chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; a lot of pain from her knees and below/really painful from her elbow down; swelling and redness of the injection site; swelling and redness of the injection site; it's hard and warm; it's hard and warm; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13Apr2021 (at the age of 60-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she received her first dose of the Pfizer Covid-19 vaccine on Tuesday (13Apr2021) and after 24 hours she presented fever, a lot of pain from her knees and below (Apr2021). After 27 hours she presented swelling and redness of the injection site. She stated that it was really painful from her elbow down, "it's hard and warm" (Apr2021). She would like to know it was normal because she had no insurance. The clinical outcome of events was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Onset around 12 hours after imm. - dizziness, generalized hurting, chills, nausea
Patient arrived for 2nd Moderna vaccine today 5/30/21. He explained that he sometimes becomes faint or passes out after having blood drawn. Inquired as to whether patient had eaten this morning and he stated that he had. Advised patient we would have him stay in the pharmacy area longer just to ensure that he didn't have any ill effects from the vaccine before returning home. Within a few seconds of receiving the vaccine, patient stated that he was "starting to feel it". At that point, rather than have him move to the recovery area, I decided to keep him in the IMZ booth and told him "I'm going to just keep you in here and we will talk for a while". Upon asking patient what his plans for the day were, he became mildly disoriented and I held his shoulders to ensure that he didn't fall from the chair. He temporarily lost consciousness (10-15 seconds) while still seated in the chair. Upon regaining consciousness, he was alert and responsive and did not show any ill effects aside from feeling warm. I had patient sit on the floor and placed ice packs on back of his neck and gave him another to place on his forehead and chest. Patient sat and spoke with me for appx 25 more minutes before leaving the area with his wife.
Patient presented to ED on Sunday 4/18/201 for chief complaint of facial numbness and trouble speaking. Concentrated on the left side. Numbness turned into pins and needles tingling. Eventually she could talk but it was difficult. This was at least 20 minute duration. Her friend took her to hospital and said she sounded like her mouth was super dry and like she was putting thought and effort into what she was saying. This has never happened to her before. CT head unremarkable. MRI brain unremarkable. Still having numbness and tingling to left hand with slight weakness today. Postulated she could have had a complex migraine but she has never had this before.
Thrombosis; The initial case was missing the following minimum criteria: Unidentifiable patient. Upon receipt of follow-up information on [13Jul2022], this case now contains all required information to be considered valid.  This is a literature report.  A female patient in her 50's received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "end-stage heart failure" (unspecified if ongoing); "non ischemic dilated cardiomyopathy" (unspecified if ongoing); "implanted with a LVAD" (unspecified if ongoing), notes: implanted with a left ventricular assist device (LVAD) as bridge to transplant; "exchange from one model to different model" (unspecified if ongoing), notes: 10 days after admission. The patient's concomitant medications were not reported. Past drug history included: Aspirin, notes: 325 mg daily since implantation. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for covid-19 immunization. The following information was reported: INTRACARDIAC THROMBUS (hospitalization, medically significant, life threatening), 8 days after the suspect product(s) administration, outcome "not recovered", described as "Thrombosis". The event "thrombosis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood lactate dehydrogenase: above 3000; markedly elevated; 4458 IU/l, notes: peaked; International normalised ratio: 2.9; between 2.4 and 3.9, notes: 2 months preceding admission; power: elevated; continued to rise; exceeded 20 W; Metabolic function test: returned hemolyzed; Platelet count: less than 150, notes: before device exchange. Therapeutic measures were taken as a result of intracardiac thrombus.; Sender's Comments: Based on the known safety profile and  information in the case report, a casual association between reported event and the suspect drug cannot be excluded. 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
This case was reported by a physician and described the occurrence of hearing deficit in a male subject of unspecified age who was vaccinated with HepB vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of HepB (unknown).  A few days after he reported getting HepB, the subject developed unilateral acute hearing deficit.  His hearing got better with time and a course of steroids.  It was reported that the subject has had three hepatitis B vaccines and did not seroconvert.  The subject was not responding to therapy.
Severe pain at injection site for 5 days;  red rash about 6 inches in length and 3 in width around injection site still visible 10 days after injection shot.  No treatment taken.
Patient woke up in the morning with angioedema of the left ear.  (Red swollen, itchy)
Information has been received from a physician concerning a 55 year old black female pt with a hx of being "bit" by a pt and also a reaction to vaccination with Hep B vaccine. The pt experienced urticaria and itching with some sloughing of the skin in the antecubital area. The pt sought unspecified medical attention.  The pt was seen by a dermatologist and diagnosed with cellulitis and allergic dermatitis. On 3/19/99, the pt began therapy with clotrimazole with good results. On 5/5/99 the pt was re-evaluted and it was noted that "her rash was coming back, starting last week after she ran out of the cream." Additionally it was noted that the pt had a Hep B antibody titer of 34 at this time. The pt was to return to the office for follow-up exam.   Additional information has been requested.
I'm kind of tired; I got the booster shot the third one is it 6 months or it is 8 months; This is a spontaneous report from a contactable consumer (patient). A 59-years-old patient of an unspecified gender received the third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported,at the age of 59-years-old) as single dose for covid-19 immunisation; estrogens conjugated (PREMARIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.  The patient medical history and concomitant medications were not reported. The patient previously received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not provided) via an unspecified route of administration on unspecified dates at single dose for covid-19 immunisation. The patient experienced I got the booster shot the third one is it 6 months or it is 8 months on 2021, I'm kind of tired on 08Nov2021. The patient stated, "I got the booster shot the third one is it 6 months or it is 8 months you have to wait?" Advised would have to transfer call to have that answered and patient stated, "No I'm kind of tired today." The outcome of the event I'm kind of tired was unknown.    The lot number for BNT162B2, was not provided and will be requested during follow up.
I started to feel extreme fatigue around noon the day after but what I found very concerning is I lost probably 80-90% of the strength in my arms.  I couldn't palm a ball i had for the kids which i normally can easily.  I had chills and nausea as well.    I can't really remember much from that day and it feels like a big blur.  I woke up the next day feeling very irritable with brain fog.  Today its gotten better and I am hoping tomorrow I will be back to normal.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 24-OCT-2012 02:26, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
SWELLING ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201a21a, expiry: not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced swelling arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling arm was not reported. This report was non-serious.
Pediatric Department; Patient went downstairs to our covid vaccination clinic to obtain a 2nd dose, MONOVALENT, PFIZER 5-11 vaccine. The online tracker already have the patient added onto our covid vaccine schedule as she should have and the appropriate dose and type was on the scheduled appointment. Unfortunately, the covid vaccination clinic gave the Pediatrics Dept. Patient given the bi-valent dose for dose 2 instead of the monovalent dose. Error was caught right away when going to document the vaccine and parent was notified and scheduled for the correct vaccine 4 weeks out, December 12, 2022. She will then get a repeat bi valent 2 months after that vaccine due to being immunocompromised. No adverse reactions or symptoms reported.
Administration error: 24 year old male patient receives second dose of Pfizer vaccine, patient received primary dose Janssen, first booster Pfizer, reason why he did not require such dose.
Severe chills, fever, shaking, weak, nausea, headache, sleepy
BODY ACHES; COUGHING OCCASIONALLY; FEVER; PAIN ON INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced body aches. On 10-APR-2021, the subject experienced coughing occasionally. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced pain on injection site. Laboratory data included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, coughing occasionally and pain on injection site was not reported. This report was non-serious.
Day of shot 9pm extreme headache.   Chills, shakes 11pm   further extreme headache, nausea   14 hours after shot   Extreme headache, throwing up dinner 16 hours after shot   Dizzy, extreme headache, chills 24-28 hours after shot    Sleeping 28 hours after shot nausea, medium headache, chills, tired 48 hours after shot functional but tired 72 hours after shot function
Redness around site of injection from MMRV. Itching and slight swelling also present. Redness spread to 3x3 inch area. Started next morning after injection. Tried Benadryl for treatment. Was evaluated for reaction by doctor.
Previously healthy 16 year old male presenting to hospital as a transfer for chest pain and elevated Troponin levels concerning for myocarditis. Patient has otherwise been healthy. Two days ago he received his second dose of COVID vaccination. He initially felt fine, but later that day had some body aches. The next day he felt feverish off and on and had dull left upper sternal border chest pain intermittently. Today, he reports sharp 7/10 mid sternal chest pain, lightheadedness, sweating, chills, and intermittent non-productive cough. He presented to original hospital for evaluation. The patient admits to tactile warmth since Sunday with no documented temperatures. He recently received his second dose of Pfizer just before onset of these symptoms. He reports difficulty sleeping since Sunday, but no shortness of breath, rashes, syncope, nausea, or vomiting. He has not had any other recent illness, fevers, or known COVID-19 exposures. He denies any history of prior cardiac disease and there is no known family history of cardiac disease, arrhythmias, or sudden death in the child or adolescent period. He denies illicit or recreational drug use. In the ED, he was well appearing with pain now 1 out of 10. POC troponin was 16.8 ng/mL. He had labs pertinent for ESR 10, CRP 3.0, BNP 24. RP2 PCR was negative. UDS was negative except for opiates (s/p morphine). IV was placed and patient was started on IV fluids. EKG was obtained and showed questionable left atrial enlargement per ED read. Cardiology was consulted and performed Echocardiogram in the ED at bedside and was within normal limits. Cardiology resident team contacted for admission. Past Medical History: No major medical diagnoses Past Surgical History: Orchiopexy, T&A Family History: No cardiac family history Social History: Lives at home with mother. Has two healthy siblings not living at home Immunizations: Up to date Medications: None Allergies: NKDA Etiology of likely myocarditis remains unclear at this time. In his age group, this would most likely represent a viral myocarditis. He would likely benefit from cardiac MRI during this admission for further evaluation of myocarditis. His EKG findings with his age group are unlikely to be secondary to myocardial infarct. No arrhythmias or heart block noted on EKG at time of admission or telemetry in ED. There is no family history of autoimmune disease or cardiac disease to suggest an autoimmune component or genetic etiology.
Few days before April 8 there was a nervous breakdown trying to find my phone to leave on time to work.  I knocked over shelves and smashed the printer.  Then I noticed that I started my period cycle Thursday morning.  I have not had my cycle in over four years.  It only lasted a few days and was very thin and watery.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 10:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In December 2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.). On 06-Feb-2022 at 10:31 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on vaccine administration date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient received the booster dose.  This vaccine was administered up until its manufacturer expiry date of 04-Apr-2022.  No treatment medications were provided.
10days after MMR, Varicella, Pneumovax & DTaP administration, pt developed an erythematous papular rash mainly on trunk.
Patient became somnolent approximately 10 minutes after administration of both COVID and second Hep A vaccines, going in and out of consciousness. Vitals were stable while being monitored in the clinic.  After being monitored in clinic for 35 minutes was taken via EMS to the emergency room for further evaluation.
20 min after vaccination , pt c/o SOB; was given Solumedrol 125 mg and Benadryl 50 mg I.M. O2 @ 2Liters. EMS was called, pt sent to ER
Patient presented to ED and was subsequently admitted on 3/21/21 as well as a hospital admission on 3/27/21.
CHILLS; HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and chills was not reported. This report was non-serious.
swelling went down to elbow; very hard and very itchy with 2 inch diameter; Redness/very red; swelling/kinda puffy; This spontaneous case was reported by a health care professional and describes the occurrence of JOINT SWELLING (swelling went down to elbow), VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE for Blood pressure.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy). On 30-Jan-2021, the patient experienced JOINT SWELLING (swelling went down to elbow). The patient was treated with IBUPROFEN on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swelling went down to elbow) had resolved and VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy) had not 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.
I had a really sore throat; my husband had tested positive for COVID-19 early so I thought I should test myself just in case I had gotten it. I took a home COVID-19 test that came back positive. I contacted my doctor through the portal, letting them know I had tested positive with a home COVID-19 test. They let me know I needed to go their testing site to get a PCR COVID-19. One the test came back positive, my doctor prescribed Paxlovid, I was able to start the medication on Friday.
RED, SWOLLEN LEFT UPPER ARM AT INJECTION SITE, TREATED WITH ANTIBIOTIC (KEFLEX, ANTIHISTAMINE (OTC CHILDRENS BENADRYL) AND ANTI-INFLAMMATORY (CHILDRENS IBUPROFEN).
On 05/19/2000, post vaccination, the patient developed 3 sores, the size of a pea, on her legs and 2 on her chest. No medical attention was sought. Additional information has been requested.
Muscle aches (body), arm sore to the touch, armpit nodes painful, low grade fever, chills, slightly nauseous.,
Mother contacted the office and states that the child is febrile (temp 102) and the child has a 1-2" area of redness at the injection site.
Pt was very fussy-high pitched crying-T was 101-site of immun was swollen & red for 3 days afterwards.