chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction to the Pfizer booster; 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 BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series , unknown manufacturer), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction to the Pfizer booster".  Patient characteristics   Sex: Female  Drug(s) Information: Characterization of Drug Role: Suspect Proprietary Medicinal Product Name: Comirnaty   Active Substance Information: Active Drug Substance Names: COVID 19 Vaccine, mRNA  Narrative case summary and further information: Originating AE Request:  Attachments: 1 Reporter Subtype: Patient PQC Present: No AE Present: Yes PQC Details:  Request Name:  Product: COMIRNATY Question: After hours page received on 11Apr2022 at 03:50 AM.  Voicemail verbatim:  "(states name but unable to hear clearly) (Phone number withheld) had an allergic reaction to the Pfizer booster. I'd like to talk about it, see if I could be compensated.  I reported it to the FDA and now I'm reporting it to you. (Phone number withheld) please give me a call back."   Agency: E-transmitting limited details from voicemail. Seems to be female consumer.  Placing in frontline queue for callback Monday. Please confirm Pfizer Covid 19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fairly immediate onset within 24 hrs, worsened after second vaccine of chest discomfort/tightness, mild shortness of breath, intermittent palpitations, chronic non-productive cough, myalgias and fatigue.  This has now been going on for 7 months and she is s/p a very extensive and unrevealing work-up except for elevated inflammatory markers (CRP, ESR).  Development of neuropathic symptoms of hands and feet at some point in course but onset timing not clear.
Pentacel given 2 errors -partial administration-HIB vial omitted and given with pediarix
Information has been received from the authors of the published literature abstract title as stated below. The objective of the authors was to address a methodological challenge for studies of the safety of concomitant vaccination. Baseline risk of adverse events (AE) in young children changes quickly with age. Timing of same versus separate day vaccination was also associated with age. The authors showed how this can create bias and how to adjust for it. They re-examined the known increase in risk of seizure and fever 710 days after measles-mumps-rubella (MMR) vaccination. They sought to identify whether other vaccines (1) independently increase the risk of either AE or (2) potentiate risk when given concomitantly with measles-mumps-rubella (MMR). The authors began with multivariable analysis including all concomitantly administered vaccines to screen for vaccines associated with AE after adjusting for all others. For identified vaccines, they used overall and age-stratified chi-square tests to evaluate whether risk in the 710 day window was different for measles-mumps-rubella (MMR) by itself vs. measles-mumps-rubella (MMR) with same day vaccination. They then used conditional logistic models that accounted for modification of MMR's effect on AE by age at vaccination and evaluated whether risk was different for measles-mumps-rubella (MMR) if identified vaccines were administered on the same versus separate days. Finally, they estimated attributable risk for same versus separate day vaccination. The authors identified fevers (N = 23,309) in children aged 1125 months. Initial analyses suggested DTaP had both an independent and potentiating effect of measles-mumps-rubella (MMR) on AEs. After accounting for age, there was no evidence for either independent or potentiating effect on risk of seizure with same day administration (p > 0.3). For fever, there was evidence for increased risk with same day DTaP and measles-mumps-rubella (MMR) in children over 18 months; X^2 = 11.1, p = 0.001, but not in younger children. The outcome of the fevers were unknown at the time of reporting. This is one of two reports from the same literature source, linked to case # 1709USA007329. Sender's Comments: US-009507513-1709USA007329.
pt recvd vax & had numbness & tingling in all extremities; seen by MD ; pt dx w/ neuropathy & still c/o pain;
Chills, Fever, Headache, Joint Pains, Muscle/Body aches, Fatigue/Tiredness
I had an attack of vertigo, came on rather suddenly. Followed with vomiting. I checked with the doctor and was given a medication. The only thing I could do was sleep. There was 2 days just of sleeping waiting for that episode to pass. When I started getting problems with hearing and pressure in the inner ear. They did an ear test and diagnosed me with Meniere's disease. My hearing on the hearing test was going down, I was losing hearing. Then it will clear up and then I would lose it again. That led to the treatment to put a tube in the ear to try to relieve pressure and then to inject steroids. There were a couple of medications they suggested. I have been taking Betahistine to help with the vertigo. The treatment pretty much came following the second episode of vertigo which was one week after getting the second dose. I do not have the vertigo at the time but I still get the pressure in my ear.
Fatigue, muscle pain, and chills at about 10pm (9 hours post vaccine) Next morning woke up after restless sleep with most severe migraine headache that I've had in several years.  The headache last to Saturday night. Saturday night as the headache faded I became nauseous and vomited.   By 36 hours after the vaccine (around midnight Saturday) I felt much better and was finally able to eat after not being able to all day. On Sunday I was tired but could function, and by today (Monday), I am fully better.
This spontaneous report as received from a registered nurse refers to a patient of unknown age, unknown gender. On 06-JUN-2013 the patient was vaccinated with an expired ZOSTAVAX (lot # 663334/1556X, expiry date 28-APR-2010). No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: patient received menactra 3 years prior with no adverse reactions. Received his vaccine in clinic- was fine, walked to the other end of store and passed out- hitting his head. He then came in clinic shaking, vomiting, hypotensive and bradycardic- EMS was called. Pt went to ED
I had a slight sinus headache and a small bout of Vertigo. I went to the doctor, and she checked my ears, and my throat was red. She said that my ears had fluid in them. I was prescribed some mediation for Sinusitis. The next night my grandson was having some stomach issues and I took him to the doctor at his primary care office. They tested both of us and we both tested positive for COVID-19 on 12/21/22. I was prescribed 5 days' worth of Paxlovid. I am feeling better, but still dealing with most of the symptoms.
Have not have a period since February and I am late.; This is a spontaneous report received from a contactable nurse, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 25Feb2021 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 04Feb2021 (at the age of 32-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 03Mar2021, the patient experienced late and did not had a period since February. The patient never been late on period in the life. Negative pregnancy tests. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive any treatment for late period. The clinical outcome of the event late period was not resolved at the time of the report.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
A 19 year old female patient experienced swollen lymph nodes while being treated with RabAvert for pre-exposure prophylaxis. She received her first dose of RabAvert on 07/22/04. Concomitant medications included birth control pills. On 07/22/04, after the first dose of RabAvert, the patient developed swollen lymph nodes on left side and to a lesser degree some swelling on the right side. The patient took Ibuprofen and the symptoms resolved within 24 hours. The patient received the second dose of RabAvert on 07/29/04 and it is unknown if she had a recurrence of these symptoms. The reporter assessed the event as possibly related to the drug. Follow up information received on 08/16/04: Upon further inquiry the lymph nodes were not affected. The swelling occurred up into the muscle above the shoulder on the patient's back on the left side of the body. The vaccine was given in the left deltoid. The dates of all the immunizations were provided. The first does was received on 07/22/04, the second 07/29/04 and the third on 08/12/04. The lot number and expiration date were provided. There were no further recurrences of the original or different symptoms.
Information received from a consumer medical inquiry on 16NOV2018. On 15NOV2018 an adult male of unspecified age received smallpox, anthrax vaccination and vaccine reported as "Japanese fly" while on active duty in (route, lot information not provided). He reported that upon awakening a small itchy rash had developed on his right forearm which was not the site of the shots. The consumer questioned whether the rash was a result of the smallpox vaccine. At the time of report, the outcome was unknown. Further information not provided.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2011 the patient was vaccinated with first dose of GARDASIL, injection (route, dose, lot number and exp.date not provided). On an unknown date in May 2013 the patient had administered the second dose of GARDASIL, injection (route, dose, lot number and exp.date not provided) and on 27-AUG-2013 the patient received third dose of GARDASIL, injection (route, dose, lot number and exp.date not provided). No adverse effect was reported. The outcome of event was unknown. Additional information has been requested.
This is a spontaneous report received from a contactable consumer who reported for a female (patient). The female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash appeared on both underarms to elbow and on both inner, upper thighs after covid-19 vaccination on 15Apr2021 with outcome of unknown. She is not pregnant at the time of vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within 12 hours of vaccine, I experienced fever, chills and sweats. I awoke from my sleep at this point, which was 4AM Friday morning. During the day on Friday, I experienced major fatigue and lethargy and had no emotional symptoms, save for being slightly annoyed/irritated about my condition. I began menstruation on Friday, April 9. Further, I slept 4pm-8pm, did some computer work from 9pm-3am, and went back to sleep. These symptoms were expected. Saturday's symptoms were not expected, regardless of onset of menstruation, and are what I would consider the adverse event. All day Saturday, I experienced massive melancholy, sadness, hopelessness, and general emotional angst. This is not normal for me, even during my period; I experienced this affect consistently years ago, from 2015-2017, when I was originally diagnosed with depression. Since 2017/2018, I have been in a much healthier emotional state, and have used an SSRI for the last 6 months with success. The following day, Sunday, I began a monophasic combination birth control, which was an original plan prescribed by a physician.  Following this, I experienced roughly 7-10 days of adverse emotional response, namely anger and aggression and mood swings, until I stopped using the new birth control on April 22. My emotional wellbeing took this roughly 7-10 days to recover. The mood change I experienced on Saturday, April 10, based on my previous experiences, was more similar to the mood change I experienced while being depressed rather than the mood change I experience from menstruation and PMS. I strongly request thoughtful consideration of the impact of the vaccine on short-term emotional and mental health changes. I was able to recover from it, and I believe that was because of my experience dealing with depression and mood swings in years past.
Right deltoid was sore and slightly bruised, slight swelling and lump and redness progressed to itchy at site and skin  was then scratched with formation over the next several days of a patch 5x6 cm of closed, noninfected pinpoint lesions due to scratching,and patient states itching also on upper back especially on right side even at one week out.
intermittent itching, some blotchy rednesss no hives or raised rash  that lasted about 3 hours, went away on its own without any treatment
Initial report received from a healthcare professional on 19 July 2013. A 30-year-old female patient whose medical history and concomitant medications were not reported, had received an intramuscular first dose of ADACEL vaccine (batch number: U4667AA, expiry date- 11-Jul-2015, anatomical site of administration was not reported) on 19 July 2013. The patient was pregnant at the time of vaccination. The patient's last menstrual period date was 12 November 2012 and the estimated date of delivery was 19 August 2013. The patient's health during pregnancy, risk factors and treatment for infertility was not reported. Laboratory investigations were not reported. At the time of this report, the patient did not experience any adverse event. At the time of this report, the outcome was unknown. List of documents held by the sender: none.
chest pain; Difficult breathing; fever; chills; body aches; Headache; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (chest pain) and DYSPNOEA (Difficult breathing) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (Headache). On 06-May-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization) and DYSPNOEA (Difficult breathing) (seriousness criterion hospitalization). The patient was hospitalized on 06-May-2021 due to CHEST PAIN and DYSPNOEA. At the time of the report, CHEST PAIN (chest pain) and DYSPNOEA (Difficult breathing) was resolving and PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and HEADACHE (Headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: negative (Negative) negative for presumed pneumonia. On an unknown date, Ultrasound chest: negative (Negative) negative for presumed pneumonia.         No concomitant medication. Treatment medication were reported as prednisone and Aztec.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information have been requested
CAME BACK APPROX. 4 HOURS LATER C/O PAIN AT SITE.
Patient states that after the vaccine was quickly "jabbed", patient says arm burned. When the patient presented on 10/29/2021 ~1pm, patient showed a large swell around the area  that she said had been growing and that should feel the pain growing down to her forearm
Telephone call with urgent care MD on 2/18/21 for c/o of itchy pink blotch at injection x3 days. Pt had received Moderna vaccine dose 1 on 2/4/21. Patient did not notice anything sxs after receiving the Moderna vaccine until the past 3 days (from when she called urgent care) as she had noticed the injection site area was itchy. Patient is unsure if symptoms were there prior and she only noticed the itchiness the past 3 days and more noticeable when scratched.  Feels slightly swollen/firm and warm per patient; but denies any pain in arm. Patient denies any other symptoms such as fever,dyspnea, boady aches, arm weakness. Pt has normal range of motion.  Pt was recommended to try topical hydrocortisone, massaging, for a few days. If persists or becomes painful or tender, pt should return for inperson exam.
high fever 5 days, red itchy bumps on chest July-bumps spread all over body, itchy red patches August- most of bumps gone, still itchy
Approximately 35 minutes after receiving the vaccine staff reported the arm that she received injection on "felt heavy then she started to have SOB, hard to breath, wants air, felt hands on her chest and chocking".  Staff noticed that she was tearing, wouldn't talk and was not responding for approximately 5 minutes. Her arms and legs were uptight. Staff also noticed some pale red patches on her neck.   Diphenhydramine solution 50mg was given to the patient orally at approximately 9:10am.    Patient started to improve in her symptoms at approximately 9:25am. Patient refused to go to the ER when offered to her by 911 staff. Per staff she was nearly 100% better at 9:45am.
First day of shot (3/5/2021), large red bump-left arm (sore and warm) went away in about 3 days.  Fourteen days (3/19/2021) after first shot  after shot, large red square-left arm (sore and warm).
(L) arm cellulitis - redness and tenderness warm to touch, edematous began with soreness at injection site.
Fever few hours after vaccines seizure, unresponsiveness, aspiration and respiratory failure 24 hr after vaccine admitted and intubated and placed on mechanical ventilator for five days.  06/11/2008 MR received for DOS 5/9-20/2008 with DX: Complex Febrile Seizures.  Respiratory Failure. Pt presented from local hospital with altered mental status, possible seizure.  Pt had 2 day hx of fever, and was becoming increasingly lethargic with decreased responsiveness. Jerking movements of all extremities noted by mom with upward eye deviation. EMS call. Upon arrival in ER pt was intubated, sedated and paralyzed and transferred to current facility. Pt suffered a R lung collapse, recovered and was extubated 5/15/08.
NO ADVERSE EVENT FOR 2 DAYS THEN ARM BECAME RED AT INJECTION SITE WITH WHITE SPOT IN CENTER. PATIENT STATES THAT ARM BURNED WHEN LAYING ON IT. STILL RED NOW BUT NOT AS BAD AS PREVIOUSLY.
Rash on forehead, nose, cheeks of face.  Skin is very dry,  itching, red, irritated; large scaling skin  flakes are peeling.   One area to the right of right cheek has a very  large scale peeled area, very noticeable, and very deep.   .
Symptoms started approximately 3-5 days after vaccine. I have had 2 separate instances of same symptoms 1-2 weeks apart: abnormal EKG, lightheadedness, dizziness, heart palpitations and chest discomfort. No treatment at this time.
Redness around injection site; Swelling around injection site; Itching around injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (Sunday) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation and patient had nothing at all. On unspecified date, with this second shot she got redness around injection site, swelling around injection site and itching around injection site. The redness/swelling/itching area was about the size of a silver dollar. It was itching more now than when it first started itching. Patient tried warm compresses which did not help with the itching. Patient did not know if she could use something else like alcohol or hydrocortisone on the area so she wanted to call and ask if those options would be ok; or if there was something, she can do to help the itching. She does not want to scratch it. The outcome of all the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
After about one hour post vaccination, patient experienced feeling cold which progressed into shaking and chills.