chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 15Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: CHLORTHALIDONE (manufacturer reported), start date: 01Oct2020, stop date: 25Feb2023; LOSARTAN POTASSIUM (manufacturer), start date: 01Jun2017, stop date: 25Feb2023. Past drug history included: Levaquin, reaction(s): "known allergies Levaquin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Feb2023, outcome "recovering" and all described as "Contracted COVID in ". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative; (2023) Positive; (2023) Negative; (2023) Negative; (2023) Negative; (2023) Negative.  Therapeutic measures were taken as a result of drug ineffective, covid-19 included administration of Paxlovid (lot number GF7285) from 17Feb2023 to 21Feb2023). It was reported that the patient had both positive and negative home tests (positive and negative) after four days of negative home tests. Contracted COVID, had four days of negative tests before returning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up with swelling and a rash on my both my hands on April 1st. On Friday, April 2n, woke up with my left foot swollen and a rash on both feet. By Saturday, April 3rd, my right feet was swollen and my elbows developed the rash. Per doctor take ibuprofen and bendryl to treat symptoms. Swelling lasted five days but rash still active on both hands, feet, and elbows.
Patient presented to emergency department on 9/28/2021 with altered mental status. Patient was admitted for further management. On 10/8/2021 patient was found to be COVID-19 positive during screening for post acute placement. Patient was asymptomatic for COVID-19 during admission. Patient was discharged to extended care facility on 10/20/2021.
Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022; Patient received vaccine after the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     The patient had not been diagnosed/tested positive for COVID-19. It was unknown that the patient had acute illness at the time of vaccination and up to one month before. It was unknown that the patient had chronic or long-lasting illness and patient had taken any prescriptions, over the counter medication, dietary supplements or herbal remedies at the time of vaccination.     On 16-May-2022 at 11:00 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the beyond use date) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 08-Mar-2022/Vaccine administered on 16-May-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Total number of vials was 6. The vial was initially stored in refrigerator on 08-Mar-2022. The vial did not undergo any temperature excursion. The patient did not report any symptoms.  No treatment medications were reported.
Vaccine induced Varicella, initial encounter. Rash - lesions on Arms, back and torso of body.
Rash red and light and fading slowly by the day. Approximately 3inches by 3 inches in area.
On April 7, 2021, a week after receiving my first  vaccine shot, my upper left arm broke out in what is called COVID arm. The rash lasted about three days and went away. However, I have lingering muscle soreness where I was vaccinated that seems to be getting worse over time. My range of motion is being affected and the pain is always there.  This did not start until the COVID arm.  While I had initial site soreness after the shot, it went away within 24 hours and then returned a week later and now has been lingering for another week. It hurts from  near my elbow to my shoulder on the left arm.  The area is not red or swollen and it does not feel warm.  It appears normal.
No fever, loss of smell, nor loss of taste but did get extreme muscle ache for 3 days plus 22 continuous days/nights of debilitating left sinus cluster headache.
Grandmal-tonic clonic seiaure. Pt received his shots on 03/07/2002. That evening he was being watched by a cousin who stated that she saw him "start shaking." He was not brought to the ER because the mother did not witness the seizure and did not think it was a seizure. He next had a seizure on 03/13/2002 at his mother cousin's house and she called the paramedics. He then was taken to ER at about 6:30am he suffered a grand mal, tonic-clinic seizure and was given Ativan to help stop the seizure. Once stabilized, he was transferred to the pediatric floor where he had another seizure about 11:30am and was given Ativan once again. Then he was loaded with Phenobarbital and maintained at a dose of 5mg/kg. He has not suffered a seizure since the 13th of March. The pt was sent home from the hospital after an 8 day stay to manage his RSV bronchiolitis and seizure stability.
Day one after injection.  Woke up to very swollen puffy eyelids and under eyes.  Used cold compress and they went down. Within days of injection. Constant ache in knees, ankles and wrists.  Swelling in ankles, stiffness and swelling in hands.  NOTE: Have had previous  swelling in  ankles due to heart condition and on feet all day due to job.  However previously prescribed diuretics reduced this.  After Covid 19 injection,   increased swelling in ankles with pain, daily chest pain and pressure, enough to increase Diuretics. Approximately 1 month after injection Irregular heartbeat and skipped heart beat. Contacted heart doctor.  After approximately 4 weeks the chest pain started to subside with increased diuretics.  Only occasional chest pain now.   Now  4 months after second covid shot, still have stiffness and swelling in hands daily.
herpes zoster; products liability - defective design/ manufacturing defect; Information has been received regarding a case in litigation from a lawyer and refers to a currently 76-year-old patient of unspecified gender. No information was received regarding medical history, concurrent conditions, or concomitant medications.  On approximately 21-MAR-2014 (reported as on or about March 21, 2014), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route and site of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by the physician due to the event. The patient claimed damages as a result of: Injury to themselves; Loss of consortium; Loss of services; Economic losses. The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; loss of consortium; punitive damages. The outcome of the events was not provided. The causality between the event and the suspect therapy was reported as related. The causality between the product quality issue and zoster vaccine live (ZOSTAVAX) was not provided.
Approximately 9 days later, redness, swelling and heat 2-3 inch diameter just below the  vaccine site
Client received Moderna 1st dose on 7/6/2021. We administered Pfizer by mistake as his 2nd dose today.
dizzy, heart racing, chest pressure, lower extremity pins and needles, EMS evaluated, pt. refused EMS transport.
fist sized knot w/redness & itching @ inj site, onset just hours p/vax;ice to decrease swelling, DPH OTC for itching @ site;improved p/24hr;sx resolved p/72hr;
This spontaneous report as received from a Medical Assistant refers to a 8 week old infant, gender not reported. On 12-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K009181, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
pt recvd vax 3MAR93 & on 13MAR93 devel fever 104.6 & had sz; taken to local ER;
Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     Patient had no medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. It was unknown if patient ever tested positive or diagnosed with COVID-19.  Previously administered products included for Product used for unknown indication: FLU [INFLUENZA VACCINE] on 11-Oct-2022. Past adverse reactions to the above products included No adverse event with FLU [INFLUENZA VACCINE]. Concurrent medical conditions included Penicillin allergy.    On 31-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 29-Sep-2022 and was administered on 31-Oct-2022).    Concomitant drugs were not reported. Patient received Dose 1 of Moderna on 06-Jan-2021 lot number 012L20A. Patient received Dose 2 of Moderna on 03-Feb-2021 lot number 010M20A. Patient received Dose 3 of Moderna on 16-Nov-2021 lot number 077C21B.  The 2.5 ml individual vial was initially stored in refrigerator on 29-Sep-2022 and did not undergo any temperature excursion.  Treatment medications were not provided.
I have body aches,fever and chills.Also soreness at injection site.This lasted for36 hours and resoved by taking tylenol and ibuprofen
Received call this morning; 10/16/14 and informed she has severe joint pain in fingers, wrists, hands, elbows, knees: R>L. Bilateral hands swollen R>L. Pain not relieved by Aleve. Referred to PCP. Agreed to follow up with our office after evaluation/treatment from PCP.
Redness at site. 6cmx5cm raised area. Dr advised to apply cold and hot compresses and apply Benadryl Cream to site.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with doses of GARDASIL (dose and route of administration not reported) lot # K011562, expiration date 08-APR-2017, that were improperly stored. There were no adverse effects reported. Additional information has been requested.
Pt. states that after receiving the 1st dose of Pneumo Polysaccharide 10/20/2021, started experiencing symptoms 3 hrs later of soreness at the injection site and throughout to the elbow, tenderness, redness in the area with slight swelling, and fatigue. Soreness throughout the left side of the chest wall/ arm/ and armpit area. Primary communications recommendation of observation.
left armpit in arm tender swollen; left armpit in arm tender swollen; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received her first doe of bnt162b2 (BNT162B2 reported as PFIZER -BIONTECH COVID-19 VACCINE; lot number: Em9810; expiration date: unknown), via an unspecified route of administration left arm on 02Feb2021 10:30 at a single dose for covid-19 immunization. The patient has no medical history and known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included clarithromycin (CLARITIN), zinc, ergocalciferol (VIT D) and vitamins nos (MULTIVITAMINS reported as mtv). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 12:00 AM, the patient had left armpit in arm tender swollen. The events were non-serious, and no treatment was received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering.
Fatigue nausea headache flu like symptoms for 4 days after very sick, ibs pain in knee, now still fatigue ibs.
Patient started with a fever and headache on 3-9-17. Patient tested positive for flu B on 3/10/17.
Information was received 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX at a pharmacy on or about 24-JUN-2014, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused him to contract a persistent strain of herpes zoster. On or about 18-AUG-2016, the plaintiff was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The plaintiff had been prescribed VALTREX and "hydrochloride" for management of her painful symptoms. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Pt had 4d fever to 102 degrees, (R) leg pain & walked around 1d with leg giving out & rash on face 48 hr after PEDIARIX.
vasculitis; Rash All over Body; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 21May2021 at the age of 69-years-old (Lot Number: EW0167) as single dose for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), First Dose, Anatomical Location: Left Arm, on 30Apr2021 at the age of 69-years-old (Lot Number: ER8731) for COVID-19 immunization. Medical History included ongoing Diabetes, ongoing Heart Trouble; 7 Bypasses, ongoing Vertigo, ongoing Sleep Apnea, ongoing Restless Leg Syndrome, ongoing High Blood Pressure, ongoing High Cholesterol, Lyme Disease. Concomitant medication reported as: "Caller states he is on a bunch of medications, but he doesn't feel they are relevant because he has been taking them for a long time, quite a few years." Caller states he got the shot and he has a rash all over his body there are little red dots everywhere, even his privates. Caller states he has been to a Dermatologist and a Rheumatologist and they don't know what it is. Caller states they took a biopsy and 15 vials of blood. Caller states it has gotten bigger and it is spreading. Caller states one part is changing shape, some are all dots and some look like scrapes. Caller states the ones that look like scrapes showed up Saturday. Caller states the Rheumatologist had him stop a couple of his medications and he put him on Benadryl and it didn't do him any good. Caller states he went to the Rheumatologist again today and they took 15 vials of blood. Caller states he asked him the rash could be a reaction from the Covid shot but he couldn't be sure. Caller states the doctor prescribed Prednisone, it is ready for him to pick up, he wants him to take it for 4 weeks and see him in 6 weeks. Starting in June head to toe rash, little red doses. Indicates flat, do not itch. All over body including privates. Pink, fade out then red again. Since beginning of Jun2021. HCP initially indicate vasculitis. Potential Duplicate AE. Rash All over Body was reported as worsened. The patient experienced rash all over body in May2021 with outcome of not recovered, vasculitis on an unspecified date with outcome of unknown.   Follow-up attempts are completed. No further information is expected.
Problems with word retrieval since 1-2 days post MMR. Slower motor skills initially after MMR. Now they are good. Slower speech, less impulsive, not able to tell stories, less imagination.
The achiness and pain left me unable to get out of bed for 24 hours.  It was, honestly, the worst amount of pain I have ever experienced with a vaccine.  I got the vaccination around 10:15am and it was around midnight that the full effect hit me.  The pain was unbearable for 4-6 hours.  Then I was strong enough to get up to go to the bathroom for a Tylenol; it barely made a difference.   The nausea is so bad that, as I write, I still can't get myself to overcome the feeling to get something to eat.  I'm feeling a bit hungry but the nausea is stronger.
Patient observed at 1647 stating she was nauseous and anxious. Patient given emesis bag and then vomited. Assisted patient in wheelchair and taken to observation private area with guardian. Obtained a full set of vitals at 1650 as follows: O2 sat 98% RA, HR 71, RR 32, and BP 110/80. Encouraged patient to slow breathe in and out of bag. Another set of vitals obtained at 1700 as follows: O2 sat 98% RA, HR 89, RR 20, BP 110/75. Pt stated she was starting to feel better. Observed patient for another 10 minutes at 1710 vitals as follows: O2 sat 98% RA, HR 83, RR 26, BP 111/79. Assisted patient to a sitting then standing position. Patient's mom stated she thinks everything is okay..and she would monitor her at home. Explained to her to seek EMS if symptoms progress. Patient's mother Verbalized good understanding. Left site at 1718.
DEATH; HEART STOPPED; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date was not reported, 1 total administered 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 heart just stopped. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. Reporter stated that, "The vac killed my sister. Her heart just stopped" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart stopped was not reported. This report was serious (Death, and Other Medically Important Condition). This case is a duplicate of 20221239778.  It was determined that Manufacturer Case Number 20221239778 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20221237358.; Sender's Comments: V0: 20221237358- death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20221237358-Heart stopped. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report as received from a pharmacist refers to a 82 year old female patient. On 28-SEP-2013 or 29-SEP-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J000435, expiration date 10-APR-2014, dose, route not reported) in one arm and a dose of influenza virus vaccine (manufacturer unknown) (lot#, expiration date, dose, route not reported) in the opposite arm. On an unknown date the patient experienced severe itching under the skin at both the injection site of the ZOSTAVAX and the influenza virus vaccine (manufacturer unknown) as of 06-NOV-2013 ("today"). Patient had sought out medical attention on an unspecified date. Patient visited an unspecified dermatologist who prescribed anti-itch cream and hydrocortisone. Pharmacist stated that patient had been using unspecified anti-itch medication prior to receiving the ZOSTAVAX and unspecified flu vaccine. The outcome of the event was reported as not recovered. Additional information has been requested.
Eosinophilia and thrombocytosis, Dysautonomia, Tietze Syndrome, Intestinal Dysbiosis, Chronic Fatigue Syndrome with symptoms of myalgic encephalymyelitis, Cognitive impairment: loss of lexical-semantic functions, planning, executive, memory and attention Loss of vision with photophobia, Cervical adenopathies and axillary, ventricular extrasystoles, vestibular neuritis, Pseudo Guillain-Barré Syndrome, menstrual disorders (more bleeding, more pain, irregular in time). From 07/21/2021 to now 12/23/2022, and continue. 17 months.
Presented 1 day after vaccination with 5x7 cm induration at vaccination site, swelling and redness essentially resolved by 07/22/2004.
Paralysis, numbness face hands feet. Ambulance to ED on 10/02/2021. Symptoms continue in arms and hands. Doctor appointment and blood drawn.