finishing Paxlovid.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
Had flare up of diverticulitis, had been dormant for over ten years, week of vaccination.  Went to urgent care, completed regime of Cipro and Flagyl antibiotics.  Second flare up  July 17, 2021, same treatment.
Reaction to redness and swelling-measure 41/2 cmx3cm. Low grade fever.
Developed small  bump, welt, redness at injection site the evening of the injection.  Removed bandaid and skin around the injection site sluffed off.  Was not sure if it was a reaction to the bandaid or reaction to the vaccine.  Arm was sore, red, warm for a couple days, it resolved.  Then  a week later was awakened  during the night  while sleeping by pain and tenderness in left arm where the vaccination was administered.  Reports  intense pain with sudden onset, along with  swelling, redness, arm was hot, tender and itchy.  Lasted for several days and continues to have mild discomfort today,  five days after onset of symptoms.   Has not seen a provider to evaluate.  Plans to get second dose of Moderna as scheduled.
MILD DISCOMFORT; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported.  The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced mild discomfort. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of mild discomfort was not reported. This report was non-serious.
Patient is a 88 y.o. female patient with history of DM2, HTN, DJD s/p THA 4/6/2023, Chronic back pain who presented to Hospital with syncope.  Found to be COVID-positive.  With adjustment of home medications and treatment of COVID patient symptoms improved.   Syncope Secondary to bradycardia and dehydration in setting of  COVID reportedly sinus pauses seen while in transport. Recent orthopedic surgery noted, poor intake. May also consider component of orthostasis.   EKG NSR 1 AVB on admisison CTPA neg for PE. Chronic incidental findings reviewed.  Head CT and CT cervical non-acute  NM Stress 9/2021 no evidence of ischemia.  Echo 9/2021 normal LV fn, EF~60%, mild to mod MR, TR Cardiology evaluated Patient had bradycardia while on lopressor and despite decreasing doses. Discussed with cardiology. Will discontinue BB as the only indication to be on Lopressor seems to be hypertension. HR 60 -65 after discontinuing BB No more episodes of syncope 30 day holter monitor on discharge, cardiolgoy office to arrange Cardiology signed off COVID 19 infection without pneumonia Covid-19 Virus Infection Date of onset of symptoms: 4/11/23 Symptoms present on admission: generalized weakness, nasuea, syncope Date of covid positive test: 4/12/23 Vaccination status: vaccinated Imaging: CT chest: no PE or infiltrates Oxygen requirements on admission: 3 L NC Current oxygen requirements: RA with sats >92% Medical therapy: remdesivir and steroids Consultants following: none Anticipated special isolation end date: 4/21/23   Post-op urinary retention  Foley was placed on admission. Removed 4/15   DM2 A1c 6.5 (3/2023) Admit glucose 218 Restart home regimen   HTN BP on higher side Continue home Norvasc increased to 10 mg today, stopped Toprol xl last dose 4/14 Started on lisinopril 4/14 given history of Diabetes.  Increased lisinopril to 40 mg on 4/16/23 PRN hydralazine   DJD S/p left THA 4/6/23 SCD's dvt ppx  Continue pain control    Chronic back pain  Hx of spinal cord stimulator  Continue home Oxycodone (NARx). Of note, pt with recent increase in dosing to cover for post-operative pain. Will restart post-op dosing schedule. Monitor for oversedation    Thyroid nodule  As noted on admit CT cervical  Recent TSH 1.167 (3/2023) Recommend non-emergent thyroid ultrasound
While Pt was sitting in the waiting area she began to has  partial upper body "seizure" also breathing problem that included tightness in her throat, husband alerted staff who then alerted EMS, upon arrival to the Pt she was saying under her breath "EPI" Pt quickly moved to the back of the tent to the EMS area where EPI .3 administered in the left thigh, lung sounds where having wheezes in both sides. within minutes she stated she felt much better. As we obtained Pt demographic she again stated her throat was feeling tight, second dose of EPI .3 given, within minutes it happened again a total of three EPI .3 given and 50mg of Benadryl given, ambulance arrived to transport.
Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 4 / Pfizer BioNTech Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 04Apr2021 as dose 2, single (Lot number: ER863S), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 55 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm and on 02Oct2022 as dose 5 (booster), single (Lot number: AS7165B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022, outcome "unknown", described as "Moderna Dose Number: 4 / Pfizer BioNTech Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2023) positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Aug2023 to 24Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300288007 same patient, different drug, different event;US-PFIZER INC-202300288090 same patient/ product, different dose/ event;