chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it is a big elongated elevated red hot itchy rash; I got swollen at the site of shot, a pretty big swelling area; I don''t know if it''s a rash or hives, it is a big elongated elevated red hot itchy rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 Immunisation; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 29Oct2021, outcome "not recovered", described as "I got swollen at the site of shot, a pretty big swelling area"; RASH PRURITIC (non-serious) with onset 29Oct2021, outcome "not recovered", described as "I don''t know if it''s a rash or hives, it is a big elongated elevated red hot itchy rash"; RASH ERYTHEMATOUS (non-serious), outcome "not recovered", described as "it is a big elongated elevated red hot itchy rash".  Additional Information: Patient got the Booster shot on 26Oct2021 at 5 PM and today is Friday 29Oct2021, so 3 days later almost the same time it's 72 hours later, got swollen at the site of shot. Patient got a pretty big swelling area and don't know if it's a rash or hives or what but it is a big elongated elevated red hot itchy rash and it is not going away. Patient didn't have that on the first two shot (first dose and second dose). Just get it on third one (Booster, Covid-19 Vaccine).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives/urticaria within 24 hour of vaccine administration. 1) PENTACEL 2) PCV-13.
Fever which did not respond to Tylenol, climbed to 103.9.  Rapid heart rate, difficulty breathing, wheezing and tightness in chest.  Emergency room visit: given Tylenol and Motrin, fever eventually broke and was sent home.
The day I received my vaccine, I was also exposed to Covid. I ended up developing  Covid Symptoms on 1-30-21, on that same day my bottom lip began swelling.  The first day it was just the left side of my bottom lip. This lasted about three hours. The next day the right side of my bottom lip began swelling and very itchy. I took an antihistamine, swelling went down in a little over an hour, itching continued for a couple more hours. The doctor informed me that they are not sure if it is a reaction to the vaccine, covid, or a combination of both. They told me to report the reaction on this website.
Allergic wheal and flare reaction at injection site lasting approximately 30 minutes. No systemic symptoms.
I have been experiencing trouble breathing, chest tightness, and "pop corn" like popping feelings in my chest as well as fast heart rate and pain in my right arm. It's hard to breath when this occurs. I began feeling this after receiving the J&J vaccine in April 2021 and it has not stopped. It occurs randomly every couple days, sometimes everyday. The discomfort/pain lasts for several hours sometimes and feels worse when I lay down on my back. I've had to sleep on my side to avoid inducing the chest tightness. I had never experienced this before getting the COVID-19 vaccine.
Large raised red rash/ welt approximately 3 inches in diameter, pt states hot and painful. MD told patient that it was questionable whether the rash was a severe injection site reaction or if it was something else like cellulitis. Patients was give a prescription for an antibiotic.
after vaccination, patient felt dizzy. seated patient who stated "im dizzy" patient stated he only had milk in am which is his usual routine. patient also stated he felt weak. patient given cup of water to drink. patient observed for 30 minutes and patient felt better. was observed while standing  with no dizziness ad weakness verbalized by patient. instructed to return to his home and rest, eat, drink liquids; also if any further reactions patient to call 911. patient verbalized understanding and left clinic ambulatory with no complaints
Developed fever 24 hours after vaccine which persisted for 5-6 days. Infant seen in office on 8/17 felt to have a viral infection - fever persisted & on 8/19 seen in ER again felt to have a viral infection. 8/21 office visit (see attached form - suspected of Kawasaki syndrome).
Both times got very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single 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 "Both times got very sick". Additional information: patient took both vaccine shots. Both times got very sick and she would like to get some feedback on why she got and why both times and what was the impact on her immune system going forward.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, GARDASIL was improperly stored outside the temperatures recommended in the product insert and was administered to an unspecified number of patients (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were vaccinated with improperly stored PNEUMOVAX 23 (MARRS # 1407USA002446) and VAQTA (MARRS # 1407USA005270). Additional information has been requested.
COVID Vaccine Breakthrough Report  J&J Dose 6/9/21 (lot NA) COVID Positive 12/1/21  11/30/21:  Patient is 96-year-old female past medical history significant for essential hypertension, CAD, dementia, depression, obesity, osteoporosis, psoriasis   Patient presented to the ED after experiencing shortness of breath of 1 day.  SOB is on exertion.  Patient has contact with recent family members wife and grandson positive COVID-19 infection.  Patient took the test at home and was found to be positive.  Per patient daughter patient sleep better recliner last night which was unusual and upon daughter checking pulse ox at home it was 88%   Patient denied any cough or chest pain.  In the emergency room patient was febrile and was saturating 88% on room air and required oxygen supplementation 3 LPM to maintain saturation to acceptable level  Labs were significant for elevated creatinine of 1.04 with BUN/creatinine ratio of 24, mildly elevated alkaline phosphatase of 130.  Chest x-ray showed cardiomegaly with mild pulmonary vascular congestion; also ground-glass opacification likely representing early edema versus atypical infection  12/3/21: 96-year-old female with CAD, dementia, hypertension presented with shortness of breath, hypoxia and fever.  Family tested positive for COVID-19.  Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 with superimposed bacterial pneumonia, was on 3 L nasal cannula oxygen briefly.  She received antibiotics, dexamethasone and remdesivir.  Subsequently weaned off oxygen to room air, remained a febrile with minimal pulmonary symptoms.  Patient will complete the 7 day steroid taper with  She has baseline dementia and considered to be close to her baseline functional status and the discharged home with VNA and family.  On discharge she was a febrile and hemodynamically stable.
A non-serious spontaneous report of administration of full dose (0.2ml) in one nostril was received from a registered nurse/health professional concerning a 28-year-old female. Neither medical history nor concomitant medications was reported for this patient. The patient received H1N1, Intranasal on 10-Nov-2009. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event is considered resolved.
Gave patient Moderna vaccine on 3/13/2021.  Patient reported that she had hives at injection site that went up and down arm and neck.  Patient took Benadryl and it was better the next next morning( 03/14/21). Patient reported no other symptoms on 3/14/21. Woke up on 3/15/21 with bad headache, eyes swollen shut and facial pain. She also noted that in the inside of her mouth was becoming sore. advised patient to seek medical treatment to rule out if is related to the vaccine. Patient was seen in urgent care, it was determined that the headache, swollen eyes and facial pain was due to sinus infection. Patient was given Augmentin 875mg twice daily for 10 days.  Will follow up with patient tomorrow.
Nothing super severe, but the following side effects for about 48 hours: low grade fever, muscle aches, fatigue, headache, nasal congestion, dry cough, some nausea, chills.
Parent notice swelling and redness to injection sites that evening. Took patient to ER following day. There impression was Rt tricep local site reaction status post vaccines. Treatment ibuprofen, ice and also warm compress.
I had vaccination on 10/18/2022. On 01/07/2023 I started to have flu like symptoms. It started with growing pain in the side of my hip. I started to have a low-grade fever with chills. I tested COVID-19 Positive from 01/07/2023 to 01/16/2023. I became ill again in 03/2023 and was diagnosed with Strep Throat. I was given a test which showed I was COVID-19 Positive again. I did have a rebound of Strep shortly after as well.
5 clients were given monovalent Pfizer Covid-19 vaccine and 1 client was given monovalent Moderna Covid-19 vaccine after guidance was given to discontinue monovalent vaccine and only give bivalent vaccine
Patient received his 1 dose of Pfizer vaccine and was waiting in our lobby for the recommended 15 minutes. He fainted after about 10 minutes. He fell from the bench to the floor where he landed on his stomach. When I ran over to him, his eyes were open but his body was limp. I tapped his back and asked if he was ok, and he was startled as if I woke him up from sleep. He was alert and was able to speak, he asked for water and I gave it to him. I asked of he wanted me to call emergency services but he declined. He then vomited in the waiting room trash can. His sister was with him and began to rub his back and fan him. I asked again if he needed to go to the hospital and again her declined. I told them to please wait in the lobby at least another 15 minutes before leaving and he did. I called to patient around 8pm to check on him and he said he was fine and had no more symptoms.
Vomiting, Fussiness. Diagnosis was Gastritis (obtained from phone call to responsible physician)
pt recv vax 8MAY96 & mom says for 1hr following vax pt became very pale including a vascular birth mark on face;
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates in August 2015, these patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L006383, expiration ate: 25-FEB-2017 or lot # L017145, expiration date: 13-MAY-2017, strength, dose and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
The patient received doses of VARIVAX, MMR, and TDaP, and has since developed a rash described as red spots near the vaccination site.; This spontaneous report was received from a pharmacist, who is also the patient's mother, referring to a 4-year-old male patient. The patient's pertinent medical history, concomitant medications, previous drugs reactions and allergies were reported as none.  On 20-SEP-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); both vaccines were administered subcutaneously. Also on the same day, the patient was vaccinated with diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (manufacturer unknown) (route of administration was not reported). All therapies were administered as vaccination (strengths, dose numbers, doses, and anatomical locations of vaccination were not reported; lot number, and expiration dates were unknown by the reporter).  On 26-SEP-2019, the patient experienced a  rash described as red spots near the vaccination site (vaccination site rash). The treatment given to the patient due to the event was ibuprofen (unspecified dose and frequency). Laboratory diagnostic or studies were not performed to the patient. It was reported that the patient did not sought medical attention.  At the time of this report, the outcome of the event vaccination site rash was reported as not recovered.  The causality assessment between the suspect therapies and the aforementioned event was not reported.
On unspecified dates, the patient received her first and second doses of Lymerix. Two weeks after dose 2, the patient experienced a left popliteal fossa rash. As of 05/08/2001, the adverse event had resolved.
COVID breakthrough first dose 5/20/2021 EW0179 second dose 1/13/2022 FJ5682.  94y.o. female with a h/o dementia on aricept and memantine, HTN on metoprolol, mitral regurgitation, hyperlipidemia who was diagnosed with COVID yesterday and taking keflex at home for UTI.  Per ED physician, daughter concerned that she has become weaker and more drowsy and thus brought her to the ED.  Labs in the ED are c/w previously diagnosed CKD.  She does have pyuria.  As patient has been weak and rolled out of bed, ED requests admission.  Upon my evaluation in the ED, she does appear slightly tachypneic with occ wheezing. She is verbally unresponsive and is lying on her left lateral side.  Her vital signs are wnl with an oxygen saturation of 98% on room air.  No CXR has been obtained by the ED.  Head CT without any acute changes.  Per d/w daughter via telephone as patient was unable to provide history.  She rolled out of her bed on Sunday morning (5/29).  She needed assistance to get back into bed.  She was diagnosed with coronavirus this morning
pt had severe anxiety attack after receiving the vaccine. pt was very tense and not breathing with eyes rolled back into her head. mother stated she had had an attack at the hospital giving blood before bc of severe fear of needles. 911 was called and she was taken to the hospital
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included cardiac failure. Previously administered products included Covid vaccine with an associated reaction of pain in extremity (On an unknown date received 6 doses and only after 1st dose experienced sore arm and tired for 2 days) and Flu vaccine. Concurrent medical conditions included chronic obstructive pulmonary disease, emphysema and blood pressure high. Family history included covid-19 (exposed to Covid in my home 5 times.).   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was resolved (duration 2 days).   The reporter considered the pain in arm to be possibly related to RSV vaccine.     The company considered the pain in arm to be possibly related to RSV vaccine.   Additional Information: GSK Receipt Date: 29-SEP-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she received all six Covid vaccine, the Flu vaccine and the RSV vaccine.  The reporter stated that the only reaction was a sore arm and tired after the first Covid vaccine that lasted for two days.  The patient reported that the RSV vaccine gave him or her a sore arm for two days. The patient stated that he or she could do whatever needed to through out it all. The flu shot is something he or she get every year. The patient had been exposed to Covid in his or her home 5 times, so far so good as patient in the extreme vulnerable range, heart failure, COPD, emphysema and high blood pressure. Follow-up would not possible as no contact details were available.
Ringing in ears has intensified in my left ear where it was previously mild and started in my right ear where I didn't have an issue
This spontaneous report as received from a pharmacist refers to a 83 years old female patient with asthma, hyperthyroidism and allergies to sulfa. The patient was vaccinated with ZOSTAVAX (0.65 ml, lot # not reported) on 28-NOV-2007. Since the administration of the product, the patient has had two cases of shingles on her face. The first incidence was in "May of 2008" where she developed pain and a rash on her face. She also was having trouble speaking at that time. "A couple of weeks ago " the patient was hospitalized for "pain in her face". Pharmacist was unsure of the diagnosis made in the hospital but knew the patient was prescribed gabapentin at that time. The patient thought that this was a new case of shingles developing and was going to follow up with her primary care physician, today on 20-AUG-2012. Pharmacist adamant since patient was not presenting with rash at present time. No other co-suspects were reported. Concomitant medications included FLOVENT, albuterol, gabapentin and prednisone. At the time of report the outcome was reported as not recovered/not resolved. Treatment of OXYCONTIN was given for adverse event. The patient sought medical attention via office visiting. The events were reported as disabling by the pharmacist. Additional information has been requested.
Information has been received from a physician concerning a 62 year old female who on 29-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (Dose and Lot# not reported). The patient was vaccinated by the intramuscular route instead of the subcutaneous route. No adverse experience was reported.   Follow up information has been received from a health professional concerning a 62 year old female who on 29-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 659760/0159X).  The health professional reported that the physician ordered ZOSTAVAX (Merck) injection. It was given intramuscularly instead of subcutaneously. The patient was notified. The patient came to office on 31-MAY-2008 and the patient presented left hand swollen. The physician though "?Gout" , not related to injection. No complaint since then.   Additional information is not expected.
4 days post vax, the pt developed redness at the injection site. Seen in our office with an indurated area and 10cm x 4 1/2 cm erythema warm and tender. Diagnosed with cellulitis. Treated with Augmentin and cool compresses.
About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest; This non-serious case was received during the Vaccines Adverse Event Reporting System (VAERS) monitoring on 12-JUL-2022 with the following VAERS Primary ID 2302595-1. The original narrative from the sender is the following:  About 10-15 min after vaccines on the way out patient developed defuse urticaria to face and chest.  8 mg  dexamethasone given and monitored in office with resolution of urticaria after about 45 min.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "defuse urticaria to face and chest".  No further information is expected.
A day after the injection, almost 24 hours later I started to feel like I was getting sick. I was expecting it since that was the known symptoms and that it would go away 1-2 days later. well for me, it didn't go away. Few days later, the mild aches and pain on the body went away but the headaches did not. Instead, it progressed day after each day with more headaches, which felt like migraines plus dizziness. On March 31, I woke up and opened my eyes my whole room was spinning. I started to take Advil here and there to ease the discomfort. Apr 16 would be the day I come back for my 2nd shot but I am so scared of the increased migraines and dizziness I might not come back.
Severe headache and light sensitivity which is not on the common list. This lasted 24 hours as severe, then lessened each day. Today I still have a slight headache and light sensitivity.  Coworkers had the same experience. This should be on the side effect listing .
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium, Systemic: Hypotension-Medium, Additional Details: During the 15 minute period after the vaccine patient was sitting down and felt nausea and diziness. He leaned forward to rest his head on his knees. This is when he fainted and fell forward hitting his head on the ground. He woke up just about 5-10 seconds later and his wife called EMS. Patient felt fine at that point and wanted to go home but wife wanted to be safe and wait for first responders to have him check out. First repsonders arrived and determined the patient was good to go home
throat started to hurt like it was swollen; It felt more muscular.; a couple episodes of trouble swallowing.; it felt like the very back of my tongue was also swollen.; This is a spontaneous report from a contactable consumer. This 53-year-old female consumer (patient) reported that who received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: En6198 and expiry date was unknown) via an unspecified route of administration on 04-MAR-2021 19:00 as a single dose for COVID-19 immunisation. Medical history was Psoriatic arthritis, osteoarthritis, fibromyalgia, asthma, allergic to Several Antibiotics, deet. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08-MAR-2021 17:00 her throat started to hurt like it was swollen. Did not have a sore(irritated) throat. It felt more muscular. She had a couple episodes of trouble swallowing. Tuesday night it felt like the very back of my tongue was also swollen. This problem was not constant. She have episodes of it happening. No treatment was received due to events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
patient took second Pfizer dose on 4/7/21 and noted excessive sweating. on 4/13/2021 left ear clogged and painful. went to walk in clinic on 4/17/2021 and treated for left ear fungal infection. Saw his ENT doctor also.
PATIENT DIAGNOSED WITH COVID-19 ON 9/2/2021 AT ER . PATIENT SYMPTOMS AS FOLLOWS, STUFFY NOSE, COUGH AND FEVER THAT STARTED 3 DAYS PRIOR TO DIAGNOSES DATE.