chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and HEADACHE (mild headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included CALCIUM and POTASSIUM for an unknown indication.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (Rash) and HEADACHE (mild headache). At the time of the report, RASH (Rash) and HEADACHE (mild headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include diabetes medication.  Treatment information not provided.
Pt developed pinching chest pain when laying flat in the days and weeks that followed vaccination.  She presented to the ED on 1/17/21 with acute pericarditis.  She was admitted to the PICU at our local hospital and did very well.  Extensive investigation into possible viral etiologies was negative.  Final diagnosis of acute idiopathic urticaria; presumed viral.
Patient passed away unrelated to covid vaccine Narrative: The patient had worsening COPD and cognitive deficits. Patient's last hospital visit is 2/2021 for COPD exacerbation. Patient received his first dose of Moderna on 1/13 and second dose of Moderna on 2/9. Patient passed away at home on 3/3. No indication that death was related to COVID 19 vaccination.
This spontaneous report was received from a registered nurse refers to a non-pregnant female patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. In approximately November 2017 (reported as "about 2 months ago"), the patient was vaccinated with a dose of M-M-R II (dose, lot #, expiration date and route were not reported) for routine vaccination. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not reported) and administered in the abdomen because the patient reported that she got an unspecified "flu shot the week before and her arm was hurting". In 2017 (reported as "about 3 weeks later"), the patient experienced "localized red reaction on the abdomen"(erythema and injection site reaction). The patient sought medical attention came back to the clinic and unspecified treatment was given. On unknown date, the patient recovered from erythema and injection site reaction.
Approximately 12:20 this RN asked the patient how they were feeling? The patient replied in a weak voice that they felt dizzy. The patient appeared to slighlty sway back and forth. This RN told the patient they were going to lay them down on the ground and put their feet up on the chair. Before this RN could fully lay the patient down she went limp in arms. The patient was placed in Trendelenburg position, called patient by name to keep alert.  12:21 HR 74, Pox 98%, Paramedics  and doctor arrived and took VS. 12:23 BP 107/75, HR 70, POX 100%, Blood Glucose 88. Patient was given fluids to hydrate and was slowly assisted into a sitting position in chair.  EKG Normal Vital signs normal. Cleared by Doctor.
Having injection site redness and a bit itching; Having injection site redness and a bit itching; This is a spontaneous report from a contactable consumer.     A 60-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date on a Friday as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced having injection site redness and a bit itching. The reporter wanted to know if the patient can take any cream. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, runny nose, loss of taste and smell, headache, fatigue, cough, diarrhea
every time she takes the COVID shot, she gets definitely sick for two days; Vomiting; Diarrhea; cannot even make it to the bathroom in time and messes up the sheet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 63-year-old female patient (unknown if pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "every time she takes the COVID shot, she gets definitely sick for two days"; VOMITING (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea; cannot even make it to the bathroom in time and messes up the sheet". The events "every time she takes the covid shot, she gets definitely sick for two days", "vomiting" and "diarrhea; cannot even make it to the bathroom in time and messes up the sheet" required physician office visit.  Additional information: Every time patient took the COVID shot, she gets definitely sick for two days. Patient had vomiting and diarrhea that she cannot even make it to the bathroom in time and messes up the sheet, it is just a night mare and I was wondering is there anything she could do like after she got the shot may be get some kind of pills from a doctor to wear this off or what.  Patient have the doctor's appointment at 10:30.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Cellulitis at injection site (R) arm, pt placed on KEFLEX 250 mg three times a day for 7 days, follow up as needed.
Painful right arm same day she had flu shot. Swollen, red blemishes with watery blisters started 9-8-10. Went to doctor 9-13-10 got medication for shingles diagnosis. C/o itching on whole right arm - and "immediately after getting the shot she had pain and burning at site. On my follow-up telephone call to her 9-20-10 she reported she was "doing much better".
neck pain worse than ever cont on & off;chest pain through to back, lungs on fire, burning;vision worsened, blurring, inability to see as well;blurring vision, fatigue, muscle soreness, achy all over, sore skin, joint pain,depression,fast H
Site of injection was inflamed and it was very swollen at Prevnar site. R thing.
I had a stroke which did not affect my motor skill but caused me to be hospitalized for 3 days. On Thanksgiving, I felt lightheaded and dizzy. My vision got blurry and I have never experienced this before. I brushed it off. My wife advised me to share this information with my doctor. On Friday February 04, 2022, I experienced a stroke. This was around 4pm when I started feeling a pain on the right side of my head. I never felt this pain before. It started on the right side as a dull pain but kept intensifying. I laid down to see if it would go away, I began to get real dizzy and my focus was not clear. When it peaked, I began to feel very nauseous and kept going to the hospital. I ignored the symptoms and went home and slept on it. The nausea went away around 11pm that same night. The next day the nausea went away but I felt a little better but still had dizziness and did not feel like myself. I was able to eat food. Sunday I started feeling a bit better but still called Monday to have an MRI completed. They completed the MRI without contrast and with contrast. On my way home, my doctor called telling me to go straight to the ER because the MRI was showing a brain bleed in the area where the pain was. I went to the ER at a hospital and they admitted me. I remained hospitalized from 02-24-2022. They completed numerous test to verify whether a clot was released but they did not see anything in the heart and the blood vessels of the brain looked good. I saw a cardiologist on March 03, 2022. I had to wear a heart monitor for a week upon discharge. The cardiologist has me taking a 81mg baby aspirin daily and placed me on 80 mg atorvastatin.
Large pinkish circle on shot upper arm on day 2.  Same occurred  for dose 1 on day 15.  Took 2nd shot on same arm.  It itched minimally right after shot.  Visited doctor after lst dose adverse event.
20 minutes after injection fell to floor unable to move, feeling very weak and funny. RX O2/ EPI x 3, Benadryl IV solution, observe hospital all night.
Swollen red hot bump and rash on arm at injection site. Very itchy. From the IPV.
Severe flu symptoms, prescribed benzonatate and methylprednisolone, recovered after several days.
Shortly after dose #2, pt. had increase liver enzymes (LFT, Alkaline) , positive ANA. developed transaminitis, auto immune hepatitis and shograns syndrome. Pt. also stated her mouth is chronically dry .
Came down with COVID symptoms and home tested positive; Came down with COVID symptoms and home tested positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Oct2021 as dose 1, single (Lot number: EL9267), in left arm and on 15Feb2022 as dose 2, single (Lot number: E6199) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's Thyroiditis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Jan1990; PRAVASTATIN, start date: Jan2010; LOSARTAN, start date: May2019. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 23Jul2022, outcome "unknown" and all described as "Came down with COVID symptoms and home tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.
confused and slurred speech symptoms lead to ER  to rule out stroke vs. metabolic enchephlopathy vs seizures
14MAY98 swelling w/redness on rt leg @ site of shot;15MAY98 fever;sz @ 7PM;taken to hosp;16MAY98 fever;sz around 6-7PM;taken to hosp;19MAY98 red rash covering body;seen by MD;
half of her body she is feeling numb; Dizzy; cannot see well from the right side of her right eye; heart is beating faster; can barely talk; throat closing; Allergic reaction; her throat clogged; difficulty breathing; Face swell; This is a spontaneous report from a contactable consumer. This consumer reported for a 37-year-old female patient (reporter's sister) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 08May2021 12:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medications included paracetamol (TYLENOL) taken for stomach hurt from 07May2021 to an unspecified stop date. The reporter called on behalf of the patient, that the patient got the vaccine on Saturday, 08May2021 at 12:15, so right after the administration of the first dose, the patient had allergic reaction, her throat clogged, throat was getting closed, had difficulty breathing and then her face started to swell, and the patient was administered or took an anti-allergic medicine and was sent to emergency room and they said it was an allergic reaction. The patient was still feeling bad. The reporter provided the important safety information, and the reporter were also asking why the common side effects was not advised before the administration. The reporter and patient went to the emergency room and was there until 1:00 am on Sunday, 09May2021. The caller was never admitted as a patient into the hospital. On 09May2021, when the patient left the emergency room, patient started that she was feeling numb on half of her body, started feeling dizzy, couldn't see well from her right-side eye, her heart was beating faster, and she can barely talk. The patient being able to barely talk comes and goes. The patient received the treatment in the emergency room. Reporter stated, "It's for side effects for vaccine she had allergies to the vaccine." The outcome of the events was allergic reaction, her throat clogged, difficulty breathing, face swell, can barely talk, throat closing unknown. The outcome of the events was half of her body she is feeling numb, dizzy, cannot see well from the right side of her right eye, heart is beating faster was not resolved.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
following a supported temperature excursion; This spontaneous report was received from a healthcare business professional (a chief executive officer) referring to a 12 months old male patient. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On 13-AUG-2021, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) was administered (lot # T031603, expiration date 15-MAR-2022; dose and route were not reported) for prophylaxis following a supported temperature excursion on 28-JUN-2021 (product storage error). The administered dose of the vaccine experienced a temperature of 8.4 Fahrenheit (F) for 1 hour 30 minutes. There was no previous temperature excursion.
Student received Td imm right deltoid. 10/30/03 in AM came to clinic 10/31/03 AM at 9 AM with 99 degrees oral temp. C/o muscle stiffness, soreness. 12:30 temp above 101. Parents notified and student sent home. Encouraged to push fluids with Tylenol. Then after shot and Friday AM no Tylenol. Student also received Hep B #2 vaccine in left deltoid. Had c/o of pain in right deltoid.
Warm; Swelling; Redness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported  No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow-up received on 06-MAY-2021 contains non-significant information(NNI)
pt exp pallor, sweating & a hypotensive shock-like episode w/in several minutes following 1st vax; tx w/Epi; pt was observed for 2-3 hrs in the office & sent home; the following day was asymptomatic;
Client reported to mother to clinic for flu shot. Reported to nurse that child was here for covid vaccine. Verified with mother that child was to receive his 1st dose, mother confirmed. Child received 1st dose of Covid19 vaccine for ages 6month-5years. No adverse side effects from vaccines noted at this time.
Pt reports "extreme pain" (9/10) markedly swollen, shoulder joint painful, tenderness into axillary area. Fever and joint pain (knees and hips).
11/30/06 Called PDDH to report he started at noon today feeling nauseated, dizzy.  No fever. Sx came on suddenly. Instructed to call MD.
Accidentally gave Moderna to patient who is 17 years old, while it is not indicated until 18 years of age.  No adverse effects patient well
When called patient about completing the series and doing the second vaccine, she stated that she had experienced a sore and swollen arm for 3 weeks after the vaccination.
SWOLLEN FACE; RASH ON NECK THAT IS ITCHY, SORE, FEELS RAW; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1806029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced swollen face. On 15-APR-2021, the subject experienced rash on neck that is itchy, sore, feels raw. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on neck that is itchy, sore, feels raw, and swollen face. This report was non-serious.
redness/warm/swelling- lt thigh 3.25 in by 6.25 in
Dizzy, Nausea, vomiting BP=98/68 HR=82 O2=97% Recorded by RN
Information has been received from a physician concerning a 22 year old white female with no relevant medical history or illness at the time of vaccination who on 06-SEP-2007 was vaccinated in the right deltoid with a second dose of GARDASIL. There was no concomitant medication. On 06-SEP-2007 the patient experienced dizziness lasting 1/2 hour. The patient called the office and was instructed to lie down temporarily. The patient was to call if symptoms worsened or persisted The office had no further contact with the patient. On 06-SEP-2007, the patient recovered from dizziness. Additional information is not expected.
p/vax mom report child has redness & swelling of lt thigh, knee to groin, noticed this AM & /vax;MD told mom not unusual;child fussy that day then swelling went down pt fine;
Visible swelling in left clavicle appears to be fluid filled.  Tender, slightly painful. Palpable swelling in left upper breast. This is more diffuse but not visible. Tender.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FAMOTIDINE from 04-Dec-2020 to 14-May-2021 for Acid reflux (esophageal), VALACYCLOVIR [VALACICLOVIR] from 06-Apr-2021 to 12-May-2021 for HSV infection.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 02-Aug-2020 and the estimated date of delivery was 04-May-2021. On 01-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy. The vaginal delivery occurred on 13-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3330 grams (7lbs 5oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Height of the female infant was 49.5 cm. Head circumference 34 cm APGAR Score was 8 at 1 minute and 9 at 5 minutes. The mother did not experience any problems during delivery. There were no complications, abnormalities or abnormalities at 1 month post partum for the infant. The mother was breastfeeding the infant at the time of this report. On 01-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Unknown          No treatment information was provided. Delivery after 41+2 weeks of gestation was reported.
Patient felt dizzy and slide down to sit on the floor before getting to the seat for post-vaccination waiting chair.  We helped patient to lie down and put legs up.  He looked pale, but responsive and coherence.  He was laying down for about 15 minutes while talking with me. He said that this happened to him a few year back when he got a vaccine and that this happened again today because he had donated his blood prior to come in the pharmacy for the vaccines.  He sat up after feeling better and sat for few more minutes and said he's feeling ok (not looking pale any more) and ready to go home with his driver.
Achiness, chills, fever (101.6), lack of appetite, painful injection site, underarm (nerve?) pain, small pimples at hairline, exhaustion
24 minutes after vaccine administration, patient experienced hives on nose, arms, chest, thighs, back and buttocks. Also experienced dizziness. 12.5 benadryl tablet was administered at 8:03pm. Patient only wanted half of the pill due to drowsiness affects. Patient was able to leave at 8:09 and denied HA. at 8:35pm, patient asked for the other half of the pill which was 12.5mg of benadryl for a total of 25mg of benadryl given for hives.  Patient was instructed to inform PCP about reaction. At 9:20, patient said the hives were disappearing.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021). At the time of the report, PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 04 Nov 2021) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vaccine was placed in refrigerator on 04-Nov-2021. Vial did not undergo any temperature excursion. No adverse events were reported. No treatment medications were reported.
Patient received shots at approximately 1:50pm on 4/11/19, that evening at 6pm spiked fever to 102. Brought in to office. Did have some respiratory symptoms though flu and rsv negative. Considered URI vs. vaccine reaction. Fever resolved within 48hrs and pt was back to baseline
13/31/2020 Left arm soreness, swelling, red and hot 5:24pm. 01/01/2021 2:23 am I woke up to with severe headache and chills, about 1:20 pm I started having Body aches, my joints were hurting, I was having chills  again  and my headache just kept getting  worse, with  fatigue.   I fell asleep about 1:30 for almost three hours.