chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joints locked; joint lock far more severe; strained muscle; Joint pain and stiffness; Joint pain and stiffness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 09:00 (Lot number: FG3527) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes - Type II" (unspecified if ongoing); "shellfish" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Past drug history included: Iodine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 01Nov2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "Joints locked". The following information was reported: JOINT LOCK (disability), outcome "recovered with sequelae", described as "Joints locked"; CONDITION AGGRAVATED (disability), outcome "recovered with sequelae", described as "joint lock far more severe"; MUSCLE STRAIN (disability), outcome "recovered with sequelae", described as "strained muscle"; ARTHRALGIA (disability), JOINT STIFFNESS (disability), outcome "recovered with sequelae" and all described as "Joint pain and stiffness". The events "joints locked", "joint lock far more severe", "strained muscle", "joint pain and stiffness" and "joint pain and stiffness" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of joint lock, condition aggravated, muscle strain, arthralgia, joint stiffness.  Additional information: The patient did not receive other prior vaccine in four weeks. The patient had other medications in two weeks Several for Diabetes and No room to list all here. The patient had Adverse events Joints locked up momentarily with 1st dose for about 2 min. The patient received 2nd dose, joint lock far more severe. The Required ER visit which turned out to be a strained muscle. The patient called only assume was caused by the lock-up. The Joint pain and stiffness had lingered to this day. The AE treatment results Muscle relaxer/pain meds in ER. The patient had covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected
Patient is a 67 y.o. female with history of atrial fibrillation, asthma, hfpef, t2dm, ckd, restless legs presented to Hospital with shortness of breath and fever .   Acute hypoxic respiratory failure d/t - resolved COVID-19 pneumonia HFpEF not in exacerbation P/w 1 week history of worsening SB found to be Covid+. Afebrile on arrival, HR 88, RR 20, BP 149/61, satting 92% on 2L by NC BNP >4K Appears dry despite BNP Initial CBC w no leukocytosis CXR: cardiomegaly, CHF-like findings CTA: no PE. Consitent with multifocal pneumonia. Pleural effusion R>L Cont supplemental O2 to maintain goal SpO2 > 88-90% Consider remdesivir pending serial labs given CKD. CrCl remains <30   Obtain baseline inflammatory markers Start Home bumex tmw for dry lung strategy  monitor I&Os Encourage IS use Contact precautions end isolation 12/30 PT recs HH therapy SW for discharge needs Back to baseline RA Continue Albuterol, robitussin-DM, tylenol PRN Continue Decadron 6mg PO daily for 10 days  Continue xeralto Follow up with pcp   Hypernatremia - resolved Na 147 initial Likely from poor oral intake Improving to 146 Continue to monitor   CKD stage 3b Anemia of Chronic Disease Cr 1.62 initial (baseline 1.5-1.7) Hgb at baseline Monitor  Continue home iron supplement Follow up with pcp  HTN Atrial Fib Continue xeralto, BB, plavix, statin   T2DM - well-controlled A1c 6.2 Hold home med ISS and accuchecks while here   Morbid Obesity  OSA Body mass index is 49.09 kg/m². Discussed dietary and lifestyle modifications Consider nutrition consult  Wears CPAP at times but not every night. Says she doesn't know where it is at home
"I am a very brittle Diabetic. I came into work and got the flu shot around 12 and felt fine. I started lifting cases of water and soda, then went to work at the cash register.  At around 1:00 pm I started feeling dizzy and noted chest tightness across my chest and shoulder blades (Like muscle aches). I became warm all over and went to the restroom to put cold water on my face and neck. I went back to where they were giving the flu shots and asked them if this is normal and the nurse said no and walked me down to be evaluated in the ER."
Headache, severe fatigue, shaking chills, muscle weakness and ocular migraine. Has now lasted for more than 12 hours, but is getting better.
This spontaneous report has been received from a Certified Medical Assistant (C.M.A.) referring unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient had been administered unspecified doses of VAQTA, (lot #, strength, route of administration and dose were not provided), that underwent temperature excursions. No adverse experiences were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a healthcare worker concerning a 62 year old female who on 05-NOV-2005 was vaccinated IM with 0.5 ml dose of Pneumovax 23 (lot # 650083/0746P). On 05-NOV-2005 the pt developed injection site reactions to include injection site redness, pain, warmth and swelling. The pt also reported fever and chills. The pt went to the ER but was not admitted. The pt was reported as recovering. The reported considered the pt's experiences to be other important medical events (OMIC). The health care worker reported that an intervention was required to prevent serious criteria (intervention type was not specified). There was no product quality complaint involved. Additional information has been requested.
C/O nausea evening after vaccine. (8/21/08) am awakened with stiff joints, fingers tingling, SOB, itchy eyes. Called HD -referred immediately to private physician. Doctor reported obvious allergic reaction to unknown component. Joints poor ROM, eyes puffy, red. Treated with BENADRYL - symptoms improved. Advised no repeat of any of these vaccines.
Immediate L arm soreness which progressed to burning sensation in L forearm.  Flushing of face and increased HR (105bpm) noted intially (6:20pm).  Progressively worsening body aches and headache through the night.  Took Tylenol with good relief of body aches. Poor sleep.  General malaise throughout day 1/28 with onset of facial flushing and increased muscle aches beginning again at 6pm.
Experienced a cold, after the first vaccine.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program Support. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported),   via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included Covid test was negative. On unspecified date the patient experienced a cold, after the first vaccine and she does not think cold, is from the vaccine. Patient was scheduled to get her second dose on 19Jul2021 and she wanted to know if she can take the vaccine if she has a cold, or should reschedule her appointment. The outcome of the event was unknown.                                                                             Information about batch/Lot number has been requested; Sender's Comments: Based on a plausible drug-event temporal relationship, a causal association between the reported 'cold' and the administration of the vaccine BNT162B2 in this patient cannot be completely excluded.
pt recv vax 25JAN96 & 3FEB96 pt exp fever;8FEB96 pt exp a rash all over face & body;
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 24-SEP-2012 the patient was vaccinated subcutaneously with an expired dose of M-M-R II (Lot# reported as 1057Z, expired date 11-AUG-2012, dose not reported). This was the second dose of M-M-R II for the patient. It was not known when the first dose of M-M-R II was administered. No adverse effect was reported. It was not known if the patient sought for medical attention. Additional information has been requested.
fever, chills for 6 days and left arm has redness and warm to touch, treatment: for cellulitis
Patient presented for 1st dose Moderna, when entering information into EMR an alert came up that the patient had a Pfizer COVID 19 vaccine on 12/15/2020 at another Medical Center.  We share an EMR with them.  Patient contacted on 3/2/2021.  He stated he did not have a vaccine on 12/15/2020 and had never been to another hospital.  He was advised to contact other hospitals HIM department.  He will continue to receive his second dose at the due time.
J18.9 - Pneumonia I95.9 - Hypotension R09.02 - Hypoxia I48.91 - Atrial fibrillation with rapid ventricular response (CMS/HCC) A41.9 - Sepsis, unspecified organism
Patient presented to walk in with swelling, redness and warmth to left deltoid area from vaccine given on 6/11/19.  Immunization was documented as being given in right arm on record.
no adverse reaction, pt. was given Moderna Vaccine after been given pfizer as first does. no reaction after administration and pt waited about 45 minutes after with no reaction.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L008356 and expiration date of 11-SEP-2016 (route of administration, dose and anatomical location were unknown) prior to its expiration date but after the temperature excursion began, for prophylaxis, reconstituted with properly stored sterile water diluent (lot # and expiration date were not provided). No adverse effects were reported. There was previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved. Additional information has been requested.
Information has been received from a registered nurse concerning a 60 day old female infant with no known allergies or pertinent medical history who on 20-JUN-2008 was vaccinated orally in the AM with a first dose of ROTATEQ (lot # 660379/0144X). There was no illness at the time of vaccination or any adverse events following prior vaccination. Subsequently, on the same day of vaccination (in the evening) the patient had 4-6 watery stools daily for 4-6 days. There were no lab studies performed. At the time of the report, the patient recovered on approximately 25-JUN-2008. Additional information is not expected.
Patient was ordered the Hep A vaccine and the Boostrix. The Pediarix and Boostrix was given in error. c/o dizziness one month later
headache in daily life; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache in daily life) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache in daily life). At the time of the report, HEADACHE (headache in daily life) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Falling out of bed, after the second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization. The following information was reported: FALL (non-serious), outcome "unknown", described as "Falling out of bed, after the second vaccine".  Additional Information: That ever since patient had the vaccine, Patient had a problem with falling out of bed. Patient has talked to his Pharmacist and his doctor, and they don't know why he is falling out of bed. The event happened right after he got the second vaccine. Patient is making the connection to his vaccine or to his Parkinsons Disease.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
DESTROYED ME AND MY LIFE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced destroyed me and my life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of destroyed me and my life was not reported. This report was non-serious.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 at 13:00 as dose 2 (booster), single (Lot number: FH3020) at the age of 64 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 14Mar2021 at 14:00 as dose 1, single (Lot number: 1805018), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "elevated cholesterol" (unspecified if ongoing), notes: elevated cholesterol; "HIV positive" (unspecified if ongoing); "interchange of vaccine products", start date: 25Oct2021, stop date: 25Oct2021, notes: Dose 1 JNJ, Dose 2 (booster) Pfizer. Concomitant medication(s) included: ENALAPRIL; ENALAPRIL+HCTZ; DELSTRIGO; VALACYCLOVIR [VALACICLOVIR]; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 21Apr2022 at 08:00, outcome "unknown", COVID-19 (medically significant) with onset 21Apr2022 at 08:00, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) positive; (Apr2022) Negative, notes: Had tested negative at day 4 and day 5 on drug with RAT; (Apr2022) Negative, notes: Had tested negative at day 4 and day 5 on drug with RAT. Therapeutic measures were taken as a result of covid-19. Clinical course: Return of symptoms after last dose of Paxlovid along with positive RAT. Had tested negative at day 4 and day 5 on drug with RAT. Antiviral details included COVID 19 treatment, Treatment start date 13Apr2022, Treatment stop date=18Apr2022, indication was treatment of COVID-19.; Sender's Comments: Based on available information in the case the plausible casual relation between the reported events and suspect drug BNT162b2 cannot be excluded.
Myopericarditis.  Symptoms included chest pain, shortness of breath, dyspnea on exertion starting 2 days after the 2nd dose of Moderna COVID-19 vaccine.
Patient felt faint, hot, sweaty, shallow breathing and dizzy.  Patient has fainted in the past and has had symptoms before in similar situations.
Injection was administered very high on left arm(at joint level). It felt like a nail went in, and then she pushed in the medicine.  Just the injection process alone made me feel ill. So I waited the 15 minutes before I left, until I felt safe to drive. At noon the meds started affecting me, which is what I expected. I've continued to experience arm pain, weakness, armpit swelling and tenderness, arm not wanting to work and posturing. This is day four and its just starting to feel like its coming back "online." Monday I reported to Colleague Health, who advised me to contact my physician, who I consulted via phone this morning. Physician requested I fill out Adverse Event form.
Day 1-4 significant lymph node swelling (arm pit), significant arm pain and fatigue followed  by  day 5-9 of dizzyness/vertigo, extreme fatigue, nausea, arm/leg tingling , intermittent shaking/chills but not fever, significant anxiety.  Went to urgent care  on day 5 7/22 and received 1 L NS fluid bolus, CBC/BMP labs checked, pregnancy test .  All labs WBL, pregnancy test normal.  Dizzy/vertigo and fatigue continued thru next 6 days and symptoms began to resolve day 9.  Seen by PCP on 7/26 for physical exam, tested for COVID and lab work done (TSH) to rule out thyroid disorder.  TSH normal and negative for COVID.  Unable to work for 1 week due to debilitating symptoms.
Patient received the second dose of the Moderna vaccine on 17 days after the first dose, which is outside of the recommended vaccination window.
This spontaneous report as received from a nurse practitioner refers to a 71 year old female patient. The patient's medical history included breast cancer in 2009, now in remission. Concomitant therapies included budesonide, SYMBICORT, VENTOLIN, magnesium (manufacturer unknown), ALEVE and DIFLUCAN. Drug reactions/allergies occurred with prednisone (manufacturer unknown). On 10-APR-2018, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot # N030111, expiration date: 21-APR-2019) (strength, dose, unit and frequency not specified) intramuscularly for the prevention of pneumonia. On 11-APR-2018, 2 days after onset of therapy the patient experienced urticaria, rash, and hotness in the arm the vaccine was administered in. The patient called Physician office and patient was instructed to take oral BENADRYL and use a cold compress on the affected area. The patient was treated for the adverse events. Lab diagnostics/studies were not performed. There was no intervention to prevent serious criteria. The events did not cause a significant disability or incapacity and hospitalization to the patient. The events were not life threatening. The outcome of the events urticaria, feeling hot and rash were reported as recovered/resolved. The reporter did not assess the causality of the event with suspect therapy. Product quality complaint was not involved.
Fevers ranging from 100F to 104.9 F per mother.  Relieved by Tylenol.
Soreness of left arm; Short of breath on walking a mile; slight fever; Fatigue is increasing; Just feel tired all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of left arm), DYSPNOEA (Short of breath on walking a mile), PYREXIA (slight fever), FATIGUE (Fatigue is increasing) and FATIGUE (Just feel tired all the time) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of left arm), DYSPNOEA (Short of breath on walking a mile), PYREXIA (slight fever), FATIGUE (Fatigue is increasing) and FATIGUE (Just feel tired all the time). At the time of the report, PAIN IN EXTREMITY (Soreness of left arm), DYSPNOEA (Short of breath on walking a mile), PYREXIA (slight fever), FATIGUE (Fatigue is increasing) and FATIGUE (Just feel tired all the time) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-066086 (Patient Link).
no additional adverse effects reported; a patient was administred an improperly stored dose of VARIVAX; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 11-MAY-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S010297, expiration date: 03-APR-2020 (strength, dosing schedule and route of administration were not provided) for prophylaxis. Administered dose of vaccine was exposed to the temperature: 7 Fahrenheit degrees for 5 hours and 4 minutes. Previous temperature excursion was: 11 Fahrenheit degrees for 3 hours and 31 minutes, as recorded by digital data logger. No additional adverse event reported.
Patient developed redness around back of arm about 5-6 inches long and also skin felt hot to touch and very itchy.
rashes all over both legs and both arms; vomiting; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (nurse) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Mar2021 Tuesday (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced vomiting on Wednesday, the day after 23Mar2021 and on Thursday, patient had rashes all over both legs and both arms. Outcome of vent was unknown.  No follow-up attempts are needed. No further information is expected.
Fatigue, feel feverish but no fever, skin rash and marks on right lower leg (resolved after a few hours- happened2 days in a row). Headache, arm pain at vaccine site. High heart rate over 100 at rest a couple times a day. High blood pressure.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Janssen product on 03/16/2021. They tested positive for COVID-19 on 08/17/2021. They presented to emergency department on 10/12/2021 with primary concern of GI bleed and anemia.  They were not admitted to hospital, but discharged to nursing home for comfort care. They died on 10/13/2021.
Vaccination given on 3/5 at 2:30 pm. On 3/13 at 7:00 pm I started unconscientiously scratching the injection site. I stopped and noticed that the site was a little warm, a little swollen and a little hard to the touch. There was a slightly raised red mottled pattern at the site and it itched. I didn't do anything to treat it and it went away in about an hour. I took 2 photos which I will attach if there is a place on this form to do so.