chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received his flu shot and 15 min later he became pale and near syncopal. His hear rate dropped to 35/Min and blood pressure was 60/30. He was given juice after 45 minutes his color improved vitals came back to normal. After ambulating his symptoms returned pale weak he was sent to the ED via ambulance.
was unable to get to the appointment due to illness; She did get the second dose last week; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (was unable to get to the appointment due to illness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get the second dose last week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (was unable to get to the appointment due to illness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get the second dose last week). At the time of the report, ILLNESS (was unable to get to the appointment due to illness) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She did get the second dose last week) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-276077, MOD-2021-276077 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up received-Patient had received second dose hence event (missed dose) was changed to inappropriate schedule of vaccine administration.
Hive-like rash on left arm and neck with itching on both arms, neck and face. No SOB, no LOC, no lethargy. Treated with Benadryl.
acute flaccid myelitis, transverse myelitis or acute demyelinating encephalomyelitis
She got her vaccine, her arm was extremely sore for 2 days.  Then on Wednesday it was itchy real bad, and noticed a lot of tiny red bumps were on it at the injection site.  Each day more and more bumps appeared.  She then put alcohol and peroxide on it.  Then she put hydrocortisone and more bumps kept appearing.  She then took Benadryl and some of them are dried up and some are not.  Near her wrist  on her arm she thought was a cut, but now she has bumps in a line.  Every day she seems to have more and more of these, but is wondering if this is from the vaccine and if she should take the other vaccine.  She has called her doctor but they have not called her back, but she is going to go to Facility tomorrow.
1. During the night after the shot--Severe stomach pain woke me up and couldn't sleep 2. During the night after the shot--lots of blood in the pee, Pee was in dark brown color 3. Next morning---heart raising, cold sweat, couldn't move, dizziness, extremely week, severe stomach pain 4. urine test showed blood inside 5. Doctor diagnosed for kidney bleeding 6. Kidney kept bleeding for a month 7. Had to do urine test repeatedly 8. Stomach pain sometimes
aches and pains; patient has decreased range of motion of left arm; joint stiffness; chills; myalgia; fever; progressively worsening swelling at injection site; patient was positive for 3 centimeter raised injection site reaction that is tender to palpation; patient was positive for 3 centimeter raised injection site reaction that is warm to touch; Initial information received on 17-Aug-2021 regarding an unsolicited valid non-serious case from a physician via Medical Information (Reference number- 00727956).  This case involves a 34 year old female patient who experienced myalgia, fever (pyrexia), chills, joint stiffness, aches and pains, (pain), decreased range of motion of left arm (mobility decreased), progressively worsening swelling at injection site (vaccination site swelling), patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch (vaccination site pain) and (vaccination site warmth), while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 13-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6831AA and expiry date: 08-Oct-2022) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 13-Aug-2021, the patient developed a non-serious event "She returned to office on 17-Aug-2021 with complaints of progressively worsening swelling at injection site" (vaccination site swelling), myalgia, fever (pyrexia), "physician states on physical exam patient was positive for 3 centimeter raised injection site reaction that is tender to palpation and warm to touch" (vaccination site pain) and (vaccination site warmth), on same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  On an unknown date, the patient developed a non-serious decreased range of motion of left arm (mobility decreased), joint stiffness and aches and pains (pain), (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.  Physician reports patient has no hives or urticaria, no airway compromise, and no shortness of breath.   It was reported that "Physician states patient is not pregnant -Last menstrual period: 30-Jul-2021. Due date AE (adverse event) symptoms or no AE. If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food and drug administration) requirement".  Details of laboratory data not reported.  Physician also states he recommended Ibuprofen, Tylenol (Paracetamol) and rest.  At the time of reporting, the patient had not recovered from the all events.
Caller states someone she knows got Covid-19, was vaccinated, and then got Covid-19 again. Caller unsure which Covid-19 vaccine this person received.; Caller states someone she knows got Covid-19, was vaccinated, and then got Covid-19 again. Caller unsure which Covid-19 vaccine this person received.; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A patient of unknown gender and age received unknown dose of BNT162B2 (COVID-19 VACCINE MANUFACTURER UNKNOWN, formulation: Solution for injection, lot number and expiry date not reported), via unspecified route on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medication was not reported. The patient was vaccinated and then got Covid-19 again (coded to drug ineffective). It was unsure which Covid-19 vaccine this patient received. The outcome of both the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
pt recvd vax & 2 days later exp a yeast infect w/vaginal bleeding; treatment OTC yeast infect product;
Information has been received from a certified medical assistant concerning a 11 year old female who on 19-APR-1996, was vaccinated with a subcutaneous dose of Varivax (Oka/Merck). Concomitant therapy included methylphenidate HCl (RITALIN). On 05-APR-2006, the patient broke out with 25 varicella lesions all over her body. She did not have a fever and no treatment was given. As of 05-APR-2006, the patient was recovering. No laboratory or diagnostic tests were performed. Follow-up information from a physician indicated that on 02-APR-2006 the patient developed chickenpox, which she then transmitted to her mother (WAES# 0609USA06665). It was noted that the patient was seen in the physician's office. It was reported that the patient had recovered. Additional information has been requested.
Case number PHEH2044US003645 is an initial spontaneous report from the pharmacist receive don 21 FEB 2014. This report refers to a 16-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number 006031A, expiry date: JUN 2014) at a dose of 0.5 ml intramuscularly on 11 JAN 2014. No adverse event reported following the medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Pt recv vax on 10/28/98; on same day pt exp unconsolable/ high-pitched crying, sore vax sites
Night of shots, aches, tired, soreness at site, minor chills.  Next day..more sorness at site, more aches..fever of 100.6 by 7PM 1-7-2010
After the observation time passed, I drove back home (7-10 miles). Syncope in vehicle one hour after injection. Intense vomiting resulting in several episodes of syncope for the next 36 hours.
ADMINISTERED PAST THE CURRENT REFIRIGERATION BEYOND USE DATE AS LISTED IN EUA
Staff member completed the form and answered yes that she was 18. Writer asked her if she was 18 and not pregnant. She stated yes. Writer did not check her actual birthdate due to her responses and she was administered the 1st dose of the Moderna COVID vaccine. This error was recognized the next day and was reported to our medical director. He advised that she will be ok due to her being close to 18 and data has shown that this vaccine may be given to those under 18 soon. He advised that she follow up with her primary care provider. He stated that this was not an adverse reaction and not to report to VAERS. Upon further investigation and after the staff member was seen by her PCP on 03/25/21, it was advised to report this to the VAERS. Her doctor also is requesting she get the second dose and wrote her a letter and prescription to receive the dose on the appropriate date. She has had no adverse reactions. She did have mild symptoms reported the day after the vaccine.
7 days post MMR, pt exp fever x 4 days up to 105.9; taken to ER & cooled & hydrated til temp 102 then send home; 3-4 days fever subsided & light body rash erupted;
Rash all over body from neck to feet. Saw Dr Monday 10/17/2011 @ 4:15 pm, patient was on Predisone 40 mg. for 4 days then taper down to 10 mg for 4 days and than stop. Allegra 180 mg 1 daily. Benadryl 2 teaspoons at Bedtime. Rash worse went to Er 10/20/2011 put on steroids at higher dosage 50 mg for 5 days/ 2 teas. Benadryl every 4-6 hrs for 3 days and see dermatologist Monday. Saw Dr 10/24/2011 and she also agreed that the rash was from the flu shot. Put on Topicort BID and take Allegra wean off steroids. If rash becomes worse return to office.
This spontaneous report was received via a company representative from a 73 years old female patient regarding herself. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date few years ago the patient was vaccinated with ZOSTAVAX (dosing details were not reported) subcutaneously. Recently on an unknown date the patient developed shingles. The reporter also stated that the shingles rash developed around her eyes and was very painful which lasted for 8 weeks. The patient sought medical attention by visiting physician. The patient acquired multiple very expensive medical bills as a result of the shingles. The outcome of the event ophthalmic herpes zoster was reported as recovering. The reporter did not provide the causality assessment between the event and the suspect therapy. Upon internal review, ophthalmic herpes zoster was determined to be medically significant. Additional information has been requested.
Intense knee pain where previous ACL replacement surgery performed 23 years ago, using patellar tendon and titanium screws. Arthritis and bone spurs present but do not cause any usual daily pain unless resulting from intense physical activity or injury.  No activity performed that should have caused any pain.  Difficulty walking without intense pain.  No swelling at site.  Pain subsided and flexibility returned after three days.
Rash and intense itching at injection site. It is very red, inflamed, raised and itchy.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperature excursion was reported as from 15°F to 46°F (33.9°F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for varicella virus vaccine live (oka/merck). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA012813.
Shingles; Blood pressure was 219/98; Excruciating pain; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 61 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 04Oct2021 15:00 (Batch/Lot Number: FE3592) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included , surgery from an unknown date and unknown if ongoing She had recently had surgery about 100 days before the covid shot. The patient's concomitant medications were not reported.  The patient experienced shingles by herpes zoster on 08Oct2021 with outcome of not recovered , blood pressure was 219/98 leading to hypertension on 08Oct2021 with outcome of unknown and excruciating pain on 08Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement at 219/98 on 08Oct2021  Follow-up (20Oct2021): Follow-up attempts are completed. No further information is expected.
VOMITING 1 CUP BRIGHT ORANGE VOMIT; SUBSEQUENT VITALS: SPO2: 99% HR 85 BP 125/83 RA TEMP 98.4 F ORAL. COLOR RETURNED TO FACE AFTER CRACKERS AND WATER. PATIENT REPORTS SHE DID NOT LOSE CONSCIOUSNESS, HAD NOT EATEN TODAY AND STARTED HER MENSTRUAL PERIOD SAME DAY. TAKEN TO DOCTOR FOR PHYSICAL AFTER VACCINE ADMINISTRATION.
I started itching after 48 hours (evening oct22nd) then developed small raised itchy welts. The itching was initially restricted to ears, under arms, in groin area and side of waist. The itching gradually increased over next few days(23rd oct) with the welts becoming more raised into hives.  Evening and morning are the worst for itching. The hives have spread much further over  my torso, back, kneck. Hives in head have turned into rigid bumps today (oct27). I had ro start taking Benydryl (oct 27th) as the itching and hives have become worse. I have experiencec no other symptoms, except for injection site soreness for one day.
On 3/3/21 patient called in the afternoon. She had just returned home from the cancer center for her treatment. She stated early in the am of 3/3/21 her arm started itching and later in the day on the back side of her arm there was a red rash from shoulder to elbow. Her doctor noticed it and told her she should report it. Otherwise she felt ok. No other symptoms noted
Four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unspecified date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The physician reported that four Moderna vaccine doses were administered from vials which had been more than 6 hours post initial puncture.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event had four Moderna vaccine doses that were administered from vials which had been more than 6 hours post initial puncture was considered resolved on an unspecified date.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Out of specification product use.
Left arm is swollen at the injection site and shows some redness and slight warmness to the touch.
Mom reports today (9-28-23) that after receiving vaccines on 8/3/2023, child had a fever and rash all over her body and family took her to the ER around 8-4-2023. Mom says the ER doctor said it was from the vaccines. Child was not admitted to hospital, was sent home. Have not been able to get records from the hospital, have called mom to get ROI sighned but mom has not returned phone call.
Developed lump on R arm at site of vaccine. Surgical excision was: angiomatoid fibrous histiocytoma with cellular atypia. Required re-excision due to malignant potential of this lesion. Lump excision was over 6 yrs after vaccine administration.
Headaches, 104 tempature, vommitting, Diarahea, hallucinations
On April 26th My mother collapsed after having an extreme pain event involving her chest,  neck and back.  Prior to the day of fainting she had had exhaustion and flu like symptoms with a runny nose. The pain was so extreme she thought she was having a heart attack. After fainting she went to lie down and the following week continued to rest in bed with the chest pain. On May 3rd she finally went to the emergency room.
45 y.o. male with a past medical history significant for DM2, hypertension, HLD, BPH, celiac disease, asthma/COPD, and solitary kidney. He presents today with complaints of retrosternal chest pain which acutely onset today around 1500. Pain is constant and associated with SOB, myalgias, weakness, and fever with t-max 101.7. He tried some tylenol with minimal relief. Patient reports his child has RSV and he initially suspected this but was concerned when chest pain persisted. He reports a suspected history of COVID-19 back in February for which he quarantined but did not get tested. In the interim, patient was diagnosed with celiac disease and obtained the first dose of Moderna vaccine two months ago. States the vaccinate made him break out in a "shingles like" rash over joints (knees elbows, ankles). Rash has persisted for two months requiring biopsy. He has therefore decided to forego the second dose while he is worked up for this reactive rash. SARS-CoV-2 positive on 10/12/21.
Patient received second dose of COVID vaccine on 02/19/21.  That evening, she experienced weakness in her legs and her legs wouldn't support her.  She fell down and ended up sleeping on the floor all night.  She was able to stand this morning, 02/20/21 and feels fine.
FLU-LIKE SYMPTOMS, VERTIGO, FATIGUE, ACHES IN ALL MAJOR JOINTS - ALL LASTING FOR 5-6 DAYS - RESOLVED ON ITS OWN OVER TIME.
STROKE; This spontaneous report received from a patient concerned a 58 year old female. 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: Unknown, expiry: unknown) with unspecified dose, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On 14-MAR-2021, 2 days after administration of vaccine, the patient had stroke, and the patient was hospitalized on an unspecified date for unspecified duration and had since made a full recovery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428874-Covid-19 vaccine ad26.cov2.s -Stroke. This event is considered unassessable. 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.
She was vaccinated, that I recall, twice after being born. The first was at the Health Dept. and the second was at the doctor's office.   She had a reaction to the first set given at the Health Dept. of vomiting and diarrhea, fever and inconsolable crying. So the doctor suggested we have the second set done in the office.   The evening of the second set she started running a high fever, her body was covered in a red rash and she was screaming a high pitched scream and had projectile vomiting and she would not nurse.  As the evening progressed she became very lethargic. She laid in my lap very limp and in like a daze and seemed to have labored breathing.  We had no insurance or money at that time and I kept calling the ER for direction through the night. I was waiting for the doctor when the office opened the next morning and he took her immediately in and said that she had experienced an allergic reaction to the vaccination. We monitored her and she recovered.   She has not had any other vaccinations to this day  and will not have any!   Not sure of the date and time but it was around the end of '95. She was born in October so however long after it would have been for a second series of shots. She was between 8-10 weeks old I would say.  And not sure of exactly what they gave back then. It was a series for newborns whatever that would have entailed. I had to enter something on line 13  but not sure of what all was given. Sorry.   I just heard about this website and felt I needed to convey this information even at this late date because it was a very scary incident with extreme adverse affects. It has affected my child in not being able to have any updated vaccinations and causes problems for school records, etc.
Aches; chills; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events aches, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not available) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced the event(s) aches, chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), aches, chills was unknown.