chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COULDN'T SLEEP LAST NIGHT IN SO MUCH DISCOMFORT; DREAMING I WAS IN PAIN; FOGGY; SLIGHT COTTON MOUTH; HANG OVER; FLU; MY JOINTS FEEL LIKE I AM 80 YEARS OLD; CHILLS; POUNDING HEADACHE; FEVER; NAUSEATED; This spontaneous report received from a patient concerned a male 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) dose, start therapy date were not reported 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 MAR-2021, the subject experienced difficulty sleeping. On MAR-2021, the subject experienced dreaming abnormal. On MAR-2021, the subject experienced foggy. On MAR-2021, the subject experienced slight cotton mouth. On MAR-2021, the subject experienced hang over. On MAR-2021, the subject experienced flu. On MAR-2021, the subject experienced my joints feel like i am 80 years old. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced pounding headache. On MAR-2021, the subject experienced fever. On MAR-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pounding headache, chills, fever, difficulty sleeping, dreaming abnormal, foggy, nauseated, slight cotton mouth, hang over, flu and my joints feel like i am 80 years old was not reported. This report was non-serious.
10/31/21: This is a 78-year-old female with history of chronic hypoxia, heart failure with preserved ejection fraction, interstitial lung disease, aortic stenosis,, paroxysmal atrial fibrillation on chronic anticoagulation with Eliquis, chronic kidney disease stage 3, severe pulmonary hypertension, hyperlipidemia and obesity who presented with worsening dyspnea. Patient states that she has been having worsening shortness of breath for the past few days. She gets short of breath upon taking few steps. She also has dry cough. She denies associated fever, chills, chest pain, abdominal pain, nausea, diaphoresis or dizziness. Patient was recently admitted on 09/27/2021 and was discharged on 10/18/2021. Patient was admitted for acute on chronic hypoxic respiratory failure, acute exacerbation of heart failure, bilateral pneumonia and interstitial lung disease with exacerbation.   In the emergency department, patient was hypoxic and was put on 15 L of O2 and then was down to 5 L of O2 via nasal cannula. Chest x-ray showed slightly worse scattered areas of linear atelectasis with interstitial lung disease. Patient was given a dose of IV Lasix, Solu-Medrol and nebulizer treatment.  11/15/21: -Patient is a 78 yo female with  medical history of chronic respiratory failure on home oxygen , ILD , paroxysmal afib on eliquis, HFpEF, Severe Pulmonary HTN, Moderate to severe aortic stenosis, HTN, Rectal -Bleeding, known hemorrhoidal bleeds.  -She was managed for COVID pneumonia (+) 10/31. She is COVID vaccinated. Remdesivir not given due to renal function. Was on Decadron and s/p Actemra. She is back to her baseline oxygen of 5L  -Admission complicated by CHF exacerbation,  hemorrhoidal bleeds and constipation that is currently resolved  -She also had AKI from diarrhoea 2/2 laxatives and IV diuresis for CHF which  improved with gentle hydration  -She has been cleared by pulmonary for discharge  -She is discharged on steroid taper  -She will follow up with pulmonology as outpatient  -Discharged on home  PO lasix 20 daily for her CHF
Itching and bumps started half an hour after injection.  They lasted for about 18 hours and were all over.  Started with left side of my neck then right leg, stomach, back and both arms
The patient received the H1N1 flu vaccine IM shot at 9 AM and started experiencing headache, dizziness, worsened cough, low grade temps.
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 09:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient had no other relevant medical history and no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included estradiol (MANUFACTURER UNKNOWN) for unknown indication from unknown date and unknown if ongoing. The patient had received other vaccines within four weeks prior to the vaccination that included second dose of varicella zoster vaccine (MANUFACTURER UNKNOWN) on 19Feb2021 for shingles vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 12Mar2021 at 06:00 the patient experienced tinnitus. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Scleroderma, Autoimmune disorder and UTI. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), FAMOTIDINE and PILOCARPINE for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, 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 experienced URINARY TRACT INFECTION (UTI). The patient was treated with NITROFURANTOIN (NITROFURANTOIN MONO/MACRO) for UTI, at a dose of 100 mg. At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown.            It was reported that the patient had autoimmune disorder . It was reported that the UTI was not associated with the vaccine, there was another cause as per reporter, UTI was started a week ago.
Started as a pin size red area and progressed to a 4 cm x 4 cm as of 3/1/16.
It?s had been two weeks and I noticed that a very large hive was present at the site of the vac
Today, 2/17/2021, a small rash around the I head toon site area appeared.  No sorry was must red rash.
The patient stated that she felt dizzy. She laid down. The nurse attended her and took her vitals. BP 112/85, O2 =99, HR=87.  The patient state that she was ok.
minor bloody nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 20-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 24Apr2021 12:45 (at the age of 20 years old) as dose 2, single dose for covid-19 immunization. No covid prior vaccination. The patient's medical history included anxiety from an unknown date and unknown if ongoing. No other vaccine in four weeks. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; batch or lot number was not reported) via an unspecified route of administration, administered in left arm on 03Apr2021 at 12:45 (at the age of 20 years old) as dose 1, single dose for covid-19 immunization. On 24Apr2021 20:15, The patient experienced minor bloody nose. Patient not tested for covid post vaccination. No treatment received for the adverse events. The outcome of the event was recovered on unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 months old female patient who was given 0.5 ml instead 0.25 ml, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Nov-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U5028AB, expiry date- 30-Jun-2019 via unknown route in right thigh. It was a case of actual medication error due to overdose. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had an asthmas exacerbation that is continuing. Since it's gotten worse, I had a shot of FASENRA, that was supposed to work right away. I am on a steroid inhaler that was prescribed as well. I have a cough and have allergic asthma. For about 10 days I did not have a voice, it's just come back. This was caused by the coughing, it's the main symptom.
Hives on ankles, (R) flank, waistline broke out 7/21/14 treating hydroxyzine and triamcinolone.
pt received his covid vaccine and then watched his sibling getting theirs approximately 5 mins after receiving his. pt complained of feeling dizzy and fell, hitting his head onto the vaccination room's door. he then complained of feeling hot after the fall and wanted to take off his jacket. we gave an iced pack to apply on his head. pt waited in the store for 30 mins after the incident. pt stated feeling ok after waiting in store and left after confirmation that he was ok.
Called HD at approx 3:20 pm and states that she had itching at injection site shortly after injection. States that she now has a rash and itching extending down both arms; worse on the left arm. Denies any other symptoms
This spontaneous report as received from a certificate medical assistant refers to an 8 week old patient. On 12-DEC-2013 the patient was vaccinated with the first dose of oral ROTATEQ (lot # unspecified) (dosage information and routed unspecified). On approximately 12-DEC-2013, the patient experienced vomiting immediately after vaccination. It was unknown if the patient had sought medical attention. The outcome of vomiting was unknown. The relatedness between the therapy and the event was unspecified. This is one of several reports received from the same source. Additional information has been requested.
Pressure built up in his lungs; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, after 11 days the patient experienced pressure built up in his lungs when started exercise and it decreased when stopped, but continued to happen every time during exercise. The outcome of the event was unknown.  Information about batch/lot number requested.
The night after receiving the vaccine (approximately 17 hours post-dose), I got up to use the restroom.  While washing my hands I became extremely dizzy, hot and nauseous.  While bending over to open the toilet (so that I could vomit) I ended up passing out.  I woke up on the floor of my bathroom (with my head against the wall), somewhat disoriented, shortly thereafter (exact timeframe that I was "down" is unknown).  I tried to get up and get back to bed but became extremely dizzy and hot again - this time bringing myself back down to the floor.  I laid there for an unknown amount of time before feeling like I could try to move again.  Once I felt a little better I crawled back to bed and laid down.  I believe I was out of bed for a total of 15-20 minutes.  I had no further dizzy/hot/nauseous episodes after that, however for the remainder of that day I felt exhausted, had a mild headache and felt like I couldn't get warm.  I did not take my temperature.  At about the 48-hr mark post-vaccination I was feeling back to normal other than a slight headache.
@ 10" after adm. of H1N1 vax, Pt c/o dizziness inplacement foot, difficulty moving LE. Taken by paramedics to ER.
Patient had history of COVID infection while in India spring of 2021.  On 10/11/21 he received his 2nd dose of Pfizer COVID vaccine. On 10/16/21 he began to experience tingling/numbness down entire right side of his body including the right side of his tongue. He sought medical care several days later for this issue. Initial MRI read as negative for stroke, but repeat imaging and review of original MRI concerning for thalamic infarct. Initial evaluation in the hospital with concern for possible ADEM, but subsequently determined to have stroke related to his underlying risk factors (DM, hpl, htn).  Most likely unrelated to his recent receipt of Pfizer COVID vaccine, but given the close proximity to onset of stroke, I am reporting.
3-inch diameter redness around injection site with itching.  3-inch long irregular redness  on arm toward the body from injection site near underarm with slight pain when touched.   Slight pain in underarm near redness when touched.
Pain in the arm; Pain in left side of the pelvis area; Pain in the hips joints and left side of pelvis area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PELVIC PAIN (Pain in left side of the pelvis area) and ARTHRALGIA (Pain in the hips joints and left side of pelvis area) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in the arm), PELVIC PAIN (Pain in left side of the pelvis area) and ARTHRALGIA (Pain in the hips joints and left side of pelvis area). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) had resolved and PELVIC PAIN (Pain in left side of the pelvis area) and ARTHRALGIA (Pain in the hips joints and left side of pelvis area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Extreme fatigue, headache, shivering/chills, night sweats, and muscle aches/soreness especially back and legs. Some joint pain in hips and ankles.  These started the next morning after vaccination. The next day I had several nightmares. And started to have a stabbing pain that I could feel in my chest and the same location in my back (like someone stabbing me from my back through to my chest)
Patient reported. Reaction to PREVNAR. Arm got itchy and then upper arm got red.
rt arm became sore p/inject 28JAN95; then it became red, warm to touch & swollen; since 29JAN95, the red area has inc, down to elbow internally;
Patient received a FLUZONE HD vaccine when it is indicated for patients over the age of 65. No adverse effect or symptoms reported. No treatment necessary.
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses include pneumonia due to covid19 virus, abnormal pulse oximetry
warm at injection site; itchy at injection site; right upper arm red spot 8 by 9 cm; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (right upper arm red spot 8 by 9 cm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), EMPAGLIFLOZIN (JARDIANCE), METFORMIN, LOVASTATIN, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and QUINAPRIL for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (right upper arm red spot 8 by 9 cm). At the time of the report, VACCINATION SITE WARMTH (warm at injection site), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE ERYTHEMA (right upper arm red spot 8 by 9 cm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.
Patient fully vaccinated (Janssen), but not boosted, admitted to the hospital on 1/11/2022 with COVID-19 and associated viral gastroenteritis. Patient was discharged on 1/12/2022.
Red Rash all over body, starting with arms and moving to other areas. Very pruritic. CLARITIN, then BENADRYL at bedtime. 10/11/16 still had some itching, but not as much.
About 30 hours after receiving the first dose, I developed a large white "floater" in my right eye.  Over the course of the next few days more developed.  Ending up with about 4 or 5 in one eye.  Visit to ophthalmologist  about 2 days later resulted in being referred to a Retinal Specialist.  Numerous eye tests and scans were done to determine how many and size of floaters.  Dr. determined we  would watch them for a couple of months to see if they slowly broke up and went away.  They did not  and after a period of 4 months surgery was performed to remove them, since they were impeding my vision and causing severe headaches.
Pt hospitalized with acute myocarditis. Per review of outpatient medical records, sinus tachycardia, chest pain, hypoxia are added. Discharge summary states fever, hypotension, hoarseness, myopathy, respirtory failure, atrial fib. msv
6/10 had a sudden spell of heat/sweating/dizziness in my home, after running an errand in high heat. Beginning 6/15 through present,  I have tingling/numbness in my right arm+hand.
Red blisters on right breast tissue and nipple. Severe {burning} feeling  chills.
A red rash like area, size of my palm, around the injection site. Feels slightly tender and tingly. It may have developed sooner but I only noticed it today after showering.
Fever, muscle aches and exhaustion.  Felt like full blown flu.  Lasted for about 32 hours. Fever and aches managed with Tylenol.  It started on Friday evening, I felt fine when I got up on Sunday morning.
Information has been received from a physician concerning a pt (age and gender not reported) with unk medical history and unk allergies who in approx Dec 2004 (winter 2004) was vaccinated IM in the arm with pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed severe vaccine (lot unk). Subsequently, the pt developed severe local injection site reactions in the same arm the injection was given but below the actual site of injection. It was reported that the pt recovered on an unk date. The pt sought unspecified medical attention. There was no product quality complaint involved. No additional information is expected.
Felt a little dizzy right after shot, but that went away after a few minutes. About an hour later, headache and nausea started along with really sore arm.
Upper left arm redness swelling 4 inches by 6 inches warm to touch since 10 hrs ago.
This spontaneous report as received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored LIQUID PEDVAXHIB (lot # L033690 and expiry date 14-JUN-2018) (dosing details unspecified) (also reported nurse was unsure of which vaccine was administered). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 64.9F. Time frame: 4 hours and 19 minutes. Previous temperature excursion: No. Data logger: Yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Tested positive for COVID after two doses of Pfizer vaccine; Tested positive for COVID after two doses of Pfizer vaccine; difficulty breathing; cough; The highest my fever got was 100.2.; tightness in my chest; This is a spontaneous report from a contactable consumer or other non hcp (patient)  providing investigation results. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8737) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection; Batch/Lot Number: ER8733) via an unspecified route of administration on 29Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient tested positive for covid after two doses of Pfizer vaccine and difficulty breathing and on unspecified date in 2021, patient experienced tightness in my chest that went on for a long time and on 31Aug2021, patient experienced cough and the highest fever was 100.2. The patient underwent lab tests and procedures which included fever: 100.2 on Tuesday 31Aug2021 and temp normal on Thursday 02Sep2021 and tested positive for COVID on unspecified date in 2021. Therapeutic measures were taken as a result of tightness in my chest, cough, the highest my fever got was 100.2 and difficulty breathing. Patient staying at home and treating symptoms per doctor's instructions and isolating for 10 days from first noted symptoms. Have not gone to the hospital and doctor recommended not going to the hospital unless patient have difficulty breathing. Patient was very happy that patient was vaccinated and very happy it's Pfizer's. As patient thought all along. The reason for patient got the vaccine is not to keep from getting Covid but dying from it. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
sore at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number G2ZF2, expiry date unknown) for prophylaxis.   On 8th October 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix on left arm. The patient experienced injection site reaction, the injection was sore. Consent to follow up was provided.