chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CRNP Note: Stroke determined by clinical assessment Change in condition patient has a right field cut he has weakness which shakes he has delayed speech response he has delayed motor response his EOMI is not intact has no awareness of where he is sending to the hospital 911 The resident was transferred to a medical facility
Went the following Wednesday for routine eye exam and found to have retinal hemorrhages in her left eye. She has since had multiple doctor visits with specialists and multiple tests and everything comes back as normal. She is a normally healthy and active teenage girl with no know health issues.  The only variant during the time frame is the vaccine.  Doctors say they cannot blame or r/o the vaccine as the cause so we are reporting so that it can be documented as a possibility.
05sep90 pt vax 3rd hepta B. pt ex nausea followed by diarrhea and abdo cramps.
Rash on face that lasted 1 week, then rash on thigh that lasted one week, then rash on face came back.  Rash is macular erythematous forming circles and lines., not pruritic or painful, not vesicular.
It was reported in a published article, title as stated above that: "Rational" Immunodeficiency should be considered in children with severe failure-to-thrive prior to administration of live vaccines. Methods: A 17 month old male with failure-to-thrive presented to the allergy consult service 14 days after a presentation to the ED with prolonged fever (Tmax 103F) and erythematous papules on his face. A respiratory infection had been diagnosed in the ED and treated with amoxicillin. Fevers persisted, and the rash evolved into grouped papules, vesicles, and crusting lesions over the face and abdomen. Past medical history revealed a growth curve below the 3rd percentile for height and weight, but no prior hospitalization or serious infection. The live attenuated varicella vaccine had been given approximately 14 days before the ED presentation. Results: Varicella infection was confirmed by direct immunofluorescence assay, and a Tzank stain showed multinucleated giant cells. Severe lymphopenia was evident, with 1% lymphocytes (57/mm3), along with decreased immunoglobulins (152 (IgG), 25 (IgM) and 10 (IgA) mg/dL) and T, B and NK cells (CD3: 27.4%, CD4: 14.7% (6/mm3), CD8: 10.3% (4/mm3), CD19 6.3%, CD16: 32.5%). The patient was transferred to a hospital after initiation of acyclovir and IVIG. Expanded lymphocyte enumeration confirmed markedly decreased T (CD3 (55/mm3), CD4 (51/mm3), CD8 (7/mm3)), B (CD19 0/mm3), and CD3+CD56+ NKT cells (6/mm3), and slightly decreased CD3-CD56+ NK cells (150/mm3). SCID was diagnosed. After RBC transfusion, lab tests revealed low levels of adenosine deaminase (ADA) (16.8 nmol/h/mg, normal 63) and increased levels of deoxyadenosine nucleotides (0.056 imol/mL, normal <0.002) in the hemosylate. Lymphocyte proliferation to PHA was decreased but present (21,377 CPM, background 189; Control 188.330, background 126). Pegylated-ADA was started at 187.5 IU IM twice weekly. Levels of ADA, lymphocyte subsets and IgG are being monitored, and after two weeks of therapy the lymphocyte count increased to 560/mm3. Conclusion: This case demonstrates the consequence following administration of a live vaccine to a child with severe failure-to-thrive who had undiagnosed SCID. To the author's knowledge, this is the first published report of disseminated cutaneous varicella infection after vaccination as the presenting symptoms of SCID-ADA deficiency, and shows the need to consider immunodeficiency in such patient's." A copy of the published article is attached as further documentation of the patient's experience.
Client received both a Hep B adult vaccine #3 and PPD skin test at around 9 am.  Client called and stated "I am broke out in itchy welts."  Advised client to go see PMD or to ER.  Client verbalized under standing.
Patient fainted/fell and developed a rash on both arms 15 minutes after administration.  Patient hit his nose as he fell. We gave the patient an icepack and administered oral Benadryl 20 minutes after injecting the vaccine.  Patient went to the ER. The ER stated that his nose was cosmetic and that the rash was a bruise instead.
very very sick; fever of 102.5°F; chills; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (very very sick), PYREXIA (fever of 102.5°F) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: Shingles and flu vaccine, Shingles and flu vaccine and Shingles and flu vaccine. Past adverse reactions to the above products included Chills with Shingles and flu vaccine; Fever with Shingles and flu vaccine; and Sickness with Shingles and flu vaccine. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa allergy), Multiple sclerosis and Blood pressure high. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high, TERIFLUNOMIDE (AUBAGIO) for Multiple sclerosis.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very very sick), PYREXIA (fever of 102.5°F) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ILLNESS (very very sick), PYREXIA (fever of 102.5°F) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.5 degree F.         It was reported that patient had never tested with COVID positive. Patient was not given other vaccines one month prior to Moderna COVID-19 vaccine. It was reported that these adverse events did not cause patient to seek medical care. It was reported that patient had experienced the similar events in the past but the reaction to the Moderna was the worst.   This case was linked to MOD-2021-029394 (Patient Link).
Shortness of breath, Lethargic.  Takin to ED and given Epinephrine IM.  symptoms resolved
Initial report was received from another manufacturer on 23 September 2011, with follow-up information received from the patient's parent who is also a health care professional on 26 September 2011; both reporters were in the same country. A nine-month-old female patient had received a second dose intramuscular injection of ACTHIB, lot number UH090AB (corresponding sanofi pasteur SA lot number E0744-2) on 15 November 2010 and approximately 40 minutes later, the patient became listless and unresponsive. When asked if the patient lost consciousness, the patient's parent stated that was difficult to answer and explained that resuscitation was not required, but she could not awaken her daughter with a jaw lift. Breathing and heart rate were fine. The patient recovered on the way to the emergency room and was not evaluated there. According to the patient's parent, the event lasted 20 minutes (also reported as one hour) from the time of onset and then her daughter completely recovered. The event did not require treatment. Laboratory and diagnostic testing was not performed. The patient has since had her Hib titers checked and her titers were adequate so she would not be receiving any further doses of Hib vaccine. The patient had no concurrent illness or pre-existing medical conditions at the time of vaccination. The patient had previously received an intramuscular second dose injection of PCV vaccine (manufacturer Wyeth, lot number 914513) on 18 October 2010. Outcome was recovered. The case was initially reported as non-serious, but was upgraded to serious by the company due to other medically significant event. Documents held by sender: None.
30% of vaccine leaked out while being injected; No adverse event; the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).), DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).), DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for UNDERDOSE (the vaccine leaked out from the syringe and around 30% of it was lost (but the patient thinks it was more).) and DEVICE CONNECTION ISSUE (30% of vaccine leaked out while being injected).    No concomitant information was reported. No treatment information was provided.
Day after shot she began to feel, nausea, hurting,  lying in bed a lot, refused to go to doctor thought she would get better. Husband left home about 15 minutes to find her dead sitting on chair, right lower leg hard and cold to touch, purple in color, blood in bilateral nares and upper body pale.
developed rashes from neck down to her feet; car accident; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 09Apr2021 as a single dose for COVID-19 IMMUNIZATION. Co-suspect included muscle relaxant. Relevant medical history and concomitant medication were not provided. On 11Apr2021, the patient experienced a car accident and was prescribed a muscle relaxant. On 13Apr2021, the patient experienced developed rashes from neck down to her feet. The patient was asking if this was vaccine related or from the muscle relaxant that she took. Treatment received for the event car accident included a muscle relaxant. The outcome of the events car accident and rash was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was confused on night she received the vaccine stating she didn't know if she was on the 1st or 2nd floor of her house.  Also, she is still having pain that's radiating down her arm and into her thumb in the arm the injection was given.  Last night & this AM her leg & ankle itched & she had to scratch hard to relieve it but that's gone now.
chills; fever, described as 99.0; injection site was hot to the touch; injection site was hot to the touch, appeared red; unspecified rash under the neck and upper chest area; Dose 2 was given in the right thigh; This case was reported by a other health professional  and described the occurrence of chills in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CB4K, expiry date 23rd August 2023) for prophylaxis.   On 3rd December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd December 2020, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced chills, fever, injection site warmth, injection site erythema and rash. On an unknown date, the outcome of the chills, fever and rash were recovered/resolved and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site erythema and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the chills, fever, injection site warmth, injection site erythema and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix on right thigh and patient experienced chills,fever of 99 degree F. also patient stated injection site was hot to the touch and appeared red. Patient experiened an unspecified rash under the neck and upper chest area. It was reported that patient received the vaccine in right thigh instead of deltoid muscle which led to vaccine administered at inappropriate site. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248611:Same reporter
ED to Hosp-Admission Discharged  4/26/2021 - 5/5/2021 (9 days) Hospital  MD Last attending ? Treatment team ST elevation (STEMI) myocardial infarction involving right coronary artery (CMS/HCC) Principal problem Hospital Course         56-year-old female with past medical history of hypertension, hyperlipidemia, IDDM T2, chronic hypoxic respiratory insufficiency (on home O2), OSA (CPAP compliant), active tobacco use with secondary polycythemia who presented to Hospital 4/26/2021 with initial complaint of dizziness and diarrhea.  Patient found to be hypotensive and found to have active C. difficile infection.  In the ED, EKG was performed which suggested subacute, possibly completed, infarction with ventricular bigeminy. Cardiology was consulted and a stat echocardiogram to assess for mechanical complication was performed which showed EF 45-50%, RV w/ dilated global hypokinesis. Patient was subsequently taken to the cardiac catheterization lab for a right/left heart cath.  She underwent DES x3 (2 x mid to distal RCA, 1 x to the ostium).  Incidentally, patient was also found to have a positive COVID-19 test.  She is overall asymptomatic with respiratory issues. Patient was transferred from cardiac catheterization lab to cardiac ICU with no evidence of immediate complication.
Pt was extremely worked up regarding getting the vaccine. She was crying and very upset took several minutes to get her to sit still. After receiving the vaccine was walking in store and fell down/fainted. EMS was called but she wasn't taken in.
After the second booster I started having pain in my both my breast, more on my left side than my right. I am very concerned since breast cancer does run in my family and raised my concerns to my doctor. I was sent for a mammogram. The results came back negative showing that I have nothing that should be causing me the pain that I am having.
This spontaneous report was received from a nurse via company representative refers to a female patient of unknown age. On an unknown date in 1999, the patient was vaccinated with the first dose of VARIVAX (merck), (lot number, expiry date and route was not reported). On an unknown date in 2012, the patient was vaccinated with the second dose of VARIVAX (merck), (lot number, expiry date and route was not reported). On an unknown date, the patient was diagnosed with chickenpox "a couple of months ago". The outcome of the reporter event was reported event was reported as recovered. This is one of the two reports received from the same reporter. Additional information has been requested.
she had the same reactions as I did / side pain all over my body; she had the same reactions as I did / she had the same reactions as I did / could not sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Lot number: HG4664), in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset Oct2023, outcome "recovering", described as "she had the same reactions as I did / she had the same reactions as I did / could not sleep"; PAIN (non-serious) with onset Oct2023, outcome "recovering", described as "she had the same reactions as I did / side pain all over my body". Therapeutic measures were not taken as a result of pain, insomnia.  Additional information: On Wednesday, patient and reporter received the vaccine for the COVID-19 the name of these vaccines it is a Comirnaty, new one they just released one month ago. Reporter stated that patient also had same reactions as he did but she was feeling better now. Patient did not received other vaccine administered on the same date.  The information on the batch/lot number for bnt162b2 omi xbb.1.5  has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300336340 Same reporter/vaccine/event, different patient;
1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient was administered expired vaccine on 07-Apr-2022, CDC expiration was 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.
some really bad shoulder pain and in her right hand; some really bad shoulder pain and in her right hand; some inflammation on the top of one hand; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on the left arm on 18Mar2021 (Batch/Lot Number: EN6208) (at age 64-years-old) as dose 2,single for covid-19 immunisation; and  tofacitinib citrate (XELJANZ), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 5 mg for rheumatoid arthritis. The first dose was received on 25Feb2021 (lot number: EN6203). The patient's medical history and concomitant medications were not reported.  Before patient did her second COVID vaccine her rheumatologist suggested she go off the medication for a week. So the night before the second vaccine patient stopped taking tofacitinib and made it a week without it which was difficult when she had been used to taking it, that how much it 'feels'. Patient stated that, so that way she had full effect and have effectiveness of the Pfizer COVID 19 Vaccine, the second one. It worked great and on 02Jun2021, patient had some really bad shoulder pain and in her right hand, and some inflammation on the top of one hand, which was there in morning and evening. It was gone on 03Jun2021, she meant XELJANZ helped so much. When confirmed if the pain was due to the Xeljanz or the COVID 19 Vaccine, patient stated that no, the COVID vaccine she took was way back, and finished the second one like in March. Patient further stated that it was not due to the vaccine. She was telling how much tofacitinib medication helped. She thinks Xeljanz does work for her, she is happy with the medication. Patient was not saying that this shoulder problem had anything to do with the vaccine, her vaccine was given in left arm, the problem that she had for just one day in shoulder was in the right arm. She doesn't think it has to do anything with Pfizer Outcome of the events was recovered on 03Jun2021.Action taken for tofacitinib was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information the reported event is attributed to  an underlying or  an intercurrent medical condition and  it is assessed as unrelated to the  suspect drug bnt162b2.
I have been having significant dizziness during my last two periods. These periods have occurred after receiving the J&J COVID-19 vaccine. The dizziness has been so bad that I visited my gynecologist for answers and potential treatment. Based off of the lab tests, I am to continue to monitor my periods for dizziness as the current cause and potential treatment is unknown.
Pt came back today 11 days later with red patch below the injection site.  Could be possible delayed allergic reaction. Gave patient Benadryl for emergency use and informed patient to reach out to physician if reaction worsens.
Moderna 2/12/21, 3/12/21, 11/16/21, 6/15/22. Positive on 7/27/22
1 am - woke up with tingling in neck and face, nausea, severe chills and shaking, weakness, full feeling in throat. No temp, heart rate:98 BPM, O2 sat: 97%, BP 110/70, temp: 97.5 degrees.  430 am - worsening symptoms, nausea caused need to vomit, passed out when walking into bathroom, becoming lodged between toilet and sink - loss of consciousness for greater than 1 minute. Carried into bedroom by parents before coming to, passed out again on bed, diaphoresis, woke up and vomited for next 5 minutes. Difficulty breathing: O2 sat - 93%, BP- 110/80, pulse: 148 BPM, temp: 97.2 degrees. Required max assist by both parents to sits edge of bed, no torso control and weakness in arms and legs. Squad called. Unable to speak clearly, slurred speech. Required parents to don clothing.  Squad delayed in coming due to volunteer staff, squad called and told not to come, parents carried to car and both parents transported to ER x 30 minute drive. Arrive at ER ~5:50 am. Required parents put in wheelchair and wheeled in, unable to walk.
Swollen red bump at injection site, approximately 3 inches in diameter, that is warm and itchy.
Patient received what he believes was the Pfizer covid-19 vaccine x 2 in March 2021.  He generally felt poorly since receiving the vaccine and was eventually tested for covid-19 in mid-May 2021 as an outpatient, which was positive.  He was admitted to hospital on 5/23/21 with pneumonia.  Transferred to Bigger hospital on 5/26/21 for ICU care.
Information has been received from a pharmacy employee concerning a 45 year old Caucasian female pt with no known drug allergies, environmental allergies and a peanut allergy who in approx. 5/01 was vaccinated in the left arm with MMRII (lot 634420/0012L). There was no concomitant medication. A pharmacy employee reported that 3 weeks, post vax, the pt developed swollen hands. Subsequently, her hands became painful to the extent she couldn't life a gallon of milk and her pain was sporadic. She was treated with nabumetone (Relafen) without relief. The pharmacy employee noted that the pt was to see a rheumatologist in the near future. At the time of this report, the pt was starting therapy with celecoxib (Celebrex). Additional information is not expected.
Soreness at the site the day after. It felt like someone had punched me on the arm, so not too bad. Very manageable. There was no negative effect on my daily life. The soreness was gone on the second day after, so it only lasted that one day.