chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 7 minutes after receiving the shot, I felt extremely flushed. I got dizzy and started to shake. I thought I was going to pass out. They took my blood pressure, and it was 200/110. At which point they said, we should call the paramedics and take you to the hospital. I refused because I didn't want to go to the hospital with COVID patients. I stuck around the store for at least another hour to an hour and a half. They kept taking my blood pressure, it went down a tiny bit but not a lot. I decided to go home even though they didn't want me to. That high blood pressure lasted the whole day. The next day I got the chills, fever, diarrhea, nausea, just everything for 4 days. My blood pressure at least had gone down. I did talk to a couple of nurses and they kind of walked me through what to do. I stayed here at home and took Tylenol and after 4 days I finally got over it. But then I noticed later on (unsure of time frame), but I noticed I had trouble breathing, like having trouble catching my breathe. I also was having tightness in my chest and heart palpitations. I set up an appointment with my PCP and I told her these things and she referred me to the pulmonologist and cardiologist. When I went to the pulmonologist, he sent me off for a breathing test and it came back that I have asthma, which I've never had in my life. So, he put me on a rescue inhaler, and he's still working with me to help me get this under control. I'm still new to all of this and he's trying different medications and maintenance inhaler. Got me on Flonase and has me on different things. He said that it could be due to the vaccine. And he said that if we find others with the same symptoms, then we can report it. His name is (Privacy) pulmonologist. So now I have asthma for the rest of my life. Then I went to the cardiologist, and he did an EKG, which he said turned out alright. He also did a sonogram which also turned out alright. He wanted to do a stress test and I did them before and I was afraid and declined. He also wanted to do a CAT scan with contrast dye, but I couldn't because of the kidney disease. I didn't do those tests, but I'm thinking about doing one of them. I do see this doctor again next month, and I'm still having some chest tightness and heart palpitations but not as much. It could be stress because of anxiety and a lot of things going on in life, but back then, I'm not sure. He also did a Holter monitor, and he saw a couple of things but no red flags and told me to see him in 6 months, which is next month. So that's where I'm at right now. I did question many doctors to see if I should get the booster, and I had 6 different answers. The NP and an infectious disease doctor noted that due to the reaction I had, that I should not get the booster because of possible anaphylactic reaction and potential risk of death. I'm just not sure if I have the antibodies. Recovery: High blood pressure - yes; Asthma - no; Heart palpitations and chest tightness - unknown.
stomach cramping, diarrhea, began to have chickenpox looking bumps on chest, abd legs;
Left upper arm swelling, redness and pain with systemic malaise for 2 days after vaccination.
patient was given vaccine, shortly after patient experience feeling of passing out, confusion, and unable to see.  patient laid on bench was given ice pack and felt better shortly after
I received my 2nd dose (shot) of Shingrix vaccine since it was recommended by my gastro MD given I am on immunosuppressant drugs for my colitis.  The first dose received about 2 months ago yielded a lot of soreness and red block near site (1-2 inches) for 4-5 days.  2nd dose yielded significant flu like symptoms (full body aches, soreness, headache, tiredness) the following morning on 10/14.  These symptoms are now almost gone 3 days later.
Information has been received from a health care worker reporting on behalf of a physician concerning an elderly male pt between the age of 65-80 years old, who last Wednesday 26NOV2003 or Friday 28NOV2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The health care worker reported that after receiving the vaccine the pt experienced nausea and weakness. The pt recovered. The health care worker wanted to know if there have been any reports of problems with this specific lot of pneumococcal 23v polysaccharide vaccine; however there was no product quality complaint reported. No additional information was provided. Unspecified medical attention was sought. The records of testing prior to release of this lot have been checked by QA and found be to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the physician who confirmed the pt was a  59 year old male on 26NOV2003, at an unspecified time in the AM, was vaccinated in the upper arm with a dose of pneumococcal 23v polysaccharide vaccine. The physician reported the pt experienced all over body aches and a local reaction which lasted for one day. The physician confirmed the pt was not hospitalized and he is recovering. The reporter also mentioned another pt who had an experience following vaccination with pneumococcal 23v polysaccharide vaccine.
Headache  Body aches  Fever Gastrointestinal  Soreness in injected arm
Is double vaccinated with a booster, and then got Covid where she was advised to get the medication Paxlovid; Is double vaccinated with a booster, and then got Covid where she was advised to get the medication Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the parent.  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at unk (once every 2 weeks) and second regimen (ongoing) (Batch/Lot number: unknown) at weekly (unk (every week)) for crohn's disease. Relevant medical history included: "Crohn's disease" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Humira for Crohn's disease. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "Is double vaccinated with a booster, and then got Covid where she was advised to get the medication Paxlovid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of covid-19.  Clinical course: Reporter reported patients height would be 5 (feet) 7 (inches) and her weight would be about 170 pounds. Patient had a Crohn's disease patient was taking Humira once every 2 weeks. And then because of this severity of her Crohn's patient was taking it every week. So she have had the Pfizer, the usual 2 and the booster, but she was immunocompromised. So when she took the Paxlovid, it worked because she was COVID positive with symptoms, within 2 days of symptoms and felt a whole lot better. But then when she took her next dose of Humira, started getting symptoms again, took another test and it came back positive and the reporter wanted to know if patient could just take Paxlovid again. Reporter causality as No.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a causal relationship between reported events, drug ineffective, Covid-19 and suspect BNT162B2 cannot be excluded.
brain fog; complete lethargy; couldn't think or organize; can't pick up feet to move; can't say words; can't remember words; Blood pressure is up; very sensitive to heat or humid in summer and could not go outside; very sensitive to heat or humid in summer and could not go outside; immune system was all screwed up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: BRAIN FOG (non-serious), outcome "unknown"; LETHARGY (non-serious), outcome "unknown", described as "complete lethargy"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "couldn't think or organize"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "can't pick up feet to move"; SPEECH DISORDER (non-serious), outcome "unknown", described as "can't say words"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "can't remember words"; BLOOD PRESSURE INCREASED (non-serious), outcome "unknown", described as "Blood pressure is up"; TEMPERATURE INTOLERANCE (non-serious), SENSITIVE SKIN (non-serious), outcome "unknown" and all described as "very sensitive to heat or humid in summer and could not go outside"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "immune system was all screwed up". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: reporter said she has 2 friends who are experiencing the same reactions, this patient is a long hauler for 3 years now.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was not provided. On15-DEC-2021, the patient was vaccinated with an expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL injection, (lot #R017624, which was considered to be valid, expiration date: 17-MAR-2021), administered for prophylaxis (vaccination scheme frequency, anatomical location and route of administration were not provided) (expired vaccine administered). The reporter stated the vaccine did not experience any temperature excursion. No additional adverse event was reported.
Slight headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Slight headache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. L-031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (Slight headache). At the time of the report, HEADACHE (Slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-037928 (Patient Link).
Extreme pain in entire right arm.  Applied heat and took Tylenol.  Movement of the arm neither aggravated nor relieved pain. Called clinic nurse for advice. Told me to keepdoing what I was doing. Fifth day started to dissipate to the point of not wanting to cry all the time and could resume normal activities, such as bathing, cooking etc. Sixth and seventh day the pain was still noticeable but did not take Tylenol or use heat anymore. Eight day pain was barely noticeable.
Following administration of vaccine, patient felt foggy and lightheaded.  BP checked and found to be SBP>220 and DBP>100.  After 30 min of observation, symptoms failed to resolve and was seen in ED.  In ED, patient did no receive any medications and was observed and was discharged in stable condition.
Exacerbations of autoimmune symptoms. The day of my second Shingrix vaccination, I experienced expected symptoms of headache, chills, fever, fatigue injection site soreness. Fatigue and headache has continued; and aversion to light, muscle weakness, exercise intolerance and brain fog began on December 15 and has continued date (December 20)
I have side effects where my face has been swollen, may be one to two weeks after that; its feel swollen and it's not going down yet; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was unknown (reported as that EW69, she doesn't know it J or 35), and Expiration Date was not reported), via intramuscularly, administered in Arm Right on 04Apr2021 (at the age of 52-year-old) as a single for COVID-19 immunization. Medical history included dialysis and blood pressure high from an unknown date and unknown if ongoing. Concomitant medications included minoxidil, carvedilol, amlodipine, valsartan for Hypertension and ascorbic acid, biotin, cyanocobalamin, folic acid, nicotinamide, pantothenic acid, pyridoxine, riboflavin, thiamine, zinc (RENAPLEX) taken dialysis, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW7534, Expiration Date: Unknown), via intramuscularly, administered in Arm Right on 12Mar2021 as a single dose for COVID-19 immunization. On 04Apr2021, after the second shot, patient had side effects where her face has been swollen, may be one to two weeks after that and its feel swollen and it's not went down yet. Patient stated that no one had told her what was happening. Patient did not receive any treatment for adverse event. The patient underwent lab tests and procedures which included tyrosine Serum, magnesium Serum, Micro HLB, CBC Differential Platelets, Hemoglobin A13, Hepatitis B antibody, Hepatitis C, Micro Keratin Ratio and Metabolic Panel with unknown results on an unspecified date. The outcome of event was not recovered.  Additional information has been requested.
Something set into pinky and fingers; Whole hand on right side affected; Feet and toes hurt/almost crippled; Hard and painful to get out of bed; This spontaneous case was reported by a patient and describes the occurrence of SKIN DISCOLOURATION (Something set into pinky and fingers), LIMB DISCOMFORT (Whole hand on right side affected), PAIN IN EXTREMITY (Feet and toes hurt/almost crippled) and VACCINATION COMPLICATION (Hard and painful to get out of bed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042821A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (seasonal allergies). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Seasonal allergy.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Apr-2021, the patient experienced SKIN DISCOLOURATION (Something set into pinky and fingers), LIMB DISCOMFORT (Whole hand on right side affected), PAIN IN EXTREMITY (Feet and toes hurt/almost crippled) and VACCINATION COMPLICATION (Hard and painful to get out of bed). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Something set into pinky and fingers), LIMB DISCOMFORT (Whole hand on right side affected), PAIN IN EXTREMITY (Feet and toes hurt/almost crippled) and VACCINATION COMPLICATION (Hard and painful to get out of bed) outcome was unknown.        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.
Influenza given the evening of 9/19/18 in the left deltoid. He woke up on 9/20/18 c/o pain in his arm. By early afternnon, his entire upper arm was swollen, red and painful. He was diagnosed with a local reaction to the flu vaccine and advised to apply ice and gice BENADRYL every 8 hours.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am veteran and I am submitting comments regarding the proposal to license Anthrax vaccine. I believe that prior to the war, I received one or more vaccinations that may have contained squalene. Within the last two years, I have been diagnosed with Antiphospholipid Antibody Syndrome and Undifferentiated Connective Tissue Disorder. I won't go into details regarding the decline in my health that has occurred within the last two years, but suffice it to say that I would not wish these medical problems on anyone.
Initial report was received on 07 November 2011 from a health care professional. A patient (name, gender and date of birth not reported) had received ADACEL (lot number, route, site and date of administration not reported) and TYPHIM VI  (lot number, route, site and date of administration not reported) and an unspecified amount of time after vaccination, experienced difficulty swallowing. No further information was available at the time of the report. The patient's outcome was not reported. The reporter for this case is the same as for case 2011-10829. Documents held by sender: none.
Patient reported to DR that after receiving the injection, earlier in the day she developed swelling in her lower lip mostly and some in her upper lip and then hives and itching all over.
Shortness of breath, racing heartbeat began at approximately 10am May 25, 2021 and continued through the night of the 25th.
I was not able to walk for 2 days and I had a very low blood pressure reading.
Face began to swell after 24 hours of receiving COVID booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2022 at 15:45 as dose 3 (booster), single (Lot number: FL2757) at the age of 10 years intramuscular, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5127), administration date: 06Dec2021, when the patient was 10-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127), administration date: 15Nov2021, when the patient was 10-year-old, for COVID-19 immunization. The following information was reported: SWELLING FACE (non-serious) with onset 17Aug2022, outcome "unknown", described as "Face began to swell after 24 hours of receiving COVID booster". Therapeutic measures were taken as a result of swelling face. The patient took 25 mg Benadryl to reduce swelling.  Follow-up (22Aug2022): Follow-up attempts are completed. No further information is expected.
Swollen and tender thigh with lumps(?) 2 hours after DTaP.
Thoughts of what would happen if killed himself; Feelings of desperation; General feeling of being off; This spontaneous case was reported on 17-Sep-2020 from pharmacist to agency (reference number: SEQW20-01893) and concerned a 38-year-old, male patient.  The patient's concurrent conditions included type 1 diabetes. The patient's past medication included Afluria Quad last year without a problem. The patient's concomitant medications included Basaglar (insulin glargine) and Novolog (insulin aspart) for type 1 diabetes.  On 15-Sep-2020 in the morning, the patient was vaccinated with Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration, anatomical location: not reported] for influenza prophylaxis. The batch number reported was P100242860 and expiry date 30-Jun-2021.  On the same day in the evening, after receiving Afluria Quadrivalent, the patient started having feeling of desperation and thinking what would happen if he killed himself. It was reported that the patient is usually a very jovial person and normally does not have this thoughts. The patient was not feeling the urge to do it but was thinking what would happen if he killed himself. Additionally, the patient felt general feeling of being off and questioned if the vaccine could cause a systemic reaction or if this could be an interaction since he has recently changed therapy with Basaglar (insulin glargine) and Novolog (insulin aspart) for type 1 diabetes.   At the time of initial reporting on 17-Sep-2020, the patient was recovering from the events. The patient stated he was feeling better but not recovered yet.  The reporter did not provide a causality assessment.  The reporter assessed the case as serious.  Company comment: The patient developed suicidal ideation, feeling of despair and feeling abnormal on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of diabetes type 1 and use of Novolog (a rapid-acting insulin) confound causality. Fluctuations in blood glucose can result in rapid mood changes, including low mood and irritability. Considering all above mentioned, causal relationship for all events is assessed as not related.; Sender's Comments: The patient developed suicidal ideation, feeling of despair and feeling abnormal on the same day after vaccination with the suspect product, Afluria Quadrivalent. Chronology is plausible. Medical history of diabetes type 1 and use of Novolog (a rapid-acting insulin) confound causality. Fluctuations in blood glucose can result in rapid mood changes, including low mood and irritability. Considering all above mentioned, causal relationship for all events is assessed as not related.
Patient received the vaccine and felt fine, and then walked out to the observation tent. As soon as she sat down in the observation tent she started to feel dizzy and after 30 seconds her vision started to go black. Patient then fell out of the chair, and regained consciousness after 5 seconds. Patient was then helped into a wheel chair and taken to a cot and waited 30 minutes before leaving and is having a friend pick her up.
Pt developed a fever of 102, vomiting and crying inconsolably. Injection site clear. The pt recovered later that day, fever subsided, no longer crying and no vomiting.
A physician reported that his son rec'd either DTaP (manufacturer unknown) or DTP (manufacturer unknown) and subsequently developed hyperactivity. No further information was available at the date of this report.