chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a dose of VARIVAX following a temperature excursion; no adverse effects reported; This spontaneous report as received from an office manager refers to a patient of an unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 16-AUG-2019, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # N034553, expiration date 05-DEC-2019, for prophylaxis (route of administration, anatomical location, dose and frequency were not reported), following a temperature excursion. The vaccine was exposed to a temperature 15 degrees Fahrenheit to 46 degrees Fahrenheit for 30 days. The call was made because of digital data logger. There were no previous temperature excursion. There were no adverse effects reported. The outcome of the events was unknown.
pt recv vax; had asthma exacerbation over next 24 hr - not relieved w/meds; er visit required; sx resolved;
66M with mantle cell lymphoma s/p 2 years of Rituximab admitted with COVID Pneumonia despite 3 COVID vaccine doses. No antibodies identified. Received dexamethasone, remdesivir, and compassionate use Regeneron monoclonal antibodies. Despite this he developed ARDS and refractory hypoxia despite paralytics and attempts at proning. No accepted for ECMO. Family decided he should be DNR/DNI and he passed with them at his bedside.
The cases were received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 18 September 2103. About 6 patients had received FLUZONE which was frozen and advised to discard. A wrong vaccine ws administered. No adverse event was reported. List of documents held by sender: none
Pfizer vaccine was administered outside of facility- reported by patient  ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/5/2021 CKD STAGE 4 (GFR 15-29)
Fever that hit very quickly. I was SO COLD. Uncontrollable shivering and chills. Fever lasted between one and two hours. Headache lasted two days. Sweating lasted two days, nonstop.
10-27-08 soreness @ site "couple hours" after injection; 10-28-08 "evening" itching at injection site then "hives around site; 10-29-08 10 AM "hives" on legs and back; advised to call PCP for evaluation
Persistent crying, shaking all over, fever, constipation, no respiratory distress. MD felt just stress related response to vaccines, no allergic reaction.
Had a fever of 100.0-102 since getting Hep A vaccine. Has been alternating Tylenol and Ibuprofen Q4hrs.
Patient fell, became unresponsive, and was shaking withing 5 minutes of receiving the vaccinations. She woke up within 2 minutes but had difficulty breathing, felt hot, and needed water. EMS came to check her out and she ended up being okay after about 20-30 minutes.
Skin on back tingling and burning. Diffuculty breathing, fever, body aches, all over ill feeling, and stomach ache.
DIFFICULTY BREATHING; PAIN ON SWALLOWING; MUSCULOSKELETAL PAIN; FEVER; HEADACHE/SWOLLEN HEAD FEELING; This spontaneous report received from a patient concerned a 21 year old male. 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, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced difficulty breathing. On MAY-2021, the subject experienced pain on swallowing. On MAY-2021, the subject experienced musculoskeletal pain. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache/swollen head feeling. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever, headache/swollen head feeling, difficulty breathing, pain on swallowing, and musculoskeletal pain. This report was non-serious.
Initial unsolicited report received from a consumer (patient's mother) via other company (Pfizer) (Manufacturer Report Number: 2016541225) on 02-Feb-2017. This case involves an 18-month-old male patient, who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) and HAEMOPHILUS TYPE B (HIB) VACCINE (HIB) and PNEUMOCOCCAL VACCINE (batch number, expiry date, dose, route and site of administration not reported) on an unknown date. Patient's medical history and concomitant medication was not reported. On an unknown date, following the vaccination, patient had brain swelling. Lab test and corrective treatment was not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event: brain swelling. List of the documents held by sender: none. Sender's Comments: This case concerns 18 month old patient who received DIPTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE along with HAEMOPHILUS TYPE B (HIB) VACCINE and PNEUMOCOCCAL VACCINE. Patient developed brain swelling. Time to onset is not reported. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and investigation results to rule out the alternative cause are needed for complete assessment of the case.
I want to report a death from a Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient's wife). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6207) as dose 1, single; via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6204) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died from the Pfizer vaccine on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: I want to report a death from a Pfizer vaccine
Reaction to vaccine 6 days after receiving Zostavax. 3" ring around sight, center white, few small blisters at top and bottom of circle.
Possible seizure about 8 hours after immunizations. Seen in ED & admitted overnight for observation.
On 1/21/2021 (1  1/2 week post injection) I started to have slight soreness at site of injection and feeling of warmth.  On 1/22/2021, I discovered a red circle around injection site where I had the warm feeling.  By 1/23/2021 the redness increased in size and became warmer and more sore.  I did not measure the width of the redness so to give an approximate size, I'd say about the size of a small orange.  I placed ice packs on it later that evening (1/23/21) which seemed to help.  By the next morning the redness was gone although still slightly warm and sore.  As of today (1/25/2021) no still no redness, but slight soreness and very little warmth.
Red Rash on the Side of the neck, Face and Arms; This spontaneous case was reported by a physician and describes the occurrence of RASH ERYTHEMATOUS (Red Rash on the Side of the neck, Face and Arms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red Rash on the Side of the neck, Face and Arms). The patient also complained of a rapid heart rate of 72 and 78 BPM however, it resolved on the same day. On 09-Apr-2021, RASH ERYTHEMATOUS (Red Rash on the Side of the neck, Face and Arms) had resolved.       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.
Reported illness symptoms began about a week ago (around 10/14) after receiving the booster 3rd dose of Pfizer at vaccine clinic, possible due to significant adverse effects of the COVID vaccine. She has been self-treated her symptoms without improvement; symptoms worsen. She had similar reactions after 2nd dose of Pfizer in the past.
Perforated gastric ulcer  - patient treated in hospital for 20 days by In-hospital consultations:  Internal Medicine; Critical Care; Nephrology; Interventional Radiology; Speech language pathology; Physical therapy; Occupational therapy. Discharged to home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
After injection, immediately had localized swelling at the site of injection (right deltoid)  No complaints of pain, SOA.  Ice pack applied.  Monitored for 30 min, no complaints at the time of discharge.  Left voice mail for him to contact his PCP for 2nd shot recommendations.
Vaccine was administered on 7/28/21. I woke to irregular menstrual on 7/29/21. The bleeding was watery and light to moderate throughout the bleeding. It lasted for two weeks. I have not had any bleeding since then.
Approximately two weeks after receiving one dose of varicella virus vaccine live the pt experienced 10-15 skin lesions on arms, chest, and face. The pt is questioning whether or not she should receive the second dose. The rash was described as macular and erythematous. No vesicles were present. The pt was treated with Atarax as needed for pruritus. Due to missing work as a nursing student, this pt considers this event to be disabling. She recovered on 08/23/99. The second dose was recommended.
For 3 days: Body Aches, 104 fever, chills, lymph node swelling & pain under right arm, pain at injection site, cough, no energy
Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history.  The patient's past medical history included COVID-19 in 2020. Concomitant products included LOSARTAN for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergy. Concomitant medication(s) included: LOSARTAN, start date: 02Nov2015. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from Mar2023 to Mar2023.
1st injection 05/10/19: Severe flu-like reaction approx 11 hours after injection, including chills (shaking), sever headache, muscle aches, joint stiffness, nerve pain in damaged nerves in legs and at site where shingles occurred April 2017. Reaction lasted 3 full days, did not respond to Ibuprofen. 2nd injection 07/25/19: Same reaction as listed with first injection occurring 8 hours after getting injection. In addition, experienced severe GI reaction with projectile vomiting and diarrhea for 24 hours. Also experienced anxiety and feelings of dread during this time. The flu-like symptoms lasted 3 days. With history of IBS, the GI response required a doctors visit, CT-scan and colonoscopy, 2-3 wks later.
RASH; RASH WITH A LOT OF BUMPS ON THE NECK; A LOT OF BUMPS ON LOWER LYMPH NODES; This spontaneous case was reported by a consumer and describes the occurrence of RASH (RASH), RASH (RASH WITH A LOT OF BUMPS ON THE NECK) and LYMPHADENOPATHY (A LOT OF BUMPS ON LOWER LYMPH NODES) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (RASH), RASH (RASH WITH A LOT OF BUMPS ON THE NECK) and LYMPHADENOPATHY (A LOT OF BUMPS ON LOWER LYMPH NODES). At the time of the report, RASH (RASH), RASH (RASH WITH A LOT OF BUMPS ON THE NECK) and LYMPHADENOPATHY (A LOT OF BUMPS ON LOWER LYMPH NODES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Redness at injection site (L) deltoid. Redness size of half dollar. Circled area, applied ice and gave ibuprofen. Advised to ice on and off every 15 min for a couple of hours and take ibuprofen every 4 hours for inflammation. Following day (even though patient did not ice), redness reduced to (L) area of orig reaction in a small C shape.
Information has been received from a physician concerning a female pt who on 2/7/92 was vaccinated with Hep-B vaccine recombinant (yeast). Subsequently, the pt developed neuritis. She was treated with prednisone and the symptoms took about 3 to 6 months to go away. It was reported that for the past 8 or 9 years the pt was fine, but presented in approx. 6/01 with severe pain. The pt reported that it was "the same pain she experienced when she received Hep-B recombinant (yeast) (MSD) in 1992". The pain was described as starting in the bicep and radiating down into the forearm. The pt was seen by a neurologist and was not dx'd with neuritis at that time. The doctor stated that the pain was severe on physical exam. The pt had refused treatment. Follow up info was recvd from MD who reported that on 7/23/01, pt presented to his office with severe arm pain. The MD gave the pt a very thorough exam and noted that the pt had weaker hand grasp on left, pain in the left bicep to elbow and increased pain with ROM. The pt has not been seen again and the current status is not known. The reporter felt the neuritis was related to vaccination with Hep-B vaccine recombinant (yeast). Upon internal review, the pt's experience was considered an "Other Important Medical Event". Additional information has been requested.
Covid Arm-woke up with a golf ball sized rash on right arm but it was about two inches away from the injection site. Itchy, raised off the skin, hot to the touch. I treated with essential oils and hydrocortisone cream two times. Woke up today and it had spread to the injection site but the itchy, redness was less severe and it was no longer raised. It is now the size of a baseball, but oblong and not symmetrical in appearance.
I had the original 2 shots plus one booster/ thank fully my symptoms were small -sorethroat, headache, chills and lasted only 2 days; I had the original 2 shots plus one booster/ thank fully my symptoms were small -sore throat, headache, chills and lasted only 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I had the original 2 shots plus one booster/ thank fully my symptoms were small -sore throat, headache, chills and lasted only 2 days". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid -19 positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Arm swelling, itchiness, warm to touch, pain with movement, temperature chills (4 days).
Severe Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8729) via an unspecified route of administration in left arm on 09Apr2021 at 13:15 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 at 13:45, the patient experienced severe headache and nausea. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events severe headache and nausea were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a healthcare worker concerning multiple patients of unknown demographics. On unknown dates, multiple different unspecified patients received a dose of VARIVAX (unspecified lot # and expiry date) that was improperly stored. No adverse effects reported. No product quality complaint was involved. This case is also related to 1506USA002056, 1507USA010860 and 1507USA010859. Additional information has been requested.
The evening of the injection, began to feel a headache, achy muscles, and sore arm. Next morning, felt these same symptoms more severely and felt feverish; lasted all day. Had to take melatonin and Tylenol to fall asleep. Next day, continued feeling sore arm, feverish, and headache as well as general exhaustion/tiredness. On day 3, the headache and tired feelings lingered and I noticed I would easily be out of breath doing things that didn't cause me this issue previously, like climbing a flight of stairs. Today (1 week since vaccine), the only thing I am still experiencing is shortness of breath at mild levels of activity.
Received flu vaccine on 11/20/2017. On 11/21/17 developed area of redness at injection site. Redness significantly spread on 11/22/17. Seen in office on 11/22/17. Diagnosed with vaccine reacton. No evidence of fever or cellulitis.
Day one after 1st dose:  Woke up with joint and muscle pain, headache, chills, low grade fever (up to 101.5F). Side effects increased in severity over the course of the day and into the night. Took one 500 mg Tylenol capsule in the afternoon against the headache. Day two after 1st dose: All side effects (above) were completely gone, but lymph nodes in the arm pits were very tender.
Pruritic rash on lower abd, under right breast and back of neck. Second vaccine, lot # EL1284. No new locations but new rash in initial locations
This spontaneous report was received from a other health professional refers to a patient of unknown age. On 30-SEP-2014 the patient was vaccinated with ROTATEQ, lot # K001935; expiry: 08-DEC-2015 (dose, dose # and route unspecified). No concomitant medications were reported. On 30-SEP-2014, it was reported that the patient was exposed to temperature outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperature outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Patient developed swollen eyes next morning after PNEUMOVAX 23. She had itchy eyes and she took Allegra 60mg (OTC) for 3 days then Claritin 10mg (OTC) for 3 days.
Felt dizzy, started feeling nauseous, started vomiting, lasted until 8pm. Called doctor around 4pm recommended BENADRYL and clear fluids; did not have BENADRYL and couldn't hold any fluids. Around 7.30pm took some VALIUM and it did help. Vomiting was weird, white fluid. Felt sleep around midnight. Today doing better, just residual arm pain but no vomiting. Spoke to pharmacist today.
Received 2nd dose of Pfizer-BioNTech Covid19 vaccine on 5/9/2021. The following day developed substernal chest pain radiating to neck and left shoulder and arm.   Also reports fever of 101 degrees on 5/10/2021.  Used Tylenol, initially with some reloief, but symptoms worsened over the course of the next few days.  Then presented to ER on 5/13/21 because of worsening pain.    EKG showed diffuse ST elevations c/w pericarditis.  Initial Troponin 11.1, ultimately peaking at 13.67, c/w myopericarditis.   Admitted to hospital for supportive care, and treated with PO colchicine.   A transthoracic echocardiogram revealed normal LV function without segmental wall motion abnormality and no pericardial effusion.  A Cardiac CT showed normal coronary arteries.     The patient's symptoms improved with colchicine.   He was discharged home with a course of colchicine on 5/15/21.   A subsequent outpatient Cardiac MRI did show epicardial and mid wall late gadolinium enhancement involving the basal to mid lateral and inferolateral walls, and a mid wall stripe of distal anteroseptal, septal and inferoseptal segments, c/w myocarditis, idiopathic cardiomyopathy or sarcoidosis.  The pericardium was borderline thickened at 3 mm.
redness, & itching at site of injection - still present (only been 2 days)
Bilat paramedian vocal cord paralysis reported in pt receiving Fluogen. Had flu vax in Nov90 & became hoarse late Dec90. Seen mid Jan & found to have bilat paramedian vocal cord paralysis. As of 18Feb91, pt better. Dx=myasthenia gravis?
Extreme pain from upper arm radiating downward to hand & wrist. Pain with/without movement.
Left arm swollen at site, red where vaccine was injected.  Redness has spread since the day of injection currently about 1 and a half inches in diameter.  Itchiness where injected, armpit tender.  Nausea, headache, fever (100.4), dizziness, feeling faint, body aches.
Pt was feeling light headed and experiencing and blurry vision. Staff talked to the pt and took vitals. Vitals were as followed: P: 98, BP: 149/106, SPO2: unattainable. Pt reported having a history of hypertension and dextrocardia. Pt was breathing well and was able to speak clearly. Pt was AnOx4. Pt stated she has had no food or drink yet today and was nervous for the vaccination. Vaccination site was not raise, inflamed, or warm to touch. Staff concluded pt was most likely experiencing dehydration and anxiety. Staff told pt to monitor symptoms and if any were to return or worsen, to call insurance nursing hotline or 911.