chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt off/really bad; Light-headed; Arm is sore; Vomiting; Running a temperature; slept all day/really fatigued/real tired; Off balance; She is worried about if this is how bad the first shot is; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: She had Covid before, and it feels like those symptoms all over again. The patient took concomitant medications. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt off/really bad"; DIZZINESS (non-serious), outcome "unknown", described as "Light-headed"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Running a temperature"; FATIGUE (non-serious), outcome "unknown", described as "slept all day/really fatigued/real tired"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance"; ANXIETY (non-serious), outcome "unknown", described as "She is worried about if this is how bad the first shot is". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient had her first Covid-19 shot on 20Apr2021 and this is day 3. The first day was really bad. Yesterday, she slept all day. Now, she woke up again this morning and was still not feeling right. She felt off, tired, and light-headed. The patient asked if all of this is normal and or is this something, she should be concerned about it. She mentioned she has heard so many people who took their first shot and had nothing but a sore arm. Her arm is sore. The first day, she had vomiting and was running a temperature. She had Covid before, and it felt like those symptoms all over again. Today was the beginning of day 3 and she was still feeling really fatigued, real tired, and off balance. She took blood thinners and high blood pressure medication daily. She was wondering if it was normal to go this long after the first shot. She was worried about if this is how bad the first shot is, what the second one will do to her. She just needed to know if this is normal. If it was normal she won't panic, she will just ride it out.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Gave wrong flu vaccine. Gave formula for under 65 and patient is over 65.  No adverse events as of this time
Rash (red spotty) on neck, chest, stomach; Nausea; Body Aches; Headache; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN 5318, Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 16Feb2021 13:00 (at the age of 31-year-old) as dose 2, single for COVID-19 immunisation at workplace clinic. Medical history included migraines, dairy allergy and egg whites allergy. intolerance from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. Concomitant medications received within 2 weeks of vaccination included ethinylestradiol, norgestimate (SPRINTEC); propranolol; escitalopram oxalate (LEXAPRO); famotidine (FAMOTIDIN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 26Jan2021 08:00 (at the age of 31-year-old) as single dose for COVID-19 immunisation. Patient previously took amoxicillin and experienced allergies. 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 COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 17Feb2021, patient experienced nausea, headache and body aches. On 18Feb2021, she had rash (red spotty) on neck, chest and stomach. Patient did not receive treatment in response to the events. Outcome of the event rash (red spotty) on neck, chest and stomach was not resolved and rest all the events were resolve don an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient's wife called to say patient was experiencing a low grade fever or 100.2 and his arm was red and inflamed at the injection site.
Severe pain in arm, couldn't move it; tiredness; muscle aches; no appetite; fever; joint pain; vomiting; chills, shaking, swelling at injection site; lasted 42 hrs.
Arm soreness, mild flu like symptoms:  fatigue, swollen neck glands, dull headache, weakness, muscle weakness
Symptoms: 2 days post second dose of Pfizer Vaccine Chest pain, nausea, tachycardia, and myocardial inflammation with elevated troponin and inflammatory markers  Treatment: Started ibuprofen 600mg Q6H and Colchicine loading dose followed by 0.6mg QD
sore arm; slight headache; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Stepmother) that an elderly female patient (not pregnant) received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection), dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 for covid-19 immunisation with no adverse reactions. It was unknown if other vaccine received in four weeks. During A Text Message Conversation on 26Feb2021, the Patient Wrote, "I Had No Adverse Reactions for the First and Second Shot. Just A Little Sore Arm and Slight Headache after the Second Shot." It was unknown if treatment received for the events. It was unknown if Covid Prior Vaccination an if Covid Tested Post Vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
FEVER OF 105 DEGREES AND SWELLING. FEVER GONE NEXT DAY. SWELLING A COUPLE OF DAYS.
Pt. was given "double" the dose for a Moderna Booster. Pt received .5mL instead of .25mL.
The patient had his vaccines for 6 months of age and H1N1 vaccine on 5/3/10. He started having fever and two episodes of febrile seizures in the early morning of 5/4/10 (within 24 hours). The patient was seen in ER at medical center on 5/4/10.
Initial solicited report received on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 20 year-old male subject with no significant medical history. The subject's concomitant medication was typhoid VI polysaccharide vaccine (TYPHOID VICPs) on 16 September 2016, influenza quadrival A-B vaccine (INFLUENZA INJECTABLE, QUADRAVALENT) on 16 September 2016, and anthrax vaccine (ANTHRAX) on 16 September 2016. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 19 September 2016. On 12 December 2016, 84 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. The lab data included on 22 September 2016 blood test was performed which showed troponin I normal, on 22 September 2016 ECG was performed which was abnormal, on 23 September 2016 Echocardiogram was normal, magnetic resonance imaging (MRI) (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The outcome of the event I30.9 acute pericarditis, unspecified was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to investigator: not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 20-year-old male who developed acute pericarditis 84 days after receiving a dose of ACAM2000 vaccine. Pericarditis is a listed adverse event that may occur within one month following vaccination with live vaccinia virus smallpox vaccines. He also received other vaccines including typhoid, influenza and anthrax vaccine on same day of ACAM2000 vaccination. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis or pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, sponsor assesses this event as not related to study vaccine.
Information has been received from a physician concerning a female with no known drug reactions/allergies who on an unspecified date was vaccinated with Pneumovax 23 single dose vaccine, injection. After receiving a single dose of Pneumovax 23, the patient developed "what looked like a bad case of cellulitis," and the arm where the dose was administered (unspecified) was very large and profound. A complete blood count revealed the patient's white cell count went "way up (results not provided)." Subsequently the patient was admitted to the hospital for an unspecified amount of time. On 13-NOV-2007 the physician received a telephone call saying the patient was "okay" and had been released. It was reported the patient had recovered. Additional information has been requested.
pt recv vax 15JAN97 & 27JAN97 pt body went rigid & turned white, eyes rolled back & stopped breathing for 30-45sec;pt adm to hosp for observation & EEG, pneumogram-both were nl;also ECG nl, CXR nl;
Narrative: On May 11, 2021 a historical ADR of influenza allergy was reported by Health Technician but no other detailed information was provided Unable to find influenza immunization record in the facility system
Narrative:  Patient tested positive for COVID-19 on 1/29 after receiving Dose #1 Moderna's COVID-19 vaccine on 1/14. She denied travel within 3 weeks, exposure to known COVID+ patient in the past 3 weeks, and no exposure to a group of people without wearing a facial covering.  Other Relevant Hx:  59 year old female received Moderna's COVID-19 vaccine dose #1 on 1/14/2021. She reported to the ED on 1/29 with chief complaint of2-3 day history of fever, chills, nausea, and body aches and was found to be COVID positive via Biofire. She was sent home with symptomatic relief and told to quarantine. She returned to the ED on 2/3 with complaints of fever, chills, cough, SOB, decreased appetite, myalgias, and n/v/d. She endorsed weakness due to decreased oral intake over the past week. She required supplemental oxygen to maintain adequate oxygen saturations and was requiring BIPAP by 2/4. Patient was started on dexamethasone and remdesivir therapy and Infectious Diseases service was consulted for management. Symptoms:  & COVID positive Treatment:  ,REMDESIVIR 100 MG EVERY DAY 200mg IV on D#1 then 100 mg IV Q24H on D#2-5
Patient developed sores after her first SHINGRIX injection (in the nostrils, ear, and one breast). This developed a few days after the injection. She states the sores crusted and healed over a period of a few weeks.
Local site reaction - erythematous and edematous at site of varicella vaccine.  Per pt report, onset of reaction was shortly after vaccine administration.  Pt presented to clinic 2 days after administration with an edematous and erythematous area around the injection site measuring 8.5 cm x 8.5 cm, with mild tenderness.  Per pt report, reaction has been improving - now with less edema, erythema, and tenderness than at onset.
The patient received the third/booster dose of BNT162b2; Soreness; Headache; Fever; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the arm on 03Nov2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration on an unknown date in Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN9581) via an unspecified route of administration on an unknown date in Feb2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 03Nov2021, the patient experienced headache, fever, fatigue and soreness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, fever, fatigue and soreness were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt 3 doses of vax 24OCT95, 28NOV95 & 7MAY96 & was found to be a nonresponder p/3rd dose;
died; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "died". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: Caller said he didn't get the vaccine but some of his family members did and he was wondering if he could have a refund for the COVID vaccine. He said they saved up from months to buy that vaccine and said he knew little (patient name withheld) died after took that shot.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died
Early period. Heavier flow than normal. Worse cramps than normal. Blood looked thicker and darker than usual.
Very fussy, temperature 103, 12 hours after receiving immunizations per mouth, cough, r/n started about 24 hours after immunizations.  Using Tylenol, pushing fluids.
This case was reported by a physician via call center representative and described the occurrence of rash in a 58-year-old male patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. Concomitant products included SHINGRIX. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, several days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left deltoid. Few days after receiving 2nd dose of SHINGRIX, the patient experienced a rash on left arm and across his abdomen.
I was feeling fatigued and for a couple of days and then started having chest pain and I used a cuff to take my blood pressure and it was quite high probably 185/98. So I took some homeopathic remedies that I would normally take and it gave a little bit of relief but the next day I had the same kind of symptoms and more concerned about the fact that I had chest pain. When I took my bp it was over 200 so I talked to a friend and told them I was going to get care. Got there in the evening and the Doctor called an ambulance. When the DR. took the bp at the clinic it was 235/118. So at the ER they had me in for several hours and gave me nitroglycerin patch and too me to observation and gave me oral medication (norovax and lisinopril).  They gave me a stress test but I couldn't complete it because my legs gave out. Was on oral medication for a week and took another stress test. When I follow-up with the Internalist he had me stop with the linsinopril and said that I can stop with norovax when my bp goes down and stays down. I've veen monitoring my bp and will followup with the Cardiologist.
Patient had rash and hives over entire body. Mostly on the extremities, face and ears. Some rash on trunk. Happened approximately 12 hours after vaccination. No fever reported. Seen at ER and give steroids then referred to allergist.
STROKE; BLINDNESS; This spontaneous report received from a consumer 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: Unk) dose, start therapy date were not reported for prophylactic vaccination.  No concomitant medications were reported. The batch number was not reported and has been requested On MAR-2021, the subject experienced stroke. On MAR-2021, the subject experienced blindness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blindness was not reported. The reporter did not report causality between covid-19 vaccine ad26.cov2.s and stroke ,blindness .Company causality between covid-19 vaccine ad26.cov2.s and stroke and blindness was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210331088-Covid-19 vaccine ad26.cov2.s-Stroke , Blindness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient reported headache, facial tingling and blurry vision within 20 minutes of receiving vaccine.
Injection site became reddened, hard, painful to touch. It continued to worsen over the course of a week & my entire upper arm area was reddened & swollen.
Several little blisters on shoulders, believed to be herpes zoster.  Had varicella vaccine on 6/1/99.
Dizziness, dehydration, nausea, severe back pain  after 2 more days diagnosed kidney stone removed surgically,  Then blackout, fall  and concussion.  Lingering brain fog and tinnitus increased
The patient is a 32-year-old, gravida 3, para 1, AB1 with intrauterine pregnancy at 39 weeks and 2 days, who presents to Labor and Delivery for scheduled repeat C- section secondary to previous C-section x1 declining VBAC.  The patient's pregnancy has been without significant complications.  She did recently have a growth ultrasound secondary to history of IUGR, but the ultrasound was within normal limits.  She is COVID vaccinated, however, she tested positive for COVID on 01/20, so she has passed her 5 days, but will still need to be in isolation until after day 10 while she is in the hospital.  She has had good prenatal care with me since the first trimester with good followup care.
Unknown for certain of this is a direct cause from the vaccine but I thought I would report because of how close it was to the date of vaccination. Maybe it can be correlated with other individuals with the same effects. I began having sudden vision loss (blurred vision) on Feb 10th and has only gotten worse since.
Vaccination was not done in the deltoid.  It was done lower on the upper arm.  Client came back to clinic to show PHN. Client has ben contacted by EMS.
Itchy red rash 2 inches below injection site. Improved over 2 days.
Janssen COVID-19 Vaccine EUA  I first had a very bad headache in the back of my head and then my entire body starting aching. I had a slight fever in the middle of the night and also woke up with a very sore arm.
pt recvd flu vax & the following day, pt devel pain, erythema, & warmth @ the inject site;
Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before.   Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED  BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL.
patient c/o shortness of breath and dizziness. Started at 2:05PM, Dr. was notified and evaluated patient  Vitals: 100/72mm hg  Pulse:  82  SPo2: 98% DX: Vasovagal syncope Monitored patient symptoms for 30 minutes patient was stable and was release home
Blood in urine; chills; Fever; Nauseous; Aching; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (Fever), NAUSEA (Nauseous), MYALGIA (Aching) and HAEMATURIA (Blood in urine) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stones (Patient has kidney stones in his left kidney.).   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 01-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (Fever), NAUSEA (Nauseous) and MYALGIA (Aching). On 02-Mar-2021, the patient experienced HAEMATURIA (Blood in urine). On 01-Mar-2021, CHILLS (chills), PYREXIA (Fever) and MYALGIA (Aching) had resolved. At the time of the report, NAUSEA (Nauseous) and HAEMATURIA (Blood in urine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication was reported blood pressure and cholesterol medicine. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Mar-2021: No specific follow-up information recorded.
Moderna COVID-19 Vaccine EUA, felt fine earlier in the day but in the evening I had a headache, nausea, fatigue and heart palpitations that made it hard to breathe. Also didn't lose my full smell or taste but things tasted off and weird. Everything kind of tasted bland but by morning that was gone. Still having heart palpitations today and hot flashes and a headace
Information has been received from a registered nurse concerning a 67 year old female with lipidaemia, breast cancer, lumbar disc disease and osteopenia who was vaccinated SQ with a second or third 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (Lot# 659199/1541U). Concomitant therapy included BONIVA. On 19-APR-2008, the patient experienced cellulitis. She was treated with an unspecified antibiotic on 21-APR-2008. No laboratory diagnostic studies were performed. At the time of this report, the patient was recovering. The reporter is requesting a lot check for the brand new vial of pneumococcal 23v polysaccharide vaccine (Lot # 659199/1541U) that she just opened. No product quality complaint was involved. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of three reports from the same source. Additional information has been requested.