chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). An 18-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunisation. The patient developed illness (got very sick for 24 hours), with outcome of recovered. Additional information: The patient got very sick for 24 hours after getting the second dose of Pfizer-BioNTech COVID-19 vaccine. She was scared to get another dose. She mentioned her school mandated the third dose for their students. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Itching, Swelling, hardness, tenderness and redness on injection site (right arm) Feels warm to touch.  Discomfort and slight swelling under right arm pit.  Symptoms started 7 days after vaccination.  Also felt a little out of breath on day 8.
I had severe pain at injection site when initially given but it went away after a few days.  I had emergency Gall Bladder surgery on Jun 9, 2021 and a afterwards, my arm where the initial COVID shot was given,  had the same pain develop at the injection site along with a slight amount of swelling
Late start to my menstruation, about a week late, when usually on time. My menstruation is about 7 days and always regular. My period started a week late and now I am currently on the 9th day and I am bleeding heavily. Feeling very tired and no energy. I have also developed a twitch to the right side of my face that comes and goes but is very uncomfortable. I get random sensitivity to the site of where my vaccine was administered. The twitch on my face started about 5 days after first dose of pfizer was administered and went on for two weeks straight. It stopped for a few days but came back after the second dose was administered and now it comes and goes daily.
Break through infection; Break through infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Feb2021 (Lot number: EL3247) at the age of 22 years as dose 2, single and administered in arm left, administration date 03Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient No allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Dec2021, outcome "recovering" and all described as "Break through infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Initial healthcare professional report received on 26 May 2010: This patient with medical history of testicular cancer and drug history of radiation in Dec 2009, received RABAVERT pre exposure series (batch number 445012A) unknown dose on 18 May 2010. On 23 May 2010, the patient's hands became itchy and red after the patient washed the dish. It was reported that the redness occurred between the fingers to the knuckles on both hands. It was reported that the redness and the itching persisted for about 2 hours after washing the dishes in the morning and then gets resolved. It was reported that the reaction had occurred since the day it started. On an unknown date, the patient missed the second dose of day 7 of RABAVERT. The outcomes of the events were not reported. The causality was not reported. Follow up report received from a nurse on 23 Jun 2010: The patient had medical history of prostate cancer and received radiation therapy in Dec 2009. The patient experienced slight itching on hands and waist (noted by patients wife), on 20 May 2010 and on 21 May 2010. On 25 May 2010, the patient's hands became red, itchy and slightly swollen; palms were red with slight rash between the fingers of both hands. The patient thought it might be related to use new dish soap to wash the dishes before work. The patient did not receive second dose of RABAVERT. The patient went to family physician and the physician did not consider the events as related to vaccine. The patient continued with the symptoms. On 30 May 2010, hands become very swollen, red and broke out hives on chest. The patient was given treatment with BENADRYL 50 mg for hives, on 30 May 2010. Outcome of the events was reported as complete recovery.
1 week after pfizer vaccination partial body rash on stomach, genitals, breasts. Pt reports painful and itchy. Rash still has not subsided as of 11/8/21. Pts tried taking tylenol and benadryl to manage her symptoms.
No Additional AE; 1st dose of MMR II ON 3/30/2023, and then 9 days later on April 8, 2023 was given VARIVAX; The pharmacist stated he knew that live vaccines should be given 28 days apart; This spontaneous report was received from a pharmacist and referred to a 32-year-old male patient. The patient's concurrent condition, concomitant therapy and medical history were not reported. The drug reactions/allergies were unknown.  On 30-MAR-2023, the patient was administered with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. On 08-APR-2023 (reported as 9 days later), the patient was administered with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. The pharmacist stated he knew that live vaccines should be given 28 days apart, and patient received the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) now only 9 days apart from the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (inappropriate schedule of product administration and off label use). On 01-MAY-2023, patient received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. On 08-MAY-2023 (reported as today), the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, lot #, expiration date, route and anatomical location were not provided) for prophylaxis. It was unknown if the patient sought medical attention and gave treatment for event. No additional adverse event (AE) (no adverse event).
Patient reports she got her second Moderna shot two days ago. Her right arm is red and warm with a rash. Patient reports that it is painful and itching. Patient was prescribed Bactrim DS for cellulitis.
Patient received first COVID vaccine 3/29/21.  Patient received second COVID vaccine 4/19/21 in the morning - patient developed headache and severe vomiting throughout the day 4/19/21 resulting in diabetic ketoacidosis (glucose 583 mg/dL) and systemic inflammatory response syndrome (SIRS) - patient admitted 4/19/21 in evening to ICU - patient discharged 4/21/21.  Patient states she had COVID disease last year.
Patient reported constant headache following 2 weeks after vaccination. No prior history of headaches or migraines.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 12/29/2020, 01/26/2021, and 11/11/2021. They tested positive for COVID-19 on 08/06/2022 twice: once at the assisted living facility at which they were a resident and once in a hospital. They were admitted to hospital same day and died on 08/18/2022. I do not see a discharge date or disposition in the records I have immediately available to me.
12/13/21 presents to ED for "left leg swelling". PMHx of "CKD, Diarrhea, ESRD on hemodialysis, Gallbladder problem, GERD, Hyperparathyroidism due to renal insufficiency, Hypertension, Joint pain, Obstructive sleep apnea, Paroxysmal atrial fibrillation, and Traumatic hematoma of lower leg "
mom reported that pt woke up next day p/vax w/hives, the hives were on legs, face, arms & trunk;hives last 5 days;T101 R;no diet changes during or before this episode;hx hives, allergy tested @ 11mo;no source found;
Pt is a 26 yr/o female status post second  COVID-19 vaccination yesterday in her right arm at around 2:30 PM who presents to the ED with an onset of soreness in her right arm with numbness and tingling radiating down to her long and ring fingers last night.  She states she has had chills but denies any documented fever.  She has had some nausea and vomiting.  She denies any chest pain or shortness of breath.   She received her Covid vaccine in preparation to have an upcoming breast reduction.
Headache, right eye pain. BP 127/70 (pulse 76), 103/66. O2 sats 100%.
lost noticed she's almost 10 lbs; experiencing achy chest pains; gets dizzy at times; experiencing watery stools 6-12x a day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (experiencing watery stools 6-12x a day), WEIGHT DECREASED (lost noticed she's almost 10 lbs), CHEST PAIN (experiencing achy chest pains) and DIZZINESS (gets dizzy at times) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Colitis. Concomitant products included TOPIRAMATE (TOPAMAX), VITAMIN D NOS, GABAPENTIN, BUSPIRONE HYDROCHLORIDE (BUSPAR), DULOXETINE, LORAZEPAM (ATIVAN), LEVOTHYROXINE, CEFIXIME (FLEXERIL [CEFIXIME]), PRAZOSIN, VALSARTAN (VALTARAN), ESTRADIOL and IBUPROFEN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DIARRHOEA (experiencing watery stools 6-12x a day). On an unknown date, the patient experienced WEIGHT DECREASED (lost noticed she's almost 10 lbs), CHEST PAIN (experiencing achy chest pains) and DIZZINESS (gets dizzy at times). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (experiencing watery stools 6-12x a day) had not resolved and WEIGHT DECREASED (lost noticed she's almost 10 lbs), CHEST PAIN (experiencing achy chest pains) and DIZZINESS (gets dizzy at times) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.
Patient gradually fainted from one chair to other chair and head down first after injection of immunization. Patient regain consciousness about 1 to 2 minutes after doctor went to patient's room. Facial color from pale to pink about 1 to 2 minutes. Patient has normal conversation with doctor and family after regain consciousness. BP 110/70 and HR 88. Neurological exam normal.
For over a month I have uncontrollable shaking and tremors. I also have hot flashes, lingering pain at the site of injection, fast pounding heart rate and chest pain.
I am an anesthesiologist reporting my own event: injection received 0900.  At 1400 I began low grade fever and not feeling well.  By 1600 I had extreme fatigue and severe mental fogginess.  This fogginess lasted approximately 24 hours.  Other reactions included chills, fever, myalgia, arthralgia, headache as expected.  I feel the mental effects could put patients in danger if healthcare practitioners are not aware of the possibility of this and receive the vaccine while on duty.  I did not experience this with the first dose.
pain and muscle weakness, saw pt today 20 days after administration and pain is mostly resolved but significant motor weakness affecting deltoid, supraspinatus. Unable to raise arm (abduct or flex) above 15 degrees actively. Passive ROM intact, lower arm muscles/ hand muscles intact. int/ ext rotation intact.
Swollen, red and hot at injection site. Hard 3inches diameter. Swelling in Underarm
On 8/20/07 received and dose of Gardasil; Pt reports 4-5 hrs later got fine papular eruption not welts; no itch, no prev allergies or hives. Dermatologist examined on 8/23/07 1700 for Morbilliform eruption so far forearms and lower abdomen minimal erythema Dx: Eruption probably due to Gardasil sensitivity
This report describes joint pain in a female vaccinee of unspecified age who received Lyme disease vaccine recombinant. This report was received as part of litigation proceedings and has not been verified by a physician or other healthcare professional. Medical history, concurrent conditions, and concurrent medications were not provided. The vaccinee reportedly received LYMErix; the number of injections were not reported. In a statement of injuries, her attorney alleged that the vaccinee "suffers from joint pain, particularly in her shoulders and knees. She also experiences flu-like symptoms and fatigue. In addition, she suffers from headaches and dizziness." Time to onset following immunization, treatment, and outcome of the alleged events were not reported. The adverse events "joint pain," headaches," and "dizziness" do not meet serious criteria but are being submitted as an expedited report by special FDA request.
Nausea, Vomiting, Fever, Chills, head and body aches
large area red raised rash localized to site of lt leg vax given sl warm to touch;
-12 hours after 2nd Pfizer vaccine, woke up repeatedly throughout the night with bizarre, vivid dreams; also awoke 3 times with eyes open and distinctly heard my cat purring on the bed, even though she passed away two years ago. These symptoms ended after the first night post-vaccine.  -18 hours after 2nd Pfizer vaccine, in the morning noticed distinct neck puffiness and swelling, especially just under the jaw line. After 1 week the puffiness persists, but is slightly less.  -48 hours after the 2nd Pfizer vaccine, noticed high-pitched buzz (tinnitus) in both ears. In a completely quiet room, I continue to hear it throughout the day and night after one week.
I got the vaccine at my workplace at 1115am. I had a normal day, no signs other than a sore arm a few hours later. I went to bed at 9pm feeling fine, and woke up at 10pm very Sick, Throwing up & a fever of 100.8 , Body aches and a Bad headache. i tossed and turned for several hours feeling worse and worse. Eventually at like 9am the next day my heart rate started racing in the 140s. I went to the ER and was told they think the shot just "Woke up" My post covid tachycardia.  I had COVID in july and a month later i started getting random bouts of tachycardia. They had subsided mostly, since late october.  They did draw my blood and my Potassium was a little low,3.5. so he sent me home with a 7 day supplement of it.
This spontaneous report as received from a medical assistant refers to a 2-month-old female patient. Her medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 12-MAR-2018, the patient might have been vaccinated with an improperly stored dose of ROTATEQ orally, lot number reported as N021099, expiration date 02-FEB-2019 (dose not reported) as prophylaxis. The vaccine was stored for 10 minutes in the range 47 Fahrenheit degrees to 77 Fahrenheit degrees. There was no previous temperature excursion. The data logger was involved. No adverse effect was reported.
Body-aches followed by cycles of fever and chills and then continued body-aches lasted 34 hours.  Period of fever cycle was over a 12 hour period.
Patient complained of fatigue for 48 hours after vaccine, causing him to sleep most hours of the following two days.
Anaphylaxis requiring two, six-hour ER visits. Treatment included multiple epinephrine injections.
Moderna vaccine #2 was given on Friday, January 29 at 1 PM.  She had no side effects that day.  On Saturday she felt mildly achy and had a headache and stayed in bed.  Sunday her heart was flip-flopping with palpitations.  She noticed new dyspnea on exertion with just a short distance as well as feeling panicky.  On Monday she went to work and continued to have the same symptoms.  Two colleagues were vaccinated at the same time she was also reported the same symptoms of palpitations, dyspnea and new onset anxiety.  Yesterday the symptoms were even worse, "really bad'.  Her vital signs were checked at work and were all normal.    Today she is not feeling as bad but still feels very anxious.  She woke up with a headache again.  She is taking ibuprofen for the HA which helps.
10 cm raised area, red. Pt reports pain and swelling. 2/26/02. improvement but not resaolved on 3/11/02 pm, nearly resolved 3/1/02.
BUD date excursion. BUD was 4-7-23 and vaccine was administered. 4-21-23.
Patient received Pfizer bivalent as second vaccine in primary series instead of Pfizer monovalent;  patient showed no adverse reactions during 15 minute wait time;  pediatrician notified
urinary tract infection; sore arm; limited her ability to do things; angiogram showed mild blockage; progressively been getting weaker/weakness; bones periodically get icy cold; had heavy breathing which was difficult to control even with her focusing on her breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient).  An 85-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Left on 17Feb2021 at 03:00 as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation and experienced asthenia on 30Jan2021. Relevant medical history and concurrent conditions included a fib. The patient has allergy to iodine. The patient did not receive prior vaccinations within 4 weeks. The patient did not receive any prior vaccinations within 4 weeks of receiving covid-19 vaccine. The patient has been keeping a daily journal for over 20 years and she noticed a trend of her symptoms after the vaccines. On 29Mar2021, the patient experienced progressively been getting weaker/weakness, a feeling from the top of her head to her knees. In Mar2021, the patient experienced bones periodically get icy cold. On an unknown date, had heavy breathing which was difficult to control even with her focusing on her breathing; on an unspecified date, the patient experienced sore arm, urinary tract infection, limited her ability to do things and on 22Mar2021, the patient experienced angiogram showed mild blockage, so it does not require surgery. The patient knows there have been reports of body aches then you could say sensations numbness, tingling, etcetera. The patient wakes up and is good for about an hour at most and then she gets weakness. The patient went by ambulance to the emergency room on 1Mar2021, due to the weakness and was out on same day. The patient underwent lab test which included, COVID-19 virus test which was negative on 01Mar2021. On 22Mar2021 Angiogram showed mild blockage. On an unknown date, the white blood cell count was normal. Therapeutic measures were taken with a bag of Rocephin. The patient was on a recording monitor and it sends reports to her cardiologist every night and it has not noted an event in over 90 days. The clinical outcome of the events progressively been getting weaker/weakness was not recovered; bones periodically get icy cold, sore arm, angiogram showed mild blockage, had heavy breathing which was difficult to control even with her focusing on her breathing, limited her ability to do things urinary tract infection was unknown.  No follow-up attempts needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021633718 similar report from same reporter
Information has been received from a male patient of unknown age referring to himself. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (1 injection, route, lot# and expired date were unknown) in his upper right arm. No concomitant medication was reported. On unknown dates the patient experienced redness, swelling, itching, and warm to the touch at his injection site. The patient did not seek any medical attention. At the time of reporting, the outcome of the events was unknown. Additional information is not expected since there was no contact information provided.
Employee went to get the influenza vaccine via the "flu clinic" at work. The arm was sore all day at work, and the employee realized the next day while showering that she had axillary lymph node inflammation (the size of a tennis ball) in the arm where she received the vaccination.  The swelling resolved in one week, however there is still some lingering pain in the lymph node area ,on occasion.
Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies who on 28-JUL-2003 was vaccinated SQ with the first 0.5ml dose of VARIVAX (Merck). There was no concomitant medication. On approximately 16-JAN-2009 the patient developed shingles. The patient was in office to see the physician on 16-JAN-2009. At that time, the patient had lesions on the right side of chest. The physician prescribed VALTREX. At the time of this report, the patient was recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/15/2009.  Information has been received from a physician concerning a 15 year old female with no pertinent medical history and no drug reactions or allergies who on 28-JUL-2003 was vaccinated SQ with the first 0.5ml dose of VARIVAX (Merck).  There was no concomitant medication.  On approximately 16-JAN-2009 the patient developed shingles.  The patient was in ofice to see the physician on 16-JAN-2009.  At that time, the patient had lesions on the right side of chest.  The physician prescribed VALTREX.  At the time of this report, the patient was recovewred.  Follow-up information was received from the office.  It was reported that the 15 year old patient no pre-existing allergies, birth defects or medical conditions developed shingles on 16-JAN-2009.  So varicella vaccine booster dose was not given.  No adverse effect.  The patient was doing well.  No further information is available.
Patient is here to talk about a possible Covid vaccine reaction. She had her first shot on July 1st at the pharmacy. She remarks that blood sprayed out when the injection was done. She got light headed driving home and felt very unstable. Her second shot was July 22nd. A few weeks later she passed out in the elevator after a routine lab check. Her pulse was extremely low and was taken code yellow by Ambulance to the ER (Aug 1st). Several tests were ordered in the ER. She had a normal EKG and was told she might be dehydrated. She continues to be dizzy and her head hurts.
"confusion, dizziness"; "an hour went by and then I threw up"; did not eat before vaccination or after; reports lack of energy; lasted 2 1/2 hours. When asked how she was feeling, "I stopped taking my allergy medicine for 3 days and don't feel well. My nose and everything is stuffy and runny.