chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) reported for himself that a 47-year-old male patient BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9267), dose 2 via an unspecified route of administration, administered in left arm on 10Feb2021 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in left arm on 20Jan2021 (at the age of 47 year sold) as single dose for COVID-19 immunisation. Medical history included High cholesterol. No known allergies reported. Concomitant medication included rosuvastatin calcium (CRESTOR) at 40 mg, the patient received within 2 weeks of vaccination. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was doctor's office/urgent care. On 05Jul2021 at 11:00 AM, the patient tested positive to COVID-19. The patient reported that he knows that the vaccine is not 100%, but research at this time is very important. The adverse event result in visit to emergency room or department or urgent care. Treatment was received for the adverse event include 2 bags of fluids, vitamin b, c, d, in injection. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included nasal swab: positive on 05Jul2021. Therapeutic measures were taken as a result of the events. The report was assessed as serious. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of rash all over body in a 26-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medications included Vitamin and ALEVE. On the morning of 22 September 2010 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left arm). On the evening of 22 September 2010, less than one day after vaccination with ENGERIX B, the subject experienced rash all over body (except for his face). The subject was treated with BENADRYL. On 29 September 2010, the event was resolved.
Began with a fever then liquid diarrhea since. 8/25 coughing an sneezing began 8/27 left side of face swollen with rash.
The patient presented to the Emergency Department for evaluation after receiving her second Pfizer vaccine for COVID-19.  She reports that after the first vaccine she became tachycardic and lightheaded with symptoms resolving.   About 30 minutes after receiving the 2nd dose of the vaccine she started to notice difficulty forming words, difficulty walking and feeling generally tired. Two hours after vaccine, patient  arrived to Emergency Department with chief complaints of altered mental status altered sensorium and difficulty ambulating.  Had difficulty word finding, speaking, ambulating altered sensation in her hands and feet.
Case previously recorded as MA2009-4052. Initial case report received from a physician via MedCom on 11 NOV 2009. A 10 year-old male patient was vaccinated with S-OIV FLUVIRIN (batch no. unknown) i.m into the right deltoid on 10 NOV 2009 and was accidentally given S-OIV FLUVIRIN (batch no. 102045P1) i.m. on the right deltoid again on 11 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007995.
6 to 8 hours of Fever, Aches, chills, nausea.  Resolved the next morning
Small amount of bleeding from vaccination site; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) 1st dose, via an unspecified route of administration in Arm Right on 06Mar2021 single dose for covid-19 immunisation. The patient's medical history was not reported. Allergies known was none. Concomitant medication included lisinopril (LISINOPRIL), and omeprazole (OMEPRAZOLE) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to covid vaccine. No other vaccines prior vaccination. The patient was not tested for covid prior to vaccination. The patient experienced small amount of bleeding from vaccination site on 06Mar2021 at 08:45. Outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, which had a lot # of M019691 and expiration date of 02-NOV-2017 (dose number, dose and concentration were not provided). It was also reported that the ROTATEQ was exposed to a temperature excursion of 47 F for 3 hours. Additional information has been requested.
Patient began to develop an itchy, diffused, red rash two days after the first dose of vaccine was administered. This condition affected upper and lower extremities, torso, face, and back.
Mid to lower upper right arm swelling, redness, edema,  irritation (near elbow area). Scant amount of clear drainage oozing from site, small amount of yellow crusting noted as well.
Patient experienced flu-like symptoms, low grade fever, chills within 9 hrs of vaccination, which resolved after 24 hours. She also experienced a non-itchy, blotchy rash over entire body (chest, torso, back, arms and legs) within 12 hours of vaccination. Rash gradually subsided, but was not completely resolved when she reported adverse event to pharmacy after 72 hours of vaccination.
Information has been received from a pharmacist referring to an 86 years old female patient. There was no pertinent medical history. The patient's concurrent condition and concomitant therapy were unknown. On 21-AUG-2016, the patient was vaccinated with ZOSTAVAX (strength and frequency were unknown; lot number M003488 and expiration date 27-MAR-2017) 0.65 ml subcutaneously. On 23-AUG-2016, the patient had experienced an itchy rash starting out in dime size from her elbow extending down to the front of her arm. The patient did not see medical attention. Treatment was not given for the event and there was no lab diagnostics studies performed. The patient was recovering.  The causal relationship between ZOSTAVAX and the event was unknown. Additional information has been requested.
4x2.5" area of severe swelling around the site of injection. Pain to touch and radiates heat
Two hours after she received her vaccine, she experienced extreme pain (pain scale 1 to 10 she described it as a 10), could not lift her arm.  It gradually decreased over the next 5 days until it was gone.
Sudden asthmatic cough, palpitating heart, chills, redness on upper arm, shoulder and chest, UNCONTROLLABLE SHAKING THROUGHOUT BODY.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site swelling (serious criteria other: serious as per reporter). On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was selected as adult as per vaccine indication. The emergency room physician told to one of the patients he had been seeing a lot of swelling due to SHINGRIX in the emergency room. This case has been linked to US2018137449, reported by the same reporter.
On the 16th of Aug., went to ER for fever, chills, and jaw pain. Was given antibiotics but was back on 17th  by request because blood test reveled a blood infection. Early on the 18 Afib, Metoprolol given for it. By midday discharged and was upset at care that was given. On the 19th Admitted to Hospital, because racked with pain and felt like he couldn't breathe. Drew blood for new tests. Couldn't drink or eat, issues with taking blood(iv lines infiltrated and kept popping out). On the 20th, contrast media given, one was a drink and one was injected for CT scan. Rapid fluids given, and had a bad response with it, Rapid afib(tried convert to sinus rhythm twice and failed), kidney issues. PCU on 21th Kidney started to fail,  BiPap, elevated creatinine, BUN elevated. On 8/22 blood test showed kidney failure imminent was then advised a kidney transplant would be needed, patient declined, discharged about 12:30PM MT and patient died under Hospice care by 6:00PM MT
01/05/22 presents to EC ED for "abdominal pain and falls". PMHx of "schizoaffective disorder"
Arm was red on the outside; arm was red on the outside was red and hurt; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red on the outside) and VACCINATION SITE PAIN (arm was red on the outside was red and hurt) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ERYTHEMA (Arm was red on the outside) and VACCINATION SITE PAIN (arm was red on the outside was red and hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, q6h and NAPROXEN SODIUM (ALEVE) for Muscle pain, at a dose of UNK dosage form. At the time of the report, ERYTHEMA (Arm was red on the outside) and VACCINATION SITE PAIN (arm was red on the outside was red and hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided   This case was linked to MOD-2021-101723 (Patient Link).
Exhaustion  Fatigue  Weakness Dizziness  Itchiness of injection site, face, arms  Runny nose  Headache
This spontaneous report was received from a consumer referring to her son, a 12 year old male patient with mold allergies and attention deficit/hyperactivity disorder ADHD), none concomitant therapies were administered. On 19-AUG-2016, the patient was vaccinated with a dose of M-M-R II injection, for prophylaxis, dose, route, lot/batch number and expiration date were not reported. It was reported that on 21-AUG-2016, the patient had an adverse reaction to the M-M-R II. It was informed that the patient experienced rashes on both sides of face, fever, chills, throwing up, and was diagnosed at an unspecified urgent care with measles (measles post vaccine) on the body, and strep throat (pharyngitis streptococcal) when sought medical attention (allergist). The patient sought medical attention (an allergist) and no laboratory diagnostics studies were done nor were treatment given for the adverse events. The outcome of chills, throwing up, measles (measles post vaccine) on the body and strep throat (pharyngitis streptococcal) was reported as recovered on an unspecified date in 2016. Upon internal review, the event of measles post vaccine was considered to be a medically significant event. Additional information has been requested.
Patient arrived at pharmacy on 12/19/14 with complaints of redness, soreness, and swelling around injection site of Zostavax administered on 12/17/14. PharmD observed approximately 3 inch by 3 inch area on arm above elbow that was red, and swollen.  I advised patient that this is most likely an inject site reaction and to apply cold compresses and possibly take an antihistamine. I informed patient that I would write a store incident report and report event to VAERS.
Patient's wife called and stated that he was experiencing stomach pain, vomiting, and diarrhea. She stated her husband said it felt like his stomach was going to burst. Patient received vaccine on 4/7/21 and reported reaction started on 4/13/21.
Throbbing "annoying" pain in the arm. Patient would massage it for relief, but painful enough to wake him out of sleep. Cardiologist trying to rule out heart complications. Recent labs show possible myocardial perfusion.
On 12/8/01, admitted with syncope; flu vaccine 2 weeks prior; 3 days prior to admission, developed generalized myalgia, vomiting, diarrhea, fever and chills. Unable to retain fluids, no urine over 24 hours. Similar episode prior year which occurred 2 weeks after vaccine. Treatment with IV fluids, O2, IV Claforan and advised not to have the flu vaccine in the future, per contact person. Discharge diagnoses also included acute gastroenteritis and dehydration for both hospitalizations. The initial hospitalization's diagnoses also included hypovolemic shock, leukocytosis, acute renal failure, and metabolic acidosis.
Patient c/o dizziness, temporary loss of hearing, weakness, nausea and sweating . Took vital signs B/P was low 104/47. After 9 minutes B/P was up to 110/70 and patient's  symptoms were resolved. He refused to be transported to ER to be evaluated and was taken  home by his friend. Parents were notified of the event.
A 36-year-old gentleman seen today in consultation for further evaluation of unusual reaction following 1st coronavirus vaccine.  He received Moderna recombinant MRNA vaccine on 12/24.  On about 01/02, he developed a maculopapular pruritic rash that he refers to as hives present over the dorsum of both hands and predominantly right side of the face.  He had some facial swelling.  No breathing difficulties or other symptoms.  He does not recall any rash, aches, fever.  A few days later, he went in to the Community Health Clinic and received some prednisone for this, a 5-day course, and apparently, symptoms resolved by about day 4.  No further problems, but he is wondering if he should receive 2nd vaccine.  Again, no immediate symptoms of any importance following 1st Moderna dose on 12/24.   No clear history of allergic rhinitis, asthma, eczema, bee sting allergy or food hypersensitivity.  No problems with previous vaccines.  He is even wondering if the vaccine and rash reaction are related and this is difficult to prove with any certainty.
Approx 1 mos after 2nd vaccine, I woke up with pink glossy eyes. I have no history of seasonal allergies and thought that perhaps I had caught something contagious from my husband who had developed bloodshot eyes that calmed to a pink glossy look over the course of a week or two. He is known for seasonal allergies and we thought that something happened during lawn mowing. However, as days went by, I started wondering if we could have caught COVID19 though vaccinated and went to Patient First to be COVID19 tested. The rapid test and PCR test were negative.  Dr. also did a rapid strep test (negative). The doctor confirmed my eyes looked irritated and jaundice, but had no suggestion except OTC eye drops. I had tried Refresh eye drops without benefit. I had an upcoming eye exam appt with eye Dr. and so kept it feeling I wouldn't be transmitting something. Dr. acknowledged the discoloration in my eyes but hadn't heard anything related to the vaccine. My husband's eyes, my eyes, and some community friends' eyes are changed and looking glossy, pink, and/or yellowed. I am concerned about the lack of information about this. I am concerned about liver function and anything else that can be contributing to COVID19 vaccine eyes. Someone needs to start paying attention to this. This week I'm notifying Drs. that my situation is calmer but basically unchanged. In making that decision today, I decided to contact vaers as well. Something is going on and I want to know what so that I can understand if there is something or someone that I need to be seeing. My eyes do not itch nor burn but sometimes feel a bit dry so I'm continuing at times with OTC eye drops.  My husband is NOT on any of the medications that I am on, my friends are not on any of the medications that I am on. The only thing we have in common regarding this matter is that all of our eyes have a changed appearance. I'm starting to be able to identify many who've had both vaccines by COVID19 pink/jaundice glossy vaccine eyes.
pt recv vax SEP96 &  OCT96 pt devel pox lesions which were still present @ time of report;5SEP97 lab results indicated failure to seroconvert p/2 doses;
Patient fainted about five minutes after shot while standing. No injuries were sustained. Patient was immediately put in supine position on floor with knees raised. Mother was nurse and promptly checked pulse at 55 then again a couple minutes later at 70. Patient was slowly brought to sitting position and given water and orange juice. Patient reports only eating a granola bar all day. Patient waited 30 minutes after vaccination and was able to leave on his own. No injuries reported and no medication attention was taken.
Bilateral neck, upper back and arm myalgias/stiffness  and tenderness to palpation. It was resistant to scheduled nsaids. Pain responded to steroids (medrol dose pack).
throbbing at the injection site; headache with nausea; Her headache has worsened since 22/Mar/2021; a heavy pressure pain in her forehead; chills; Headache; body aches; Joint pain; fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of CHILLS (chills), HEADACHE (Headache), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue). 27-Feb-2021, the patient experienced HEADACHE (Headache), HEADACHE (Her headache has worsened since 22/Mar/2021) and HEADACHE (a heavy pressure pain in her forehead). On 22-Mar-2021, the patient experienced NAUSEA (headache with nausea). On 05-Apr-2021, the patient experienced VACCINATION SITE PAIN (throbbing at the injection site). On 01-Mar-2021, CHILLS (chills), MYALGIA (body aches), ARTHRALGIA (Joint pain) and FATIGUE (fatigue) had resolved. On 06-Apr-2021, VACCINATION SITE PAIN (throbbing at the injection site) had resolved. At the time of the report, HEADACHE (Headache), HEADACHE (Her headache has worsened since 22/Mar/2021) and HEADACHE (a heavy pressure pain in her forehead) had not resolved and NAUSEA (headache with nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details included following : Tylenol, Ketorolac 30 mg injection, sumatriptan hydrochloride, Naproxen, Inderal (propranolol).
12/19/2001 Vaccine Adminstered 12/20/2001 Mom noticed while bathing the patient, areddish/purple area- 5-6" x2-3' around the  injection site on his left arm. no fever or tenderness. 12/21/2001 Mom reports reaction
The patient was sitting in a chair while in observation and reported to the observer that she was nauseated at 12:15pm. The patient stated she had a similar reaction to the first dose. The patient was assessed by paramedics and refused transport to the hospital.  Pt stated she felt better after we checked her out. The patient signed out AMA as she did with the first dose. FFPM asissted with assessment and did the AMA paperwork.
Dizziness, Headache, NauseaVomiting, ftaigue Narrative:
recently diagnosed with Covid as a breakthrough case; recently diagnosed with Covid as a breakthrough case; aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart Failure" (unspecified if ongoing), notes: I am a Heart Failure patient. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "recently diagnosed with Covid as a breakthrough case"; PAIN (non-serious), outcome "unknown", described as "aches"; CHILLS (non-serious), outcome "unknown", described as "chills". Customer Verbatim: I personally wanted to say thank you for the time & effort put into the Covid Vaccine. I received 2 doses & I am a Heart Failure patient and was recently diagnosed with Covid as a breakthrough case. I literally had 1 bad day during my whole quarantine and that day overall was still mild! Just some aches & chills. I am a true believer in your vaccine & have told everyone I can & will continue pushing for people to get vaccinated. Maybe it didn't prevent it but it sure did make it mild.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Mild tenderness similar to regular flu shot until day 8 (2-11-21)  Upper part of left arm swelled up became hot and tender to the touch.  It itched.  No noticeable redness.  I used warm water in the shower and then cold pack on and off for about 2-3 days.  The 4th day (Sunday) it got better and the swelling subsided.
Red swelling at injection site - recommended seeing MD - she did & he prescribed cream if still a problem.
Heart palpitations, pulse going down to 33, feeling a terrible pressure on my head. I saw my doctor and he said I had heart palpitations and had two tests done: ECO & wear a heart monitor. Severe fatigue, body aches (all over my body), shoulder pain, now being treat it with physical therapy for my shoulder.
pt rcvd vax; pt devel pruritic rash; rash were large, hive-type eruptions; pt also devel fever; rash lasted for 3 wks before drying up & flaking off;
after her vaccination on 4/2/21, she was tired on 4/5/21. on 4/11, she was achy, had HA, sens to light, stomach, backache, nauseous, bilat sciatic pain, temp up to 102, fatigued, oxygen sat 92%. she had visual hallucinations. she went to ER on 4/15/21.
Rash-trunk, extremities, referred to dermatologist, medicine (steroids) prescribed, antihistamines.
Developed itchy rash day after vaccines given.  Started on back and now spread to entire body. On exam on 11/19/07, noted to have s/s erythema multiforme.  Multiple lesions over entire body.
Friday evening 10/10/09 through Sat. 10/11/09 - about 24 hrs. She felt achey all over, especially back, neck, legs, joints. Also felt warm - feverish - didn't take temperature. Stomach felt queasy about 1 wk. 10/16/09 1st day felt completely normal.
Pt alert, oriented X 4. Denies any pain. Pt c/o of lower lip and chin tingling and in past having lips swollen due to cipro meds reaction. Pt felt the "lower lips been feeling swollen with tingling". Pt denied any breathing issue. No throat swelling noted. Pt was seen in ER for further care.
Pt had immediate redness at injection site. Give Benadryl 125mg PO and observed for 45 minutes 8/19/05 spoke with pt's mother and no further problems.
Non-continuous sharp pain in lower left abdomine over 24 hour period,  soreness left arm at injection site.