chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0470 2orZ 1A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not reported. Treatment information was not provided.  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 has 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 has been requested.
Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot/knows four people personally who have had miscarriages; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient (pregnant) received BNT162b2 (BNT162B2), 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: ABORTION SPONTANEOUS (medically significant), outcome "unknown", described as "Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot/knows four people personally who have had miscarriages". The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death.  Clinical course: Non-HCP general public is calling about the Pfizer BioNTech Covid 19 vaccine and how unsafe the vaccine is, as it has been attributed to 20 million deaths, stillbirths, miscarriages, infertility, spontaneous abortions. The reporter got the vaccine, he even states that there is a depopulation issue, and they have to bring in dreamers to help with jobs. Famous OB GYN has come out and stated that it has caused spontaneous abortions and fertility issues. There was no decrease in birth rate in 2020 so it can't be from just Covid, its attributed to the vaccine. It was a 10 minute video talking about the rises of spontaneous abortions, and due to "standard deviations"- he didn't understand what that meant, his wife had to explain it to him, his wife had to explain it to him. The miscarriages have been on the rise for the last year and a half. Early data is showing an enormous amount of miscarriages, and there could be people having trouble conceiving and delivering. Breastmilk could be dangerous to infants. They could be wiping out an entire generation that's needed to continue the human race. He knows four people personally who have had miscarriages, their children are dead. Their OB GYNs feel bad they recommended this. His wife is a psychologist who speaks with people who have vaccine remorse. People know they were lied to. Asked about data there is on miscarriages, pregnancy and infertility. He especially wants to see where Pfizer says its safe. Had family members and friends that had miscarriages and lost their children, their actual children have died due to the Covid-19 shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201387547 same reporter/drug/AE, different patients;US-PFIZER INC-202201389517 same reporter/drug/AE, different patients;US-PFIZER INC-202201389516 same reporter/drug/AE, different patients;
ended up with shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: ended up with shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAR-2023 This case was reported by a patient's friend via interactive digital media. The reporter sated that he/she had several friends and family members that had shingles. The reporter stated that one had seen how it affected a patient and thought she would get the shingles vaccine. The patient ended up with shingles a few weeks later and it was bad.  The reporter further stated that what had happened to vaccines. They were for preventing infection once upon a time and many diseases were eradicated by vaccines and that was no longer true. The follow up would not possible as no contact details were available.
t104 the noc that got immun 6JUN94; t102 next day;
Local reaction sore, swelling at the injection site pt is using ice at the site no short of breathe or hives.
more than 35 days from the first dose and still did not get the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days from the first dose and still did not get the second) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (more than 35 days from the first dose and still did not get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 35 days from the first dose and still did not get the second) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Shortly after the vaccine I experienced tingling in my arm and face increasing fatigue arm soreness and neck soreness in a start of a headache. I went home took some Tylenol and lay down for a while.  At about 10:15 PM on January 22 I develop the worst aches and pains fever of 100.4 bodyaches chills headache neck ache arm sore.  I then took ibuprofen Benadryl drank some hot tea covered up with an electric blanket and slept for a few hours eventually. Woke up about 4 o?clock with a fever of 100° and body aches.  I then took some Tylenol and was unable to get any sound sleep. This evening at approximately 830 I had another temperature of 100° and took some ibuprofen. I?m still achy and have no energy.  This is the 2nd vaccine.  The first vaccine was on 12/26/2020 and I experienced a very sore arm for at least 0 days, headache extreme fatigue and although I am through my menopause phase and was only experiencing limited hot flashes- after the first vaccine they came back with a vengeance!!!!!!!
Astra Zenica second shot given. Sore arm  48 hrs only reaction to first shot. This time no sore arm, but severe muscular pain lower limbs, abdominal distension and pain, atrial fibrillation, severe SOBOE. Note. I am an Infectious Diseases Physician (retired). All the investigations were ordered by my GP.  We do not appear to have an adequate reporting system for adverse events.
It stared out with just stiffness in my legs and back. Then at night I couldn't put my legs down they hurt and my shins felt like I had shin splines.  This lasted about a week or more. I went to a Dr. because my left knee and shin were hurting so bad.  The Dr. was not sure and did a Doppler to see If I had a Blood clot in my left knee but I didn't. She put me on an antibiotic, that I really didn't need I don't think. I took that for  a few days and stopped because it wasn't helping any. On the 14th I went to see another Dr. and he put me on Prednisone, at this time I could barley walk my right hip was hurting so much. I was taking little bitty steps.  The prednisone has been helping, it's allowed me to walk and to function. I was to the point it was getting so bad. I'm still having some stiffness, my left elbow gets inflamed at times, my left hand and knuckle swell and get stiff at times too. It seems to move around at effect different places.  The medication helps me move better, I have been off work for 7 weeks, I plan to go back and try half days.
Severe redness, burning, pain and rash on arm starting from shoulder to below elbow which was diagnosed as celluitis and was treated with antibiotics.
Varivax on 7/20/09 - Developed, 2 days later a 3X3.5 cm area of light pink induration with surrounding blanching.  5x7cm area of mod. erythema - no streaking - no axillary nodes.  Keflex for 5 days.
I received Zostavax Vaccine on 3/23/07.  My wife started having pain on Monday 3/26/07 by 3/28/07 she was running a fever over 101 & started to get a rash.  The fever lasted approximately 2 days and the rash continued to expand and blister.  She saw her Doctor on Monday 4/3/07.  He said she had shingles and gave her Famvir 500mg and Propo-N/APAP 100-650 Tab.  She has since returned to see the physician 2 times for symptoms.
After the booster shot intense arm pain out of no where is occurring months after the shot. It is a vary distinct pain and it?s accompanied by a feeling of muscle fatigue as well.
high protein in urine; This is a spontaneous report from a contactable consumer (patient's father). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on an unspecified date in Jun2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the PFIZER COVID VACCINE less than 2 weeks ago in Jun2021 and went to his doctor for a regular annual check-up and for the first time, he had high protein in his urine on an unspecified date in Jun2021. The outcome of event was unknown.  Follow up attempts are needed; Information on lot number/batch number has been requested.
sore arm again; knot on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE MASS (knot on my arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE MASS (knot on my arm). At the time of the report, PAIN IN EXTREMITY (sore arm again) and VACCINATION SITE MASS (knot on my arm) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Shakes, weak standing muscles, minor disorientation, sweating, fever 99.1, shivering, headache especially behind eyes. Lasted more than 24 hours after shot. Went back to bed at 10:45 Thursday morning. Friday morning still a bit foggy brained but cleared by 11AM.
Numbness, tingling, stinging sensation at injection site and across upper back which started the morning after injection and has continued as of this reporting day (10-19-17).
Pt recvd vax & exp flu-like sx & fatigue; The next day pt exp nausea, diaphoresis, dizziness, ill-defined chest error discomfort, blue hands & blue thighs; presented to ER where was noted to have an elevated BP & irregular puse;
Heart rate 114 to 120 for about 4 hours   I just rested in bed, drank water and heart rate finally came down to 88 and then 77 4 hours later.   It started around 1:30 am. I was also having body aches,  sensitive skin,  fatigue, mild fever(but I'm only assuming because I never checked my temperature,  was feeling hot)and a  moderate headache but had read that those were common to have.
(L) deltoid - light pink felt itchy approx 10 min after injection. Applied ice 10 min - redness went away, itching still felt. BENADRYL 25mg PO with H20. States upset stomach last weekend. States no sleep last night.
Fever and entire body covered in chicken pox like rash.  began 1 week after vaccine was given.
This spontaneous report as received from a nurse refers to a pediatric patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-AUG-2018, the pediatric patient was vaccinated with an adult dose of VAQTA, 1 ml, intramuscular (Lot # and expiry date was not reported) for prophylaxis. There was no adverse effects reported. There was no product quality complaint involved.
This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. The healthcare worker reported that three vials of sterile diluent (manufacturer Sanofi) for haemophilus influenza B vaccine (HIB) was missing from the stock and was not shipped that way, so it could have potentially been used to reconstitute M-M-R II. Product (packaging) confusion was involved.. It could not be ruled out if M-M-R II was or was not reconstituted with the sterile diluent and administered to the patient. No adverse effects was reported. No product quality complaint was involved. Additional information had been requested.
Red, hot, itchy rash on left arm. Also headache and fatigue. Treating with hydrocortisone cream. Tylenol for headache.
Headache, bodyaches, low-grade fever, fatigue Treatment: Tylenol, hydration, bedrest
Large red area around vaccine site, advised Benadryl, otc pain reliever and cool compress.
Increased inflammatory reaction to mosquito bites  Random blotches of itchy skin recurring over months (started in October 2021
patient states she broke out in hives along her stomach, back and legs around 6 hours after receiving vaccination
no adverse event; Drug use in unapproved age group; This spontaneous report was received from a nurse, concerning a 3-month-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 27-MAY-2021, the patient was vaccinated with 1 dose of the following vaccines: hepatitis a vaccine, inactivated (VAQTA) 25U/0.5ml pre-filled syringe (lot number T035720, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-APR-2022), varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T032930, which was verified to be a valid lot number, expiration date reported as 28-SEP-2022 but upon internal validation established as 08-SEP-2022) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) (lot number T006165, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 19-FEB-2022) (frequencies, routes of administration, anatomical locations and vaccination schemes were not reported). All the vaccines were administered as prophylaxis. The vaccines were reconstituted with sterile diluent (lot number T022570, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 08-FEB-2023) (product use issue). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
COVID hit me in October 2020. In May 2021, I went to my primary doctor because I wasn't thirsty, and they did a blood test and sent me for a kidney test because I was 50%. At risk of collapsing my kidneys. The Doctor told me that if I had COVID, it could be the effects of COVID, or the vaccine. I am undergoing treatment for my kidneys and am taking supplements. I have pain on the right side of my kidneys.
This spontaneous report was received from a Registered nurse and refers to multiple patients of unknown age and gender. There was no information about the patients' pertinent medical history, concurrent conditions, and drug reactions or allergies. On unknown dates, the patients were vaccinated with multiple doses of improperly stored VARIVAX (lot number M034583, expiration date 27-JUL-20180 and (lot number M047661, expiration date 02-DEC-2018]) (dose, frequency, route of administration, and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent. Sterile diluent used for reconstitution of vaccines was properly stored. The vaccine was exposed to a temperature of -14 C to -10 Celsius for time frame of 24 hours. There was no previous temperature excursion and the call was not because of a "data logger". No adverse effects were reported. There was no product quality complaint involved. No further information was provided. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA012558.
Patient left voicemail stating she went to ED with cough and mucous, and sinus tachycardia with PVCs.    she did not return my phone call to her
diagnosed COVID positive 1 wk prior to hosp admission (8/28); End-stage renal failure, dialysis 3xwk; has missed 2 rounds of dialysis due to increased weakness; EMS brought pt to hosp due to confusion and weakness; dx with COVID pneumonia; hypoxic; experienced hypotension and A Fib with RVR during dialysis tx in hospital; required emergent cardioversion; DNR/DNI; pt's condition rapidly worsened on the day of dc from hospital to a nursing facility and pt expired in the hospital
Itching and hives on neck, back, hips, arms, palms and feet.
ABDOMINAL PAIN; DIARRHEA; SEVERE CHILLS; FEVER; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number:1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 103 F. On 20-MAR-2021, the subject experienced abdominal pain. On 20-MAR-2021, the subject experienced diarrhea. On 20-MAR-2021, the subject experienced severe chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 21-MAR-2021, and had not recovered from severe chills, diarrhea, and abdominal pain. This report was non-serious.
8 hours of uncontrollable chills, shaking; terrible 8/10 headache, low grade fever, body aches, muscle spasms in legs and back, nausea and thirst
Sore shoulder muscle at injection site - soon after the injection through 5/20/2021; Fever and chills - starting 12 hours after the injection and lasting 18 hours; Skin sensitivity - starting and lasting similar to the fever and chills Tired - Lasting 2 days
TOOK TWO DOSE ON DAY 1 AND 2; This spontaneous case report (PVX2019-2536) was received from a consumer on 10-Oct-2019. It described a female consumer who "took two doses on days 1 and 2" (PT: Inappropriate schedule of product administration), while being on oral Vivotif for typhoid fever.  Case report: The consumer took two doses in a row. The doses were taken on 09-Oct-2019 and 10-Oct-2019, respectively.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two doses on days 1 and 2" was considered as not applicable. ; Sender's Comments: Company's Comment: The causality of the event "took two dose on days 1 and 2" was considered as not applicable.
Initial case report received from a physician on 20 NOV 2009. A 59 year old male patient (a physician) was vaccinated i.m. for the first time with FOCETRIA (batch no. 1007396P) on 09 NOV 2009. On 12 or 13 NOV 2009, he experienced muscle pain at the injection site. The muscle pain progressed to posterior axillary pain with erythema and pustules. On 16 NOV 2009, the patient developed subcutaneous painful nodules. On 17 NOV 2009, he developed vesicles and hyperthesia of the affected site. The reporting physician stated that the patient had 4 - 5 lesions with neuropathic pain and neuritis which looked like Zoster. The outcome was not reported. These events were reported as suspected Zoster and injection site reaction (muscle pain). Reference no.: NA09-008665.
The morning after her shot, the injection site became itchy and has been itchy ever since then.
Shot 1 - left arm ached 2 days; 5 days later diarrhea for a few days; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 01:15 PM (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included osteoporosis, sleep apnoea, reflux. Concomitant medication included VITAMIN D [VITAMIN D NOS], Multi Vitamin and omeprazole (PRILOSEC [OMEPRAZOLE]) at once a day taken for an unspecified indication. It was reported that after Shot 1 in left arm ached 2 days, 5 days later diarrhea for a few days. Outcome of the events was recovered on unspecified date.   Information on lot/batch number has been requested.
MD reported on 10/21/03 that pt got hepatitis A vaccine on 02/20/03, and PPD the same day.  9 hours later pt was found in car seat with his head hanging out with temperature 102.8F and black lips.  Pt was taken to ER.  Follow up on 02/27/03.  Pt was seen by MD on 10/20/03.
Bilateral progressive arthralgia  3/20/2017. Resolved 4/10/2017.
Patient called to complain of lingering arm soreness that has lasted since November. Advised him to see his physician however at this point he has not. He reported the event to us at the end of January.  Patient informed us that the vaccine did not seem that it was too high (most likely rules out SIRVA).