chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This incident happened today sometime after 4pm. Patients mother is MD I work with and I noticed them in the waiting room. Nurse clinic has been very busy with patients flow for past few weeks with COVID RSV AND FLU vaccines. We are administering vaccines most of the day in clinic. ( back story I worked COVID clinic and I have administered to children before so this didnt feel like something I shouln't be doing) I drew up COVID vaccine for patient, sibling, and father when seeing all of them on schedule. I was in auto pilot from the busy afternoon. I called back all 3 together. Patient  sibling was crying and screaming because he did not want to get vaccine. Normally when this is the case  vaccine is administered as quickly as possible to avoid patient to get sticked with needle twice, waste a dose, or even get your self injured from patient kicking or stick self with needle.  Once given to all 3 patient sibling and father they left. Once I started to document I realized I made a huge mistake. COVID vaccine administered  should have never been given to patient.  I immediately called patients mother DO to inform her of the mistake that was made myself because I believed she should hear it from me and as soon as possible so she can look for any adverse reaction to wrong vaccine administered. As soon as I was off the phone with Dr I immediately reached out to CS via teams. After I didn't get a response within a minute or two I walked myself to admin to report my mistake to MOA. I explained to MOA everything that happened and she let me know next steps to take with report. I am truly very very sorry. I was working fast, its been a long week we are all so short staffed and I honestly was trying to make the visit as convenient as possible for Dr. whom I really enjoy working with. But today I learned convenience is not always safe for my patients.  I take full accountability  for what happened today.
Dizziness, feeling like in fog, chills, fatigue, fever to 100.9, headache, pain in arm of injection. Began about 04:00 AM on 2/28/21 and lasted until about 11:30 on 3/1/21 AM
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Numbness settled in 5 minutes after the vaccine. Patient has full range of motion with no pain. No pain at the time of injection.
Pt began to scream when arrived home approx 1 hr /p vax. Mom tried ear drops, rocking, walking, finally stopped crying 6-7pm. Pt did not sleep, Saw MD 1 wk later, gave Tyenol q4h X3 days. High pitched cry, no fever
So sick I thought I was going to die.  Heavy dizziness, so much so it was actually like a couldn't see.  Throw-up violently for 7 hrs.  The first one came on so stronge I couldn't even get 1 foot away before throwing up like the exorcist.  From then on it was every15 minutes. But if I was able to stay completely still it would stretch it out for 20-25 minutes.  Heavy sweating as well.  Major, major migraine and I'm use to migraines.  Very weak and tired, so much so my had to almost drag me up the stairs. Shivering but hot.  I got so scared with all the throwing up, I almost called 911 but I figured they just say I had a bug.  I'm also pretty stoic. At the 6hr point I did call my sister to come over. It never occurred to me it was from the shot because others I knew had no adverse affect, but apparently the paper included had the problems that could happen, I was told only about 1% get sick like this, so I didn't think it would happen to me because I never have adverse affects from meds. It got half better everyday till after 3rd day it was gone. I did tell my Dr. later when I saw her about it and she said she had been hearing this from a lot of patients.
This spontaneous report was received from a other healthcare worker refers to a 60 year old patient. On 07-MAY-2014, the patient was vaccinated with expired ZOSTAVAX lot # J002692 (expiry: 30-APR-2014), 0.65 ml, right deltoid subcutaneous. The reporter stated that the dose ZOSTAVAX had not been exposed to any temperature excursions. The patient did not reported or demonstrated any adverse effects. No additional information was provided. Additional information has been requested.
Positive COVID-19 test after full vaccination. Immunizations given 01/10/2021 and 02/07/2021.
Infection on the hand; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (Infection on the hand) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Hand surgery) on 08-Feb-2021.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced LOCALISED INFECTION (Infection on the hand). At the time of the report, LOCALISED INFECTION (Infection on the hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information included antibiotic. the patient stated that he developed an infection on it's hand and needed antibiotic.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up infomation received on 07-jul-2021  contains No significant information
pt woke up with redness at elbow fold, under breast and around neck the next morning after flu shot
p/vax pt exp bilat flank pain & flu-like sx: chills & upset stomach;the flank pain increased then decreased in severity lasting 2-3minutes;
pt recv vax 4JUN96  & w/in 24hr devel fever (subjective), fatigue, gen aching, nausea, emesis, & pain @ inj site
I developed a bruise that turned into a rash on my left side torso about a week after receiving my second Covide vaccine.  When it did not appear to be getting better on its own I sought treatment with a dermatologist.   A skin biopsy was done, and  I  was diagnosed  with Morphea.  Diagnosis was about 6 to 8 weeks after Covid vaccine.
Becoming acutely dizzy, light headed, nausea, head ache, diaphoretic, feeling like about to faint
Severe chest pain on the left chest area; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Feb2022 13:00 (Lot number: FM0698) at the age of 40 years as dose 1 (tris), single for covid-19 immunisation. Relevant medical history included: "Thalassaemia minor" (unspecified if ongoing), notes: Other medical history: Thalassemia minor; "Known allergies: Shellfish" (unspecified if ongoing), notes: Known allergies: Shellfish, mango and mango tree sap; "Known allergies: mango and mango tree sap" (unspecified if ongoing), notes: Known allergies: Shellfish, mango and mango tree sap. Concomitant medication(s) included: CLARITIN ALLERGIC. The following information was reported: CHEST PAIN (non-serious) with onset 01Mar2022 16:00, outcome "unknown", described as "Severe chest pain on the left chest area". Therapeutic measures were not taken as a result of chest pain.  Additional information: Patient had no covid prior vaccination and covid was not tested post vaccination.
On 07/27/2002, child having fever of 104 deg F. and sometimes higher, rash all over, some swelling of neck and cheeks, no appetite, not sleeping well. He was seen in ER on 02/27/2002. Physician stated it was measles (after examinations). On 03/04/2002, mom stated child was seen by family doctor on 03/01/2002. Measle test not back but x-ray showed some fluid in the lungs. He was put on Albuteral and Zithromal. On 03/04/2002 mom stated rash is almost gone and fever is down.
Client reports that arm became swollen around the injection site several hours after the injection.  The day after the injection (10/11/19) the arm was red, swollen, and hot to the touch down to her elbow and she began to develop a vesicular rash.  On 10/12/19 the rash extended down the left side of her of her torso.  I spoke with the client on 10/16/19, she said that symptoms had resolved.
R facial numbness x 1wk, onset 5 days after receiving vaccine. Constant. Mild.
Developed Raynaud's Phenomenon in the hand of the arm that received the vaccination.; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in Arm Left on 18Mar2021 at 11:45 (at the age of 33-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included known allergies to latex, red dye, and tree nuts and past drug included PCOS, and LHON. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was a clinic. On 20Mar2021, patient experienced Raynauds phenomenon in the hand of the arm that received the vaccination. Device Date: 17Jun2021. There was no treatment for the event. The adverse event resulted in a visit to doctor or other healthcare professional office/clinic. The event was assessed as non-serious. The outcome of event was not recovered.
TMM: Patient#1 COVID 1/6/21. Subsequently developed Covid (sx  onset 1/13/21 and tested positive 1/14/21). Has competed 10 day quarantine and all sxs have resolved. Patient is back to work. Patient is scheduled for #2 vaccine dose 1/27/21.
1" dia red spot at injection site that itches and warm, 9 days post vaccine.
Nose is running; Aching all over the body; Fever 100.5 F after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Nose is running), PAIN (Aching all over the body) and PYREXIA (Fever 100.5 F after 2nd booster) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Home test was positive) on 05-Jan-2022. Concurrent medical conditions included Immunocompromised and Asthma (uses Advair Discus inhaler). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for Asthma.   On 06-Apr-2022, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2022, the patient experienced RHINORRHOEA (Nose is running), PAIN (Aching all over the body) and PYREXIA (Fever 100.5 F after 2nd booster). At the time of the report, RHINORRHOEA (Nose is running), PAIN (Aching all over the body) and PYREXIA (Fever 100.5 F after 2nd booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2022, SARS-CoV-2 test: positive (Positive) Home test was positive. On an unknown date, Body temperature: fever 100.5 f Fever 100.5 F.         No information on treatment medications was reported.  Patient received 5 doses of Moderna vaccine (3 primary doses and 2 booster doses).   This case was linked to MOD-2022-539790 (Patient Link).
12/20/22 presents to ED for "hypotension" "fatigue". PMHx of "dementia".
painful erythematous indurating diameter 5.0cm, localized on the lt deltoid area;
Patient was given injection. Approximately 5 minutes later, he passed out momentarily. He woke up immediately, sat down and then experienced seeveral more fainting spells. We laid him down and raised his legs to force blood pool back toward head. Called 911. They arrived--checked him--portable cardiogram, blood glucose count and bp test. Called their reference MD and said that he appears OK.  Advised mother to watch him tonight and in the am for any more problems if they would occur.
ActHIB was reconstitued with a sterile water diluent not supplied in ActHIB packaging; Initial information received on 03-Jun-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demography who received vaccine HIB (PRP/T) VACCINE [ACT-HIB] and reported that ActHib was reconstitued with a sterile water diluent.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of potential medication error due to wrong solution used in drug reconstitution.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report was received from a medical assistant refers to a 9 week old male patient. On 05-MAR-2014, the patient was vaccinated with ROTATEQ (Lot# J008752, expiry date 26-NOV-2015) series of 2 ml, oral. On 11-MAR-2014, the patient experienced diarrhea. The patient mother was instructed to take the stool sample to the lab by the physician. On 13-MAR-2014, the stool sample was taken to the lab. On 15-MAR-2014, the result of the stool culture was negative. The result for stool sample for rotavirus was positive. On 15-MAR-2014, the patient was diagnosed with rotavirus by the physician. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
EXTREME FUSSINESS, RARELY EATING/VERY LITTLE AT EAT FEEDING, DIFFICULT TO CONSOLE, SPITTING UP, UPSET STOMACH. ALL LASTED FOR 9 DAYS. WITH IN TWO WEEKS OF VACCINATIONS, SHE BROKE OUT WITH ECZEMA AND STILL HAS IT.
JAUNDICE; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate with unspecified race and ethnicity. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.71 kilograms, and height was 51 centimeters. The patient's pre-existing medical conditions included: The baby has been overall healthy with no birth defects; genetic or inherited disorders have been diagnosed. The patient's parent's medical history included anxiety, the mother had no relevant obstetrical history and no history of alcohol, tobacco or recreational drug use, the mother's first day of the last menstrual period (LMP) was calculated to be 12-Aug-2020.  At gestational age 34 weeks and one day, the patient's mother initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: 042A21A and expiry: Unknown) dose was not reported, 1 total, administered on 08-APR-2021 for covid-19 immunisation. The patient (baby) received it via transplacental route exposure. Maternal concomitant medications included prenatal vitamins. On 08-APR-2021, the patient experienced fetal exposure during pregnancy. At gestational age 40 weeks and two days, the mother delivered vaginally a live, full-term, male neonate. The mother spent three days in the hospital for the delivery. The neonate's birth weight was 8 pounds and 3 ounces and body length was 20 inches. On 25-May-2021, the neonate was hospitalized due to jaundice, the duration of hospitalization were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 21-MAY-2021, and the outcome of jaundice was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2., and jaundice was related and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210728807.; Sender's Comments: V0: 20211112636-COVID-19 VACCINE AD26.COV2.S- Jaundice. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20211112636-COVID-19 VACCINE AD26.COV2.S-Fetal exposure during pregnancy. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
dizzy, nausea, eyes blurry (no anaphylaxis);pt seen by ER MD;
8 days after receiving my first dose of the Moderna COVID-19 Vaccine EUA, I had a small, red circular rash on my arm. The rash was itchy but not painful. The next morning I woke up, the red rash spread down the length of my upper arm, and covered most of my upper arm where I received the injection. The rash was itchy, but not painful. The rash was on my arm for the next 2 days.
1 week after 1st dose, dizzyness that lasted 6 weeks, after 2nd dose caused inflammation throughout arm, back. affecting ability to use arm
arm pain; a little uncomfortable; fatigue; tired; breathing issues; The initial case was missing the following minimum criteria: Adverse event NOS. Upon receipt of follow-up information on (20Feb2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.     A female patient of (Age: 79; Unit: Unknown) received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization.  Medical history included ongoing asthma and reflux; patient had Covid virus from Mar2020 to an unknown date, Patient was tested for antibodies over the summer and had antibodies, patient had no idea how much, the test indicated presence of antibodies. The patient's concomitant medications were not reported. After about an hour of vaccination, patient had arm pain, a little uncomfortable. Patient reported she iced arm, and kept icing arm, at night was uncomfortable, the next day, had a little problem but it was okay, she could raise arm. And she states that she was told, and read that she should just keep exercising arm, back and forth up and down, it seemed to help and went away and by the day after it was gone. I was a little usa and had to lie down. Patient had a little fatigue for 2 days or so and was having some breathing issues, but wasn't sure because she have asthma and reflux. Patient had a sensation when breathing, couldn't really tell you if she was short of breath or not, and was a little concerned, took antacids and it went away. that is why patient didn't think it had to do with the shot. It went away the next day, and didn't bother her at all, Patient feel her response was quite mild. Patient reported her left arm hurt a little bit, that was the arm she had the shot, and was tired. Patient reported she will be getting her 2nd dose on 23Feb2021. Patient had a sars-cov 2 antibody test recently and had no antibodies. Therapeutic measures were taken with antacids and ice (iced the arm).  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Patient reports that she developed redness, swelling and warmth in the area of the injections about 2 days after receiving it.
Patient reported slight headache after 15 minutes of being monitored. no other symptoms noted. patient stable upon discharge.
Red rash, more like a welt around it; Red rash, more like a welt around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Red rash, more like a welt around it) and VACCINATION SITE RASH (Red rash, more like a welt around it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Red rash, more like a welt around it) and VACCINATION SITE RASH (Red rash, more like a welt around it). At the time of the report, VACCINATION SITE URTICARIA (Red rash, more like a welt around it) and VACCINATION SITE RASH (Red rash, more like a welt around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 03-May-2021 included no new information; the patient did not consent to further follow-up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt had a hyporesponsive episode witnessed by a ped emergency room physician;pt was poorly perfused has had good HR & resp;
Information has been received from a licensed practical nurse concerning a 15 year old male patient who on 08/25/00 was vaccinated with a 1st dose of Hepatitis B vaccine recombinant. On 09/02/00, the patient developed generalized itching. On 09/04/00, the patient was seen by a physician and diagnosed with "acute contact dermatitis". Unspecified medical attention was sought. Follow up information from a licensed practical nurse indicated that the patient "complained of poison ivy" and was treated with "Mechal dose pak". Follow up information from a licensed practical nurse indicated that no additional info is available.
Horrid headaches for 3 days, body soreness 4 days, reduced cognitive function (speaking, forming sentences) and I got my period for 1st time in 5 years (and I have Mirena IUD).
Injection site soreness immediately after and continuing for days (to present at time of writing). At 12 hours after injection, feeling feverish, chills, crawling skin, full body aches. Feverishness and chills resolved after a night of sleep, and aches and crawling skin continued for one more day. Managed with rest, oral painkillers, and fever reducers.
Pt recvd vax & 15-20 second episodes of apnea @ home; none documented on hosp stay; normal exam;