chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted after receiving his flu vaccine. Mom states he may have an aversion to needles. Patient was caught by mom and did not hit his head. He looked flush and pale afterwards. We had him lie down and got cold compresses. We also got him some apple juice and after resting for a while and consuming the apple juice he started to look better.
Unusually Severe uterine/menstrual cramping, heavier flow than normal. This has continued through the next menstrual cycle as well.
Don't feel well; Fatigued; Has a heart condition; Nausea; Chills; Throwing up all night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2) (Lot number: EW0169) at the age of 76 years as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Don't feel well"; FATIGUE (non-serious), outcome "unknown", described as "Fatigued"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "Has a heart condition"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VOMITING (non-serious), outcome "unknown", described as "Throwing up all night".  Follow-up(14May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  Follow-up(19May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  Follow-up(23May2021): This is a follow-up spontaneous report from a contactable consumer reported information included.  No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates in 2016 the patients were administered improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017) (dosage, strength and route unknown) following a temperature excursion on 07-JAN-2016 (temperature 32.2 degree F, time frame 40 minutes). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe pain in muscles and joints all over my body.  I could not sit or lay still because of the pain.  This was much worse than an "ache" as described in the side effects.
I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have Friends that got the Shingles Shot 11 of them now have shingles/ Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JUL-2023 This case was reported by a patient's friend via interactive digital media. The patient received shingles vaccine and now he or she had shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset  and laboratory test confirming shingles were unknown at the time of reporting. This case was 11 of 11 cases for the patient reported by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR104617:same reporter US-GSK-US2023AMR104619:same reporter US-GSK-US2023AMR104620:same reporter US-GSK-US2023AMR104621:same reporter US-GSK-US2023AMR104622:same reporter US-GSK-US2023AMR104623:same reporter US-GSK-US2023AMR104624:same reporter US-GSK-US2023AMR104625:same reporter US-GSK-US2023AMR104626:same reporter US-GSK-US2023AMR104627:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104628:same reporter US-GSK-US2023AMR104627:same reporter
Six hours post vax, pt experienced rash to bilateral arms, chest, and back with itching.
Found a lyophilized component / alone, without the adjuvant suspension; Found a lyophilized component / alone, without the adjuvant suspension; Circumstance or information capable of leading to medication error; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, they found a lyophilized component of Shingrix alone, without the adjuvant suspension. They were not aware of any patient receiving the adjuvant alone, which led to inappropriate preparation of medication, inappropriate dose of vaccine administered and circumstance or information capable of leading to medication error. The reporter consented to follow up.
Sore arm after dose 1 (mild, ,resolved); Mild-Moderate side effects after dose 2 (headache, fatigue, muscle aches, dizziness, chills, sleeplessness) persisting past 48 hours and ongoing but fluctuating; At 72 hours: Injection site is red, with raised welt around 2 inches in diameter, with itching and warm to touch; ongoing.
Arm and shoulder pain and weakness, radiating down arm, into armpit, into back. Very painful and movement & use impaired.  Can't lift arm.  Trouble driving and daily routines such as dressing.  Doctor said nerve may have been hit.  Chiropractor said muscles involved too.  Treatment is gentle exercises to maintain motion and NSAIDs. 18 days out, my left arm is still VERY PAINFUL, can't be used properly, and symptoms continue to worsen.
6NOV98 pt called to report 2 days p/vax began having external weakness, chills, low grade temp, n/v, achiness, neck pain & upper back pain;1wk p/vax pt no better;advised to take APAP & call pvt MD;
This is a spontaneous report received from a contactable consumer or other non-HCP (patient) via a Pfizer-sponsored program (159558). A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient had a ligament sprain/foot is swollen/it looks like a sprain, and pain/ache in the toe, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Less than 12 hours, post vax, pt began aching over whole body, severe shaking, fever 100F (orally) and chest hurting. Severe local reaction with redness and swelling from site spreading 11cm X 8cm down left arm to where small 1cm X 4cm blister appeared. Pt also states that fever blister appeared around same time as blister on her arm. She was referred to MD.
This spontaneous report as received from a physician refers to his daughter in her early teens. The patient's medical history of similar reaction (vasovagal syncope, confusion and sweating) while getting blood drawn. The patient was recently vaccinated IM with the first 0.5 ml dose of GARDASIL (lot number not reported). Recently on an unknown date after getting the vaccination the patient experienced the vasovagal syncope. After about 4-6 hours the patient experienced sweating and confusion, which went away within 24 hours. The patient was given BENADRYL for the adverse events. No lab diagnostics studies performed. The patient sought unspecified medical attention. At the time of the report, the patient had recovered from the events. Additional information has been requested.
pt recvd vax 19OCT93 115PM APAP given q 4 hrs; 9PM t103.2 R; 1025PM t102.8 R MD called to cont w/APAP; 20OCT93 230AM t102 R, 630AM t102 R no excessiveness  redness or swelling;
Sore arm; full body aches; headache; This is a spontaneous report from a non-contactable consumer (patient).   A 25-year-old non-pregnant female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration, in right arm, at single dose, on 16Feb2021, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication, received within 2 weeks of vaccination, included melatonin. The patient previously, on 27Jan2021, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration, in right arm, at single dose, for COVID-19 immunisation. On 16Feb2021, the patient experienced sore arm, full body aches and headache for 24-48 hours after shot. No treatment received. The case was assessed as non-serious (Seriousness criteria-results in death: no, seriousness criteria-life threatening: no, seriousness criteria-caused/prolonged hospitalization: no, seriousness criteria-disabling/incapacitating: no, seriousness criteria-congenital anomaly/birth defect: no). The patient recovered from the events on an unspecified date, in Feb2021. Post the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible, information about lot number cannot be obtained.
about 2 weeks after 2nd injection, have had 3 episodes of left arm and hand (stroke affected), tingling, then hand seemed to shake progressing to arm violently shaking for a few minutes, conscious each time, but seemed like a dream, wet the bed unknowingly until waking up and feeling nauseous. The third time 05/30/2021, went by ambulance to emergency room and told they were seizures. was prescribed Levetiracetam 500mg. No seizures so far.  Followed up today 06/10/2021 with primary care physician. Have July 21,2021 follow up appointment with neurologist  *The reason I am reporting is because of my primary care physicians response to a comment I made to him about my sister thinking it could be the covid vaccine, while I thought perhaps it might be mini strokes, and he said it wasn't known that it might not be the vaccine. They told me in the hospital that the mri didn't show any more stroke damage than what had occurred  from the initial stroke I had earlier.
Severe hypoglycemia; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient (pregnant no) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 17Mar2021 10:00 at single dose for COVID-19 immunization.  Medical history included Known allergies: Pineapple, Type I insulin dependent with pump. Concomitant medication included insulin.  The patient previously took fluoroquinolones and experienced Known allergies: Fluoroquinolones, first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on Feb2021 11:00 AM in left arm for covid-19 immunization.  The patient experienced severe hypoglycemia (life threatening) on 17Mar2021 13:00.  Therapeutic measures were taken as a result of severe hypoglycemia as Glucose. The outcome of event was recovered in Mar2021. There was no Covid prior vaccination and no Covid tested post vaccination.  Information on lot/batch number has been requested.
disseminated shingles; This is a spontaneous report from a contactable nurse (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 07Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: Sjogren's syndrome, Hashimoto's thyroiditis, HBP (high blood pressure), Vit D deficiency, and Vit B deficiency. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications were reported as normal everyday medications, not specified. The patient previously took and had known allergies to hydroxychloroquine sulfate (PLAQUENIL) and BUPROPION HYDROCHLORIDE (WELLBUTRIN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 17Dec2020 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunization. On 23Mar2021, the patient was diagnosed with disseminated shingles. Treatment included valaciclovir hydrochloride (VALTREX) and steroids. The outcome of the event was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Reported event of Disseminated varicella zoster vaccine virus infection is most likely an intercurrent condition and unrelated to BNT162B2 vaccine. Case will be reassessed upon receipt of additional information. 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.
Her arm has a very round circle that is red; Itchy; A little sore; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her arm has a very round circle that is red), PRURITUS (Itchy), PAIN (A little sore) and SWELLING (Swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 02-Mar-2021, the patient experienced ERYTHEMA (Her arm has a very round circle that is red), PRURITUS (Itchy), PAIN (A little sore) and SWELLING (Swollen). At the time of the report, ERYTHEMA (Her arm has a very round circle that is red), PRURITUS (Itchy), PAIN (A little sore) and SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Immediate nerve and joint pain that has lasted over 9 days, headache, nausea, dizziness, numb tongue on right side, pain on right side of body, misused words when talking, heart palpitations
Pt recvd 1 dose of Engerix-B (dates of administration unk) & 28OCT91 exp visual disturbance & pain on inject site; As of 4NOV91 visual disturbance persists;
Dizziness starting on Sunday morning 10/04/15, slowly lessening but still dizzy on Tuesday 10/06/2015.  It has not resolved as of the writing of this report.
After the first shot I had the normal symptoms of arm pain, swelling, fever, and high blood pressure. Later that night I started having pain shoot throughout my body (MS Relapse which I have not had since March 2020). I then began having stiffness and pain in my back and legs. During the week of Christmas, I started having upper back, neck, and jaw pain. After the second injection, 2 hours later, I began having weakness in my left arm. I started experiencing Trigeminal neuralgia symptoms (which I have never had before). It has gotten progressively worse. I am barely able to eat and drink. I have trouble talking and it keeps getting progressively worse. I am also having trouble sleeping due to the intense pain with no relief. I am not able to give much detail due to fear of the web page timing out AGAIN!
PT reports he worked the afternoon of IIV receipt, but started feeling nauseated while at work. When he got home, he reports his nausea worsened, and he also experienced shortness of breath with his throat feeling "full". When he changed from his uniform, he noted "blotches" all over his body with increased itching. His nausea was associated with dizziness and got worse with movement. He denies emesis; he tried to throw up, but experienced dry heaves. He also reports anorexia through the long week-end, but tolerated liquids. His shortness of breath was described as feeling like he "couldn't breathe"; when asked how it compared to the "air hunger" he describes related to his asthma, he described this reaction as "much greater magnitude." He denies fever and headache. He denies itching in mouth or throat, facial swelling, flushing, cough, wheezing, watery red eyes, rhinorrhea, and difficulty swallowing. He noted the vaccination site had some redness, itching, and tenderness which was greater than with previous vaccinations. PT did not self-treat. He recalls lying down shortly after getting home. Describes as feeling "awful". Reports nonspecific symptoms of aching, fatigue and decreased concentration. He reports most of the symptoms continued through the week-end and says he was "pretty much bed-ridden". Although he returned to work on Tue, 15 Oct, he said he did not feel 100% for about 1 1/2 weeks. (Immunization Records per, PT received IIV4 on 16 Oct 2019, but per patient history, he received IIV4 on 10 Oct, which was Thursday prior to 4-day week-end for Columbus Day. ***Based on Lot # P100122537, Patient received Sanofi-Pasteur Fluzone vaccine, IM. PT does not recall what time of day he received his influenza vaccine or in which arm he received the vaccine. (He admits that because it was over 1 year ago, he cannot recall exact timeline or all of details.) He did not receive any other vaccines on the same day. He reports feeling well of the day of vaccine receipt. He denies any unusual exposures or unusual food intake. He does not recall experiencing symptoms of infection in the weeks leading up to vaccine receipt. He did not have any sick contacts around that time.
In a nutshell Gardasil has ruined my life. I was a healthy 23 year old until the day I decided to listen to my pushy gyno and take the shot. That was probably the worst decision ever. After having the set of 3 shots I began to have days where I couldnt get out of bed. All of a sudden I didnt care to go to class (which was completely opposite of what I believed) I began to sweat profusely anytime I had even the slightest anxiety. (I mean soaking wet sweating within a minute) Til this day anytime I get nervous or anxious it happens. I've had a foggy mind and I just down right don't feel good EVER! My once completely normal menstral cycles have now turned into one every 4-5 months if I am lucky. Doctors have told me that I have hormonal imbalances and most likely will not be able to conceive. (I haven't gotten to the pt of accepting it) Not to mention the weight gain, the constantly burning of the soles of my feel, dry eyes, acne- the list goes on. I am no longer the same person and I constantly have a feeling of something is wrong within my body.
Bumps on face, neck, leg and back. Swelling, redness and heavy feeling at injection site. Muscle aches in thighs and calf on left side. Urination every hour the night of administration. Extreme sore throat.
This report has been received from the nurse reported that VARIVAX (Merck) (lot # H020587, expiration date 13-NOV-2014) and PROQUAD (Merck) (MARRS# 1311USA012185) were trough unsupported temperature excursions on 26-JUN-2013, 01-JUL-2013, 22-JUL-2013 thru 31-JUL-2013 and the entire month of August 2013. On 23-AUG-2013 the patient was administered the unsupported VARIVAX (Merck) (dose and route not reported). This is one of several reports received from the same source (MARRS# 1311USA002616, 1312USA003307, 1312USA003308, 1312USA003306, 1312USA003310, 1312USA003311, 1312USA003312, 1312USA003313, 1312USA003314, 1312USA003315, 1312USA003316, 1312USA003317). Additional information is not expected.
Very sore arm at injection site for first couple of days.  Difficulty raising the arm.  Began noticing rash 7 days after injection and then on eight day a large raised rash appeared at injection site.  Day 8 and 9 a systemic rash with red raised bumps appear and spread from hands and feet and progress up arms and legs up to thighs.  Also found rash on face near cheek bones.  Ears very red and ichty.
Patient was administered 4th dose booster COVID-19 Moderna vaccine past beyond use date and time. No harm to patient or monitoring provided. Per CDC guidelines, Moderna manufacturer has been contacted for information on the stability of the vaccine and whether the dose needs to be repeated. The patient will be contacted for follow-up once this information is available.
Pain and swelling in left arm about 4 hours after IZ. Since IZ has experienced numbness, tingling, inability to move arm for a few hours at night on 5/13/21, 5/18/21, 5/19/21 in left arm, experienced same symptoms in right arm on 5/21/21. Reports has had full body aches, primarily focused in arms/legs off and on since IZ date.
vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042721) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Nov-2021. On 03-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy). On 03-Mar-2021, EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient's second dose was scheduled on 31-Mar-2021. Treatment information was not provided.
Low grade headache, tried with low energy, with some early body aches  However, the body aches have subsided.  After several days, still battling a low energy and tired condition.  Had no issues with the first shot, however this second one  has caused the above conditions.
Severe upper arm pain for two weeks, causing shoulder immobility. Pain gradually improved during next week. Visited ER for pain relief two days after injection - received DILAUDID injection, and PERCOCET for home use. Also  had nausea for several days after injection. Now three weeks after injection, pain is nearly gone and I can again use my arm.