chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blooded stools; Eyes are a little bit itchy; Right eye swollen; A spontaneous report was received from a consumer who was an 83-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blooded stools, eyes are a little bit itchy, and right eye swollen.  The patient's medical history was not provided. Concomitant medications reported included magnesium.  On 04 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J00/NA) intramuscularly for prophylaxis of COVID-19 infection.   On the evening of 04 Jan 2021, the patient experienced blooded stools, eyes are a little bit itchy, and right eye swollen. The patient reported having blooded stools that were not diarrhea, but had occurred three or four times. Treatment for the events included non specified allergy medicine for the eyes.  On 06 Jan 2021, the patient reported feeling better in regard to the blooded stools and was unsure if it was actually blood or not in her stools and she had ate spicy and red food.  Action taken with mRNA-1273 in response to the events was not provided.  The event, blooded stools, was considered resolved. The outcome for the events, eyes are a little bit itchy and right eye swollen was unknown.; Reporter's Comments: This case concerns an 83-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot 025J00/NA), and who experienced the unlisted serious event of Haematochezia and the unlisted non-serious events of Eye pruritus and Eye swelling.  Based on the current available information and temporal association between the use of the product and the start date of the event on the day of vaccination, a causal relationship cannot be excluded making the events possibly related to the vaccine.
pt devel severe bruising & petechiae on body;adm to hosp on 6OCT98 for tx;pt had very low platelet count was dx w/ITP & given med;
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a physician 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, several months prior to this report the patient recently had a breakthrough Covid-19 infection after receiving the Janssen vaccine. The patient further stated that he just had congestion and aches as symptoms (Suspected clinical vaccination failure and Suspected COVID-19- infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210849843 -Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Initial information received from another manufacturer on 18 July 2014 with additional information received from a consumer who is also the patient. A female patient was vaccinated on an unknown date with Tetanus, diphtheria toxoid on an unreported date 10 to 15 years ago, (manufacturer, route, site and batch not reported). An unspecified time later, the patient experienced side effects arm and neck swelling that was red and hot. The patient was treated with steroids. The patient was not hospitalized for the event. The patient has a medical history of spinal stenosis, degenerative disc disease, herniated discs, cervical and lumbar radiculopathy, fibromyalgia, hypercholesterolemia, GERD, HTN (hypertension), asthma, arthritis, cauda equina syndrome, sleep apnea, plantar fasciitis, endometriosis, acute renal failure, pulmonary edema, mild bronchiectasis, chronic sinusitis, colonic adenocarcinoma, gestations diabetes, osteoporosis, cysto with fulguration of the bladder in 1975, tonsillectomy in 1976, cesarean in 1989, tubal ligation in 1990, extradural cyst excision with near total laminectomy T-12-L2; placement 2 metal aneurysm clips for wound closure in 1993, colon resection 2003, bilat oophorectomy, appendectomy, excision of lymph node chain and artery supplying 1/2 foot section of colon, right shoulder arthroscopy, bursectomy, numerous epidural, trigger and facet joint steroid injections, L5-S1 lt microdiscectomy in 2001. She has a family history of cancer and drinks alcohol 1-2 drinks a year and caffeine use, one glass of tea a day. Current meds on 18 June 2014 were: LASIX 80 mg tablet twice a day, omeprazole 50 mg capsule delayed released 1 capsule in morning 1 QHS, ABILIFY 2 mg tablet daily, CYMBALTA 30 mg 3 once a day at breakfast, LYRICA 75 mg capsule qhs, methadone HCL, 5 mg tablet, e tablets every 12 hours, pravastatin sodium 20 mg tablet 1 tablet every other day, COREG 25 mg tablet, 1 tablet with food twice a day, clonidine HCl, 0.1 mg tablet qhs, estradiol 1 mg tablet Q?OD, KLOR-CON M20 20 MEQ tablet extended release tablet Qday PRN, Lisinopril 10 mg tablet a day, dronabinol 5 mg tablet twice a day prn, tizanidine HCl 6 mg capsule TID, tramadol HCl 50 mg tablet as needed every 6 hours. Her allergies are BACTRIM: anaphylaxis, topiramate - hives, fire ants - anaphylaxis, adhesives - hives, baclofen - anaphylaxis, LIPITOR - shortness of breath, BENADRYL - rash, pseudoephedrine cold - allergy, side effects, KEPPRA - side effects, codeine phosphate - side effects, hydrocodone bitartrate - side effects, erythromycin - stomach upset, MRI steel aneurysm clips on spinal cord - contraindication. The patient outcome was recovered. According to the patient, she did not know the name of who administered the vaccine and did not have any further information to provide. Documents held by sender: medical assessment records.
Palmoplantar Psoriasis being treated since 03/31/2022, outcome negative, still have problem and getting worse.  (chronic Psoriasis on hands and feet has not been cured, 02/27/2022 to today 08/15/2022).
At 11:05a, patient in observation area made complaint to medical monitor of trouble breathing and chest tightness 5 min after receiving vaccine. Patient stated she'd been feeling well prior to this. Medical monitor notified POD supervisor to call 911 and stayed with patient. At 11:10a, patient brought back to room with recliner and vital signs taken: HR 67, BP 168/98, RR 20, O2 Sats 98%. Patient continued with complaints of chest pressure with pain rating 3/10 'like someone's pushing on my chest', feeling 'very warm', and felt like 'I am having trouble catching my breath'. Cool cloth placed on forehead. Fire arrived at 11:16a to assess and take over care of patient. Patient transported to hospital.
Pt started to feel unwell the morning after receiving the vaccines, but went to school any way.  Came home from school in the afternoon complaining of pain in all joints and had a temp of 100.2.  Had red area around site of injection on left arm "about the size of a quarter" per his grandmother.  Stayed home from school 11/7 and 11/8 and grandmother reports he is "starting to feel better today".  Redness at site of injection is gone and pt is afebrile.  Not seen in the office since the date of the injection.  I am answering "no" to question 20 below, because he is not fully recovered, yet.
Pressure in head (on-going), a lot of pain behind eyes and light sensitivity. Chest pain, like pressure on my heart. Joint pain. Chills. Even my teeth hurt. I had some kind of an event after 3 days that may have been vertigo, it lasted only a second but also made my heart race. Symptoms have lessened but are still present at 4 days after. Difficulty reading screens at work - feels like it may set off vertigo again - some dizziness.  The pressure in my brain and chest persist.
Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Subsequently the patient experienced abdominal pain and recovered.
Patient started having shortness of breath and tingling in fingers shortly (approximately 10 minutes) after receiving vaccine dose.
10 MINUTES AFTER RECIEVING THE 2ND MODERNA VACCINE THE PATIENT C/O DIZZINESS 148/172 -P -86 -99% PULSE OX, HYDRATION AND REST THE PATIENT IMPROVED
This spontaneous report was received from a nurse practitioner and refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies. The reporter stated that improperly stored doses of GARDASIL 9, lot number M018810, expiration date 08-MAY-2018 (dose, route, and anatomical location were not reported), for an unknown indication were administered to the patients' on an unknown date. The vaccine was exposed to a temperature between 32 Fahrenheit (F) and 36 F for 64 hours, due to a data logger issue. The previous temperature excursion was between 32 F and 36 F for 24 hours. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Injection site is hard; It is bigger than it should have been, it's just like a little hard ball in there; it's warm to the touch; it itches all around the edges; This is a spontaneous report from a contactable consumer (patient). A unknown age patient of unspecified gender received bnt162b2 (COMIRNATY, Solution for injection, Lot Number EL3249 was reported), via an unspecified route of administration on 12FEB 2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient took Historical Vaccine BNT162B2 (COMIRNATY, Solution for injection, Lot Number unknown), via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date the patient experienced Injection site is hard, and it was bigger than it should have been, it's just like a little hard ball in there; it's warm to the touch; it itches all around the edges. Reporter wanted to know if the injection go to my 'anatomy' or it just go into my arm, you know into the muscles of my arm. It's quite big and it's just about the second one but it is a size of a very small ball and around the edges it is very itchy, it itches all around the edges. So, reporter (patient) was wondering if this is something should be concerned about. The clinical outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Headache and chills evening of shot, body aches as well. Temp was 101.4 at peak but now normal. Remaining symptoms are mild headache, occasional chills, and body aches...as of 3/21/2021
DECREASED IN VISION; DECREASE IN MEMORY; DECREASE IN HEARING; DECLINE IN HEALTH AND HYGIENE; BLURRY EYES; TEMPLE PAIN; NECK PAIN; CHEST PAIN; OPPRESSION; FEELING STALKED, MONITORED, HARASSED; TRAUMATIZED; OVERWHELMED; EXPOSURE TO ELEMENTS; SWOLLEN ANKLES; MENTAL STRESSED; UNCOMFORTABILITY; This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) on an unspecified date for prophylactic vaccination. No concomitant medications were reported.  The patient filed a complaint in the  Court on 20-APR-2021. Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants.  Place of occurrences. Dates of occurrences were between 11-APR-2021 and 16-APR-2021.  Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene,  blurry eyes,  temple pain,  neck pain, chest pain,  blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed,  exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the decreased in vision, decrease in memory, decrease in hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, felt harassed, mental stressed and uncomfortability was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient concerned a female patient (age, race and ethnicity not reported) who experienced the below complaints unspecified time after vaccine. No past medical history was reported. No concomitant medications were reported. The patient filed a complaint in the Court . Federal statutory rights including retaliation, abuse of power, discrimination, and persecution were reported as violated. She listed defendants. Injuries were reported as: decreased in vision, memory, hearing, decline in health and hygiene, blurry eyes, temple pain, neck pain, chest pain, blocked path to housing and food, oppression, feeling stalked, monitored, traumatized, overwhelmed, exposure to elements, swollen ankles, re-worn dirty clothes, harassed, mental stressed, and uncomfortability. A meaningful medical assessment can not be made of this legal case, although the events are unlikely to be related to vaccine.
Pt administered expired flu vaccine consulted with district, state, CDC and manufacturer. Revaccinated on 10/05/2006 no problems from expired vaccine.
9 days after injection,  injection site began to itch. The following day, while still mildly itchy, the skin around injection was slightly raised, had a warm feeling and was warm to the touch. Was approximately a 3.5 inch in diameter,  perfectly circular area with the injection site in the center.      Had a phone appointment with a physician. He ordered a prescription for Hydrocortisone 2.5% to use topically and advised me to take a once daily antihistamine, but to take it twice a day instead. The itchiness was less the next day and the area of red skin was much smaller, then gone by the end of that day(02/01). Stopped the cream and antihistamine. But area began to itch again on 02/03 and had a red blotchy look to the skin(approx 2? area). Again started Claritin twice a day. Itchiness and rash? we?re gone by 02/04, but I continued Claritin for another 2 days. Stopped Claritin on 02/06 and had no return of symptoms.
killed my roommate; This is a spontaneous report from a Pfizer- sponsored program. A Non-contactable consumer reported for a patient (reporters friend) that a patient of unspecified age and gender received bnt162b2 (BNT162B2, the Pfizer COVID Vaccination), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer reported that "you killed my roommate, My friends death is worth nothing to you" on an unspecified date. The patient died on an unspecified date.  The outcome of the event was fatal. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: killed my roommate
pt recv vax 11FEB97 & 18FEB97 pt devel a typical vesicular chickenpox rash consisting of greater than 100 lesions on an erythematous base on antero-posterior trunk, anterior pelvic region & face;pt also devel inflammation of nodes
Symptoms first began 4/19 with skin rash under arms pits and below breast. During my 2nd vaccine shot appointment with hospital, I mentioned the symptoms and spoke with a Doctor before taking my 2nd vaccine on 4/23. He indicated that since the rash was mild and it took longer than 4 days since the first shot to develop, that it was most likely my body reacting to something else. I took the 2nd vaccine shot. He prescribed cortisone cream to help with itching. Then on 4/25 the rash spreader all over my body. To include legs, things, full arms, full stomach and full back. And it is continuing to spread around my neck, face and hands. The rash are spotted and start off red then turn light brown. But when it is itchy they turn red again. They are very uncomfortable. Healthcare provider saw me on 5/1/21 and she prescribed Oral Corticosteroids 10mg tablets to be taken after 5/7/21, which is 2 weeks after 2nd vaccine shot. Photographs are available upon request.
Patient is a personal acquaintance of reporter.  Patient contacted reporter on 4/15/21 at 10:18 pm complaining of onset of extreme dizziness, vomiting, "eyes not catching up with my head",  extreme fatigue, and feeling like they are "about to pass out".  Patient also noted onset of SOB and lower chest pain accompanied by "weird taste" but not metallic taste.  Patient was unable to describe the unusual taste. Patient was encouraged to use OTC medications to treat headache and fever, encouraged to use OTC Benadryl/Dramamine. Monitor for worsening and report to ER if symptoms worsened, changed, or failed to improve. Per patient,  symptoms lasted through the night and until approximately 3:00 AM on 4/16/21.  Patient's wife reported blood sugar of 154 mg/dl, B/P 164/88, and Pulse 70 bpm using home monitors.  On 4/16/21, the patient reported onset of fever greater than 101 at approximately 2:00-3:00 AM which lasted approximately 18 hours.  Fever onset was accompanied by headache which has persisted from 4/16/21 through 4/22/21.  Patient contacted writer on 4/21/21 to state that he still does not feel well, headaches continue and fatigue is persistent.  Generally states that he does not feel well.
Patient stated he " blacked out after vaccine"RN spoke with Dr. and advised that patient receive second dose of vaccine in physicians office. Patient verbalized understanding. Patient declined ED services.
Localized redness/Warmth/Swelling (Worst was experienced on the second day but has since decreased)
Admin flu vaccine high dose PFS (FLUZONE) (L) U4790AA/Exp. date 30 June 14 - Lt deltoid IM on 12-9-13 at 5pm. Subject called and stated at 1230pm on 12-10-13 approx. 12 hrs post vaccination developed "localized oval" area below injection site that was slightly raised/warm to touch. Vaccinated without incident last year similar reaction 2 yrs ago. Refused medical f/u. Referred to PCP to monitor.
unconsolable, high pitched cry for at least 6 hrs; no significant fever-local swelling @ site;
Arm soreness; Lymph node inflammation; Fever up to 101.8F; Head and body aches; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 26Apr2021 at 15:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN); taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the right arm on 02Apr2021 at 14:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. On 27Apr2021 at 16:00, the patient experienced arm soreness, lymph node inflammation, fever up to 101.8 F and head and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 27Apr2021, the patient underwent body temperature and the result was fever up to 101.8 degrees Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events arm soreness, lymph node inflammation, fever up to 101.8F and head and body aches was recovering at the time of this report.  No follow-up attempts are possible. No further information is expected.
Right after vaccination, patient became pale, non-responsive. Was supported safely to the floor, seizure-like activity (arms and legs posturing, head shaking). Color from pale to red to purple. After 20 seconds sat upright. EMS arrived, assessed patient, offered transport to ER, patient refused. Friend picked him up from clinic. Patient doctor is notified.
mild symptoms of COVID-19; fever; chills; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild symptoms of COVID-19), PYREXIA (fever) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 011D21A, 015M20A and 013L20A) for COVID-19 vaccination.     Patient had no allergies to medications, food and other products. Patient had no medical history related to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concomitant products included DOXYCYCLINE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022, the patient experienced PYREXIA (fever) and CHILLS (chills). In July 2022, the patient experienced COVID-19 (mild symptoms of COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 11-Apr-2022, PYREXIA (fever) and CHILLS (chills) had resolved. In July 2022, COVID-19 (mild symptoms of COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2022, SARS-CoV-2 test: (Positive) Positive.         The adverse event did not cause patient to seek medical care. The patient did not experience a similar event in the past.   This case was linked to MOD-2022-656370 (Patient Link).