chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 different events: 1) 20-30 minutes after the shot, I felt dizzy and disoriented, similar to car-sickness, but I wasn't in a moving vehicle; It appeared that the center of the field of vision for my left eye had become blurred. Subsequently, I had a bad headache and body aches, which lasted most of that day and the next day. My vision is still blurred. A visit to my optician on 13 April 2021 confirmed an epi-retinal membrane, which was not present at my previous eye exam.  2) about two weeks after the shot, I experienced severe pain and raised blood vessels in different areas of both my fore arms, hands and fingers, and my lower left leg and left foot. These lasted a few minutes and then subsided. They were severe enough to wake me up multiple times every night. I finally went to my doctor's office on April 26, saw the nurse practitioner who actually watched one of these episodes. She consulted Dr., they were only concerned about my left leg being a potential blood clot; said the other areas were unlikely to cause significant problems, sent me for an ultrasound examination of my left leg on April 27th, which showed no blood clot. The intermittent raised veins and pain continued for another week or so then subsided.
Employee reported chills, shaking, dizziness "like you feel after you faint, spacey".
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On unspecified dates, the unknown number of patients were inadvertently administered (Oka/Merck) PROQUAD, that had been improperly stored (strength, dose, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of inadvertently administered (Oka/Merck) PROQUAD that had been improperly stored was unknown. Additional information has been requested.
ARM REDNESS, SWELLING, AND FEVER ON THE SKIN AT INJECTION SITE & A KNOT AT THE BASE OF MY NECK ON THE LEFT SIDE ABOUT THE SIZE OF A GRAPE. STERIOD SHOT WAS GIVEN AND THE KNOT HAS GONE DOWN SOME IN THE PAST WEEK.
I started feeling fatigued, and my joints started aching Having arthritis; I started feeling fatigued, and my joints started aching Having arthritis; This is a spontaneous report from contactable consumer (patient) reported for herself. A 81-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202), via an unspecified route of administration in the left arm on 17FEB2021 10:00 as a SINGLE DOSE and previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration in the left arm on 01FEB2021 13:00 for COVID-19 immunization. Medical history reported as penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. Patient's medications received within 2 weeks of vaccination olmesartan 40mg, multivitamin, Omega 3, D3, Tumeri. On day after second shot patient started feeling fatigued and joints started aching. Having arthritis used to some joint discomfort, but this went beyond want was normal to patient. The fatigue was so encompassing that patient lay on the couch and watch tv most of the day, interspersed with naps. The pain and fatigue lasted from 25Mar2021 until 10Mar2021 when it has begun to ease. Patient still nor back to where she was but feel better. Not being sure why reaction was so bad and glad she had the vaccine and would repeat it even knowing how I would react. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering. Information on the lot/batch number is requested.
Immediately after receiving the vaccine, patient had pain 10/10 in left arm from should to elbow.  As day progressed area became swollen, red, hot and painful from injection site to elbow.  As of 5/9/19 at 10:00 am, pain is 8/10 with analgesics (Tylenol), area remains red, hot and swollen from injection site to elbow.  Patient advised that she could continue to take analgesics for pain (Tylenol or ibuprofen); seek medical attention if condition worsens.  No loss of range of motion or pain/swelling/redness distal to elbow.  Advised to contact public health nurse on 5/10/19 in follow-up.
Patient reported swelling of lymph nodes in armpit, inflamed injections site, pain.  Recommended icing the area, take diphenhydramine and  some Tylenol and/or ibuprofen for pain and inflammation.
chills, low grade fever 100. just not feeling wee. Started around 1 am.  Its 8 am now.
Discolored arm size of a $1 coin  where the shot is and never left still on my arm since the shot  Shingles April 11th
Left side neuropathy and weakness Chills Headache Watery and itchy left eye Muscle aches
covid; covid; covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Batch/Lot number: unknown), on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), on 26Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 30Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" and all described as "covid"; DISEASE RECURRENCE (medically significant) with onset Sep2022, outcome "recovered", described as "covid". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid in May2022. Therapeutic measures were not taken as a result of disease recurrence. Symptoms in Sep2022 was a nuisance but not serious enough to warrant meds. There was no other products that were taken together with those indicated above.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300132731 same patient/reporter/product, different dose/event;
eyes swelled-lip swelled-intense itching Benadryl-prednisone-nystatin ointment
Swelling and erythema that started in the injection site area and spread up to the shoulder; Swelling and erythema that started in the injection site area and spread up to the shoulder; Patient under 65 years of age reecived Fluad (TIV); This spontaneous case was received on 12-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-03386) and concerned a female patient of an unspecified age, who was under the age of 65 at the time of this report.  The patient's medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml; route of administration: intramuscular and anatomical location: not reported) (explicitly coded as 'Inappropriate age at vaccine administration') as influenza prophylaxis. The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving Fluad (TIV) vaccine, the patient experienced severe swelling and erythema that started in the injection site area and spread up to the shoulder. The patient's arm was twice its normal size.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202005144 and 202005145 (the same reporter).  Company comment: The patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient's medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes). Product administered to patient of inappropriate age is assessed as unrelated per company conventions.; Sender's Comments: The patient under the age of 65 was administered Fluad (TIV). The patient experienced extensive swelling of vaccinated limb and vaccination site erythema (reported as severe swelling and erythema that started in the injection site area and spread up to the shoulder) an unknown amount of time after receiving vaccine. The patient's medical history and concomitant medications were not provided. With information available, causal role of the suspect vaccine is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes). Product administered to patient of inappropriate age is assessed as unrelated per company conventions.
Soreness near injection site for 1.5 days No other symptoms until approximately one week later Arms - front and back of both arms have red bumps, hives, red dots, inflamed Legs - front and back of both legs - rash with red dots everywhere  I took Benadryl and put aloe lotion on entire body - still have the spots, dots and hives seem to be going down  DO NOT ITCH
Fever-101.1.  Pain at injection site starting approximately 1 hour after injection with fever onset approximately 5 hours after injection.  Treatment with Cipro 1 gram every 10 days.
Reported dizziness, sob, and feeling lightheaded 10 minutes after receiving the vaccine. : 114/76, 02: 100%, P-100, Resps: 18.EMT called.  Informed by EMT that they did not bring patient to the hospital, she was taken home as she was medically stable.
Information was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider(s), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On 01-APR-2008, a healthcare provider at a medical office, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. In 2015, the patient was treated by a healthcare provider at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
09Jan97 pt recv vax & 18Jan97 pt devel erythema multiforme. MD felt rxn R/T to vax.
Temp 103, leg where immun given swollen from site of injection to knee, hot to touch; blood work done all nl; temp started Sat night, Sun AM started vomiting; during day Sun temp 99-100; seemed OK; Sun PM back up to 101, taken to clinic;
About 2 min after injection transient dizziness, abdominal pain, which shifted to low back spastic pain. These symptoms subsided in about 15 min. But noted BP elevation to 198/86 without any  other reaction of s/s. No Tachycardia or dyspnea. HR in 70's. O2 sat 97-48% in air, BP 17% to one hour after the onset of dizziness.
Slight headache, 101.5 fever, muscle aches, sore arm. Treated with acetaminophen approximately 4pm May 23rd. Headache,fever,muscle aches went away. Sore arm still continues.
? SIRVA. Chronic pain/soreness at injection site. Tried NAPROSYN and meloxicam with no relief. Pain has persisted > 6 months.
Mom stated pt had shrill cry for approx 2 1/2 day p/vax; t100;
Chills; Joint pain; Runny nose; tired; slight cough; This is a spontaneous report from a contactable nurse (patient).   A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6201), via intramuscular route, administered in Left  arm on 23Feb2021 17:20 (at the age of 72-years-old) as dose 1, single for covid-19 immunization.  The patient had no medical history and concomitant medication. Prior to vaccination, patient did not receive any other vaccines within 4 weeks and no other medications within 2 weeks. Patient experienced chills, joint pain, runny nose, tired, and slight cough which started less than 24 hours after the shot. All her symptoms continued for five days.Her second dose is scheduled for 25Mar2021. Treatment was taken for the events with Tylenol. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021261813 Same reporter/product, different patient/event
Convulsions began about 6 hours after vaccine. With each convulsion I lose ability to speak and struggle to breathe. I cannot control the shaking. I get very dizzy and have had a headache since about 2 hours after the vaccine.
Cutaneous lupus erythematosus; This is a literature report.  A male patient in his 60's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included: "Lung cancer" (unspecified if ongoing); "Erythema" (unspecified if ongoing); "Peripheral scaling on the abdomen, back, and bilateral upper extremities" (unspecified if ongoing); "Focal Hyperkeratosis" (unspecified if ongoing); "Necrotic keratinocytes" (unspecified if ongoing); "Lupus erythematosus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single Manufacturer: unknown), for COVID-19 immunization. The following information was reported: CUTANEOUS LUPUS ERYTHEMATOSUS (death, medically significant), outcome "fatal", described as "Cutaneous lupus erythematosus". The patient underwent the following laboratory tests and procedures: antinuclear antibody: 1:540, notes: and the patient was positive for anti-SSA/Ro antibodies; biopsy: showed an interface lymphocytic infiltrate with, notes: vacuolar changes of the basal cells. The epidermis demonstrated focal hyperkeratosis and few necrotic keratinocytes were noted; pathology test: stated that the findings could be consistent, notes: with the clinical impression of a drug reaction and differential diagnosis as lupus erythematosus. Therapeutic measures were taken as a result of cutaneous lupus erythematosus. The patient date of death was unknown. The reported cause of death was lung neoplasm malignant. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded or assessed. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Lung Cancer
This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the third of six reports. A child (age and gender unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date, approximately five to six days after vaccination, the patient had large, raised, dark red swelling about 4 inches in diameter at the vaccination site and fever. Outcome was unknown.
Macular degeneration; Information has been received regarding a case in litigation, referring to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and/or zoster-related conditions (strength, route, frequency, lot# and expiration date were not reported). On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for macular degeneration. As a direct and proximate result of the patient's zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of macular degeneration was not reported. The reporter considered macular degeneration to be related to zoster vaccine live (ZOSTAVAX). Upon internal review, the event of macular degeneration was considered to be medically significant.
Right after receiving vaccine, pt said she feels dizzy. within a  minute she felt worse. Her husband came in IMZ room to help her. she was pale and turning blue. Called 911. informed AP. Fanned her and gave her apple juice. she had little breakfast in AM and nothing after that husband said. didn't drink water either. she felt better after having apple juice. Paramedics said BP, sugar, oxygen was normal. pt refused to go to hospital as she felt better.
Patient received a dose from an undiluted vial. so staff drew 0.3ml of undiluted/concentrated product
Lymphadenopathy; Unable to raise left arm; This spontaneous report was received from physician and referred to a non-pregnant 5-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered in the right arm for immunisation (strength, lot #, expiry date, vaccination scheme, and route of administration were not provided).  On 14-SEP-2023, (approximately 24h after receiving the suspect vaccine), the patient developed lymphadenopathy. She presented pain, lymph node swelling under the left arm (lymphadenopathy) and was unable to raise left arm (mobility decreased). Moreover, pain was "so bad" that on an unspecified day in September 2023, the patient sought medical attention and was admitted into the hospital. She received treatment due to the events. She was "having tests run" and it was unknown what testing the patient was having. At the reporting time, she had not recovered from the events.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
Breakthrough case admission after three vaccines Moderna 2/27/21 Lot# 025A21A;  Moderna 3/26/21 Lot# 008B21A;  Moderna 10/26/21 Lot# 012 LAST LOT # IS TAKEN FROM               DATABASE
Received shot 1.11.10 @ 4pm and reported fever (103.2) and vomiting at about 9pm. Message taken at 9a 1.12.10
Headache, Sedation, Myalgia, Fever, Developed fever, chills, HA, myalgias, fatigue,sedation, and arm swelling 13 hrs post injection of 2nd COVID 19 vaccine. Narrative:  Developed fever, chills, HA, myalgias, fatigue,sedation, and arm swelling 13 hrs post injection of 2nd COVID 19 vaccine. Missed 2 days work.
patient's daughter reported that he was experiencing confusion and disorientation the day following vaccination and wet himself.  was taken to emergency room for observation and released later that day.
acute urticaria; shingles like rash/rash on her chest; blistery area/Vesicular rash; red, puffy, itchy, and some blistery area; red, puffy, itchy, and some blistery area; puffy rash; This case was reported by a nurse via sales rep and described the occurrence of urticarial rash in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 12th October 2021) for prophylaxis.   In May 2020, the patient received the 2nd dose of Shingrix. In May 2020, less than a day after receiving Shingrix, the patient experienced urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin. The patient was treated with ALOE BARBADENSIS + LEVOMENTHOL + PRAMOCAINE HYDROCHLORIDE (GOLD BOND CREAM). On an unknown date, the outcome of the urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin were not recovered/not resolved.   It was unknown if the reporter considered the urticarial rash, red rash, blistery rash, papular rash, itchy rash and puffy skin to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix 3 days ago and at the time of reporting had painful shingles like rash on her upper torso.  The rash started on her chest that day and spread to right shoulder and back over the weekend.  The patient called the clinic and the physician recommended she come in to be seen. At the clinic, she was noted to have red, puffy, itchy, and some blistery area with slight vesicular rash on her arm that did not follow the dermatome. A diagnosis of acute urticaria was made and the treatment recommendation provided to the patient was to utilize cream for itch.
Persistent Arm Pain:muscle  ache in area of injection, worse with exercise, & flexing arm, also, during eye surgery 11/1/17, blood pressure cuff on left arm (caution on right arm because of right side breast cancer) left arm became extremely achy, hand was ice cold and numb. Going to face second arm surgery 11/15/17.