chrisvoncsefalvay/vaers-outcomes huggingface dataset:
face swelled up; Chills; Fever; Runny nose; Body aches; Little weak; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 58-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Feb2021 13:30 (Batch/Lot Number: E102501262) as a single dose (at age of 58-years old) for covid-19 immunization. Medical history included ongoing blood pressure increased, ongoing gout, blood potassium abnormal from an unknown date and unknown if ongoing. She was medication for high blood pressure. She takes Potassium for Potassium. She was also on a medication for gout. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE(s) following prior vaccinations was no. Prior Vaccinations (within 4 weeks) was no. The patient experienced face swelled up, chills, fever, runny nose, and body aches on 17Feb2021 12:00 and little weak in Feb2021. It was reported that, she went and got the vaccination for COVID and had a lot of side effects. She got it on Tuesday and felt alright. Yesterday, Wednesday 17Feb2021, she had chills, fever, runny nose, body aches, and her faced swelled up. Her body was aching really bad all over. She came home from work yesterday and took some Tylenol for body aches and when she woke up this morning the fever was gone. She sweated it out last night. For the event fever, she has recovered with lasting effects. She was still feeling a little weak and sore. Her face was still swollen, but it was a little better. It was just the left side of the face that swelled. She doesn't think it was a medical emergency. Therapeutic measures were taken as a result of body aches; Tylenol . Adverse events did not result in Emergency Room or Physician Office visit. Relevant Tests was none. The outcome of the event fever resolved with sequelae on 18Feb2021 while the outcome of the events chills, her faced swelled up, runny nose, body aches was recovering. The outcome of the event little weak was unknown.   No follow-up attempts are possible. No further information is expected.
10 days of symptoms and they continue -- aches, dizziness, decreased appetite, flushed, headache
09/20/2017 evening pt went to work and experience numbness in arms, cold to touch, and bluish color to the arm. 9/21/17 called pharmacy and reported her symptoms. 9/22/17 Pt said her symptoms were better and she only had soreness near the injection site-MD told pt if she did not get better to go to the ER. But pt did feel better on 9/22/17.
HOSPITAL COURSE: Patient is a 75 y.o. male with Severe COPD, Hypertension, DMII and Hyperlipidemia who presented to the ED on 01/21 with progressively worsening shortness of breath. Patient states that he had shortness of breath and a cough x 2 weeks. He was seen by his doctor in the VA and started prednisone and doxycycline. Symptoms did not improve. He completed a course of medications yesterday. At nighttime, his symptoms worsened and he decided to present in the ED. For more detail, please see admission administrator. Hospital course dictated by problem: Acute hypoxic respiratory failure secondary to COVID-19 PNA and acute COPD exacerbation. SXS of dyspnea and cough started around 1/14. They gradually progressed to where patient came to ED. In ED tachypneic with O2 SATS in mid 80s. He was placed on BiPAP in ED initially for respiratory support. COVID-19 test positive at admit on 1/21/22. He received TX with IV solu-medrol and scheduled SABA. His respiratory status improved and O2 SATS were stable on room air. By discharge, O2 SATS were stable at rest and with activity and his dyspnea had resolved.  Will complete steroid taper for COVID/COPD exacerbation. Pulmonary evaluation as outpatient (patient has an appointment scheduled this month). Elevated Troponin 2/2 demand ischemia, Severe aortic stenosis, bicuspid aortic valve. Trop elevated in setting of demand ischemia from respiratory distress (COVID/COPD). EKG without acute ischemic changes. At no point did patient have chest pain. His dyspnea resolved completely w/ targeted TX for COVID/COPD. Echo was obtained due to troponin and HX moderate aortic valve stenosis. Echo showed severe aortic valve stenosis with valve area < 1cm. At discharge no chest pain, dyspnea at rest or with activity. No lightheadedness/pre-syncope. Due to COVID + status not candidate for intervention at this time. Will optimize, wait until convalescent, and have HVI f/u for further mgmt. of AVS- HVI f/u for aortic stenosis, consideration of valve replacement. Hypertension: Blood pressures elevated- PTA Toprol-XL, losartan, Type 2 diabetes mellitus, Continue PTA regimen. DISCHARGE DIAGNOSES: As above, COVID-19 PNA and COPD exacerbation.
Hard lump in the underarm area of the arm that received the shot. Size approximately of a dime. Lasted four days so far with strong soreness, weakness in arm and arm "falling asleep" during night.
Shortness of breath, chest pain, back pain, fever, nausea, leg pain, headache
pt recvd pneumococcal vax 3DEC91 & the inject site subsequently became red, swollen & painful; MD felt that the vial was contaminated; No further details were provided;
Rash started under my right breast 8/1/  by 8 /2 a patch started on my Right lower leg by Monday 8/5 the rash has traveled down my left arm from shoulder to wrist  as of now  8/10 the rash is down the left side of my neck I also have a patch of it in my right groin . I'm still getting new spots coming up. I went to my health care provider on 8/5 stared   Valtrex HCL 1 gram every 8 hrs for 7 days and prednisone 10mg for 10 days starting 4 pills a day for 4 days and tapering  down. I don't seem to be responding to treatment.
gen shaking/tremors;no LOC, eye movements not observed lasting for few sec;witnessed by grandma, father;
The entire body was swollen. Heart inflammation. Heart ache. Difficulty breating. Dizziness and vertigo.  The doctor proceeded to take blood work that confirmed heart inflammation doctor recommended meclizine 12.5 mg every day  for vertigo and dizziness
20 days, post vax, pt had itching and 7 or 8 few papules. The next day pt was seen by physician with 7-8 scattered papules, one pustular lesion and itching. By four days later, all the lesions had crusted over and pt recovered.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patient pertinent medical history was not reported. On 18-FEB-2014, the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka/Merck) VARIVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka/Merck) VARIVAX. This is one of the several reports from the same reporter. Additional information has been requested.
p/vax pt devel sore throat, tight w/inc URi, low grade fever & GI sx, diarrhea;
tested Ag positivie am 18May2022; tested Ag positivie am 18May2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "tested Ag positivie am 18May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18May2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Covid-19 prior vaccination was unknown. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown reported.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events vaccination failure and Covid 19  cannot be completely excluded.
pt recvd vax 2FEB93 & exp flu-like sx including fever as well as a swollen arm; No further details were provied;
Fever, Headache, tired and loss of muscle control thru whole body (this lasted for approximately 10 days). I had no control of bladder muscle and still have issues with this. My arms and legs felt like they were made of jelly.  I would get very shaky and would have to concentrate hard to get control of them. I told my husband that I didn't feel like myself and wanted "ME" back which took almost 2 weeks/
Within 5 minottes (min) she Felt tired looked dazed. dev. hA. felt she cooldn't move her legs. She was lied down. Approx 10 minutes later she started to Feel Better. She remained lying For 10 More Minutes She was then Sat Up and felt well. She was able to stand + All symptoms had resolved
A good friend of mine died from the vaccine; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A good friend of the reporter died from the vaccine (death, medically significant) on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: A good friend of mine died from the vaccine
Approximately 3 days after the immunization, the patient developed severe lower extremity pain, from level of hips to knees, including anterior thigh. No associated numbness, tingling, weakness, bowel or bladder problems, or back pain. He insists that the pain began proximally and then proceeded distally. His pain was bad enough that he spent about 2 days in bed, only rising to use the bathroom. On the third day his symptoms resolved spontaneously. He is now back at work and asymptomatic. He has had prior flu immunizations without any adverse reactions, he reports.
Pt received vaccine Fri PM, had fever next day 99.9 constant HA, muscle soreness. Still fever on Mon. Also thumbnail size raised area at inj site surrounded by redness, tender to touch and itchy.
Swollen, large bump, soreness on arm where injection site. Vaccine administered at 10am, came back w/reaction after 5pm. Advised to ice it, pain reliever.
Chills, sweats and shaking starting at around 5 PM day of shot, temp 101.2 (all temps were symotaneously  taken orally with a mercury thermometer and a digital contact thermometer,. Further temps taken at 7:30 102.00, 8:00 103.6, 9:00 105.98, 9:30 105.2, 10:00 104, 11:05 102.9, 8:00 AM 102.00, 10:00 102.00,...temps throughout Saturday ranged 101 to 102.4....Sunday morning 4AM 102...continous liquid consumption , cold (ice) compresses throughout mild diarrhea and vomiting
extreme fatigue, disorientation, confusion, anxiety spike, depression low, sleeplessness, no appetite, lack of muscle strength
Pt recvd vax on 4JUN92 & approx 1 hr following vax exp blurriness in one eye, felt disoriented, nauseated & had h/a; exp recurrence of blurred vision, disorientation h/a & nausea; sore arm @ the inject site & stiff neck;
armpits start hurting; body ache; swollen right arm and it is tender; I do not know if it is my lymph node; swollen right arm and it is tender; I do not know if it is my lymph node; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FJ6369) as dose 3 (booster) , single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1ST DOSE, Lot number: EW0176 (first shot).), for covid-19 immunization; Bnt162b2 (2ND DOSE), for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 16Jan2022, outcome "unknown", described as "armpits start hurting"; PAIN (non-serious) with onset 16Jan2022, outcome "unknown", described as "body ache"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Jan2022, outcome "unknown" and all described as "swollen right arm and it is tender; I do not know if it is my lymph node". Therapeutic measures were taken as a result of axillary pain, pain, peripheral swelling, pain in extremity.  Additional information: Drug Code number, Product Code number and expiry date of COVID-19 vaccine was unknown. No any other product. Patient had no history. She got the booster pfizer shot on Saturday morning (not clarified further hence, not captured in tab) morning. She felt fine and then the next day Sunday, she felt okay, she did not had you know not a lot of body ache but last night she mean yeah, last night Sunday she noticed, actually afternoon, she noticed that her armpits start hurting. she looked at it and it is swollen right arm and it is tender. So, she was  thinking, she don't know if it is her lymph nodes. So, she want to know if that is like a side effect of that but it is like it is tender and then it is swollen. She dont know lot number of second shot. No nay other medical conditions. Lab tests reported as no. The birth control reported as no. Treatment received for event she just took Ibuprofen and Tylenol. Sunday she took 650 milligrams twice and then Ibuprofen she did not take Ibuprofen until like Monday morning or night, fell like it, sick, really swollen arm, Ibuprofen 600 milligrams.  No follow-up attempts are possible. No further information is expected.
Redness < 1" started ab 27-28 hours after vaccination. No fever, no tenderness/resolved on 06-23-07.
Within 2 hours showed symptoms of head ache,  nausea, stomach cramping,  diarrhea, slight fever,  dizziness,  muscle aches, chills... lasted 2 days.
URI; Cough; Axillary lymphhadenopathy; second dose on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable other HCP reported for herself that a 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 66 years, via intramuscular in right arm on 15Jan2021 04:30 (Lot number: EL3248) as a single dose for COVID-19 immunisation, in hospital. Relevant medical history included: "heart disease" (unspecified if ongoing); "allergies" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Hyperlipidaemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE taken for hypertension (ongoing); ZETIN taken for hyperlipidaemia (ongoing); ISOSORBIDE taken for coronary artery disease (ongoing); METOPROLOL taken for hypertension (ongoing); LIVALO taken for hyperlipidaemia, start date: 22Feb2021 (ongoing); ASA taken for coronary artery disease (ongoing); OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). 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-19 vaccine. Patient was not pregnant at the time of vaccination. The patient historically received first single dose of BNT162B2 at the age of 66 years via intramuscular in right arm on 29Dec2020 05:00 AM (Batch number: EL0140) for COVID-19 immunisation. Since the vaccination, the patient has not been tested for COVID-19. The patient took Zithromac orally from 17Feb2021 to 21Feb2021 for URI and cough. On 01Mar2021, the patient experienced axillary lymphadenopathy. Event "axillary lymphhadenopathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, upper respiratory tract infection, cough. CT chest on 01Mar2021 showed right side axillary lymphadenopathy. Diagnostic mammography on 10Mar2021 showed axillary lymphadenopathy and USG right axilla on 10Mar2021 showed mildly enlarged axillary lymph node. On 22Mar2021, it was reported that the patient provided information to the HCP regarding the reported adverse events with the use of product and considered the Pfizer product to have had a casual effect to the adverse event. Outcome of the event axillary lymphhadenopathy was recovering and of the other events was unknown.  Follow up (22Mar2021): This is a follow up-spontaneous report from a contactable other HCP.  Updated information: vaccination details (route of administration and lot/batch number of doses 1 and 2), relevant medical history (HTN, hyperlipidaemia, CAD, and GERD), concomitant medications, laboratory data (CT scan, diagnostic mammography, and USG right axilla), and reaction data (new events axillary lymphadenopathy, URI, and cough).  No follow-up attempts are needed. No further information is expected.
The patient developed a cough, esophageal inflammation, a sore throat and hoarseness, shortness of breath, fatigue, and weakness.
Positive COVID test. Sx. Difficulty breathing, Cough, malaise, chills, sore skin, stomach sore (but no vomiting)  required albuterol inhaler a week later due to continued tightness. After taking that for 2 days symptoms fully resolved
Pt developed hives going up the arm and neck- stated swelling of left ear, patient called facility on 10/23/08 and took Claritin 10mg after that no more hives, swelling, etc. Stated had same reaction with PCN and Sulfa.
Patient complained he was not feeling well. Patient was sweating profusely. Lasted for about 30 minutes
This spontaneous report as received from a registered nurse refers to a 8 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012725 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the number US-009507513-1610USA014706 has been changed from Company Number to Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-SEP-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 120 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient received Pfizer COVID vaccine on 1/21/21 (lot # EL3247), 2/12/21 (lot # EM9810), and 9/30/21 (lot # FE3590). On 1/9/22, patient admitted to our hospital for acute hypoxic respiratory failure, COVID-19 infection with concern for bacterial super-infection. As  of today (1/11/22), patient is still admitted in our med/surg unit.
fatigue; nausea; headache; fever; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 09Feb2021 (age at vaccination: 33-years-old) (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for covid-19 immunization/ protection from Covid. Medical history included covid infection from an unknown date in Dec2020 to an unspecified date (caller reports that he had covid infection previously, had symptoms in late Dec2020, he was fully recovered from Covid four weeks ago), severe headaches from an unknown date and unknown if ongoing (had a CT scan of his head in Dec2020 because he had severe headaches). There were no concomitant medications. Patient wanted to know if he needed the second dose of the covid vaccine if he already had covid prior to his first vaccination dose and if he experienced side effects, which were likely a sign of already having some immunity, with administration of his first vaccine dose. Patient reported that he had covid infection previously but was then offered the covid vaccine and he received his first dose. He had since experienced fatigue, nausea, headache and fever following vaccination with the first dose and his family who had not had covid previously did not experience these side effects. Patient had Covid four weeks ago. He was required by his work to get the vaccine. He was fully recovered from Covid four weeks ago and his pulmonary system was not involved. Patient was tested for Covid and was negative. He had symptoms in late Dec2020 and tested positive on 05Jan2021. He used Tylenol and Proton Pump inhibitors for acid when he had Covid. He had a CT scan of his head in Dec2020 because he had severe headaches. The patient experienced fatigue, nausea, headache and fever on an unspecified date in Feb2021. The patient underwent lab tests and procedures which included CT scan of head: unknown results on Dec2020, Sars-Cov-2 test: negative on an unspecified date and was positive on 05Jan2021. The events were assessed as non-serious. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 17-APR-2014, the patient received improperly stored VARIVAX dose 2, from lot # H018451, expiry date 09-OCT-2014 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.