chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tired; Low energy; Chills; Headache; Nausea; Feel unwell; This is a spontaneous report from a contactable healthcare professional (other HCP; patient himself). A 65-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration in the left arm on an unspecified date (at the age of 65-years-old) at a single dose for COVID-19 immunization at a hospital. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN), ciprofloxacin (CIPRO) and amikacin sulfate (BIOCIN) and experienced allergies (drug hypersensitivity). No other vaccine was given in four weeks. The patient has not been tested positive for Covid prior vaccination. The patient has not been tested for Covid post vaccination. On 23Jan2021 09:45AM, the patient was tired and experienced low energy, chills, headache, nausea and felt unwell. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Chills, @1am. Awesome to fever of 100.7 at 6am. Arm hurts, throbbing.
Sore arm, headache, fatigue, fever (100.7 deg F), took Tylenol
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 24-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K0077264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Tremors (generalized) without LOC approximately 10 days after vaccine administration. Dx ataxia x 1 1/2 months with 1 fall.
Pneumococcal vaccine given IM for PPD. Redness at site 2"x2"; soreness with 9" red line up arm towards axilla. No fever. Treated with Celebrex by MD. Pneumococcal 0.1ml given.
Swelling, redness, Pain in left upper arm, at site if vaccine injection. 8 hrs post-vaccine adm. Given Benadryl- decreased in redness. At the time of vaccination , left upper arm-red, swollen, sore-9 x 12 cm induration and erythema.
I had some common symptoms after the 1st shot.  Really run down a little nauseous arm hurt but not swollen for a couple days.  I also had some symptoms that I don?t think are common.  My arm muscle was twitching and my pinkie and ring finger were tingly and cold. All went away after a couple days.  Day 8 discovered a lump on my arm where the injection site was.  Was red, hot and a little itchy fingers tingly again.  Saw doc on day 9.  Gave antibiotics incase of cellulitis/infetion but not sure the cause.  Now that is 90% cleared up.
I was experiencing  chest pain and shortness of breath.  I initially noticed shortness of breath about 3 days after receiving the vaccine-this was during everyday normal, routine activities although especially when climbing stairs, it was worse at night when I tried laying back to sleep.  I've never experienced any of these symptoms before this. By Monday, 5/31 my breathing was very labored and I could feel a heaviness like a clutch in my chest which was more pronounced on the left side. I had to sit all the way up in bed and was unable to lie down without a great deal of discomfort-That was when I checked in at the emergency room.
Pain in left arm at injection site.  Pain is persisting and increasing. Reported to doctor.  Motion is becoming limited.  Pain began immediately upon receipt of second injection, but did not go away after a few days as expected.  Instead it has increased gradually and consistently and is centered precisely upon the point of injection.  It is beginning to interfere with my ability to perform my job or even function in daily activities. Arm motion has become limited and the progression of developing pain shows no signs of lessening. Does not respond to anti-pain medications or plasters.
Dizzy, lightheaded, off balance Sore arm, neck, shoulder, back on left side Knot on arm, swollen and hot at injection site
in her previous doses she experienced redness in her arm and it felt hot; in her previous doses she experienced redness in her arm and it felt hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history included: "First heart rate" (unspecified if ongoing), notes: Fast heart rate She has a fast heart rate that she takes medication for, the issue is that her her heart rate is around134 beats per minute but she did not have that problem last night.; "High cholesterol" (unspecified if ongoing), notes: High cholesterol The High Cholesterol is under control with medication; "Allergy" (unspecified if ongoing), notes: Allergy Her Nose runs quite a bit this time of year, it is environmental or happens when she goes outside, but this happens to a lot of people. Concomitant medication(s) included: PLAVIX. Vaccination history included: BNT162b2 (DOSE 2, SINGLE , Lot: EN6199), administration date: 06Mar2021, for covid-19 immunization; BNT162b2 (DOSE 1, SINGLE , Lot: EN6201), administration date: 12Feb2021, for COVID-19 IMMUNIZATION. The following information was reported: FEELING HOT (non-serious), outcome "unknown", ERYTHEMA (non-serious), outcome "recovered" and all described as "in her previous doses she experienced redness in her arm and it felt hot". Relevant laboratory tests and procedures are available in the appropriate section.
pt recv vax;anaphylactic rxn;feels dizzy; resp shallow; heart rate dec to 40; BP dec to 80/40; pallor;required epi & O2;
Received vaccine about 3:15 pm, awoke 1 am with vomiting and "tingly" arm in which vaccine administered.  Soreness at site of injection noted about 1 am.  At time of reporting, 9:40 am the next day, still with arm tingling, nausea and headache.
Pt received vaccines 12/08/11 and 11 days later developed a lump at site of Hib & varicella injection areas. Mother states similar thing happened when pt received HIB vaccine at 12 month check-up but this is worse. Pt was evaluated by Dr. who believes this (hard, round, red area at injection site) was a reaction to Pedvax Hib vaccine. Notation made on pt file and flagged in WIR.
Information has been received from GlaxoSmithKline and was assigned manufacturer report number A06636909A for diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX). On an unspecified date, a patient (unspecified age and gender) was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wister RA 27/3). Suspect vaccination included a dose of poliovirus vaccine and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The patient's medical history and concurrent medications were not provided. At an unspecified time after vaccination, the patient experienced anaphylaxis that required an emergency department visit. the patient's outcome was unspecified. Anaphylaxis was considered to be an other important medical event by reporter. This was originally reported by a pharmacist. No further information is expected. This is in follow-up to report(s) previously submitted on 5/30/2007. Information has been received from GlaxoSmithKline and was assigned manufacturer report number A0636909A for INFANRIX. On an unspecified date a patient (unspecified age and gender) was vaccinated with a dose of MMR II. Suspect vaccination included a dose Poliovirus vaccine and a dose of DtP. The patient's medical history and concurrent medications were not provided. At an unspecified time after vaccination the patient experienced anaphylaxis that required an emergency department visit. The patient's outcome was unspecified. Anaphylaxis was considered to be an other important medical event by the reporter. This was originally reported by a pharmacist. A lot number was not provided by the agency therefore a lot check of concern cannot be completed for this report. No further information is expected.
Flu Vaccine was not administered correctly.  The dose was not injected into the muscle of the arm as recommended.
On Saturday same night that I got my second Moderna shot, against COVID-19,  I got shills with some fever, body aching, and nauseas. Next day on Sunday, my body was feeling sore and tired.
315AM administered DTP/OPV/TB skin test; 430PM mom stated pt shaking-chilling ref to local ER t105 ax; MD stated next time give DT or 1/2 dose;
Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3302, expiry date: unknown), via an unspecified route of administration in the left upper arm, on 12Jan2021 at a single dose for covid-19 immunization. Medical history was not reported. Concomitant medications included other medications but declined to provide those medications. The patient previously took azithromycin and amoxicillin, clavulanic acid (AUGMENTIN) and experienced allergies. The patient had no history of previous immunization and no additional vaccines administered on same date of the suspect drug. The patient had no prior vaccination within four weeks. On 13Jan2021, the patient experienced severe nausea and headache. The patient reported she just stayed at home and drinking ginger ale and crackers. The events did not require visit to emergency room or physician office. Therapeutic measures were taken as a result of the events nausea and headache. Outcome of the events nausea and headache was not recovered.
DAY AFTER SHOT DEVELOPED 104 DEGREE FEVER, BODY ACHES AND HEADACHE
no other AE; Temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      In March 2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number T017688, expiration date 21-MAY-2022 (route of administration not provided) for prophylaxis. No other adverse event details were reported.  The vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for 4 hours and 15 minutes. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several reports reported by the same nurse.; Sender's Comments:  US-009507513-2012USA013501: US-009507513-2012USA013524: US-009507513-2012USA013533: US-009507513-2012USA013539: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013603:
pt recvd vax;mom called 23dec 4pm, stated that later @ noc of vax,pt cried continuosly x 4 hrs;was cranky then slept all day next day except when awakened for bottle;mom states pt never slept like this before;even w/apap,pt still cried 4 hr
pt who was given vax on 15DEC92 during that noc had crying episode most of the noc & was felt to be inconsolable; had subjective temp & vomited the next morning 16DEC92; no treatment needed;
First day: Sore arm at injection site Second Day: Whole Body Aches, Fatigue and later in the evening sore right underarm(OTC's used and alleviated symptoms) Third Day: Swollen underarm on the Right side that is painful to the touch(OTC's used, Hot/Cold compresses with little relief)
My mother who was completely healthy, alert and active on the morning on May 16 was found by me at approximately 12:30pm deceased on the floor in her bathroom. There were no signs or symptoms prior.   Coroners autopsy concluded: hypertension type cardiovascular disease with myrocardial fibrosis, mitral valve prolapse and severe cardiomegaly  (in which she was never diagnosed prior)
Administer expired vaccine to 450 patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that dose administered after 30 day Use By Date or after manufacturer date of expiry. 173 doses were administered. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contain non significant information include reporter details updated.
Symptomatic COVID infection after 2 doses of Pfizer COVID vaccine.  12/22/20 Pfizer vaccine #1 1/15/21 Pfizer vaccine #2. LOT# EL8982 1/21/21 COVID positive 1/21/21. Asx at the time; tested due to family members positive. 1/22/21 Sx onset: : chills, body aches, sore throat, 100.4. Comorbidities: DM A1C 9.9%, BMI 46, HTN, Asthma. Protracted symptoms of body aches (lasted 2-3 wks), fever (lasted through day 10), sore throat, nasal congestion. Not hospitalized. O2 sat nadir 92-94% RA. Did not receive monoclonal antibody
SHAKING; BODY ACHE; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 4 decade old female. 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: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced shaking. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shaking, body ache, chills, headache, and fever on 26-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210442616.
On 10/14/2015 approx. 6:30 PM patient came to pharmacy complaining that she got sick from PREVNAR 13. Started feeling tired and diarrhea since Sat 10/10. Diarrhea now better but still feel under weather. Denies fever, coughing or other symptoms. Feels like "got hit by a train". Referred her to her physician for further evaluation. Diarrhea better but still feel tired after 1 week.
Headache at 14 hours. Fever 99-100.9 and chills at 18 hours lasting ~20 hours. Rash, itch and tenderness progressing around injection arm, starting about 3 inches below injection site, worst on 3rd and 4th day; gradually easing until nearly gone on day 8.
Chills; aching joints; back pain; soreness at injection site; nausea; insomnia; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp received via a sales representative. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced chills, aching joints, back pain, soreness at injection site, nausea and insomnia. Event took place after use of product. At the time of this report the outcome of the events were unknown.  No follow up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRI-SPRINTEC; FLOVENT HFA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: If Vaccine received: Yes. Other medication in 2weeks: Yes (Tri-sprintec, Flovent HFA 110mcg). The patient was treated with Paxlovid from 28Nov2022 to 03Dec2022 with lot number 1921153A. Rebound COVID-19 7 days post completion of Paxlovid, symptoms include sore throat and cough.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug BNT162B2 cannot be excluded.
Chills: I had chills when I was trying to fall asleep.  I was cold but I felt my body hot at the same time.  I took 1 pill of DayQuil Severe + VapoCool (Acetaminophen 325 mg, Dextromethorphan HBr 10 mg , Guaifenesin 200 mg , Phenylephrine HCl 5 mg) It lasted about 40 minutes. Then I fell asleep. Fever, headache and nausea: I woke up an hour later with fever, mild headache and nausea. It lasted about 4 hours. I took 2 pills of tylenol and had a shower. Started feeling better afterwards but I was too tired because I wasn´t able to sleep. I was okay the whole day but too tired. Then, I got a fever and headache again around 6 pm. Fell asleep for around 3 hrs and woke up feeling better.
Pt had motor vehicle crash and some swelling on upper arm near vaccination site caused by crash and vaccination. Ibuprofen 800mg 1 po tid. No erythema, no warmth around vac. site.
shoulder and chest pain; shoulder and chest pain; pressure across his chest; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 30Apr2021 at 16:20 (age at vaccination: 56 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history included heart attack in Dec2017. Past drug included Imdur (60mg once per day by mouth), lisinopril (10mg once per day by mouth), Atorvastatin (40mg once per day by mouth), and Carvedilol (6.25mg and takes two per day of one in the morning and one in the evening). Concomitant medications included lisinopril, isosorbide mononitrate (IMDUR), atorvastatin calcium (ATORVASTATIN AL) and carvedilol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on 07Apr2021, as dose 1, single dose for COVID-19 immunization. The patient did not received any vaccine prior vaccinations (within 4 weeks). The patient experienced shoulder and chest pain 4-5 days after his second shot on an unspecified date. He just had the vaccine 2nd dose on 30Apr2021 and was telling his cardiologist how he was feeling and told him with activity and pushing his heart on the treadmill he did not feel any-thing but then he started putting the pieces together. He began having pressure across his chest and looked it up on the CDC and it said during the trials there were three heart attack type things reported and he wanted to find out if Pfizer had narrowed down that information to a particular medication or it happened almost right away after the vaccine or if it was a few weeks later; states he did not have the reported events prior to the Pfizer COVID vaccine and has worked very hard and lost 80 pounds and changed his diet and the pressure in his chest started about 4 days after the 2nd dose of the Pfizer COVID Vaccine. The patient stated he has not yet required treatment for the reported events. The adverse events did not require a visit to emergency room. There was a Product Complaint. Outcome of the events shoulder and chest pain was unknown and pressure across his chest was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
CHILLS; HEADACHE; This spontaneous report received from a patient via a company representative concerned an adult male. 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: Unk) dose was not reported, administered on APR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced chills. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on APR-2021. This report was non-serious.
coughing; fatigue; body aches; This is a spontaneous report from a contactable healthcare professional (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 10:30 at a single dose for COVID-19 immunization. The patient's medical history was unknown. Concomitant medication included paracetamol (TYLENOL). The patient experienced having side effects that started on the night of 25Dec2020 including coughing, fatigue, and body aches. She received a Fact Sheet for Recipients and Caregivers as well as instructions on how to report her symptoms to VAERS.  She has not reported her symptoms to anyone yet. She stated her facility has antigen testing every day that results in 15 minutes and a COVID test every Monday with results in three days. She has been negative for her testing for 12 weeks and has not received any positive test results to date. The outcome of the events was unknown.  Information about lot/batch number has been requested.
PATIENT CALLED TODAY AND STATED THEY HAVE A RASH THAT DEVELOPED A FEW DAYS AGO AWAY FROM THE SITE OF THE INJECTION.
1/9/22 pt brought to ED via ambulance due to cardiac arrest; not sure how long pt had been down; 30 mins of CPR without ROSC obtained; pt had a positive COVID test earlier in the week (1/6/22)