chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red mark around the injection site; Also some spots have sprouted away into the inner side of her arm; She stated that it keep getting worse and it is abnormal/it keeps getting larger and larger and it is now as big as her hand; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8736, expiry date: unknown) via an unspecified route of administration on 04May2021 (at the age of 78-year-old) as dose 2, single for covid-19 immunization. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number, expiry date: not reported) via an unspecified route of administration on an unknown date in 2021 as dose 1, single for covid-19 immunization. Stated that she had a history of lot of allergies but, a low thyroid from an unknown date and occasionally take hydroxy, which is an antihistamine for hives. If something causes her to get hives, she doesnt take it daily, takes as needed. She had a route canal and was taking Amoxicillin; she took the last pill the day before she had the second Covid shot, and this was her primary suggestion. Patient was suggested that it was alright to get the Covid shot with the Amoxicillin, it wouldnt cause a problem. Patient's concomitant medication included small amount of levothyroxine sodium (SYNTHROID) for low thyroid from an unspecified date. Reporter stated that she had the second dose of the Pfizer Covid-19 dose a week ago tomorrow, and she started had red mark around the injection site but it keeps getting larger and larger and it was now as big as her hand. Also some spots had sprouted away into the inner side of her arm. She stated that it keep getting worse and it was abnormal. She started out with a little red around the shot, the size of a penny, size of a quarter and now it was the size of the palm of her hand on her upper arm. She stated that it was red and was getting larger and larger and she was wondering and queried for was that considered a rash that will soon cover her arm and then her chest and then her body.  No follow-up attempts are needed. No further information is expected.
3 dose (2 plus booster) COVID vaccinated patient admitted through ED and died with COVID diagnosis.  Provider discharge note below:  Reason for Admission:  SOB    "80 YO male w/ history of Hypertension, hyperlipidemia presented with worsening dyspnea of 1-2 weeks duration. He notes dyspnea at rest but worse with exertion. Associated symptoms include decreased appetite, and weakness   Hospital Course: No notes on file  Acute hypoxic respiratory failure due to COVID 19 infection Unvaccinated host History of Emphysema; Former tobacco user  -supplement O2 with goal SpO2 92-96%. Wean support as tolerated. -prone positioning as tolerated - Albuterol MDI, Decadron therapy , tessalon perle, Mucinex - not candidate for Remdesivir due to duration of symptoms - strict isolation and hand hygiene precautions  Oxygen requirement has progressive increase since admission, from 3 L to 5 L   Patient developed cardiac arrest, had PE a, cardiac resuscitation was done, However it was unsuccessful, patient passed away at around 10:30 a.m."
Mom would like to report child the evening of the shots that he started with 102 fever, aches, headache, diarrhea lasted till 10/2/2017.
My son received his second dose of the Pfizer COVID-19 vaccine on 12/9/2021. On 1/30/2022, he tested positive for COVID-19. He wasn't especially sick, however. He had a fever, sore throat, and a bad cough. It lasted for about 2 weeks. Thankfully, his symptoms resolved pretty quickly. I didn't really give him much medicine, aside from maybe Tylenol and ibuprofen. Several people in the family got COVID-19 at the same time, and they were also breakthrough cases. Fortunately, none of them got very sick and they all recovered pretty quickly. No one had to receive medical attention, either. My son was actually back in school by 2/7/2022.
Menstruation came a week early and was significantly more painful than usual.  I am nauseous, shaking, pale, and the cramps are bad enough that I had to leave work.  While I usually have a painful period, it's regular and the discomfort is controllable with ibuprofen.
Patient states had problems with "legs giving out and weakness."  Noticed symptoms on 1/27/2009 and went to emergency room.  Patient states was treated with immune globulin while hospitalized.  Currently being treated by MD. 2/11/09-records received for DOS 1/27-2/1/09- DC DX:Bilateral upper and lower extremity weakness, possible Guillain-Barre syndrome status post intravenous immunoglobulin treatment. History of seizure disorder. Presented with bilateral upper and lower extremity weakness of sudden onset. Unsteady gait and confused. PE: decreased sensation on left side face, arm and legs.   2/16/09-neurology consult and diagnostic test received-neurolgoy exam C/O heaviness of right upper extremity and legs. Appears anxious, decreased sensation on left side face, arm and legs, grip is better on left, reflexes not elicited on left ankle. Vibration decreased on left knee and elbow. Assessment:acute onset lower extremity bilateral heaviness and right upper extremity heaviness and weakness with decreased sensation on left side face arm and leg.Treated with IVIG.
At 8pm on June 8th 2019 I was sitting down about to watch a movie when I suddenly became VERY DIZZY. Called for my daughter to help me. Started severe vomiting which lasted for more Than 1 hour. EMS took me to Hospital. 9-9:30 I was still woozzy until Doctor gave me meclazine + started an IV. I underwent many tests (Negative) and was kept overnight for observation. Released 4 p.m. on the 9th.
Information has been received from a nurse practitioner concerning a a retired 86 year old white female with no medical hx and no allergies who on 29SEP2003 was vaccinated IM in the left deltoid with a first dose of pneumococcal vaccine 23 polyvalent. There was no illness at the time of vaccination. There was no adverse events following prior vaccinations. On 29SEP2003, within hours of the vaccination, the pt developed a serious rxn with injection site redness, swelling, and pain. It was reported that the pt developed cellulitis from the mid-forearm to the shoulder and extending into the axilla and upper back. the pt was seen at a clinic and treated with NSAID's and local ice. Subsequently, the pt recovered. The duration was reported from 4 hours to 6 days. No product quality complaint was involved. It was also reported that three other female pts were vaccinated with a dose of pneumococcal vaccine 23 polyvalent vaccine and developed injection site redness, swelling and pain. No further information is expected.
Information has been received from a physician concerning a female who on 23-JUN-2007 was vaccinated intramuscularly with the first dose of the Gardasil. Concomitant therapy included 'other vaccines". A couple of minutes after the injection, in the waiting room, the patient fainted. The patient was given "smelling salts and it didn't help, and then she was given epinephrine and the patient didn't react to that either." About about fifteen minutes, the patient "finally came to." Unspecified medical attention was sought. It was reported that the patient recovered on an unknown date. No further information is available.
The patient experienced an immediate brief loss of consciousness upon injection. She was able to answer questions from the nurse immediately after, but she had lost bladder control during the syncopal event. She had not been aware of losing bladder control until after it had occurred. Vitals remained stable throughout her time in the clinic with exception of intermittent tachycardia. She was placed in supine position after and then she proceeded to vomit several times. About one hour later, the patient experienced syncope again for about 30 seconds. She vomited again after the second LOC. She was given two doses of ZOFRAN 4mg SL tabs. We were unable to start an IV in the patient, but after the vomiting had ceased the patient was able to sip fluids. She was kept in our clinic for about an hour after the last syncopal event, and was sent home with significant other. She follow up the next day and was completely improved. Denies any history of seizure-type activity. The patient's mother informed her that she had a vomiting reaction to flu vaccination several years ago.
Pt recv vax on 11/15/98; on 11/20/98 pt exp indurated/ itchy area of LA, headache; tx=Ibuprofen/Tylenol, Keflex
Low Fever 100 degree F; hot flasher/ cold chills; hot flasher/ cold chills; This is a spontaneous report from a contactable Consumer. This 36-year-old- (Pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1284) via an unspecified route of administration, administered in arm left on 10Jan2021 (Batch/Lot Number: EL1284) as second dose, single dose for COVID-19 immunization. Medical history included polycystic ovaries, hypothyroidism from 2016 treated with Levothyroxine. The patient was allergic to Flagyl (historic not active) and experienced drug hypersensitivity. The patient previously receive first dose of bnt162b2 (Lot/Batch number: #1-EK5730) and experienced off label use. Concomitant medications included progesterone (PROGESTERONE) from 13Dec2020; escitalopram oxalate (LEXAPRO) from 2015; buspirone hydrochloride (BUSPAR) from 2015; levothyroxine (LEVOTHYROXINE) from 2016. The 41-year-old father had a heart disease and had exposure to products Crestor (Oral, 10mg/day) from 2016, Cialis (oral, 5mg/day) from 2020. Both were neither smoking, nor drinking alcohol nor using illicit drugs during the pregnancy. On 11Jan2021 3:30, the patient experienced hot flasher/ cold chills. On 11Jan2021 6:30 the patient experienced low fever 100degree fever. The mother reported she became pregnant while taking bnt162b2.The mother was 1 Months pregnant at the onset of the event. The mother was due to deliver on 30Aug2021. The patient reported that she was five weeks pregnant and received first COVID-19 vaccination at 3 weeks 4 days (25-days/gestational period at time of initial exposure reported as 1 month/ 1st trimester as reported) on 20Dec2020. The patient underwent lab tests and procedures which included Ultrasound scan: Normal (Ante-natal check-up) on 18Jan2021.The outcome of the event cold chills/hot flashes was recovered on unspecified date and the event fever outcome was unknown.  No Follow-up attempts are needed. No Further information is expected.
This spontaneous report as received from a medical assistant refers to a 9 year old male patient. The patient's medical history included liver transplant and gastric tube replacement. There was no information about the patient's concurrent conditions or concomitant therapies provided. On 02-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M004318, expiration date: 12-OCT-2017 (exact dose, route of administration and anatomical location were not provided). On 02-NOV-2016, the patient experienced swelling, fever and body sweats after vaccine administration. The patient was admitted to the hospital on the same date and on 03-NOV-2016, during the night he was transferred to intensive care unit (ICU). At the time of the report, the patient had no lab diagnostics studies performed. The outcome of the events was reported as not recovered/not resolved. Causality assessment was not provided. The reporter considered the events to be life threatening. Additional information has been requested.
Had Dtap vaccine #5 has 7x17 cm of erythema cellulitis of left outer arm. Placed on warm compress and antibiotics.
Severe head pain, jaw pain not relieved by APAP; BP inc to 190/130;
Dry mouth, difficulty swallowing and chewing food, swollen tongue, numbness of the tongue, thick and heavy tongue feeling.
First day was the usual pain in the arm. That night she had extreme shivers and was weak the next day. Now she is still very weak and now has pain in her mid back. Her throat is also now sore.
Five hours after the vaccination, I started having pain, swelling, and redness at the injection site. I also had mild upper body myalgia. While I was in bed that night, I woke up multiple times with chills.  The following morning, my injection site pain was a 6 out of 10. The redness and swelling had also gotten worse. I had a headache, intermittent chills, and generalized myalgia. My symptoms continued to increase throughout the day.  It?s now been about 30 hours since I got the vaccine. I have 7 out of 10  pain, moderate redness, and moderate swelling at the injection site.  It also feels warm to the touch. My headache pain level is a 7 out of 10. I have fatigue, myalgia, aching joints, and alternating chills/sweats. It feels similar to the first day of influenza.  I have been alternating Tylenol and Motrin with minimal relief.
Extreme muscle aches, severe headache, fever (101.5), nausea, dizziness, fatigue
I was encouraged to complete this form by a telephone service person after responding to a Vsafe text indicating I experienced COVID recently.  Symptoms of COVID became noticeable on the evening of Sept 8 2022 and included headache, slightly sore throat, sinus drainage, and low grade fever. By mid-day Sept 9 2022 I was experiencing increasingly higher temperatures of 100 with body ache and worsening headache. I called my doctor's office and got scheduled for the morning of Sept 10 2022. I had little to no appetite from the morning of Sept 09 2022. By the morning of Sept 10 2022 my temperature was up to about 101. When at my doctor's office, I was tested for strep, flu, and COVID. My COVID test came back quickly as positive. I was offered Paxlovid and agreed to take it. I started taking Paxlovid the evening of Sept 10 2022 and took the full 5 day course of a dose every 12 hours with last dose on the morning of Sept 15 2022. My fever broke by the evening of Sept 11 2022 and I slowly gained back my appetite. I experienced significant fatigue and confusion for the next several days with significant "brain fog" on Sept 15 2022. I don't believe I regained full strength back until about Sept 22 2022.
On 8/16/03 right arm swollen and reddened from elbow. 8/19/03 mild swelling over deltoid area with some erythema, minimal pain.
Inappropriate schedule of vaccine administered (3rd dose administered on 09-DEC-2013); Inappropriate schedule of vaccine administered (2nd dose administered on 06-OCT-2010); This spontaneous report has been received from a physician, via a medical record (MR) from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (# 2309USA005464) concerning a 2-month-old male patient. Concomitant therapies included haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown), unspecified polio vaccine inactive, rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) and unspecified diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP). His historical vaccines included Hepatitis B Immune Globulin. His medical history and concurrent conditions were not provided.       On 02-FEB-2010, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided). On 06-OCT-2010, he was vaccinated with the second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administered). On 09-DEC-2013, the patient was adminstered the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) (inappropriate schedule of product administered)   This is one of 4 reports referring to the same patient (linked # 2309USA005464, 2309USA008646 and 2309USA008647).; Sender's Comments:  US-009507513-2309USA005464: US-009507513-2309USA008646: US-009507513-2309USA008647:
This spontaneous report was received from a consumer via a company representative and refers to a 16-year-old male patient. The patient had no pertinent medical history, concomitant medications and drug reactions or allergies. On an unknown date in June 2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (site of administration, lot# and expiration date were not reported) for human papillomavirus "HPV" prophylaxis. A few weeks after the vaccination, the patient developed alopecia areata. On an unknown date in August 2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (site of administration, lot# and expiration date were not reported) for HPV prophylaxis. The event of alopecia areata continued to progress after an unspecified amount of time after the second dose of GARDASIL 9. No lab diagnostic tests were performed. The patient was referred to an unspecified dermatologist. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL 9 was not provided.
A skunk was involved with an altercation with two of his dogs. The skunk turned out to be rabid. In the process of separating the animals, he sustained a small laceration on his left hand near the thumb.
This spontaneous report was received from a healthcare worker concerning an approximately 51 year old female patient. Current condition of the patient included hives to VICODIN. On 14-OCT-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J002241 and 21-MAY-2014 respectively), subcutaneously in the left arm. Concomitant therapies included losartan and trazodone. Approximately on an unknown date in October 2013, the patient experienced redness and pain at the injection site, low grade fever and left axillary pain. The patient sought medical attention (office visit). The patient was advised to take MOTRIN and to apply ice locally. No further treatment was given at the time of report. No lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
lt thigh w/tender red fine 5cm rash;DPH, ice packs;
Pt. reported redness & itching (L) upper arm at deltoid area beginning 1/30/11 or 1/31/11 then dissipating at this area & moving down arm 2/1/11 to (L) upper inner arm area. No fever. Pt. applied cortisone cream 2/1/11 & 2/2/11 to relieve itching. Area red, warm to touch, approximately 3" x 3" area with irregular borders (L) upper arm below deltoid 2/2/11 at office visit. Rx given for KEFLEX 500mg TID x 5 days. Going out of country for 2 wks at time report written.
This is Day 3 of a delayed arm rash that started 3 days after my 2nd injection. Redness, swelling and severe itching. The rash has spread more each day and currently nearly forms a complete circle around my right upper arm. It's painful to the touch. The swelling is more predominate near the injection site and back of arm forming a large hard bump. Skin under my arm where the rash is has small bumps. The itching is worse than the pain & swelling. I've been using Cerave Hydrocortisone Anti-Itch Cream twice a day, but it doesn't completely relieve the etching.
passed out; not breathing; shaking; not awake; not coherent; not feeling good; arm was aching a little bit/her arm was hurting and her arm was achy; This is a spontaneous report from a contactable consumer (patient) and patient's mother.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 13May2021 20:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got to work on 14May2021 at 08:00 and the manager let her go home because her arm was hurting and her arm was achy, and she was not feeling good, but she was feeling fine when she got home. At 11:00 AM, she came home and went into the house and came back outside. The patient's mom said that they were on the front porch and her daughter passed out and looked like she was having a seizure kind of thing (shaking really bad), she was not awake, not coherent and not breathing. They got her into the house once she came to, they cooled her off and let her sleep for about 45 minutes. Patient said that she felt like she went to sleep and what she remembered next she felt like she was waking up. She said that she slept and nowshe feels fine. Outcome of events was recovered.    Information about Lot/Batch number has been requested.
Breathing problems, headaches,  running nose  Using a inhaler and on medication for headaches
COVID in Jan2022; COVID in Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID in Jan2022". Clinical course: Got COVID after receiving Pfizer Vx. Mild case of COVID in Jan2022. Symptoms: Fatigue. Believed getting vaccinated prevented her from getting much sicker.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Our family caught a stomach virus in which the pt. didn't recover like the rest of us.  She would not eat or drink and was lethargic.  What worried me was she was complaining her feet hurt, she was picking at her face for no reason and she was emotionally detached from the family.  What started as a stomach virus on Sunday 3/15/2009 became a potential reaction to the MMR shot she received on 3/11/2009.  Everyone recovered from the virus within 3 days but she did not.  It seems to me a bit more than a coincidence she had this vaccine and 10 days later she is in the ER because of foot pain and a weird habit of picking at her face.  She also had not passed urine for 24 hours.
itchiness; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness) and MYALGIA (body aches) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (itchiness) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchiness) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
I experienced a breakthrough case of COVID-19  with the following symptoms, diarrhea, sore throat, watery eyes, fever, loss of appetite, post nasal drip and coughing.
Patient received the Moderma Shot IM to L arm 0.5m CoVid  Vaccine at 11:30am on 012220221  and then was taken to observation room and observed for 15 minutes.  At 15 minutes the patient complained of Nausea and dizziness Blood Pressure was taken by 158/90 pulse 64 R 16 T 97.4  She noted no signs and symptoms of Distress   Paramedics on the scene transported to ER at 12:00pm Paramedics reported diffuse rash all over body by the time the patient arrived at the hospital
Devel rash, same day, on check, chest, and thigh. No fever. Macula/papular rash with itching. Also in genital area.