chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; My left lymph nodes were swollen; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-hcp). The reporter is the patient.  A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 at 11:15 (Lot number: FJ1611) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication included unspecified birth control medication. Past drug history included: Monosodium glutamate, reaction: "Reaction to monosodium glutamate", notes: Known allergies: MSG. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0195; Anatomical location: Left arm), administration date: 02Jun2021, when the patient was 37 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0191; Anatomical location: Left arm), administration date: 23Jun2021, when the patient was 37 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 at 11:15, outcome "unknown", described as "Dose number 3"; CHILLS (non-serious) with onset 29Dec2021 at 23:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 29Dec2021 at 23:00, outcome "recovering", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 29Dec2021 at 23:00, outcome "recovering", described as "My left lymph nodes were swollen". Therapeutic measures were not taken as a result of chills, pyrexia and lymphadenopathy. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. After 12 hours of receiving the vaccine booster, the patient had chills, a fever, and her left lymph nodes were swollen. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.
Employee came in exhibiting redness, itching & swelling to injection site which was (L) back of arm measuring 70 x 70 mm No fever, vomiting or nausea noted.  2 25 mg Benadryl Tab was given per Dr.
right arm swollen red and in pain, couldn't move my arm for a couple of hours with out it hurting.   On May 4th at 3:30 am is when I started to get the chills, and feeling like well crap.  Slept most of the day, ran a fever on 101 in the afternoon.  Took Tylenol thought out the day to keep my temperature down, finally broke the fever @ 7PM.  I also had a real bad headache, no so much muscle pain other than my arm, (which is still very swollen, and now is getting a rash)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CANNABIDIOL, start date: 09Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: On 05Jul2022 patient received paxlovid for COVID 19 Treatment and the stop date was 09Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash/rash on her body, her neck, back, and arms; diarrhea; nauseous; headache; had pain in the injection site; itching on her body/itching on her knees, feet and arms; some swelling of her lymph nodes; pain in her chest; arms and neck are aching and itching; arms and neck are aching and itching; she is not feeling well; This is a spontaneous report from a contactable consumer (patient's husband) reported that. A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 15Apr2021 vaccination in the afternoon and in the evening around 7-8pm she got nausea, a headache, and pain at the injection site. States the next day on 16Apr2021 she had diarrhea lasting to yesterday. Caller states she is a bit better, that the frequency has reduced. Caller states that last night, after 72 hours on 18Apr2021 she got a rash on her body, her neck, back, and arms. States she put moisturizer on it, and it helped a little. The patient reported that she has itching on her body/itching on her knees, feet and arms and her arms and neck are aching and itching.  He also observed some swelling of her lymph nodes and that she experienced some pain in her chest and she is not feeling well on an unspecified date in 2021. Caller states he has been reading and these are listed as common, but he is not sure if they are severe. The patient wanted to know if following these side effects, if his wife can get/take anti-inflammatory or pain-relievers. The event outcome was unknown.  Provided disclaimer: -Pfizer is unable to make any treatment recommendations for individual patients who may receive the Pfizer-BioNTech COVID-19 Vaccine.  clinical judgment made by your physician/HCP based on the medical history. Clinical status of a specific patient should dictate the appropriate actions to be taken.  PSCC Communication: Referred caller to his wife's healthcare provider for medical advice. Provided caller with phone number and hours of operation. Attempted a warm transfer to Medical Information staff. Caller disconnected before transfer could be completed. Medical Information staff states she will try to call the caller back.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
The patient was due for a DTaP and an IPV. I administered the KINRIX, not realizing that it is only administered to patients who are 4-6 years of age, and as one of the booster doses.
Information has been received from an office manager ( also reported as health care student) for VARIVAX (Merck) and GARDASIL, two Pregnancy Registry products, concerning a female baby whose 18 year old mother with "high blood pressure kidney" was vaccinated with a second dose of VARIVAX (Merck) (lot number not reported) and a first dose of GARDASIL (Lot number not reported), on 17-FEB-2010. It was noted that the LMP was not documented (per the chart the patient was 7 months pregnant on 29-APR-2010), and the actual delivery date was reported as 03-AUG-2010. The office manager reported that the baby girl was brought into the office on 11-DEC-2010 for her routine check-up by the grandmother. The reporter stated that "The baby received her shots, her weight was improving (formula issue at birth), growth was ok, and the baby was sleeping well". The baby was scheduled to be seen in February 2011, but was a "no show". The mother's experience has been captured in WAES 1005USA00866. Additional information is not expected.
Beginning about 7-1/2 hours after the shot, I began to feel lethargic and dizzy. Over the subsequent 12 hours feelings of fogginess, nausea, headache, chills, and sweating increased, peaking at about 3a.m., including a low fever. Symptoms then began to slowly subside until by around 4p.m. the next day I felt mostly normal.
About 10 minutes after Covid vaccination was given patient experienced itching up and down left arm (which was the arm the injection was given in).  Patient describes itching as mild.  Vitals 1820: BP:129/94 P:83 SaO2: 99% Itching still present but has not worsened or moved to more areas of body. Vitals 1830: BP: 132/88 P: 85 SaO2: 99 Patient states itching has lessened somewhat.  Patient denies the need for further care or medication. Patient was able to stand/walk without dizziness and had no other symptoms or complications. After her 30 minute wait time was complete patient left.
Pt developed fatigue, heart fluttering, anxiety within 24-48 hrs after receiving Pfizer booster
Joint pain in all joints that lasted approximately one month. Tested positive for autoimmune issues two months later.
Patient had a possible allergic reaction: itching, burning, whelps, rash, felt swollen, red blotches on back of neck. Began day after flu shot given, has lasted for 1 week but is getting better.
Symptoms : Fever 101.5°-103.5°F,increased salivation, occasional vomiting, general feeling of malaise lasting over 15 hours  Treatment : Alternating acetaminophen and ibuprofen, increased fluids, lukewarm bath
Received Pfizer vaccines on 1/8/21, 2/1/21. Tested positive for COVID-19 by PCR on 7/14/21. Symptom onset 7/11/21 with  Fever, New cough, New shortness of breath, New sore throat, New muscle aches, New headache
Fever, body ache all over, fatigue,and slight headache.No sore throat and no cough.
11:20: hives and shortness of breath; took Zyrtec. 1:00 pm: fatigue. 4:30 pm: fever, weakness, could not perform ADL; bedrest. 6:00 pm: difficulty breathing, aches, chills and continued fever. Took inhaler and Tylenol. 5:30 am: fever broke, but body aches and fatigue the rest of the day.
Mom called MD in mid-March concerned that patient's speech had decreased & he was not saying new words & maybe fewer words than before. She is not sure exactly when it started but feels it was after Nov 2010.
Information has been received from a registered nurse (RN) concerning a female patient (age not reported), who in approximately 2006 ("about one year ago") was vaccinated with the first dose of Gardasil (lot # not reported). On the same day, the patient found out she was pregnant. Subsequently the patient terminated her pregnancy (date not reported). The nurse stated that the pregnancy was not intended, and the "termination had nothing to do with the Gardasil vaccine." At the time of this report, the outcome of the event was unknown. No additional details were available. Upon internal review, the event of "terminated her pregnancy" was considered to be serious, as an other significant medical event. No further information is expected.
Patient recieved 2 doses of pfizer 2/18/21 and 3/11/21. Then developed covid ARDS requiring hospitalization. Also troponin elevation, AKI. Intubated in ICU curently. Had code blue during intubation, but appears to have stabilized for the time being.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. On unspecified date, the patient was inadvertently administered improperly stored VARIVAX lot # R002054, expiration date 22-JAN-2020, N034559, expiration date 05-DEC-2019, N031938, expiration date 13-NOV-2019 (strength, dose, frequency and route were not provided). The excursion temperature was 6 to 14 degree Fahrenheit for 2 hours 10 minutes. There was no previously temperature excursion. The call was because of a data logger. Concomitant therapy included STERILE DILUENT. The STERILE DILUENT used to reconstitute the product was stored properly. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1808USA002557.
1. 2/20 sharp rib pain.  Predominantly right hand side 2. 2/23 Covid 19 shot /Headache/ Tightness in lungs afterwards  3. 2/24/21 shortness of breath, struggled with getting sentences out, rib pain, raspy voice 4. 2/25 called pulmonary.  Said if not better by tomorrow call. 5. 2/26 Pain in ribs worse, struggled with breathing, short of breath. Prednisone prescribed & X-ray  6. Lungs eased, rib pain remained, sweaty, pounding in heart 7. 3/3 called pulmonary.  Very winded, fatigue & rib pain.  Dr. thought pleurisy & upped prednisone & antibiotic 8. 3/10 Sought out Pulmonary again. Short of breath, rib pain tolerable w/800 mg Tylenol. Extreme fatigue. Cat scan & blood work ordered  9. 3/11 note Cymbalta not renewed (cold turkey w/d) until ordered 3/12.  Arrival expected Monday. 10. Fast forward lungs better, winded easily.  Rib pain intermittently, extreme fatigue  Fatigue - No reprieve, when move, get easily dizzy, feel like going to faint, feels like I?m tanking.  Light headed goes away, fatigue seems to be getting worse.  Dr. upped Losartin due to BP has changed since this event.  No one is saying this is related.  I go to a heart specialist next.
Patient is a 66 y.o. female patient of MD with history of COPD, and bipolar depression, breast cancer on chemotherapy, recent axillary DVT 6/2022 on Eliquis,now presented to Hospital with shortness of breath.   Acute hypoxemic respiratory failure secondary to COVID-19 pneumonia COPD exacerbation Symptoms of cough with purulent sputum, upper respiratory congestion, hypoxia for 3 days. Date of onset of symptoms: 11/6/2022. Noted to be hypoxic on adm, now on 1-2L NC O2, improved sputum production.  Home o2 eval and 2L NC ordered, pt instructed to f/u with PCP for resolution.  Afebrile, leukocytosis, mild tachycardia now resolved.  Albuterol HFA.  Cough and deep breathing exercises.Guaifenesin DM. Date of covid positive test: 11/9/2022. Vaccination status: vaccinated Chest x-ray showing chronic emphysematous changes without acute abnormality. Started on  steroids,  zithromax for possible COPD exacerbation from viral infection IS/ PEP and self pronation reiterated  Anticipated special isolation end date: 11/16/2022.   Right axillary vein DVT Diagnosed in June of this year. Continue home Eliquis.   Stage IV invasive ductal carcinoma  Status post 7 cycles of chemotherapy with next cycle of chemotherapy set to start this upcoming Friday. Continued management at the discretion of oncology. Continue methadone and Percocet pain control. Continue Remeron and Marinol appetite stimulant.   Bipolar depression  Continue home Abilify, Celexa, Lamictal, and Remeron.   cigarette dependence without complication Counseled on cessation for 3 to 10 minutes. Will write for tobacco replacement patch.   Severe protein calorie malnutrition BMI 16.46. Consult nutrition to evaluate and treat.   Asymptomatic bacteriuria UC with GNB, no pyuria on UA.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Pt had vasovagal response 2 minutes after administration. Pt with hx of fainting with injections/medical procedures. Fainting episode lasted <5 seconds. Pt did not fall. No head injuries. BP immediately after incident 90/50, HR 50. After drinking water, taking a sugar tablet, and laying supine for 15 minutes, BP was 110/70, HR 70. Pt states he felt fine at that point. Normal gait, coodination observed. Pt alert and oriented prior to discharge. Escorted home by girlfriend. Follow-up call sched
24 hours after receiving the vaccine (dose 4) I started feeling sick; vomiting; diarrhea; joint pain a low low grade fever I felt like I had influenza. About 2 weeks after the last vaccine (dose 5) I started experiencing a rapid heart rate; heart palpitations; insomnia; dizziness and fatigue I was prescribed ELIQUIS but am no longer taking the medication. Everything has normalized at this time.
Erythema, swelling, ecchymosis 8" x 4" around injection site (R) deltoid & upper arm.
CIDP; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Patient had no listed conditions besides CIDP.     On 24-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) (seriousness criterion medically significant). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) had not resolved.            It was reported that patient did not receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient receives 1st dose of moderna vaccine on 13-Jan-2021 (lot number:- 013L20A), 2nd dose of moderna vaccine on 10-Feb-2021 (Lot number:- 006D21A), 3rd dose of moderna vaccine on 22-Oct-2021 (lot number:- WOG4545) and 4th dose on 08-Apr-2022 (Lot number:- 065K21A)  It was reported that patient was diagnosed with Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on Mar-2023 and on 28-Sep-2023 she was treated with IVIG treatment. Company comment: This spontaneous case concerns a 70-year-old female patient, with no medical history of reported, who experienced the unexpected, serious(medically significant) AESI of Chronic inflammatory demyelinating polyradiculoneuropathy which occurred app. 4,5 months after Spikevax Bivalent .222 (Original/Omicron BA.4/5) dose administration, which was the 5th dose of COVID-19 vaccination schedule. Primary vaccination series (1st and 2nd dose) with 2 booster doses were performed with Moderna Covid-19 vaccine. Event treatment included intravenous immunoglobulin and was reported to start app. 6 months after event onset. No further clinical information or details on event course, medical history, etiologic and diagnostic work up were provided for medical review. Event outcome was not resolved at the time of the report. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Itching and redness at site with increasing redness and swelling for past two days, with body aches and low-grade fever.
Fever; Nausea; Headaches; Elevated Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headaches) and BLOOD PRESSURE FLUCTUATION (Elevated Blood Pressure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headaches) and BLOOD PRESSURE FLUCTUATION (Elevated Blood Pressure). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headaches) and BLOOD PRESSURE FLUCTUATION (Elevated Blood Pressure) outcome was unknown.            No relevant concomitant medications were reported.
A pharmacist reported the occurrence of elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) concentrations in a 41 y.o. male who was vaccinated with Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject of this report was the reporting pharmacist. There was not relevant medical history, concurrent condition, or concurrent medication. On 8/16/02, the subject received his first injection of Engerix-B. On 8/19/02, three days post-immunization, he was found to have elevated concentrations of AST (105), ALT (58), and cholesterol (237). The most recent info. was received on 12/10/02. The elevated concentrations of AST, ALT, and cholesterol resolved on 10/30/02. The subject considered the events to be possibly related to Engerix-B administration.
Was given a booster MMR Vaccine because the Measles (Rubeola) titer was low.  The Rubeola AB, IgG, was <0.91 indicating a negative result.  Approximately one year later, I started to develop hearing loss in the right ear.  The hearing loss was slow to progress, I didn't even know that's what I was experiencing at first.  In 2017, I saw an ENT specialist.  The specialist diagnosed me with Otosclerosis with moderate to severe hearing loss. My hearing has progressed to severe and now need surgical intervention, stapedectomy.  After discuss with my specialist, Dr., MMR vaccines have a correlation with Otosclerosis. The timeline fits the disease process.
arm cannot stop bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (arm cannot stop bleeding) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (arm cannot stop bleeding) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE HAEMORRHAGE (arm cannot stop bleeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unknown thyroid medication.   Treatment medications were not provided.  Very limited information regarding this event has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Hurt on injection, in about 5 days that was gone, but itch started. The itch progressed into eruptions and looks like shingles. Not too painful, but still itches. She has been trying to keep moist with petroleum jelly.
Time of incident 10:38 am. Patient was seen in clinic for vaccines. Returned to office 15 minutes later. Pt states she felt her BP drop, fell and hit her head of the floor.
A few months after the Pfizer covid vaccine I started losing weight drastically and unintentionally. I developed swollen lymph nodes that aches, inflammation all over body, joint/muscle pain, stomach pain, swelling in my chest, constant tinnitus, left atrial enlargement, vascular issues, numbness, extreme fatigue and more. I have had numerous test and can not receive a diagnosis. I did NOT have ANY of these problems until after the vaccine and I am continuing to feel unwell.
Severe Hypertension causing: loss of vision in left eye and myocardial infarction over a period of approximately 5 years. Hypertension has been moderately controlled by the use of medication and follow-up treatment. Stents were recently placed in 2 arteries of the heart. ***dates below are estimated  9/12/05 D/C summary indicated final diagnoses were new onset hypertension and polycythemia. Symptoms at onset were sudden headache, photophobia, and blurred vision.
First shot required antibiotics 10 days after injection for subcutaneous infection  Second shot required antibiotics 2 days after injection for similar subcutaneous infection