chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 7-month-old female was admitted into the hospital on 12/25/2022. On 12/28/22, it was planned for the patient to be discharged. Prior to discharge, staff wanted to administer 4 catch-up vaccines (3 IM, 1 oral- Rotarix)- all 2nd doses. With notice that the patient's ride was suddenly here, nurses grabbed the 4 vaccinations to administer.  Rotarix was mixed at bedside and administered in a specialized vial with a different tip than the typical system. Nurse administered Rotarix vaccine intranasally instead of the standard oral route. Patient did not experience any apparent adverse effects. Current plan is for patient to receive another dose of Rotarix through the recommended oral route before the age of 8 months.
Head cold symptoms with bronchial and ear involvement.  Wheezing, thick mucous, cough, sneezing and diarrhea. Covid test negative.
Within 5 minutes of receiving COVID vaccine, she had SOB, throat tightness, coughing, itchiness. BP 182/91 HR106, RR 30. Lung were clear. Patient was given PO diphenhydramine 25 mg x1 with no change in symptoms. EMS on site evaluating symptoms. Repeat BP 142/100 HR 97, RR 22. Patient's symptoms continued to remain unchanged therefore EMS called for transport to local ED. One hour post initial event patient was being evaluated in ED with improvement of symptoms.
Got 1st covid vaccine 2/2/2021.  Stayed at site for > 45 minutes.  Was ok so she went home.  Later that afternoon at 430 pm she was feeling short of breath.  Not unusual for her, she has COPD.  Nose plugged up.  Thought the feeling would go away.  Did not sleep well last night.  Speaking in full sentences. Took her ventolin last night, did very little and then nebulizer last night.  Did another nebulizer treatment this am.  States breathing is "crappy".   Went to ED on 2/3/2021
Sore arm at injection site and headache at bedtime.; Sore arm at injection site and headache at bedtime.; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899) via unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. The patient experienced sore arm at injection site and headache at bedtime on 20Dec2020. Outcome of the event was recovered on unspecified date in Dec2020. No treatment received for the events. The events were assessed as non-serious.
Approximately 45 minutes after receiving the first dose of the Pfizer covid vaccine I entered my home and had my first syncopal episode, collapsing on the floor.  About 20min after the first episode I collapsed again.  Both times I had severe ringing in my ears and my husband said all color faded from my face and my lips turned blue.  I laid down for a couple of hours and felt ok.  For the past 6 days (days following the first dose). I have had a consistent headache as well as a stiff neck and general joint pain.
1 hour after vaccination patient felt dizzy and collapsed on kitchen floor.  Paramedics were called and patient transported to Medical Center.  Patient died several hours later.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age and gender (previously reported as child), patient with no pertinent medical history reported. On 21-NOV-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Narrative:  Patient presented acutely for rash. He originally thought this was poison ivy with itchy bumps on ankle/wrists. He was out raking in the yard. About  5-6 days later, he suddenly developed bumps across mid=section, numerous  bumps that were red, very itchy. No blisters. He has been using Hibiclense the past 3 days and applied hydrocortisone topically for relief, which seems to help.  He feels uncomfortable. Seemed to start a day after his second covid shot, so wonder if could be reaction. +Itchy. With first dose of covid vaccine, only had  transient, slight headache. Rash seems to be getter better. Degree of itching has improved. He hasn't needed hydrocortisone today. Rash is not painful. Not blistering. Rash only on anterior abdomen - does not involve chest or back. Lesions on legs, ankles/wrists are more like blisters. Looks more like his typical poison ivy rash. Blisters on ankle/wrists 3/27 COVID 2nd dose 3/31 Rash on trunk started 4/1 Patient prescribed triamcinolone cream 0.1% twice daily to treat rash on 4/6/21 by Primary Care Provider. Patient with NKA allergy history.  No additional info available as of 4/12/21.
Immediately after administration of vaccines, experienced "funny taste in mouth" with generalized tremors & nausea, BP 136/90, Pulse 96; Benadryl 25 mg 2 tabs given PO; Continued to experience tremors, lightheadness, nausea & frontal HA; When moved to wheelchair unable to maneuver right foot & bear wt; Transported to ER; IV started with Benadryl IV & Solu-Medrol iv given; Symptoms began to resolve post 1 hr 10 min, yes
Myopericarditis marked by chest pain, ECG abnormalities and elevated troponin (max 6.6). Normal coronary angiogram.
Arm pain is pretty bad.  It began 30-60 minutes after the injection and had steadily gotten worse. Injection site shows no redness or bruising, but the pain has been so bad it has interrupted sleep and is preventing me from being able to lift my arm or carry weight. 800mg Motrin and a heating pad seem to help, but I still have limited range of motion.  This feels similar to the ache from a tetanus shot, just worse.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients whose on an unknown date, were vaccinated with an improperly stored doses of GARDASIL (lot # L040459, expiry date 06-APR-2017). The vaccine was exposed to 51 degrees F for 7 hours and 30 minutes. No adverse effects were reported. This is one of two reports from the same reporter source (linked to MARRS# 1609USA009605). Additional information has been requested.
Patient who received a dose of the Moderna vaccine that had expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.  The health care professional thinks that the vaccine administered was the patient´s first dose, not completely sure.
Where the site was, it started to become a knot; red; very very hot; swelled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Where the site was, it started to become a knot), VACCINATION SITE SWELLING (swelled), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (very very hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (swelled) and VACCINATION SITE WARMTH (very very hot). On an unknown date, the patient experienced VACCINATION SITE REACTION (Where the site was, it started to become a knot) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE REACTION (Where the site was, it started to become a knot), VACCINATION SITE SWELLING (swelled), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE WARMTH (very very hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included Patient stated that she kept swimming and exercising because she read that online.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 18-NOV-2015 at time- 02:06, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 4.3 and 2.2 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
6 hours after vaccines he developed vesicular rash initially on bilat lower extremities w evolution to involve bilat upper extremities. vesicles superimposed on erythem papules -similar appearance to poison ivy or perhaps even varicella like. But no systemic symptoms, otherwise well
4mm blister at injection site. Received vaccination on Thurs. 9/26 and noticed blister on Sunday 9/29. Use antibiotic ointment on Monday 9/30. No pain with blister.
p/recv vax pt exp swollen area, big red hot welt, about size of big coffee cup, felt feverish & ill. treated at med ctr, antibiotic/benadryl
There has been a large lump in the patient's leg since the shot was administered on July 8, 2004.  The lump has gotten considerably smaller, but it is still there today.  The child was also feverish and cried for about 2 hours on the night that she received the vaccination.
the needle unscrewed and leaked; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on 25th November 2020).   On 28th May 2021, the patient received the 2nd dose of Shingrix (unknown). On 28th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, during administering needle unscrewed and leaked, which led to accidental underdose. The Healthcare professional would contact CDC for recommendations regarding revaccination scheduling. The reporter consented to follow up. The Healthcare professional agrees to postal follow-up.
Gardasil 9 was administered to a patient intramuscularly at the ventrogluteal site.; No additional AE/PQC filed.; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.     On an unknown date in June 2020, the patient received his first dose, on August 2020, his second dose and on unknown date on mid-November 2020, his third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) at a dose of 0.5 milliliter for prophylaxis, intramuscular at the ventrogluteal site (product administered at inappropriate site) (strength, lot number and expiration date were not reported). No additional adverse event/PQC filed
The wife of the patient stated "my husband has to get a booster shot of MMR II because there is an outbreak in our area; circumstances or information capable of leading to medication error; This spontaneous report was received from a consumer (patient's wife) referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were unknown.      On an unknown date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, anatomical location, route, lot # and expiry date not reported). The reporter stated that on an unknown date, the patient had to get a booster shot of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) because there is an outbreak in their area (product administered to patient of inappropriate age and circumstance or information capable of leading to medication error).
Positive LOC after administration, gradual return within 2 min. Positive bradycardia resps slow, slightly shallow: pt. enc. to take slow deep breaths, heart rate 76, skin slightly damp. Pt moved to supine position and symptoms resolved. Pt drinking fluids prior to ambulation.
Information has been received from a nurse practitioner concerning a now 19 year old female who in 2008 was vaccinated with the first dose of GARDASIL, IM. On 16-JUN-2010 the patient received the second dose (lot # 666118/1539Y), IM. On 16-JUN-2010, the patient experienced pain radiating "over the shoulder, to the elbow and finger tips" since the second dose was given, in addition, the patient experienced a rash, vomiting and fever. The patient did not have any reaction from the first dose, the patient went to urgent care center for medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
STUDENT PASSED OUT AFTER MCV4 AND TDAP SHOT. AFTERWARDS HE WALKED TO CLASSROOM AND THEN BACK TO NURSE WHERE WE WERE LOCATED. STATED HE DID NOT FEEL GOOD AND PASSED OUT. BEFORE NURSE COULD GET TO HIM SITTING DOWN HE THEN HIT THE FLOOR ON RIGHT SIDE OF FACE. COLOR PALE AND SWEATY. PULSE 124. RESTED ON FLOOR, WATER AND CHIPS WERE GIVEN TO HIIM. STATES THAT HE DID NOT EAT BEFORE COMING TO SCHOOL AND THAT HE HAD PASSED OUT BEFORE. RESTED. COLOR RETURNED TO PINK. PULSE 89 AND OXYGEN SAT 96. ALERT AND ORRIENTED X3. ASSISTED TO NURSE OOFICE AND NURSE WILL NOTIFY GRANDMOTHER. LEFT IN NURSES CARE.
sore arm- lasted about 3 days  redness, hot spot at injection site- developed within an hour and lasted 2.5 weeks hardness at injection site- developed within hours of being administered, still there at almost 3 weeks pain/tingling in arm developed within hours, lasted for a week headache- developed in both my husband and myself within an hour or so after injection, lasted until the next day  massively aching joints- developed the next morning, lasted 3 days
Information has been received from a physician and a hospital medical librarian concerning a 59 year old female who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not provided).  On 01-JAN-2009 the patient developed fever, joint aches, and mental status changes.  The patient was admitted to the hospital.  She was subsequently diagnosed with viral encephalitis.  The physician stated that the patient's cerebral spinal fluid had been sent for varicella zoster virus identification polymerase chain reaction testing and it came back positive for varicella zoster virus.  Some of the spinal fluid was still frozen and kept in the freezer if further test needed to be done.  The patient's viral encephalitis persisted.  Additional information has been requested. 2/3/09-records received for DOS 1/8-1/9/09 DC DX: Viral meningeal encephalitis unknown etiology. Mental status changes and fever secondary to #1. Fever resolved, and mental status changes improved. Admitted for evalutaion of one week of fevers, joint aches and 2-3 days increasing mental changes with word finding difficulties, confusion and balance issues.On 1/1/09 fevers, chilling, arthralgias migratory fashion.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: F14989) at the age of 74 years, in left 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's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Mar2017, stop date: Jul2022; NATURE MADE C, start date: Jan2010, stop date: Jul2022; NATURE MADE CALCIUM, start date: Jan2010, stop date: Jul2022; NATURE MADE VITAMIN D3, start date: Jan2010, stop date: Jul2022; NATURE MADE FOLIC ACID, start date: Jan2010, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Treatment received for COVID-19 as Paxlovid from 14Jul2022 to 18Jul2022.
Myalgia, Fever, c/o fatigue,chills,injection site sore Narrative:
SORE ARM; FATIGUE; FELL; This spontaneous case was reported by a consumer and describes the occurrence of FALL (FELL), VACCINATION SITE PAIN (SORE ARM) and FATIGUE (FATIGUE) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free,Solution for injection in pre-filled pen. In 2022, the patient experienced FALL (FELL). On an unknown date, the patient experienced VACCINATION SITE PAIN (SORE ARM) and FATIGUE (FATIGUE). At the time of the report, FALL (FELL), VACCINATION SITE PAIN (SORE ARM) and FATIGUE (FATIGUE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
On February 6 through February 8 I had severe diarrhea, followed by loose stools for several more days.  I lost 5 pounds.   It has taken 2 weeks to get my GI tract partially normal again.  I was wiped out of energy.
Case previously recorded as MA2009-4280. Initial case report received from a pediatrician on 04 NOV 2009. A 8 year-old male patient was vaccinated with 0.5 ml FLUVIRIN 2009/2010 (batch no 100813, expiration date 01 FEB 2010) i.m. on 02 NOV 2009, an off-label indication. No adverse event was reported. NA09-007607
I got my Covid vaccine on Wednesday, 5/5/21. That night I experienced the typical side effects (Chills, Aches, Pains, Soreness in the injection site on my right arm). By Thursday afternoon I was feeling significantly better. However, on Friday evening I started to feel a tightness and pressure in my chest and left arm and neck. The chest pain felt like I was having a heart attack but my heart rate was mostly normal. I felt shortness of breath  where I couldn't get a good deep breath in and I was also nauseous and had no appetite. At times I felt lightheaded and weak. These symptoms continued over the next couple days. On Monday 5/10/21 I decided to got to the ER to get checkout since I was still having chest pains and tightness. They ran a series of tests and concluded that I was just experiencing typical aches and pains from the vaccine.  My symptoms continued for another full week and at times the shortness of breath and chest pains felt really severe. By the following week I was starting to feel a little better on and off. I got my appetite back and and I was able to start exercising again. After about 2 full weeks after receiving the vaccine most of chest pain and pressure + shortness of breath has disappeared and I feel better.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L028279, expiration date 28-OCT-2016 (dose, frequency and route were not reported. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Day after vaccine, developed itchiness; Then I began breaking out in hives throughout my body; Also suffered from bouts of nausea and have trouble keeping things down; This is a spontaneous report from a contactable other HCP (patient) .  This 24-year-old female patient received,at hospital, the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19) intramuscular on arm left on 20Dec2020 (reported as at 02:30 PM) at a single dose for COVID-19 immunization.No Allergies to medications, food, or other products; No other Medical history Concomitant medication Omeprazole, Terbinafine. No Covid prior vaccination and no covid test vaccination provided . Day after vaccine, on 21Dec2020 at 12:00 PM, the patient developed itchiness. Then she reported "I began breaking out in hives throughout my body. Also suffered from bouts of nausea and have trouble keeping things down". The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was tretated with Steroid shot and was prescribed with medication for nausea.All events were reproted as non serious.The outcome of the events was recovering at the time of the report.  Information about lot/batch number has been requested.
few weeks after last dose started having increase in headaches and then numbness/tingling in hands and feet which spread to legs and torso. This lead to blood testing, MRIs and Lumbar Puncture to confirm diagnosis of MS with several lesions on the brain and spine.