chrisvoncsefalvay/vaers-outcomes huggingface dataset:
burning pain in the elbow to wrist; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 50-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Nov2022 as dose number unknown (booster), single (Lot number: GH9697, Expiration Date: 15Dec2022) intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BURNING SENSATION OF UPPER LIMB(medically significant) with onset 30Nov2022, outcome "not recovered", described as "burning pain in the elbow to wrist". Therapeutic measures were taken as a result of pain in extremity.  Clinical course: Patient given a shot (to deltoid unspecified if left or right) yesterday and is now complaining of burning pain in the elbow to wrist. Has been about 24 hours since the shot.  Didn't see anything on the package insert online other than extremity pain.  Wants to know how common it is, management, or other information. Patient started taking ibuprofen to treat it.  Doesn't know any further information other than what was on the text message he received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 75 year old female who on 05-OCT-2010 (reported as "she got it yesterday") was vaccinated with a dose of PNEUMOVAX 23. On 05-OCT-2010 (reported as "yesterday", the patient experienced a violet, red area fairly widespread on her upper arm, no welts, just strange coloration. No known swelling or problems with the lymph nodes was observed. At the time of the report, the patient was recovering from the adverse event. This occurred 4-6 hours after injection. The patient sought an unknown medical attention. Additional information has been requested.
elevated heart rate occurred/ notice additional elevated heart rate occurring while just sitting; body aches and soreness with continual nerve twitches thru-out body: neck, back, calves and right hand fore finger/ sharpness of needle like pain in calves, fore finger, neck and back; Pinch nerve with tingling in right hand forefinger, back, neck and legs (calves)/ with continual nerve twitches thru-out body: neck, back, calves and right hand fore finger; sharp pinch in neck; slight dizziness (1 hour afterward); headache; sore arm in left (injection site); tingle right finger/ Pinch nerve with tingling in right hand forefinger, back, neck and legs (calves)/ continual tingles in neck, back, calves; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 13Apr2021 at 09:00 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no allergies to medications, food, or other products. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 11:00, the patient experienced at slight dizziness (1 hour afterward) headache, sore arm in left (injection site), sharp pinch in neck and tingle right finger. On 14Apr2021 the patient experienced  pinch nerve with tingling in right hand forefinger, back, neck and legs (calves). On 15Ap2021 and 16Apr2021 she had continual tingles in neck, back, calves. On 17Apr2021 patient had elevated heart rate, body aches and soreness with continual nerve twitches thru-out body, neck, back, calves and right-hand fore finger. On 18Apr2021 she noticed additional elevated heart rate occurring while just sitting, same symptoms, sharpness of needle like pain in calves, fore finger, neck and back. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event slight dizziness (1 hour afterward) headache, sore arm in left (injection site), sharp pinch in neck and tingle right finger, pinch nerve with tingling in right hand forefinger, back, neck and legs (calves), continual tingles in neck, back and calves, elevated heart rate, body aches and soreness with continual nerve twitches thru-out body, neck, back, calves and right-hand fore finger and additional elevated heart rate occurring while just sitting, same symptoms, sharpness of needle like pain in calves, fore finger, neck and back was not resolved at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Pt broke out in hives, fatigue and joint pain. Pt took Benadryl and Allegra daily.
Lymph nodes in the left side of  started swelling, then the pain and swelling moved down into my left axilla and breast.  My nipple started swelling and then spontaneous clear discharge began.
76/F pt with obesity (current BMI 33), DM, diabetic CKD (baseline creatinine 1.01-1.07), HTN, HLD, asthma, fully vaccinated for COVID including booster, was in USOH until diagnosed with COVID on 12/21. She was having dysuria for 2 days prior, had a TAV as she started having fever and vomiting x 1. On AM of admit she woke up with shaking chills, and dyspnea -> called EMS and came to ED where she was noted to be hypoxic to 90% and hence was placed on 2 L of O2. She was given LR due to UTI + COVID. ROS on admit positive for back pain, and nausea. She lives with her family at home, independent for ADL's, daughter and grand daughter both had tested + for covid (12/20 and 12/17 respectively), her husband is negative. Vitals on arrival T-101.4, 84, 23, 96-99 % on 2 L, BP 115/56. Labs notable for cr of 1.28 (bl 1.0-1.07, GFR in CKD 3a range), elevated lactate at 2.0 (improved to 1.5 with LR total of 500 cc), CRP of 10.3, Covid positive, WBC normal on admit but with bandemia, d-dimer 1.71, UA was positive and CXR negative for focal infiltrates or congestion. She met criteria for severe sepsis on admit.        UTI with pyelonephritis Keflex given in ED, changed to Ceftriaxone on admit.  2/2 blood cx's growing E Coli. Urine cx also  with E.Coli (sensitive to cefazolin, no prior positive urine cx's in the system) - Continue Ctx per d/w ID through today, will change to Cipro at discharge to complete 14 day course.      Covid positive status. Brief hypoxia to 90% on RA on arrival. Brief dry cough per history.  Was started on dexamethasone (received total of 2 doses 12/25 and 12/26). Had brief hypoxia of 90% in ED (while febrile), since then recovered. Currently on RA saturating 98%. Also has negative CXR. - Stopped steroids per d/w ID, given she has active bacteremia and underlying DM.  - Not given Remdesivir d/t elevated creatinine. Also hypoxia was brief.  Enhanced isolation to continue for total of 10 days through 1/1/22, considered mild infection. D/W Dr./ID.  - CRP up from 10.3->13.8 but could be from bacterial infection.  - LFT's are normal. D-dimer 1.71->1.55.   Elevated troponin No EKG changes.  Likely type 2 MI in the setting of severe sepsis.  PTA ASA/statin continued. Telemetry monitoring for now Troponin peaked at 0.40 (0.08-> 0.40-> 0.21). Pt had no exertional symptoms prior to getting sick, hence no out pt ischemia w/u recommended per Dr./Cardiology.    Mild persistent asthma On Wixela and prn Albuterol.   DM2 with CKD stage 3A. Glipizide and Metformin on hold NPH (7 units BID new) with SSI started on admit.  Current FS values in 200-300's, from steroid use in the setting of DM.  Last A1C was 7.2 in 10/2021 (prior was 10.3 in 01/2021).  - Increased NPH to 10 U BID AC for elevated blood sugars while here. - Resume home regimen on discharge.   HTN/HLD On PTA Amlodipine and statin. ACEi held on admission d/t rise in creatinine.  Reason for Hospital Admission (Admitting Diagnosis):  SOB and UTI
For about 20 minutes I experienced severe belly pains, profuse sweating and cold and clamminess, my temperature dropped to 93 degrees. When I finished with these symptoms my temperature climbed back up to 97.7. I have been having intermittent belly pains since then but they are nothing like they were last night and they are getting more mild and far between as I write this.
Case number PHEH2011US07654, is an incomplete initial spontaneous report received from a healthcare professional on 19 Oct 2011: This report refers to multiple patients. These patients were vaccinated with MENVEO (batch number: unknown) on unspecified date. MENVEO has been reached 29 Fahrenheit every few days in the mornings and then goes back with in refrigerator in the afternoon, temperature of the refrigerator had fluctuated over the past 30-days and vaccine did not freeze. No adverse events occurred following this drug administrator error.
Redness; Itching; The dose of vaccine was administered subcontaneously; This is a spontaneous case from, reported by other health professional to agency [reference number: SEQ19-05072] and initially received on 18-Oct-2019, concerning a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date in Oct-2019, reported as '16. and 17-oct-2019', the patient was administered Flucelvax QIV [Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: subcutaneous, anatomical location: deltoid, batch number: 259809, expiration date: 31-May-2020] (explicitly coded as 'Inappropriate route of vaccination') for prevention of seasonal influenza.  On an unspecified date in Oct-2019, unknown amount of time after vaccination, the patient experienced redness and itching. The patient was advised to use hydrocortisone cream, however, no corrective treatment was given for the events.  At the time of initial reporting, the outcome of the events was not reported.    The case was assessed as non-serious.  The reporter did not provide causality assessment.  This case is linked to cases 201905345 and 201905346 (same reporter).  Non-significant follow up received via agency (reference number: SEQ19-06325) on 06-Dec-2019: Additional numbers were added. No changes in narrative.  Company comment: The patient experienced erythema and pruritus after incorrect route of the suspect product Flucelvax QIV product administration. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Causal relationship between the suspect product and incorrect route of product administration is assessed as not related per company conventions. For the events erythema and pruritus, causal role of the suspect product is assessed as related.
Myocarditis diagnosed after presenting with chest pain and elevated and rising troponin levels.  Chest pain developed on 6/27 and troponin elevated noted on 6/27.  Admitted to the hospital for trending troponin levels which initially were rising over 6/27 and then started to decrease on 6/28.  ECG and Echo were normal on 6/27.  Cardiac MRI showed evidence of myocarditis.  Patient had no arrhythmia during time in hospital.  Discharged home on 6/28 on Naprosyn bid with exercise restriction.  Will follow up in cardiology clinic in 2 weeks.
Patient given injection intramuscular in deltoid muscle. Patient having pain in the arm. Patient claims gave inside of arm.
Pt had fever, swelling of thigh; admitted to Hosp 8SEP90; transferred to Naval Hosp on 9SEP90 for surgery for compartment synd on 10SPE90;
This spontaneous report as received from a nurse refers to a patient of unknown demographics. On an unknown date, the patients was vaccinated with a dose of GARDASIL (Lot number, expiry date and dose were not reported), intramuscularly. On an unknown date, the patients experienced syncope. The healthcare professional present also agreed with the nurse who works for the same practice. It was not stated as to where in the dosing schedule the event syncope had occurred. The outcome of syncope was unknown. This is one of several reports from the same reporter MARRS# 1304USA016449. Follow up information has been received from the registered nurse reporting that she was unable to remember the patient. Additional information is not expected.
Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate, eye twitching
Patient complains of pain and numbness on left arm/shoulder radiating toward the left side of the face after getting the vaccine. Symptoms did not resolve after couple days and patient was admitted to ER due to syncope. At the time of admission, patient had raised blood pressure, systolic blood pressure of 170 mmHg,
pt recv vax 24SEP97 & the next day 25SEP97 pt exp fever (unspecified), sore throat, stiff neck & nausea;
The day after the vaccine he woke up and when he moves his arm he has a lot of pain in movement.  He also said his right eye was red but no pain.  He still has the pain in his right arm when he is moving.  He went to 4 different ER.    1) 10/29/2020  Urgent Care 2) 11/17/2020  Hospital 3) 11/20/2020  Emergency Dept. 4)  11/20/2020 Hospital ER 5) 12/03/2020  Dr.
Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe
Pfizer Dose 1 3/18/21 (EN6207) Pfizer Dose 2 4/8/21 (EW0161) COVID Positive 1/8/22  1/8/22: 94 years old male patient who presented to the emergency department because of feeling off balance  Patient has a history in the documentation of being on anticoagulation with Eliquis however unclear reason. States that he has been feeling lightheaded, dizzy, associated with palpitations.  He did fall this morning and hit his head reportedly and reports neck pain and knee pain. Denies shortness of breath, hip pain, abdominal pain, chest pain. Patient lives at home with his wife who has been feeling ill with cold-like symptoms.  Patient denies ever losing consciousness, having incontinence of any kind.  CT head without contrast was negative for any acute abnormalities. He did undergo CT angio chest for PE which noted bilateral PE and findings concerning for pneumonia. He was febrile in the ED with Tmax at 100.9.  He was given Levaquin and started on heparin drip in the emergency department. Patient reports drinking alcohol daily, last drink of wine was yesterday  1/11/22:  A 94-year-old man who presented to the emergency room with complaints of feeling lightheaded.  He fell and hit his head on the morning of presentation.  In the emergency room, patient was febrile T-max of 100.9 degrees.  CT head revealed no abnormalities.  CT angio of the chest revealed bilateral pulmonary embolism and bilateral pneumonia.  COVID-19 screen resulted positive. Patient is on room air and not requiring oxygen. Echocardiogram done to rule out right heart strain was negative.  Patient was initiated on IV heparin infusion and transition to apixaban for anticoagulation therapy.  Was assessed by Physical therapy, recommendations for skilled nursing facility.  For COVID-19, patient is on room air with no oxygen requirement.  Patient is being discharged to skilled nursing facility in a stable condition.
bad rash on my body; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient received the first dose of the Covid vaccine a week before and reported 5 days later, she had a really bad rash on her body. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented with urticaria to back, abdomen, chest, and face with swelling to bilateral orbital region and lower lip. Patient treated with 25mg IV Benadryl, 20mg IV Pepcid, and 50mg IV solu-cortef at 2315. Patient was monitored for 2 hours following medication administration. Improvement of symptoms was noted after observation and patient was discharged home.
Ran a fever for 48 hours; several times over 105.  Extreme joint and bone ache in forearms and shins to the point where it was too painful to move.  most side effects ended 72 hours after injection but I am still experiencing a random and lower pain level in my forearms and dizzy spells.
Headache, entire body shaking,chills, to and below normal temp. Eyeball pain
sore arm; swollen lymph nodes under arm pit on same side an injection; headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced sore arm, swollen lymph nodes under arm pit on same side an injection, headache and fatigue on an unspecified date after second dose of Pfizer Covid vaccine with outcome of recovered (duration reported as 3 days).  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
3 DAYS AFTER FIRST PFIZER SHOT, MILD-HEAVY SPOTTING FOR 2 WEEKS THAT IS ONGOING --- 6/18/21
Patient reported to the pharmacy with redness, rash/hives, itching, burning in her lower arm.  The location of the redness was not in the same location as where the vaccine was given (lower arm vs deltoid).  Due to the redness/burning/warmth experienced, patient was referred to a physician who prescribed clindamycin 300 1potid for 7 days to treat the possible infection.
92 y.o. male admitted 1/9/2022 with a past medical history significant for ESRD on HD, COPD, CHF, HTN, HLD, BPH, and OSA who presents to the ED due to cough and shortness of breath. The patient was recently diagnosed with pneumonia on 12/22/2021 and completed a course of doxycycline. Over the past several days he has developed a productive cough.  He notes that sputum has been mostly clear. He he also endorses increased shortness of breath on exertion, fever at home, and weakness.  Patient has been previously vaccinated for COVID-19.   In the ED, chest x-ray revealed mild CHF with persistent bibasilar atelectasis that is stable on the right and mildly improved on the left from 12/22/2021.  Labs reviewed and significant for creatinine 5.81, EGFR 11, procalcitonin 1.15, WBC 2.96, hemoglobin 9.6, and platelets 40.  COVID-19 PCR was positive.  Vital signs reviewed and significant for SPO2 of 94% on 2 L in the ED.  The patient will be admitted by hospital medicine for further evaluation and treatment.
Fever of 101, headache, nausea, stomach ache, abdominal pain, and general body aches.
Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Dec2022 as dose 3 (booster), single (Lot number: CSJ6738) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High sensitivity Pneumonitis", start date: 2022 (ongoing), notes: High sensitivity Pneumonitis Diagnosed last year. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown, She only had the sore arm right after receiving the covid shot. It lasted like 3 days. It was hard to lift the first day. It happened with both doses.), for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Dec2022, outcome "recovered", described as "Sore arm".  Additional information: While reporting on her husband, caller said that she had a sore arm after receiving the vaccine. She only had the sore arm right after receiving the covid shot. It lasted like 3 days. It was hard to lift the first day. It happened with both doses. She has completely recovered from the sore arm. It only lasted for like 3 days or so. That was the only side effect she had. Caller does not know the exact date of her sore arm.
Information has been received from a healthcare professional regarding an unspecified number of patients of unknown age. On an unknown date, the unspecified patient received improperly stored PEDVAXHIB (dose was not provided, Lot number reported as J011964, expiration date 19-JUN-2016). Two doses of the improperly stored PEDVAXHIB were received on 28-MAR-2014. The improperly stored PEDVAXHIB was exposed to 13C for an undetermined timeframe. Healthcare worker will provide timeframe when products are back in recommended storage range. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Started itching after taking vaccine, but thought it was due to dry skin.  Noticed a rash all over body on 1/2/21.  Self-reported taking benadryl.
cold, vomiting, diarrhea, elevated T, treated @ ER-Rx-Phenergen 6.25 mg-2 gr Tylenol, Rocephin 250 mg,IM, Tigan 100m supp q6h prn, Suprax 100 mg/5cc, 3cc qd X 10 days
pt recv vax 25NOV98 & mom reported on 24MAR99 that w/in a hr noticed a rash which was described as raised sand paper like red bumps on the face & trunk;disappeared in about 3 days;mom felt poss allerg rxn;
I have an itchy rash all over my body; little white bumps; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient (not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number; E19269) via an unspecified route of administration on right arm on 03Feb2021 18:30, at single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included unspecified birth control within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she had an itchy rash all over her body, they were little white bumps on 04Feb2021. The patient was not received any treatment for the events. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Seriousness of the events was assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.
Patient developed redness and swelling at the site of injection as well as axillary swelling.  She also developed a severe headache (worst headache of her life) 4 days after administration.
Had redness and swelling of (L) deltoid area 10 mm x 7 mm. Red, warm to touch. No itching or pain no difficulty breathing or swallowing. Rx BENADRYL, ibuprofen, and ice to arm.