chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was pregnant at the time of vaccination; The patient was pregnant at the time of vaccination; Miscarriage; This is a spontaneous report from a contactable consumer (patient, self-reported). The patient reported information for both herself and fetus/baby. This is a maternal report. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID, prior vaccination. The patient was not tested for COVID post vaccination. The patient was pregnant at the time of vaccination. The Patient's last menstrual date was 09Jan2021 and delivery date was 16Oct2021. The mother reported she became pregnant while taking BNT162B2. The mother was 14 weeks pregnant at the onset of the event. It was reported that on 21Apr2021, the pregnancy resulted in spontaneous abortion- miscarriage and resulted in emergency room and physician visit. Outcome of the event miscarriage was reported as not recovered and for all other events, it was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a pharmacist via a company representative refers a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (Vial 19400 PFU) (lot, dose and route not reported). Concomitant medication was not reported. On an unknown date, the patient experienced allergic dermatitis on the arms after receiving ZOSTAVAX. The patient went to an unspecified physician and was placed on an unspecified steroid to treat the allergic dermatitis. The outcome of allergic dermatitis on the arms was not reported. This is one of two reports from the same source. Additional information has been requested.
PARENT PROVIDED WRONG BIRTH YEAR SO THAT CHILD COULD RECEIVE THE VACCINE. NO ADVERSE EVENTS REPORTED.
6 days post injection, large (2inchx3inch) hard red bump, warm to touch, very itchy, numb at surface
SWOLLEN, PAINFUL ARM, RED STREAKS ON ARM - OCCURED DAY AFTER VACCINE WAS ADMINISTERED. PATIENT WENT TO ER, ER DOC GAVE SHOT OF ANTIBIOTIC (PER PATIENT)AND SENT HER WITH A PRESCRIPTION FOR CEPHALEXIN 500MG FOUR TIMES DAILY AND INSTRUCTIONS TO FOLLOW UP WITH HER FAMILY PHYSICIAN.  PATIENT HAS AN APPOINTMENT WITH FAMILY DOC MONDAY (5 DAYS AFTER EVENT).
Patient had influenza vaccine 10/27/09. Began feeling sick within that 24 hours. Returned to clinic 11-2-09 with complaint of cough, stuffy nose, sore throat. Quarters for 24 hours, Benzonatate & ROBITUSSIN DM. Returned 4 Nov. 09 with fever & sore throat - worse. Given  amoxicillin & subsequently recovered.
expired PENTACEL vaccine administered to a patient, No AE; Initial information was received on 06-Jul-2021 regarding an unsolicited valid non-serious case received from an other health professional (Medical assistant) via Physician (Inquiry Number: 00669898).  This case involves a three months old patient gender unknown who was administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On 05-Jul-2021, the patients received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE Formulation: Solution lot number: UJ334AA and Expiry date: 13-Jun-2021, Frequency: once, Strength: standard via intramuscular route in the right thigh for prophylactic vaccination.  It was case of an actual medication error due to expired vaccine use (latency: same day).  It was reported "Medical assistant calling to report that three patients were given expired PENTACEL vaccinations on 5-Jul-2021. Caller stated that all the vaccines were given intramuscularly in the right thigh. Pasteur Adverse Event Reporting Refunds/ Credits will not be issued due to adverse events. Emergency Room/ Doctor visit and date 05-Jul-2021. Reporter relationship: Caregiver, Product used: Used, First time product used: No, Still using product: Yes and Was Device Used: No."  At the reporting, no adverse event was reported.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.; Sender's Comments:  US-SA-2021SA230547:
Light headaches started the second day after the second vaccine injection and sill lasting after two weeks I did not take any treatment for the effect
10 days after shot I have a 4 inch round redness that is hot around injection site
Too young to receive vaccine.  The year of birth on screening form was 2003 both for the first dose(lot EL9261) on 1/21/2021 and for the second dose (lot EL9269)on 2/11/21.
After Booster on December 27th, 2021 within 2 1/2 weeks on January 13, 2022 mother suffered a severe Ischemic stroke and was hospitalized for 4 days and then put into a Rehabilitation Facility and will most likely not be discharged.
FIBROMYALGIA; BLEEDING NOSE; COLD; SORE AFTER RADIO FREQUENCY PROCEDURE; This spontaneous report received from a patient via a company representative concerned a 47 year old female. The patients height, and weight were not reported. The patients concurrent conditions included rheumatoid arthritis. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number was not reported) dose, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included adalimumab for rheumatoid arthritis. On 2021, the patient experienced fibromyalgia, bleeding nose about a week and a half, cold about a week, and sore after radio frequency procedure. In Mar 2021 patient had a radio frequency procedure completed on lower back and was sore afterwards The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from bleeding nose, and cold, had not recovered from fibromyalgia, and the outcome of sore after radio frequency procedure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210508103- COVID-19 VACCINE AD26.COV2.S -Fibromyalgia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 20-OCT-2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage, and route of administration not provided), at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
After recovering from Covid, Our 15 year old went for Booster Shot. 24 hrs after receiving the Booster he was Cold and had a headache. 48 Hours after the shot he had high fevers 103.7 for 3 days, had night terrors, sweat through sheets and then broke out in a full body rash.
Cellulitis. 12 7/8 right leg, 11 7/8 left leg. Augmentin 600 4cc/Benadryl 1/2 tsp TID
Information has been received from a physician concerning a male patient under 65 years old who on an unspecified date was vaccinated IM with a dose of PNEUMOVAX 23 (lot # not reported). On an unspecified date the patient got headaches, dizziness, myalgia and edema. At the time of reporting, the patient's headaches, dizziness, myalgia and edema were recovering. Headaches, dizziness, myalgia and edema were considered to be other important medical events by the physician. Additional information has been requested.
Sleepiness, Headache, Extreme Rash on arms, legs, head, & ears
Joint aches and pains. headache, eye pain, aching testicles, light headedness, and fever.  Symptoms diminished to headache and slight joint pain after 24 hours.
BURNING PAIN IN THE CHEST AREA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose was not reported, administered on 28-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced burning pain in the chest area, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the burning pain in the chest area and headache was not reported. This report was non-serious.
back pain; HYPOAESTHESIA; PARAESTHESIA; Information has been received from a registerd nurse and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N020353, for prophylaxis(strength, dose, frequancy, lot # and expiration date wete not provided)  On an unknown date, the patient experienced numbness and tingling in all four extremities and back pain. At the reporting time, the outome of the event was unknown.  The causality between the aforementioned events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.; Sender's Comments:  US-009507513-1808USA004811:
Today I began itching at the exact spot the injection was given.  I rubbed it and the more I rubbed the spot the more it ached and itched.  Later when I looked at the injection spot, I noticed a 3-4 inch in diameter red spots like hives or shingles.  The place is a circle.  Rem8indes me of shingles but I've had both shingle shots over a year ago and never had problems.
Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; Swollen eyes, face, lips, hands, left leg and ankle; This is a spontaneous report from a contactable consumer.  A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0177), dose 1 via an unspecified route of administration, administered in left arm on 30May2021 at 12:00 (at the age of 40-years-old) as dose 1, single for COVID-19 immunization. Medical history included orange allergy. The patient was not pregnant at the time of vaccination. The patient had not been tested for COVID-19 nor before neither since the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID-19 vaccine. No concomitant medications was reported. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced swollen eyes, face, lips, hands, left leg and ankle on 30May2021 at 17:00. Treatment include Benadryl. The outcome of the events were not recovered.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Onset occured 5-7 days post 2nd dose of vaccine. Developed intracranial hemorrhage / hemorrhagic brain bleed causing death.
Baseball sized hives all over my sons body. Fever, swollen bumps all over body, aches.
I am 38 years old with no history of medical problems. I do NOT have a history of miscarriages and have one healthy child who is 22 months old.   On 1/13/21, I took a home pregnancy test which came back positive. At that time, I had a missed period but also had several common pregnancy symptoms such as bloating, acne, fatigue and tender breast. later that week, I called OB/Gyn and spoke to an RN to schedule my 8/9 week ultrasound and to inquiry about the vaccine during pregnancy since I had no clue whether it was recommended/safe or not. the RN, very confident and without any disclaimer, stated that hospital is recommending all of their pregnant patients to receive the vaccine. Obviously, I decided to trust this medical professional who was so confident in her response.  My normal pregnancy symptoms continued. On 1/19/21, I was 5 weeks pregnant and received my first dosage of the vaccine. felt fine other than a sore left arm. on 1/20/21, I woke up with a lot of abdominal cramping and pain. It was new to me but assumed it was normal. My cramping and pain continued until 1/21/21. On 1/21/21, I woke up without the cramping and pain. But, I also noticed that my breast were no longer tender and my skin had completely cleared up. I became concerned but prayed everything was fine since my home pregnancy test was still positive. On 1/22/21, by cramps continued once again but more mild. My pregnancy symptoms seemed as if they were no longer present but remained hopeful. On 1/23/21, I woke up with light spotting that only lasted through the morning. Soon after, I started having extreme abdominal pains. I prayed everything was fine. The pain continued and became worse. That night, the pain was so bad that I just went to bed. Right before going to bed, I noticed I had started spotting again. A little heavier than in the morning. I made sure to lay on my left side, hoping it was normal in pregnancy. On 1/24/21, I woke up with heavy bleeding and clotting. I went to the doctor and got an ultrasound and blood test. I was told by the doctor at Hospital that I had a miscarriage.
Person became nauseated immediately after receiving vaccine in the evaluation area. Upon evaluation, Firefighter/EMT and this nurse noted inspiratory wheezing on auscultation. At 10:20am, this person's O2 sat was 92%.At 10:23 am, person's O2 sat rose to 98%, but saturation fell to 93% at 10:28am. Person stated she is diabetic and hypertensive.  Person stated she took her accucheck at 08:30 am this morning and it was 145.  EMT repeated accucheck  at 10:40am, and it was 148. Person was cold, and blanket applied for comfort. Paramedics were called, and person was transported to hospital.
Elevated BP and Heart Rate.  BP was 155/95 and beats per minute was over 120
My Blood platelet count rose from 78, to 785 within one month. (I have ITP for 35 years).
Mother states that around noon on Thursday, 10/9/03 her son had red, itchy blotches on his face and torso.  She used some cortisone spray to help relieve the symptoms.  Later in the evening around 9:00 to 9:30 p.m., the itching had gotten worse and she went next door to get some Bendadryl.  By the time she got back, his face appeared very red and blotchy, which appeared to be hives.  She called a minor emergency clinic at 10:00 pm, but the doctor had already left; the nurse told the mother to take her son to the hospital emergency room.  The parents took him to Hospital.  By the time they arrived the benadryl had started working and some of the symptoms had decreased.  Did not have any respiratory symptoms.  They treated him for an allergic reaction.  I spoke with the mother and recommended that she call her son's medical provider to inform her of the reaction.
This spontaneous report was received from dietician and refers to a 4 month old female patient with no pertinent medical history, concurrent conditions or drug/reactions allergies. On 15-JUL-2014 the patient was vaccinated with ROTATEQ dose 1, intramuscular in the patient's right tight (lot number reported as A41FD390A). It was unspecified which thigh the ROTATEQ was injected into. 23-SEP-2014 while the patient was at the physician's office to receive the 2nd dose of ROTATEQ, (the physician noted that the "joint tissue on the left hip area was loose (onset date was unknown), (The 2nd dose of ROTATEQ was received via the oral route by the patient on 23-SEP-2014.) The patient has not recovered. Additional information has been requested.
Shot was Friday 28May21 12:50 pm. I awoke Saturday with a sore arm, armpit and left ribcage into breast. By night fall, it became Inflamed lymph nodes in armpit with slight swelling in left breast. This lasted throught Monday night. I also had a tender right armpit on Monday.  A severe ocipital headache accompined this.  I did a hot soak in the bath with epsom salt on Sunday. I took ibuprofen and excederine migrane for the headache and inflamation, along with hot and cold compresses, primaraly hot. Inflamaiton is almost gone, but still tender today, Tuesday 01Jun21. I notified my Doctor today. Side note, it is possible that I had an undiagnosed case of Covid-19 last February-March 2020.
Headache, nausea, heartburn, muscle pain, and chills. Passed  out cold without any warning signs. Called urgent care twice. Severe facial bruising across mouth, nose and both eyes. Small cuts on nose and top lip.  Too weak to go to urgent care, self care at home.
?Covid arm? - a large hive (about 4?) with rash at the injection site manifesting a few days after the shot. Very sensitive, very Very itchy. Treated with additional antihistamines and neosporin in case of cellulitis (family history).  Lasted about 9 days.
chills and low-grade fever (approx. 100 degrees) for about 24 hours followed by 2-3 days of mild fatigue (much milder than the side effects from my first dose which had included dizziness, headaches, body aches, and loss of appetite along with fever and chills); I took Tylenol this time--hadn't known I could take anything the first time; both times side effects appeared about 8 hours after the injection; arm got sore both times (worse first time) and itchy a few days later
Broke out in hives; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Broke out in hives) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Broke out in hives). At the time of the report, URTICARIA (Broke out in hives) outcome was unknown.            Concomitant medication not reported.  Treatment medication included Steroids.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-040658 (Patient Link).
Local erythema and edema to the left deltoid area. The area was 3x6 cm warm and not indurated. Seen in office 4/11/06.
Diarrhea, NauseaVomiting, CHILLS, FATIGUE Narrative:
Pt came to ER with altered mental status.  BS in the 30's.  Mental status did not improve with improved blood sugar.  Tested positive for covid earlier in the month.
I woke up with 102.6 fever,  chills, aches in joints.  I  took  Took Tylenol cold and flu and IB profen for 12 hours until fever broke and chills went away. And got some sleep. Joints still ache.
macular rash on abdomen + thighs minimal pruritis slightly aggravated by 2nd dose no urticaria lesions are staying in same location, just not improving She was in the office today for another reason, and I am reporting based on her recall I examined her skin today...the macules range in diameter from 1cm to 3 cm no distinct pattern, just scattered
Received 5 Covid Vaccines in the span of a month; Received 5 Covid Vaccines in the span of a month; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 76-years-old-female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 MRNA VACCINE; solution for injection, lot number EN5318 and expiration was unknown), via left deltoid, on 24Jan2021(at age of 76 years old) as a single dose for COVID 19 immunization. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of COVID-19 vaccine MRNA (MODERNA COVID-19 VACCINE, solution for injection, lot number and expiration was unknown), via unspecified route of administration, on 19Jan2021(at age of 76 years old) as a single dose for COVID 19 immunization. The patient medical history and concomitant medication was not reported. The patient took third dose (Pfizer COVID Vaccine, Lot: EJ1686), via Right deltoid on 28Jan2021 as a single dose for COVID 19 immunization. The patient took fourth dose (Moderna Vaccine, Lot: unknown), via unknown route of administration on 16 Feb2021 as a single dose for COVID 19 immunization. The patient took fifth dose (Pfizer COVID Vaccine, Lot: EL9264), via left deltoid on 19Feb2021 as a single dose for COVID 19 immunization. Lot: EL9264. The caller had a patient who was hospitalized and found the patient received five COVID Vaccines in the span of a month. The caller is asking if Pfizer has case reports or data on this?  The caller states she is going to follow up with the patient today, 29Jun2021 to see how the patient is doing. The patient was in the emergency room and admitted until 19May2021.The patient received the five COVID Vaccines between 19Jan2021 and 19Feb2021, well outside of the window of this being recent.  The patient had been hospitalized since the Vaccines, hospitalized on 12May2021, 19May2021 and 22Jun2021. The caller clarifies, no the patient was transferred to a rehabilitation center on 19May2021 and then looks like she was in the rehabilitation center until 28May2021.    Follow-up attempts are possible. Further information is expected.; Sender's Comments: As per the information provided in the narrative, the relationship between the hospitalisation of the patient and vaccination error cannot be excluded.
Pt. states that after receiving the 1st dose of J&J 07/27/2021, started experiencing symptoms 07/27/2021 (8hrs after) possible throat swelling (difficulty swallowing) lasting estimated 2hrs before subsiding. Started experiencing symptoms 12/30/2021 of shortness of breath with chest pain and rapid heart-beat. Emergency Room visit 12/30/2021 resulting in Blood Work, Chest X-Ray, and Cat-Scan, located a blood-clot in the Left Lung Lobe. Recommendations of Follow-Up with Primary and treatment of Long-Term Blood Thinners.