chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 10/09/03 concerning a (approximately 50 year old female vaccinee who experienced swelling in her arm on 10/8/03 and developed a red rash on 10/9/03 after receiving Fluvirin vaccine on 10/8/03. On 10/08/03 the vaccinee was administered Fluvirin and later that evening she developed swelling in her arm. On the morning of 10/09/03, the vaccinee had a 1"x2" red rash. The vaccine has no medical conditions, has no allergies (specifically no allergies to eggs or thiomersal) and is not taking any medication. The outcome of the event was not reported. There was insufficient information to determine the reporter's causality assessment. Update1, 11/4/2003, Follow up information received from a health care professional indicated that the vaccinee was 55 years old. The vaccinee experienced swelling at the injection site on 10/7/03 and a 1"x2" rash at the injection site on 10/08/2003 after receiving Fluvirin on 10/7/2003. The vaccinees symptoms abated two days after the injection. The reporter has assessed the relationship of the vaccine to the events as probable. No follow up pending.
Feb. 19: onset of itchiness at injection site Feb 20: itchiness with red swollen patch (3.25"x2.25") at injection site  Feb 22: severe itchiness with red, hot to the touch, increased swollen patch at injection site Feb 23-Feb 24: milder itchiness with red swollen patch and vicious looking rash at injection site Feb 25-Feb 28: slowly decreasing itchiness and swelling as well as less vicious looking rash at injection site Mar 1: No longer itchiness, swelling and very mild lingering rash at injection site
no adverse event; Past lot that had also been expired that was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) in a 70-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Past lot that had also been expired that was administered to patient).    Patient age was reported as 70 Year 11 Month. No concomitant medication was provided. NDC ID number was reported as 80777027399. The lot number O70H21A was administered to patient between 08-Apr-2022 and 15-Dec-2022.  Treatment medication was not provided by the reporter.
On 11/06 suddenly was hit with severe flu-like symptoms, minus a fever. I also had a very swollen lymph node on my neck. By the next morning, the flu-like symptoms were suddenly gone but I continued to get more swollen lymph nodes, all on the left side of my body. By Saturday night, a large area on the back, left side of my head began hurting. It started as an odd tingled, then began to feel like someone was pulling my hair, and then finally just became a very sharp pain. On Wednesday 11/11, I was diagnosed with shingles. I am a very healthy 31 year old and have never had shingles before.
First had nonproductive cough couple days after vaccine then broke out in full body hives with swelling of lips and eyes about 6 days after receiving the vaccine.
pt recv vax 1NOV96 & pt devel vomit & diarrhea w/o fever 48hr p/inj;this is one of 25 cases reported by a pharmacist;
Information has been received from a licensed practical nurse concerning a 5 year old female with no allergies or pertinent medical history who on 17-AUG-2007 was vaccinated SC with a 0.5 ml dose of PROQUAD (Lot#656891/0914U). There was no concomitant therapy. On 26-AUG-2007 the patient developed a rash described as 12 papules. Unspecified medical attention was sought over the phone by the patient's mother. No lab studies were performed. The nurse was not interested in VZV analysis by PCR. The patient has no other symptoms. At the time of this report the patient had not recovered. It was noted that the patient's vaccination history included VARIVAX given 15-JUL-2003. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/6/2007.  Information has been received from a licensed practicall nurse concerning a 5 year old 42 lb.  42 1/2 in. female who was 9 lb.  12 oz. at birth with no allergies or pertinent medical history who on 13-AUG-2007 was vaccinated SC with a 0.5 dose of PROQUAD (Lot#656891/0914U).  There was no reported illness at the time of vaccination and no adverse events following  prior vaccination.  There was no concomitant therapy.  On 26-AUG-2007 the patient developed a rash described as 12 papules and was itchy.  Unspecified medical attention was sought over the phone by the patient's mother.  No lab studies were performed.  The nurse was not interested in VZV analysis by PCR.  The patient had no other symptoms.  At the time of the initial report the patient had not recovered.  It was noted that the patient's vaccination history included VARIVAX (Merck) given 15-JUL-2003.  No further information was provided.  There was no product quality complaint involved.  Follow-up information from a licensed practical nurse indicated that the patient had recovered.  Additional information has been requested.
pain/ hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "pain/ hurts". Additional information included: The patient was calling about Abrysvo and was originally calling to find out if it was ok to take Excedrin for pain. She reported that she hurt and said that she may have gotten side effects from the Abrysvo. The patient didn't feel that the pain is related to the Abrysvo. The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.; Sender's Comments: Pain/ hurts occurred following the administration with ABRYSVO might be related to the vaccine use given the known adverse event profile of the vaccine.
Patient reports swelling on the right side of face and left arm. Vaccine was administered in the left arm. No swelling of the tongue, no trouble breathing. Swelling  started about one week after vaccination and lasted for one week. Patient reports taking tylenol and feeling better. Patient also reports gaining weight.
Crohn's disease aggravated; Sinus infection; After second covid-19 vaccine felt pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (Crohn's disease aggravated) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FEELING ABNORMAL (After second covid-19 vaccine felt pretty bad). In October 2021, the patient experienced CROHN'S DISEASE (Crohn's disease aggravated) (seriousness criterion medically significant) and SINUSITIS (Sinus infection). In 2021, CROHN'S DISEASE (Crohn's disease aggravated), FEELING ABNORMAL (After second covid-19 vaccine felt pretty bad) and SINUSITIS (Sinus infection) had resolved.            No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 26-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease. The patient experienced flare up of Crohn's disease approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved within the same year. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 26-year-old female patient with medical history of Crohn's disease, who experienced the unexpected, serious (medically significant) event of Crohn's disease. The patient experienced flare up of Crohn's disease approximately 5 months after receiving the second dose of mRNA-1273 vaccine. Clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved within the same year. Medical history of Crohn's disease remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Blood clots right lung, fluid right lung Part of the right lung had to be removed after several attempts to remove the fluid was unsuccessful  Currently still in the hospital
Suddenly developed tinnitus in both ears. One ear was very loud and first and then quieted a little. Still have the tinnitus in both ears 24 hours a day.
no adverse effects are being reported; she received the MMR II vaccine incorrectly via IM in the right deltoid; This spontaneous report was received from a female registered nurse of unknown age via a company representative. The nurse was referring to herself. The patient's medical history included delivery. The patient's concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 22-DEC-2018, after delivering her child, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), (dose, lot # and expiration date were not reported) incorrectly via intramuscular route in the right deltoid instead of subcutaneous route of administration. No adverse effects were reported.
pt recv vax 28MAR96 & 6MAY96 pt devel 5x10 cm vesicular rash on lt buttock;in addition devel vasculitis or phlebitis in lt thigh vein;
Approximately 10-12 hours after administration, right arm became sore - hurt upon turning over in bed onto right side.  Dis not see PMD until 11/4/2014 who put him on Celebrex.  Presciption has now run out-no refill. Was effective.  Still has trouble sleeping when turns over in bed, shovels, lifts, exercises. No external signs at this time.
Developed fine pin point red rash at approximately 11 AM on 9/1/04. Areas of weepy like blotches noted several minutes after pin point rash developed on various parts of the body. Pt brought infant to health department. Sent pt directly to doctors office. Doctor thought possibly milk allergy: formula changed to flu by doctor 9/3/04
Side effects started 3am Sat morning including: HA, cold sweets, hot flashes, cramping and vomiting. Intensity peaked around 3pm.  Symptoms decreased by 530 pm leaving fatigue/sore arm.  By Sunday Noon symptoms resolved.
Information has been received from a licensed visiting nurse, for the GARDASIL a Pregnancy Registry concerning a 23 year old female with hypothyroidism and a history of 3 pregnancies: 1 live birth at 39 week from LMP, 2 spontaneous abortions including an ectopic pregnancy in March 2008 (5-6 weeks from LMP), with no birth defects of infant complications in previous pregnancies who on 20-MAR-2009 was vaccinated with the first dose of GARDASIL (lot# 661952/1129X). Concomitant therapy included levothyroxine Na. The nurse reported that the patient was pregnant. Her LMP was 03-MAR-2009 and her EDD was 08-DEC-2009. On 26-MAR-2009 the patient started spotting. The nurse stated that the patient was having heavy bleeding and was in the process of miscarrying. Laboratory tests included urine beta-human chorionic gonadotropin test and progesterone performed on 03-APR-2009. On 06-APR-2009 an ultrasound was performed due to her spotting with result intrauterine pregnancy early vs missed abortion. On the same date an urine beta-human chorionic gonadotropin test was done. Additional ultrasounds performed on 09-APR-2009 due to the patient's spotting revealed fetal cardiac activity as well on 13-APR-2009 there was fetal cardiac activity. On 17-APR-2009 the patient experienced spontaneous abortion (7 weeks from LMP), and she has chosen to wait and see if the fetus will pass on its own. It was reported that the patient has a follow up visit in 2 weeks and will have an ultrasound. If the fetus does not pass the patient will be scheduled for a dilation and curettage. On 21-APR-2009 an ultrasound revealed no fetal cardiac activity, there was no fetal heartbeat. Upon internal review in the process of miscarrying was considered to be an other important medical event. Additional information is not expected.
Patient received second dose on day 16, which is less than the minimum required 17 day spacing between dose 1 and dose 2 of Pfizer vaccine.    Dose one was received on 12/28/2020 Dose two was received on 01/13/2021
puffiness at bottom of eye; Blurred vision within 45 minutes of taking vaccine; Within 9 hours, right eye lid drooping; pupil dilated; pain with pressure behind & around eye; pain with pressure behind & around eye; blurred and double vision; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 01Aug2021 11:00 (at the age of 53 year old), as dose 1, single for COVID-19 immunisation.  Medical history included type 2 diabetes and high blood pressure. Patient had known allergies to sulfur, gold, hydrocodone. Concomitant medication included atorvastatin, estradiol, metformin, semaglutide (OZEMPIC), llisinopril all taken for an unspecified indication. Prior vaccination, the patient was not diagnosed with COVID-19, no other vaccines administered. The patient was not pregnant at the time of vaccination. On 01Aug2021,11:45,  patient experienced blurred vision within 45 minutes of taking vaccine. Within 9 hours, her right eye lid was drooping, pupil got dilated, experienced pain with pressure behind & around eye, got blurred and vision was double vision. The events required visit to Emergency room/department or urgent care. The ER/Hospital agreed the symptoms were reaction to the vaccine. The Pain and blurred vision lasted approximately for 3 days. And 15 days later, on 16Aug2021, she had pain in left eye with puffiness at bottom of eye. The patient underwent lab tests and procedures which included, on an unspecified date, CT Scan, blood work and EKG was taken and all found normal. No treatment was given in response to the events. It was unknown whether the patient tested COVID since vaccination. The outcome of the events pain and blurred vision was recovered on 04Aug2021 and of all other events was not recovered.
Patient developed sharp substernal chest pain that was worse when lying down ~36h after her second dose of the Pfizer COVID vaccine in addition to typical side effects including subjective fever and malaise. Pain became constant on the second day post vaccination, and patient presented to the ED and was admitted to the Cardiac Progressive Care Unit. Laboratory data suggested acute pericarditis. PE was ruled out by CTA. The CTA also revealed normal appearing coronary arteries without calcification (a coronary event is unlikely). Her echo was normal, suggesting no significant myocardial involvement. No pericardial rub was heard. She was treated with high dose aspirin and became asymptomatic rapidly.
Started itching about 2 weeks after the dose was given. Broke out in hives, still itching to this day, when itching occurs I break out in welts. Benadryl has helped a little bit.
Day of injection, mild pain left arm. Following morning slight fever (2 degrees above normal) on arising. Later in day - about 1:00 PM developed chills with heavy shaking and general malaise which lasted until bedtime. Two days after injection (today) felt much better, no chills, no malaise, but slight feeling of "spaciness" and - unsure of this - increased sensory acuteness (outdoor light seems extremely bright, tastes and smells seem stronger).  No treatment except acetaminophen (1000 mg 2times per day). No medical treatment sought.
hives; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0153) via an unspecified route of administration in the arm left on 29Apr2021 at 17:30 (at the age of 58-year-old) as dose number unknown, single for COVID-19 immunisation. Medical history included Thyroidectomy (take levothyroxine 125 mg had thyroid removed one year ago). Concomitant medications included oxybutynin (MANUFACTURER UNKNOWN) 10mg, turmeric (MANUFACTURER UNKNOWN) 1500mg, omeprazole (MANUFACTURER UNKNOWN) 20mg and levothyroxine (MANUFACTURER UNKNOWN) 125mg. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01May2021 at 00:00 the patient experienced hives. It was reported that hives were located everywhere including in her hair. Definitely worse on her body trunk. Therapeutic measures were taken as a result of the event and included treatment with benadryl but it was not helping, more hives were out. The clinical outcome of the event hives was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I was generally very achy, weak, and exhausted when I had my breakthrough case. I was really sick for three days, though I never had a fever or GI issues. I felt sort of exhausted for a week afterwards. I tested positive on 1/28/2023, and I began taking PAXLOVID that day.
This morning at about 745am we were about to begin our dialysis treatment and my husband had to blow his nose and when he did there was blood in the tissue, so I got him more tissue and there was more blood in the tissue. I then got a cold compress and had him lay back with feet up and put cold compress on his nose and a small ice bag on his forehead and for a little bit when I took the tissue from left nostril that is where the blood was coming form and i saw that there was clotted blood.  After changing the cold compress on his head the nosebleed began to subside and he continue to sit with his head back but when he sat up after about a half hour it started to bleed again out of the left nostril and that is what he has began experiencing. whenever he sits up it begins again it begins but no clotted blood.
Pt Called c/o of sternal CP and "feeling kind of fluttery"  which began Wednesday night, but she was able to "brush it off".  (Pt had 2nd dose of Moderna COVID  Vaccine Tuesday late afternoon). CP continues into Thursday and is to the point she can "no longer ignore it." Denies hx of gastric reflux. Denies any radiation of pain. Describes CP as a "constant soreness" . When asked if she continues to have palpations or "fluttering" she stated "yes, my chest feels unstable."   Pt advised to go to ER to be assessed for cardiac concerns. Pt stated she would do so and express gratitude for the advise.
pt recv vax 7NOV96 & 8NOV96 pt exp tachycardia;had cough w/SOB which was treated w/ventolin;14NOV96 pt total bilirubin was elevated, but all other labs were WNL;pt exp herpes zoster or herpes labialis on lip;next day had anorexia & fatigue;
Vaccination site red - hot to touch - slight swelling - and tenderness. Prescription for BACTRIM DS 1/1 BID x 7 days.
This spontaneous report as received from a Registered Nurse refers to a multiple patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (strength, dose, frequency, lot number and expiration date were not reported). The patients received a dose of RECOMBIVAX HB that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Patinet doesnot have any symptoms of pain or fever or anythingelse but patient has really bad brusing around the vacination area
shingles, reaction on right arm, HZ infection; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2023, the patient received the 1st dose of Shingrix (left arm). In APR-2023, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles, reaction on right arm, HZ infection). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date:21-APR-2023 The reporter called to report that after Shingrix vaccine a week ago on Monday, doctor experienced active reaction on the right arm which was the opposite where the injection was, similar to an herpes zoster infection.  His dermatologist checked the reaction and said it looked like shingles infection.  No data about lot number or expiration day at the moment of the call. The reporter consented to follow up via email.
time course) and treatment, if any:   Headache, Sedation, Myalgia,   chills, soreness in neck radiating into head  Narrative:
Pain, Swelling and itching of left arm around injection site. Hives covering body.
I had flue like symptoms, chills, a cough, a fever (maybe 101), aches and pains.
After 2-3 days Persistent  Large bruise around vaccination site ...  Legs began to break out in red patches and what looks like Hives.  Arms also to a much lesser extent.  Itching is moderate ... but can interfere with sleep.
pt recv vax & devel diaper rash & was taken to clinic but they refused to see pt because had chickenpox;mom described rash as starting on 28AUG96 w/swelling on the rt side of the face;29AUG pt had red bumps;t103 30AUG96;
This spontaneous report as received from a health professional refers to a 18 month old patient. On 23-JUN-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # J013907, expiration date: 30-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
COVID Arm -  circular red rash around injection site that lasted a 7-10 days with neck pain and bad headaches behind left eye