chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; sweating; feeling cold; soreness; swelling/arm pit is swollen; arm where the injection was given is sore all the way down to the elbow; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 63-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 16Mar2021 (age at vaccination was 63 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient received his second dose of the Pfizer COVID-19 vaccine on Tuesday of that week. After the second shot of the Pfizer COVID-19 vaccine, on an unspecified date, the patient experienced side effects, fatigue, sweating, feeling cold, soreness and swelling. Since receiving the second injection, the patient reported experiencing fatigue, sweating and feeling cold. He also reported that his arm where the injection was given was sore all the way down to the elbow and that was arm pit was swollen. The outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot been obtained.
feel minor aching; I felt faint/ inconsistent dizziness spells; It could of been anxiety; feeling of adrenaline rush; my vision was slightly askew as though I could not focus on objects.; my vision was slightly askew as though I could not focus on objects.; This is a spontaneous report from a contactable consumer, the patient. This 46-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8735) via unspecified route on 21Apr2021 at 10:00 (at the age of 46-years-old) in the left arm as a single dose for COVID-19 immunization. Medical history included migraines. Patient had  allergies to sulfa. Patient did not have COVID-19 prior to vaccination. There were no other vaccines received within four weeks of vaccination. Concomitant medications taken within two weeks included collagen, multivitamin and THC-free cannabidiol (CBD). On 21Apr2021 at 10:00, after a few seconds of being injected, patient felt faint. It could have been anxiety but then minutes later he had these inconsistent dizziness spells and a feeling of adrenaline rush. He felt many times like he could faint. It subsided after a few hours. Also his vision was slightly askew as though he could not focus on objects. On 22Apr2021, the next morning, he just felt minor aching. There was no treatment received for the events. The clinical outcome of the events felt faint/dizziness spells, anxiety, feeling of adrenaline rush, vision was slightly askew, could not focus on objects, and minor aching was recovering. Patient was not COVID tested post vaccination.
Diarrhea 5 times in 24 hours; This is a spontaneous report from a non-contactable other hcp. A 28-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), intramuscular, administered in Left Arm on 04Mar2021 15:30 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus, blood cholesterol increased. Concomitant medications included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE, SITAGLIPTIN]), atorvastatin (ATORVASTATIN), dapagliflozin propanediol monohydrate (FARXIGA), fish oil (OMEGA 3 [FISH OIL]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Mar2021 15:30, (24 hours after receiving vaccine) The patient experienced diarrhea 5 times in 24 hours. No treatment was received for adverse event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected
Rash - Information has been received from a health professional concerning a male who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation in his left leg lot 633819/0992k.  Aproximately 10-11 days after the vaccination the patient developed a maculopapular rash on his neck, chest and trunk.
2cm x 4cm area of Redness and Swelling, (+) itching, (+) hot to touch at injection site of varicella vaccine noted at Dr appt - symptoms had improved from onset Redness Swelling had decreased
MMR administered. Left arm SC and Varicella administered right arm SC on Monday 6/3/02 in AM. Client states that rash was in left deltoid area and right arm in AM of 6/4/02 and progressed over body. No complaints of fever or breathing difficulty.
pt recvd vax & the next day exp the following inj site rxn: warm to touch,raised reddened area ( 6 3/4 x 6 1/2cm),& itching;pt took an antihistamine for itching & sx resolved 9OCT94;
Day 1: body pain and tingly face that evening. No sleep Day 2: headache, extreme body pain, chills, fever (100.5-101 degrees), unable to work, last all day Day 3: moderate body pain, headache, chills, no fever though.
Immediate itch in the head  and arm fifteen minutes after shot along with slight swelling of the lip. Then 2 weeks after 2nd dose the same itch has returned all over the body along with some open rashes on the skin.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact dates, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 19-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # L007560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
13 y/o patient and mother presented to pharmacy for a Boostrix shot and a Menveo shot. Immunization selection tool was used and patients shots were input and sold. Needle was attached to prefilled Boostrix syringe. (MENVEO shot was never given). Pulled patient into vaccination room and asked mother to stay for shot, she insisted and gave permission to give it and she went to car. Boostrix shot was given IM into left deltoid and bandaid was placed on arm. Patient went limp and I thought he passed out. Patient then began seizing and I helped lower him to the floor and protected his head and called out for help. I had someone call 911. Patient came to a few seconds later and knew his first name, but not his last. He was unaware of what happened. I monitored pulse and temperature while waiting for EMS to arrive. Both were normal except patient was pale. Paramedics arrived and checked him out and he seemed okay but they took him to check him out. No treatment was given and 911 suggested not to give any food or water.
8-10 hours post vaccine pt noted scattered small pink mildly itchy papules 1-2mm diameter on abdomen. Since then spread of similar mildly itchy pink papules over front and back torso, neck, arms, legs. No fever chills sweats myalgia, no angioedema
Student presented to the clinic with c/o right upper arm itching "where shots were given". Onset reported 11/14/18 at round 9:00pm. States arm began itching and mother gave him Tylenol. Presented to the School base clinic on 11/16/18  with redness (school base nurse describe redness area the size of a baseball) to right upper deltoid, reports itching and he reported "has been scratching site a little".  School base placed Ice pack to area. No respiratory distress, denies headache or pain. Mother was instructed by school base to follow up with PCP and to continue with ice packs and cortisone crème as needed. BP 120/77, P 118, R 20, T 98.3 oral.
Went to ER with temp 104 degrees - severe headache and vomiting. All began morning of 4-16-11 - stated E.R. physician thought pneumonia but chest x-ray clear. Given bag of IV antibiotics.
Patient stated that had an itchy throat and developed a rash through the body.  She also reported itchiness through the body.
Erythema, swelling, induration, pain and itching. Onset in evening after vaccine administration. Treated with antihistamines and antibiotics for secondary cellulitis.
24OCT91 5PM t104 silver dollar size swelling on rt deltoid where HIB was given; 25-26OCT t102-103 all day; 27OCT91 t101, sneezing MD prescribed Suprax & Polyhistine HD;
Day after vaccination patient reported large swelling, erythema and hot to touch area the size of her hand. She denied itching or dyspnea. Swelling gradually decreased over course of 4 days cont remains red. No treatment given. Recommended that she see her primary care physician.
Swelling and induration on left arm 8cm X 9cm, noted 2 days, post vax.
The lumps appeared on my back of head and front near eye brows. Their sides are about nickel. Pain without touching for about 4 days, then pain only when touched. No itching nor red.  The symthom is persist as of today 11/23 /2023. The other is neck stiffness. BTW, i did not save the vaccine info.
Approximately 5 minutes following the administration of the influenza vaccine (Sat 10/31) Patient fainted. She was caught by her family members who took her down to the ground. She was awake and coherent when I got back to her. She stayed down for a few minutes and got some water. After a few minutes her family walked her over to the chairs we have to the side and had her sitting up. I took her out some candy just to help get her blood sugar back up quickly. She stayed for about 15 more minutes and the family insisted she was fine and that she had probably just worked herself up leading up to the shot. Upon following up with her dad on Mon 11/2 he told me she was fine and that he thought something similar had happened post flu-shot once before.
Symptoms include Shortness of breath, joint pain, fatigue, intence coughing. Resulting in prolonged treatment for Interstital Pulmonary Fibrosis and Rheumatoid Arthritis
none of the patients responded to PPV23; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 65 years old male patient with chronic lymphocytic leukaemia. He received no course of antibiotics in the year before enrollment. Prior to ibrutinib, the patient was on therapy with fludarabine (+) cyclophosphamide (+) rituximab.  Pre-vaccination, the number of Streptococcus pneumoniae serotypes with immunoglobulin G (IgG) titers greater than 1.3 microgram/milliliter was 4. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, route, and site of administration were not reported) for prophylaxis. Concomitant therapies included ibrutinib.  Post-vaccination, the number of Streptococcus pneumoniae serotypes with IgG titers greater than 1.3 microgram/milliliter was 0. The patient did not respond to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (vaccination failure). The outcome of event was unknown. The authors considered vaccination failure to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience  This is one of ten reports derived from the same literature article (cross referenced with MARRS# US-009507513-2103USA003406).  Literature report: Sender's Comments:  US-009507513-2103USA003406:
Pt initially notified staff that tightness and palpitations were felt. This occurred about 20 minutes following vaccine. Pt was planning on waiting 30 minutes d/t prior reactions to medications. Writer assessed pt and pt was talking to writer without any struggling or difficulty. Writer asked pt if this feeling was r/t anxiety or if this feeling was r/t the vaccine administration. Pt stated that for sure anxiety. Pt also mentioned then that tongue felt scratchy and throat felt scratchy.  Pt has benadryl  and epi-pen in purse at all times d/t history of anaphylaxis. Pt did not appear to be concerned at all about scratchiness and asked if a bendadryl could be administered. Writer administered 25 mg diphenhydramine with positive effect beginning. Pt felt as if she were able to leave without issue. Pt denied the need for ambulance transfer or visit to the ER by another form of transportation (friend, family). Pt has a Dr. appt next week and will discuss the second dose at that time. Pt ended up leaving  following 50 minutes after vaccine was administered.
ENORMOUS BLOOD CLOT IN LEGS; LIMB AMPUTATION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) 1 total, dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported that, in the period of end of JUN-2021 and at the start of JUL-2021, patient's foot was swollen and was turning purple along with legs. The patient went to the hospital and they found enormous blood clot in legs they had to amputate it. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the enormous blood clot in legs and limb amputation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211203989-Covid-19 vaccine ad26.cov2.s-Enormous blood clot in legs, limb amputation. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
stiffness; sore; vaccination site pain; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), ARTHRALGIA (sore), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO INFORMATION WAS PROVIDED.  Concurrent medical conditions included Fibromyalgia. Concomitant products included GABAPENTIN and FLUOXETINE for an unknown indication.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), ARTHRALGIA (sore), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), ARTHRALGIA (sore), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant: Gabapentin, Fluoxetine TREATMENT DRUGS LIKE IBUPROFEN IS USED   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow-up appended
4 dermatologost appointments since May 2021, increasingly vicious,  intense itching, Unpredictable, can hardly wear clothes, scratching during sleep, causes open wounds, quality of life changed, in all areas, very small relief with shower, wears gloves to bed, nothing stops the itching
Woke up on 9/6/2021 with sore throat, headache, sound sensitivity, chills, runny nose. Contacted  AF nurse health line, advised to get tested for Covid. Tested negative. Advised to go to where tested negative for strep and given Augmentin EQ 875 mg and BromPhen/PSE/DM. Developed lower back and chest pain, which migrated up into upper back and then into sternum over next 2 days. Main symptoms continued for 4 days, accompanied by joint pain. Coughing and headache finally fading today, 11 days later. Fatigued; sleeping 10+ hours a night since shot.
Handwriting illegible with arm that vaccine was injected.  No treatment given, Handwriting improved 8 hours after adverse event.
03/13/22 presents to Birth Center Triage for "Induction of labor". PMHx of "ADD, Anxiety, CAP (community acquired pneumonia) 1/11/2017, Hepatitis C carrier"
Strong Hissing in both ears (still present), high blood pressure (147/92 pulse 98).  Pressure in my head and 'feeling my heart pounding'. Normally I do not have high blood pressure, nor pulse nor headaches. Mild chills that went away Hissing still present but at lower levels. Blood pressure is back to normal. Taking Metroprolol in addition to the hives medication mentioned in the beginning. It is helpful. Also took Iboprufen and Tylenol the first two days after vaccination. Have been given Singulair for anti-inflammatory action re. my ears that show congestion. Will follow up in a week and if it does not help might switch to cortizone. Will follow up with a dr. appointment at the end of the month.  Blood test next week Feeling better slowly and hopefully surely.
Information has been received from a registered nurse concerning a female patient with no pertinent medical history who on unspecified date in 2001 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# not reported), and on 17-NOV-2010 was vaccinated with a second dose of 0.5 ml of PNEUMOVAX 23 (Lot # 665903/1427Y) (Exp date 03-JUL-2011). The nurse stated that the patient contacted office by phone on 17-NOV-2010 and reported that she had swelling which extended from her shoulder to her elbow. The nurse also stated, it was localized swelling and the physician recommended patient used warm compresses on area and TYLENOL. At the time of the report the patient's outcome was unknown. The patient did not seek medical attention. The patient had a history of allergy to alendronate sodium (MSD, WAES 1012USA03173). Additional information has been requested.
Information has been received from a registered nurse concerning a 7 year old male with no known allergies and no pertinent medical history who on 29-MAR-2001 was vaccinated with VARIVAX (Merck). On 04-MAR-2008, the patient developed chicken pox. The patient was seen in the physician's office on 05-MAR-2008 and the chicken pox was described as less than 50 lesions and generalized over whole body. The chicken pox was itchy, but no fever was noted. Laboratory diagnostic studies were not performed. As of 06-MAR-2008, the patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008.  Initial and follow up information has been received from a health professional concerning a 7 year old male with no known allergies and no pertinent medical history who on 29-MAR-2001 was vaccinated with VARIVAX (Merck).  The patient was seen in the physician's office on 05-MAR-2008 for an itchy rash that was present for one day prior to evaluation in the office.  Upon examination it was noted that the patient had 10 to 12 papular vesicular lesions with some scabing lesions scattered on the trunk and legs, also described as less than 50 lesions and generalized over whole body and was itchy.  The patient was afebrile.  A clinical diagnosis of varicella was made.  Laboratory diagnostic studies were not performed.  At the time of reporting the patient had recovered on an unspecified date.  Additional information is not expected.
I ALREADY FILLED OUT ONE PRIOR FORM CONCERNING MY REACTION REGARDING THIS INJECTION. MY NECK AND NECK NODES ARE STILL ENLARGED AND TENDER,IT IS MY SCAPULAR REGION AND POSTERIOR NECK REGION.  THIS IS NOT NORMAL . I'M NOT SURE I REPORTED RIGHT ARM TENDERNESS AND ERYTHEMA. IK HAVE A PHOTO. I ALSO EXPERIENCED TINGLING AROUND LIPS BUT THOUGHT I WAS GOING TO GET A COLD SORE, BUT TALKING TO PEOPLE SAID I SHOULD REPORT THIS AS WEL SINCE I DIDN'T GET A COLD SORE.  I HAVE INCREASED FATIGUE SINCE INJECTION.
Pt stated shortness of breath and chest tightness. Pt stated pain at 2. Pt vitals taken by emt spo2 99 on room air, hr 75, bsg 61. Pt sat on floor by nurse and emt. Pt given bottled water and orange juice by nurse. Pt bsg after orange juice was 145.
onset of gen hives on 26APR95; tx in ER 28APR95 w/prescription for DPH; completely subsided by 1MAY95;
exhaustion; achiness; headache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got vaccinated on Friday (29Jan2021). The patient experienced exhaustion, achiness, and headache on an unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Fever / chills began at bedtime.  Barely slept, alternating between chills and profusely sweating all night.  In morning, took a shower and fainted / lost consciousness without any warning in shower.  Impacted side of tub and impact caused large laceration in chin (lower incisors cut all the way through) and loosened/mobile lower teeth, including small lower tooth fracture discovered by dentist x-rays.  (Patient is healthy with clean medical records.  Never fainted or abruptly lost consciousness before; no history of such events.)
Day after vaccination, woke up right shoulder shoulder has loss of sensation, over one week the numbness spread lower arms and upper chest right side, 2 weeks numbness now beginning in top of right thigh. Headache for 3 days since vaccination. April 18th light pain and swelling left eye lid, and right ankle.
Pt reported to ER for a suture check, with an injection site reaction 4 days post vax. The site was unusually red and swollen
Intense itching and red area larger than a quarter at injection site for 5 days.  Resolved after 5 days or so, but still slightly itchy more than 10 days later.
Patient presented to the emergency department on 5/31 for weakness and increased confusion at home. She tested PCR positive for COVID-19 on 5/31.  She was admitted from 5/31 - 6/10. This meets criteria for VAERS reporting.