chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; diarrhea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of diarrhoea (received 1st dose on an unknown date and experienced fever, headache, malaise, refer case id US2019230529).   On 6th December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than 2 weeks after receiving Shingrix, the patient experienced fever, vomiting and diarrhea. The patient was treated with paracetamol (Tylenol) and electrolytes nos + glucose (Pedialyte). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the fever, vomiting and diarrhea to be related to Shingrix.  Additional details were received as follows: The patient received second dose of Shingrix, and experienced fever and diarrhea which has lasted for several weeks as well as vomiting that lasted for about 2 days. The patient used tylenol and pedialyte to treat her symptoms. The patient consented to follow up.
Patient received the flu vaccine at approximately 12:19PM. Stayed seated in the vaccination area for a while to recover. Patient fainted and hit the back of his head on a shelf in store aisle when getting up to go home at 12:30PM. Pharmacy and store staff did initial evaluation and paramedics came and fully checked patient for signs of a concussion as well as need for stitches or other medical treatment.
Morning after getting FLUZONE, developed fever, sore throat, congestion, body aches, dizziness.
Information has been received from a pharmacist concerning a 66 year old female who on 09/15/03 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (manufacturer unknown). The pharmacist reported that on 09/15/03, after being vaccinated, the pt felt "clammy" and developed an increased heart rate. Unspecified medical attention was sought. At the time of this report, the outcome was unknown.  Additional information has been requested.
11/29/2021 vaccination. 05/22/2022 I felt 'off', fatigued. As the day went on, I kept getting more and more tired. 05/20/2022 I had to drive as my aunt had a heart attack. I think that is where I got exposed to COVID. 05/23/2022 I did at home COVID test govt sent home for free, COVID positive.
Rapid heart beat, went from normal 60 BPM to 110 up to 135 BPM went to ER as instructed in handout sheet
Initial report received from a health care professional on 08 Dec 2009: The patient received treatment with FLUVIRIN, subcutaneous, on 02 Dec 2009. On 02 Dec 2009, the patient's vaccine injection site became hard with an egg size hard lump in left arm accompanied with flushed feeling, bruising and was sent to emergency prompt care. The patient received treatment with ZANTAC 150 mg and BENADRYL 25 mg, on an unspecified date. On 08 Dec 2009, the patient recovered from the large egg size lump. The outcome of bruise and feeling flushed were reported as recovering. The causality of the events were not reported.
No apparent injury, patient was monitored for 30 min in the COVID vaccine clinic in the gym no adverse reactions noted
Soreness at injection site for 3 hours. Pain in upper arm/shoulder joint started a few hours after injection, and is diminishing into Day 2. Pain in various joints is very noticeable by 9:00am the day after injection. Left hip joint pain up to a 6/10 on pain scale. Also pain in right hip, knees, and right shoulder, not to exceed a 4 or 5 on pain scale. Also at 9:00am on Day 2, headache is quite noticeable and persisting through Day 2. I rarely get headaches normally.
I spoke to patient by phone on Saturday morning around 9:20am. He was concerned about the fatigue, nausea, headache, chills, and muscle aches he had the night before. He felt better when I spoke to him. He wanted to know when those side effects would go away finally. Since I had the Moderna vaccine I said 24 to 36 hours. But I didn't know about the J&J vaccine. We disconnect the call at 9:40am Saturday morning. After the call at some point he fixed lunch or dinner and stopped eating before finishing his meal. He had left the food on the table and in the pans he fixed it in. Very unusual for him.  The patient then went to his room where is was found Monday 3/22/21 around noon in his bed laying on his chest (he hated to lie on his chest) by the police and the HR officer from his work.   The HR officer had called my other brother around 11:15am on 3/22 /21 to ask if we had heard from the patient because he had not reported to work or phoned in. He has passed sometime between noon on Saturday till Sunday evening alone at his residence. He had towels and a trash can beside his bed when he was found.  The coroner call it death by natural causes and would not do an autopsy when even asked by his PCP.
she noticed the lot number  written on the immunization card is the same for the first and second dose.; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-years-old female patient received Pfizer-Biontech Covid-19 Vaccine, dose 2 (Lot Number: EL1283 expiry date was unknown) via an unspecified route of administration at arm right on 16Feb2021 (at the age of 81-years-old) as a single dose for covid-19 immunisation. Medical history included chemotherapy from an unknown date and unknown if ongoing. Januvia [sitagliptin phosphate] for diabetes mellitus. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Time the Vaccination Was Given: Not provided. Historical vaccine COVID-19 Vaccine, (Lot Number: EL1283, Expiry Date: Unknown) via intramuscular route of administration arm left of date on 25Jan2021 as a single dose for Covid-19 immunisation. Reported she received her second COVID-19 Vaccine shot yesterday (16Feb2021). She said there was something that concerned her. She said the COVID-19 Vaccine immunization card that was given to her listed the same exact Pfizer Lot Number for her first and second COVID-19 Vaccine shot (circumstance or information capable of leading to device use error). She said it struck her funny that she would have the same exact Pfizer COVID-19 Vaccine Lot Number administered to her 3 weeks apart. She said she didn't know if there was anything she should be concerned about. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. Reported the only reaction she had, if it was even a reaction, was that she found herself to be very tired yesterday after receiving her second COVID-19 Vaccine shot. She said she just went to bed. Treatment: Reported she just went to bed. Patient Weight: unfortunately, 200 lbs., as provided by the reporter. Reported she was on chemotherapy in the past and has been on diabetes medicine for a while. She said about 6 months ago her doctor put her on Janu via because she went from being borderline diabetic to over the line. She said her doctor said if she loses weight, she may not need to take any medication. No further details provided. Outcome of the events was not recovered.    No follow up attempts are possible. No further information is expected.
diagnosed with cellulitis; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (wife) reported for husband that a male patient of an unspecified age received bnt162b2, via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced diagnosed with cellulitis and in hospitalization on an unspecified date with outcome of unknown.   Information about lot/batch number has been requested.
I got my Covid 19 vaccine in my shoulder not my arm. I got all flu like symptoms with sore swollen arm, all my symptoms went away within 48 hours except for my arm my arm got worse. I can?t move my arm in certain direction. I went to urgent care twice and going back to see my primary care doctor tomorrow because nothing has helped me and it?s been over two weeks. The pain in my arm is so severe that I cannot stand the pain anymore. I?ve taken ibuprofen and aspirin every four hours for the past two weeks where I don?t think I should be taking it anymore and I don?t think it?s working anymore I?ve done ice and hot therapy my friends husband is a physical therapist and I?ve been doing some of his recommended exercise.
Patient came to the pharmacy to ask for 1st dose of Moderna. Patient denied of having any previous COVID-19 vaccine previously. After counseled patient on Moderna vaccine, and the vaccine was administered, pharmacist found out that patient had Johnson & Johnson vaccine via vaccine records in March 20, 2021. Even though patient was counseled by the pharmacist that J&J and Moderna haven't been approved for any booster, patient didn't disclose to the pharmacist that patient had J&J already. Patient and his spouse admitted that they did some research on J&J that wasn't effective to protect them from the variant, so both of them decided to get Moderna, even pharmacist mentioned at consultation . No symptoms and adverse effects were reported at this point.
DURING VACCINE, PATIENT FELT A SHARP TINGLING/SHOOTING PAIN DOWN HIS ARM. PAIN WENT AWAY, BUT HE WAS AWOKEN FROM SLEEP THAT NIGHT FROM THE PAIN. ARM WAS SORE AGAIN IN THE MORNING BUT THAT EVENING FELT AS THOUGH IT WAS SHOOTING AGAIN. PATIENTS WRIST STILL HAS TEMPERATURE SENSITIVITY AND CONSTANT NERVE PAIN, AND PATIENTS ARM IS SWOLLEN TO THE ELBOW.
Information has been received from an RN concerning a pt who was vaccinated with pneumococcal vaccine 23 polyvalent (lot 637487/1071K). Subsequently, the pt developed redness, warmness, swelling and cellulitis. The pt went to the local ER and was treated with warm soaks. The pt was not admitted to the hospital. Subsequently, the pt recovered. The nurse had requested a lot check of lot 637487/1071K. The records of testing prior to release of this lot had been checked by GMP Compliance and found to be satisfactory. The lot complied with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
rt upper outer arm blister; sl local wheal reaction w/redness noted @ inject site upon immediate needle withdrawal; 3-4 days rt thigh DTP inject site had a 2-3 splotchy, reddened area p/running & playing in the park;
3 doses of Engerix-B given on 8JAN90, 8FEB90 & 8JUL90; Titer done 8AUG90, post 3 doses of vax. Vaccinee did not convert. Fourth dose given 30AUG90.
I  had a red rash that came after the second vaccine a few day after and within a few days of the booster shot, I had the rash spread further. Dermatologist stated that the allergic reaction had unknown origin. I was experiencing eyesight issues and extreme vertigo. I was throwing up due to the vertigo consistently, I cannot focus my eyesight for some unexplained reason and that attributes to the vertigo as well. Skin patch testing that was ordered was positive in two sections: Thimerosal, gold.
received his third Covid 19 vaccine; received his third Covid 19 vaccine; fluttering heart; fast-beating/heart rate as high as 220 beats per minute; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Aug2021 (Batch/Lot Number: TC3182) at 72 years of age as dose 3, single for COVID-19 immunisation. Medical history included compromised kidneys, Trigeminy, and Paroxysmal atrial tachycardia. The patient takes unspecified medications for years. Historical vaccination included bnt162b2 received by the patient on 06Jan2021 as dose 1, single (Lot number EL1284) and on 27Jan2021 as dose 2, single (Lot number EL9262); both at 72 years of age for COVID-19 immunization. He is a physician who called about the COVID-19 vaccine. He received his third COVID-19 vaccine, his booster on 26Aug2021. Within 24 hours (Aug2021), he had feelings of a fast beating, fluttering heart. He knew this can be an expected side effect and he's asking about how long it's expected to last. He reported he has a history of compromised kidneys, trigeminy, and paroxysmal atrial tachycardia. He's trying to trace his side effects to something and can't. His history with cardiac issues was usually short-lived and he hasn't experienced those cardiac issues in a while. He was followed by a cardiologist. His fast beating, fluttering heart is not incapacitating, he usually has a warning that his heart rate is going up, so he stops what he's doing and sits or lays down until it resolves. His fast beating, fluttering heart hasn't gotten worse but it is persisting. He's checked an electrocardiogram on his Apple watch and it's normal but he has seen his heart rate as high as 220 beats per minute. He checked his heart rate recently and it was 89 beats per minute. He doesn't think his side effects have required any additional care. Outcome of 'fluttering heart' and 'fast-beating/heart rate as high as 220 beats per minute' was not recovered.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events Cardiac flutter, heart rate increased and the suspect drug BNT162B2.  Consider also possible contributory effects from patient's pre-existing risk factors, namely, Trigeminy, and Paroxysmal atrial tachycardia.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever, chills, fatigue, muscle and joint pain x2 days  Advil, Tylenol, muscle relaxer
pt states she developed strange headaches that would come that would last about 2 seconds and then go away.  They would come and go every day a couple of times a day for a few weeks.  They eventually let up and went away.  Pt will discuss w/ her PCP at her next visit scheduled for 11/16/21.
This spontaneous report was received from a nurse practitioner via medical records and refers to a 15 year old female patient. On 24-AUG-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011117, expiration date: 07-DEC-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 5 hours, which was detected by a data logger. There was also previous temperature excursion, but more details were not available. No adverse effects were reported. All available medical records will be provided upon request. This is one of several reports received from the same source. Additional information is not expected as all follow up information was received. Additional information is not expected as all follow up information was received. Sender's Comments: US-009507513-1609USA007391: US-009507513-1610USA002333: US-009507513-1612USA003506: US-009507513-1610USA002334: US-009507513-1612USA003508: US-009507513-1612USA003509.
On Wednesday night, 4/5, pt started developing redness, rash, and swelling on left thing. On Thursday night, 4/6, rash increased in size and pt mom noticed the rash was warm to the touch
Pt recvd 1 dose of Engerix-B & 3 days later devel extreme lower abdominal cramping, blisters on rt corner of outer mouth, throbbing h/a & a mouth sore;
Narrative:  Patient with history of diabetes and hypertension. He had been off all medications for the past 2 weeks. Started to feel intermittent lightheadedness and nausea with poor PO intake a few days ago. After receiving his vaccine, these same symptoms started so he was brought to the ED for further evaluation.
Narrative: 8/27/21: S: patient is doing much better this morning. Heart rate is much better and patient is down to FiO2 of 45%. Patient continues to ask when he can get out of the hospital. O: General- Patient sitting in the chair by the bedside and looks significantly better today, patient remains on high flow at 45% but satting around 95% Heart-irregular rate and rhythm with heart rate in the mid 80s this morning Lungs-crackles noted in the bases Abd- soft Ext- No LE edema Neuro- CN 2- 12 grossly intact A/P: patient is a 70-year-old male who admitted on 8/16/2021 with acute hypoxic respiratory failure due to Covid. Patient remains on high flow but we are working on weaning off 1. Acute COVID 19 pneumonia -S/O mRNA COVID-19 vaccine x 2 -S/P Tocilizumab on 8/17/21 - Patient has now completed remdesivir but remains on steroids and patient should complete steroids on 8/29/2021 2. Acute hypoxic respiratory failure - This is due to the Covid pneumonia and continue weaning oxygen to keep oxygen saturation to 88% and greater -Patient has been weaned further and FiO2 currently 45% 3. Elevated D Dimer -CTA was done on 8/23/21 that was negative for PE so currently on prophylactic Lovenox 4. CAD -S/P 4-vessel CABG -stable, no chest pain -continue medical management 5. Acute on chronic combined systolic & diastolic CHF (HFrEF) -LVEF ~ 25-30% -compensated, no peripheral edema - continue Torsemide -Entresto on hold due to hypotension 6. Chronic peristant atrial fibrillation -S/P AVR -Patient required some IV metoprolol on 8/24/2021 for elevated heart rate -Patient's metoprolol has been increased however unable to go up any further given some hypotension -Cardiology consulted and we have placed the patient on digoxin and heart rate seems significantly better today - Continue digoxin 0.25 mg p.o. daily - CHADVASC score noted to be 2 but has been documented extensively in the past that the patient is not a candidate for anticoagulation given recurrent GI bleeds 7. Hypotension -Now seems resolved 8. Stage IIIb CKD -Creatinine this morning was noted to be 1.2 and this is even better than the patient's baseline, patient's baseline creatinine appears to be 1.3-1.5 - Continue to follow intermittently 9. Diabetes mellitus, type 2 -Blood sugars currently acceptable and patient is currently on a regimen of 20 units of glargine along with sliding scale insulin -Continue this regimen 10. Generalized anxiety with slight panic attacks -secondary to acute medical illness - Seems resolved at present -Physical therapy and Occupational Therapy following and recommendation is for home health at the time of discharge 11. Obesity with a BMI of 64 -Patient counseled about weight loss 12. Hypocalcemia -Very mild at 7.2 but when corrected for albumin is almost within normal limits -We will give 1 g today F/E/N-cardiac diet Prophylaxis-prophylactic Lovenox Full code Dispo: Home with home health once medically stable. Continue weaning oxygen. Patient will transfer to the floor today.
began running a fever of 101 on 16JUL95;pt cranky 14JUL95 to 15JUL95;woke up 4AM crying;fever cont until 23JUL95 8PM;MD called stated was rxn to vax;24JUL95 broke out w/red, circular rash everywhere had a mosquito bite; yellowish pus
Deceased (10.23.21);  Hospitalized (10.20.21);  COVID-19 positive (10.20.21);  fully vaccinated  Primary Care Physician at Discharge Admission Date: 10/20/2021  Date of Death: 10/23/21 Time of Death:  5:47 PM Preliminary Cause of Death: Pneumonia due to COVID-19 virus DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Supratherapeutic INR Acute on chronic anemia Acute respiratory failure due to COVID-19   HOSPITAL COURSE: 86yo Afib on coumadin, trip/fall on 10/20, admitted to IM for INR-7.3, recent GIB (9/13 EGD with coag, 10/1 21 friable polyps resected for oozing and need for anticoagulation), found to be COVID + (full vax with Pfizer and booster), symptoms of weakness, poor appetite since 10/14, 10/22 Azith/Rocephin started for CAP, pt mentation declining, taking off his oxygen, not following commands, early AM 10/23 pt removed oxygen, went into PEA arrest.  ROSC obtained after 15min.  Intubated, cooled to prevent fever, no target temp. CT head done and NEG, EEG ordered however son came in to see patient, held a family mtng and decided to go comfort care. Therefore pt was extubated this afternoon, sedation off and passed away peacefully.
Hospitalized with increased confusion, weakness, and diarrhea after testing positive for COVID. 3 day course of Remdesivir.
LOCAL SITE REACTION - ERYTHEMA, SWELLING, INFLAMMATION (ALL ON LARGE PART OF UPPER ARM), FEVER DIARRHEA.  MISSED WORK THE DAY AFTER VACCINATION. ALL SYMPTOMS STARTED THE DAY AFTER VACCINATION. SAW DOCTOR 4 DAYS AFTER VACCINATION BECAUSE SYMPTOMS STILL PRESENT. RECEIVED CEPHALEXIN, 7-DAY COURSE FROM DR.
Massive bleeding ulcer, not related to vaccine; Blood Transfusion; This spontaneous case was reported by a pharmacist and describes the occurrence of ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy and Drug allergy (Quinolones).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) (seriousness criterion medically significant) and TRANSFUSION (Blood Transfusion). At the time of the report, ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) and TRANSFUSION (Blood Transfusion) 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 considered ULCER HAEMORRHAGE (Massive bleeding ulcer, not related to vaccine) and TRANSFUSION (Blood Transfusion) to be not related.    No concomitant medication was not given. No treatment information was not given.  Treatment included Blood Transfusion.  Company comment Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.