chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BURNING PAIN LOWER LEGS AND FEET; This spontaneous report received from a patient via a company representative via social media and concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (hospitalized for a serious case of covid-19 in JAN-2021). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced burning pain lower legs and feet (dose number in series 1). Laboratory data (dates unspecified) included: Cholesterol Raised (2-3 weeks later). The reporter stated "I had J&J vax and booster, first vax was burning pain lower legs, feet, raised cholesterol levels 2-3 weeks later (all after hospitalized for a serious case of covid jan 2021 before vax availability)" The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of burning pain lower legs and feet was not reported. This report was non-serious.
EXTREME NAUSEA ABOUT 1-2 HOURS AFTER THE SHOT WAS ADMINISTERED; This spontaneous report received from a patient concerned a male of unspecified age. 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: 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 patient experienced extreme nausea about 1-2 hours after the shot was administered. The action taken with covid-19 vaccine was not applicable. The outcome of extreme nausea about 1-2 hours after the shot was administered was not reported. This report was non-serious.
The child has developed urticaria around 3/17/16 of unclear etiology, still going into April.  Seems to be heading toward chronic urticaria.  Possibly an immune reaction triggered by immunizations?
pulmonary fibrosis resulting in death; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GJ2524) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. Vaccination history included: Covid-19 vaccine (Primary immunization completed, manufacturer unknown ), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 3 (BOOSTER), Unknown Manufacturer), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 4 (BOOSTER), Unknown Manufacturer), for COVID-19 IMMUNIZATION. The following information was reported: PULMONARY FIBROSIS (death, hospitalization) with onset Oct2022, outcome "fatal", described as "pulmonary fibrosis resulting in death". The event "pulmonary fibrosis resulting in death" required emergency room visit. The patient date of death was Oct2022. Reported cause of death: "pulmonary fibrosis resulting in death". It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the limited information provided in this case, a contributory role of the suspect product BNT162b2 (COMIRNATY) to the reported event of Pulmonary Fibrosis cannot be excluded. There is very limited information provided in this report. Case will be reassessed upon receipt of additional information.; Reported Cause(s) of Death: pulmonary fibrosis resulting in death
Woke up with chills, fever~100 degrees, aches, just feeling sick. Symptoms gone by late afternoon on same day.
Dizziness since receiving vaccine-as of today-4 days of dizziness. L arm with redness, edema and warmth. L arm tender and "feels heavy". Nausea. No treatment recommended.
Pt recvd TD & MMR vax for admission to college; pt counseled by nurse re: pregnancy & risk;  pt counseled postpone pregnany x 3 months; pt called 1JUL94 stated preg test pos;
Varicella-like rash that developed by 4-10-04. Pt. received acyclovir 800 mg 5/day x 10 days as well as pain medications.  Pt. had a good outcome.
Left arm red, swollen. Complaint of pain. Reported to clinic and Rx given for Eludel BID and Benadryl. Follow up on 3/16/04 by medical clinic. Patient doing better. Follow up on 3/18. Site clear and patient ok.
Lump on her arm It is still there and it is swollen; It itches and she has been scratching it; Caller stated it is hard and where they stuck the needle is swollen; Sore: Her arm has felt sore since Thursday 22APR2021; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number ERFWO171, Expiration Date: was not reported) via an unspecified route of administration on 21Apr2021 at around 07:00 in the morning (at the age of 64-year-old) in upper right arm as dose 2, single for covid-19 immunization. Medical history included dialysis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number E7R8737, Expiration Date: was not reported) via an unspecified route of administration on 31Mar2021 (at the age of 64-year-old) in upper right arm as dose 1, single for covid-19 immunization. The patient did not receive any prior vaccination within four weeks. The patient was not having family medical history related to adverse events. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. It was reported that the patient received her second dose of vaccine, and she had a slight lump on her arm in morning and was still there and it was swollen. The patient stated, people at dialysis still felt it on her arm. It was hard and where they stuck the needle was swollen. She clarified it was the upper right arm because she cannot be stuck on the left arm since it was her dialysis arm. The patient stated it itches and she had been scratching it. As treatment she had been using an over-the-counter steroid, hydrocortisone cream on her arm. Her arm had felt sore in morning since Thursday (22Apr2021) and was still sore. The patient stated it may be from her scratching she does not know. She got the second shot on Wednesday and that last week Thursday, Friday, Saturday, and Sunday it had been sore and swollen. The second dose of vaccine caused the lump on her arm and the soreness she felt. She just kept a warm cloth and heating pad on her arm. The adverse events did not result in emergency room or physician office visit. The outcome of all the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Confusion, Fever, SkinRash, Rash, Diarrhea, NauseaVomiting, HYPERtension, SWOLLEN TONGUE W/RASH; HIGH SED RATE
Legs very weak, fever, shivers, nausea, diarrhea. Started at 3 pm lasted until midnight
Pt received ZOSTAVAX vaccination on 8/2/11 at 230pm. She developed a lesion on 8/4/11, above rt. breast. 2nd lesion appeared under rt. arm on 8/5/11. Pt saw MD evening of 8/5/11 & was prescribed acyclovir 800mg, 1 5x/day x 7 days.
Felt tired with sore arm and H/A on  Saturday AM then started vomiting @ 1630 on Sunday then diarrhea @ 2000. Has increased fluid intake per her husband who is a nurse
Narrative: 67 year-old male patient with PMH HTN presented to ER with severe shoulder pain radiating to the back on 6/15/2021. He was diagnosed with NSTEMI and treated. Patient's diagnosis was within 6 weeks of his COVID-19 Janssen vaccine. Information is limited as patient was hospitalized outside of our health system. Per PCP profes notes, patient developed hypotension and MI from COVID-19-VACCINE
Shooting pain from injection area; The pain goes down my left arm and across my chest and into my neck.; The pain goes down my left arm and across my chess and into my neck; The pain goes down my left arm and across my chess and into my neck; The pain also goes behind the shoulder; I can not lift my arm or carrying anything in my left hand; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, chronic myeloid leukaemia from an unknown date and unknown if ongoing, bronchopulmonary aspergillosis allergic from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient took other medications within 2 weeks prior vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EZ6199), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 02:30 PM (at the age of 57-year-old) as dose 1, single for covid-19 immunisation within four weeks from dose 2. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 07:00, the patient experienced shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder, can not lift arm or carrying anything in left hand. It is a constant pain patient can't get rid of. Patient had tired heating pad, massages and acupuncture. Therapeutic measures were taken as a result of shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder included aleve twice a day for the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were not recovered.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
I started having gastrointestinal issues. I went to see Dr.  after a week of taking Pepto-Bismol, antacid tablets and loperamide hydrochloride. He prescribed pantoprazole sodium 40 mg. After 2 weeks of using the medication, my problem didn't go away. After that I went to see Dr. he prescribed famotidine. I went back a third time and saw Dr. He ran some blood work and he told me to discontinue taking the famotidine and continue with pantoprazole. He told me that if it continues that he would refer me to a GI specialist. After a couple weeks, I was referred to a GI specialist. I am seeing Dr. I went and saw Dr. and he suggested an endoscopy. I had one done on 06/04/2021. He said it looked like there is an ulcer, but it did not perforate the stomach and he said that I have H-pylori. I had a follow-up appointment on 06/17 where Dr. prescribed me to take amoxicillin, omeprazole and clarithromycin. As of today, with the antibiotics it's causing me to have diarrhea several times a day. I am eating a lot of vegetables, fruits and only pork or beef. If I eat any fried foods or meat, it causes me to have black stools with blood in it. The doctor told me that it was my upper intestines that are affected. Dr. did advise me to not take my pravastatin while I'm taking my antibiotics. I was advised by all of the doctors to stop taking the ibuprofen and naproxen and switch to Tylenol. I am scheduled for a colonoscopy 07/19.
Tenderness at site immediately, and persists to this day.  Then shoulder joint pain developed in 9/21, with popping and feels unstable.  Neck popping then developed.
Pharmacy came to worksite on 10/3/19 and gave flu shots to employees. I received Fluarix QIV PFS 2019-2020 Injection 0.5 ML. To date, 10/31/19, having burning, numbness, tingling, muscle & joint pain in upper left arm where injection was given. Arm is "shaky" at times and writing is difficult.
HYPOTENSION 1/18/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Incorrect dose administered. A non serious spontaneous report of dosing error (gave half of the vaccine) was received from a RN concerning a four-year old male patient. The patient has no relevant medical history. The patient was not taking any medications at the time of the event. The reporter did not remember removing the clip from the FLUMIST pre filled syringe and thinks that the only one-half dose of the vaccine was given, three times total, to a family that included a mother and her two sons. Upon follow-up, the reporter confirmed that there was no adverse event associated and the event is considered resolved. This case is submitted in accordance with post marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Additional information was obtained on 30-Oct-2008 and incorporated into the narrative: Confirmation from the reporter that no adverse evens occurred from the dosing error gave half of the vaccine.
29AUG91 mom called & said pt c/o mild to severe h/a, that continued today, holds head, screams until APAP takes effect; Advised to see pvt MD; MD found no cause for h/a;
Wet cough in chest that occurred for several days. Sinus drainage with cough. Low grade fever that never exceeded 100.  After 4 or 5 days went to Urgent Care. Had evaluation and chest X-Ray.
Large rash (few cm) started on day 10 of the vaccine administration, woke up to it being red and itchy. It was slightly raised. Over the days the rash faded away and the itchiness faded.
attended a covid booster clinic at her employer and received the Pfizer vaccine but her initial 2 doses were Moderna.
Received expired vaccine beyond 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond 12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Patient fainted 15 minutes after vaccination. EMS evaluated, determined she had low blood pressure, and gave her water. Patient's mother drove her home.  6/1/21: 11:56am - TC to parent. Spoke to mom. Child doing well - no fever. Requesting if child can lay down for second shot -  Mom made aware to let staff know for the next scheduled vaccine. No other concerns expressed.
After vaccination, at 10pm I started feeling flu like symptoms, fever chills shakes feeling miserable and this lasted 3 days straight, I also had diarrhea, nausea and vomiting. I woke up with a swollen juggler vein that ended up being a blood clot, 10 days later my arm was swollen up twice the size of my leg, the juggler was still swollen. I call the urgent care nurse they said to go to ER. I went to hospital got a CAT scan and ultrasound, I was given a shot of warfarin that was supposed to last for 12 hours. I went home and the next morning instead of going to the hospital, I went to hospital and they found 2 blood clots in brain, arm and leg and neck. I have had no history of blood clots and this all happened after the J&J vaccine. They did a procedure where they tried to put a balloon to relieve the pressure. The blood clots in the brain cannot be removed because of their location and it would be dangerous to remove and I am on blood thinners for the rest of my life. Multiple blood clots in body brain, arm and shoulder.
Pt. experience swelling at arm, experience nausea, chills, and pain on arm. (left) at the night after receiving vaccination pt. received Pneumovax 23 on left arm
This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
24° after shot ~2" round/raised/red/swollen/itchy area away from injection site. 48° after shot - same area but now larger/redder ~2"x4"
Client's mom called, her daughter developed fever 102F, swelling on injected site at night on 05-20-2008, fever not dropped down with 2# advil,suggest to see p.m.d  if get worse, 05-21-2008 , called pt. for detail information as I was with client at time, couldn't reach, left message, Dr informed about.
July 2/2021 Lower back pain, tendinitis July 16/2021 Multiple stiff joints, elevated sedimentation range. July 23/2021 Acute pain of right knee, Arthralgia, strain of right knee. July 26/2021 Elevated sedimentation range. August 25/2021 Leg pain left, Cervical radiculopathy. October 29/2021 Multiple joint pain, Autoinmune disease, Rheumatoid Arthritis
1 day later I expirenced dizziness and nausea. 3 days  I was weak and very dizzy with nausea. I went to the dr 2 weeks later and I was prescribed motion sickness pills and pills for nausea.  It's been 3 weeks and I still feel like this
BLACK SPOT INSIDE THE LEFT SIDE OF THE CHEEK (INSIDE); This spontaneous report received from a patient concerned a 50 year old female. 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: 043A21A, and batch number: 043A21A expiry: /6/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced black spot inside the cheek. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from black spot inside the cheek. This report was non-serious.
Fever; body ache; headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 31Mar2021 at 08:45 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to food, medications, or other products. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021, the patient experienced fever, body ache and headache. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of fever, body ache and headache was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Nausea; Diarrhea; Mild headache; This is a spontaneous report from a contactable consumer (patient herself).  This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 30Dec2020 at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included sertraline, levothyroxine and furosemide. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. Age at vaccination was 81-year-old. No other vaccine was received in four weeks. On 01Jan2021 at 12:00 AM, the patient had nausea, diarrhea and mild headache. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
The day after recieving the shot I woke up with chills, Ache , fever. Temp. was 101.0, took tylenol. The next morning I felt a heaviness in my chest. Patient continue to experience aches, chills and fever.
1140 Pt. c/o severe body heat and red spots to arms while sitting in Covid monitoring area; is less than 10 minutes post 2nd dose of Pfizer vaccine - Lot #ER8733. 1142 Escorted to monitoring cot into semi reclined position. Is alert, no SOB, with continued body heat and redness to arm / chest. Vitals 158/90, P 76, O2 sat 99%. 1147 EMS called to site. 1148 Benadryl 50 mg IM right deltoid given. 1152 Vitals B/P 122/74, P 79, O2 Sat 99%. Remains alert with c/o of throat soreness. 1154 Pt. voiced feeling better with decrease in body heat with noted decrease in arm / chest redness; EMS arrives and pt. assessed. 1200 Pt. declines EMS transport to hospital; voiced will monitor self at home. 1205 Pt. sitting on side of cot with no SOB / lung wheeze. Noted throat soreness & body heat back to normal; slight redness to arms / chest - much improved. 1210 O2 sat 99%, P 74, BP 132/76. At time provided instructions to monitor self and alert 911 if s/s return. 1210 Ambulated with no difficulty with noted drowsiness / HA. 1217 Provided education to friends who will drive pt. home and monitor. Ambulated to car with 3 friends with no c/o for f/u