chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial numbness around the nasal area; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (Facial numbness around the nasal area) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HYPOAESTHESIA (Facial numbness around the nasal area). At the time of the report, HYPOAESTHESIA (Facial numbness around the nasal area) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was reported.   Reporter did not allow further contact
Immediately following vaccine administration soreness/pain in left arm below injection site. Has gotten progressively worse to cause pain that radiates down and into left arm. Patient reports inability to lift left arm on occasion. Dr visit required.
numbness, tingling, and twitching of lower lip, left side; infection at injection site; clumsiness when walking; difficulty enunciating words; EXTREME burning, tingling , and numbness of fingers and hands; difficulty concentrating; significantly increased neuropathy pain in hands and feet. ALL symptoms are continuing 2 weeks AFTER injection. I sent a message to my Primary Physician but haven't received a response yet.
No additional adverse effects reported; incorrect product storage; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-DEC-2020, the patient was vaccinated with improperly stored hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot# R028529, expiration date 09-JUN-2021 (formulation, strength, dose and route of administration were not reported) for prophylaxis.  The administered doses of the vaccines were stored with the lowest temperature of 34.3 Fahrenheit during 4 hours. There was a digital data logger involved, but there was no previous temperature excursion.  No additional adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
This spontaneous report was received from a back office lead and refers to a 29-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 31-JAN-2016, the patient was vaccinated with an improperly stored dose of hepatitis B vaccine (recombinant) (manufacturer unknown)(left deltoid, route of administration: intramuscularly, dose number not reported, lot number: L038499, expiry date: 26-JUN-2017). Concomitant therapy was not reported. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever to 102.8 Severe headache Body aches  Chest tightness & Coughing with every breath  Extreme fatigue  Moderate pain in left arm All symptoms lasted 12 to 24 hours
DISCHARGE DIAGNOSES: Principal Problem:   AKI (acute kidney injury)  Active Problems:   Essential hypertension, benign   Pneumonia, suspected bacterial   ATN (acute tubular necrosis)    Suspected HAP/VAP (gram negative or MRSA pneumonia)HOSPITAL COURSE: Briefly, This is a 57 y.o. male with a past medical history of Alport's Syndrome, HTN, renal disease w hx renal transplant (2006), recent COVID PNA, HLD, GERD who presented to the ED on 1/14/21 with the chief complaint of shortness of breath and confusion, found to have acute on CKD, multifocal CAP in setting of recent COVID+, subsequently admitted for further cares.     For more detail, please see admission H&P.  Hospital course dictated by problem: Sepsis 2/2 Below, Present on Admission Multifocal Bacterial PNA Acute Hypoxic Resp Failure Fever, Improved COVID 19 PNA Reports tested positive on 1/3, repeat here positive, was seen in ED on 1/10, CXR w bilat infiltrates, was not hypoxic at that time, started on Ceftin/Azithromycin, no dex as non-hypoxic. Ongoing SOB, febrile to 103 in ED, altered mental status. WBC nml, lactate neg. CXR with multifocal PNA, worse than prev. Started on IV CTX/Azithro/Vanc on admit, Required 2L O2 11/16-11/18, since weaned and stable. Will switch back to PTA Prednisone from Dex 6mg QD at DC. Neph supported diuresis process. Asymptomatic from respiratory status today and stable for DC to home.  - s/p 6-days IV ABX ( -> Cefepime/Azithromycin), will complete 7 day course w/ Cefdinir + Azithromycin x1d - Restart PTA prednisone 5mg QD   Acute on Chronic CKD Hx Renal Transplant (2002) Alport's Syndrome Metabolic Acidosis Worsening confusion in setting of worsening renal function. Baseline Cr 3.4, 3.92 on admit.Transplant renal US nml. Repeat Cr 3.92->3.61->4.24 -> 4.6 -> 4.52 -> 4.38 today. Ongoing metabolic acidosis, bicarb 16->17->19. Could have component of Vanc nephrotoxicity, since DC'd. Nephrology consulted and diuretics held, slow improvement in renal function, cleared for DC to home today with outpatient f/u transplant team - Cont PTA Sirolimus, Prednisone - Hold PTA ACE/ARB, Bumex - Avoid nephrotoxic mds - f/u outpatient within 1 week advised   Elevated D-dimer Checked w Covid as above, elevated at 1.33,  LE DVT US neg. Was not on O2 but now is, unclear if process being driven more so by bacterial PNA vs COVID PNA. Switched to therapeutic lovenox as started tx for COVID as above. Weaned to room air by 1/17 and denies resp sxs Repeat d-dimer .81, switched to heparin sq for ppx, none needed at DC.    Confusion, Poss Metabolic Encephalopathy, Improved May be related to worsening CKD vs PNA vs COVID. CT head neg. Mentation normalized with treatment of PNA, fever control and metabolic stability.    Anemia Smoldering MM Per chart review, seen at hospital in August, supposed to follow up in 6 months. Hgb 10.0->8.8->8.5->9.2, baseline 10.  -Onc follow up as prev scheduled   HTN BP 136/66 on admit. 160/88 this AM. was 118-152/70-90s yesterday. cont PTA coreg, clonidine patch. holding PTA Bumex, irbesartan, avoiding hypotension and renal insult. F/u PCP this week.    GERD: cont PTA PPI   HLD: cont PTA statin
High blood pressure   since 4/11 night   (164/95  ) 4/12 morning (176/99 )  (175/103 )(182/107) . went to ER,    4/13 morning (184/102)  (193/97)  (205/128)  went to ER again 4/14  (171/108) (176/104)
Swelling in lips; Face is itchy; Face is prickly; Tongue is so sore; Could hardly drink and eat food; Mouth sores; Dizziness; Skin rash; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore) and FEEDING DISORDER (Could hardly drink and eat food) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Myelofibrosis.    The patient's past medical history included Hysterectomy, DEXA scan, Mammogram, Resection of rectum, Blood transfusion, Pacemaker insertion (cardiac), Bone marrow biopsy and Holter monitoring. Concurrent medical conditions included Malignant breast neoplasm, Monoclonal gammopathy, Osteoporosis, Hypertension, Hypothyroidism, Stress urinary incontinence, Chronic cystitis, Diverticulitis, Ex-smoker, Menopause (hot flashes), Splenomegaly, Anemia, Urosepsis, Recurrent atrial fibrillation, Headache, Fatigue, Dyspnoea exertional, Vision loss, GERD, Congestive heart failure, Lactate dehydrogenase increased, Drug allergy (epinephrine), Drug allergy (morphine), Drug allergy (iodine), Drug allergy (penicillin g), Drug allergy (sulfonamide antibiotics), Ankle fracture since 2017 and Arthropathy since 2017. Concomitant products included APIXABAN (ELIQUIS), IRON, FUROSEMIDE (LASIX [FUROSEMIDE]), LOSARTAN, VITAMINS NOS, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), SPIRONOLACTONE, DOFETILIDE (TIKOSYN), ESTRADIOL (VAGIFEM), AMITRIPTYLINE and GABAPENTIN for an unknown indication.   On 04-Sep-2019, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 5 milligram once a day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore), FEEDING DISORDER (Could hardly drink and eat food), STOMATITIS (Mouth sores), DIZZINESS (Dizziness) and RASH (Skin rash). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Swelling in lips), PRURITUS (Face is itchy), PARAESTHESIA (Face is prickly), GLOSSODYNIA (Tongue is so sore), FEEDING DISORDER (Could hardly drink and eat food) and DIZZINESS (Dizziness) had resolved and STOMATITIS (Mouth sores) and RASH (Skin rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was treated  lotion ("unsure of the name").
Continued crying 71 hours, both legs red, sent to ER for evaluation. No temperature.
No adverse event.  Patient recieved Flu shot by mistake and requested a COVID booster instead.
Tingling in lateral aspect of first didget of left hand. Exacerated by position/squeezing hand and grip. Increased with abduction. Seems to spread with certain movements, such as making a fist - felt into part of hand. Seems to have gotten somewhat worse since it started but not more so over the past few days.
15 minutes after vaccine experienced "tingling" on the tip of her tongue, progressing over the next 10 minutes to a feeling of  "thickening" which progressed from the tip toward the back of the tongue.  Also c/o headache.  No shortness of breath or difficulty breathing.   BP and pulse O2  WNL,  HR elevated at 104 beats/min.  Taken to ED for further evaluation and treatment
Approximately 10 hours after injection I experienced the following symptoms: Muscular and skeletal pains, headache, high fever (102°). Symptoms lasted about 8 hours.
Pt recv vax on 11/20/98; 2 hr post vax pt exp fine/ red rash over body, 8 hr post vax site puffy & red; tx=oatmeal bath
his neck pain; This is a spontaneous report from a sponsored program received from contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported as patient received first dose today and was asking when he can take pain medications like Advil for his neck pain on an unspecified date in 2021. He believes the neck pain was not related to the vaccine dose. The Clinical outcome of the event (neck pain) was unknown.; Sender's Comments: There is not a reasonable possibility that the event neck pain was related to BNT162B2 based on the available information.
Mild-Moderate Muscle/nerve spasms through out body every 15-45 seconds for the past 12 hours. Otherwise symptoms are listed as common.
JOINT PAIN; ARM HURT FOR A FEW DAYS; MUSCLE ACHES; 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 joint pain, arm hurt for a few days, and muscle aches. Treatment medications (dates unspecified) included: fexofenadine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, and muscle aches, and the outcome of arm hurt for a few days was not reported. This report was non-serious.
He has a history of fainting  with vaccines and blood draws. He passed out bout 10-15 seconds after it was complete. He came to temporarily and went back out. We got him down to the floor and raised his feet above his head. We used ice packs under his neck and wrists. He came to again while on the floor and wanted to lower his legs a minute or two after. He stayed laying down for about 5 minutes, then he sat up on the floor for another 4-5 minutes. He then stood up on his own with out assistance. He then sat for the remainder of his 30 minutes and was much better upon leaving.
no adverse events; patient received a dose of PROQUAD following a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent. On 21-NOV-2019, the patient was vaccinated with a dose (1 dosage form) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), following a temperature excursion (product storage error), lot # S017239 and expiry date 01-DEC-2021, (strength, route and anatomical location were not reported) for prophylaxis. The temperature excursion details include temperature of 15 degree fahrenheit to 46 degree fahrenheit (-9 degree Celsius to 8 degree Celsius (16.2 degree fahrenheit)) with a time frame of 1 hour 30 minutes. It was reported that the call was because of data logger. No adverse events were reported. No product quality complaint (PQC) was reported. The outcome of product storage error was unknown.
muscle pain in thigh area; felt like muscle pain, cramp; This is a spontaneous report from a contactable consumer. A 52-year-old female patient received BNT162B2 (solution for injection, lot number EH9899/expiration date unknown), via an unspecified route of administration on 14Dec2020 at a single dose for vaccine. Medical history included blood pressure (abnormal). Concomitant medications included unspecified blood pressure pills. The patient experienced muscle pain in thigh area in Dec2020. She further reported that she was asleep and when she woke up somewhere around it went wave like 1-2 minute. It felt like muscle pain, cramp. The outcome of the event was unknown.
High loud pitched cry for 3 hrs or longer could not be comforted; t102 R; pt was seen by MD for other reasons & was told of rxn;
Mother called the next day after shot and said that it was swollen and red. The area was sticking out almost as much as his shoulder. Instructed mother that he should go see a doctor or if redness or swelling gets bigger or he can't move his arm or has severe pain go to ER. Mother said she was waiting for their doctor to call them back today. I strongly encouraged having it physically looked at by a doctor and she said she would wait.
My eyes started to get swelled up; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN6199, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 11Mar2021 16:15 as first dose single for covid-19 immunisation. Medical history included anaemia, high cholesterol (Under control) and Known allergies: aspirin. Concomitant medications included ascorbic acid (VITAMIN-C) and cholecalciferol (CALCIFEROL) both are taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any other vaccine in four weeks. On 11th March 2021 (The day patient received vaccine first dose) around 7:15pm, patient eyes started to get swelled up. Patient took Benadryl. Swelling decreased during the night. Then, in the morning, patient woke up with her eyes swollen again. patient took Benadryl once more. Around noon, swelling dismissed. As per the reporter seriousness criteria for the event reported as medically significant. The outcome of the event was recovered on an unspecified date in Mar2021.   Information on Lot/Batch number was available. Additional information has been requested; Sender's Comments: As there is limited information in the case provided, the causal association between the event eye swelling and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.
Initial information received on 05 February 2010 from a health care professional. A 42 year old female patient developed swelling of the axillary lymph node on the right side 3 days after he received an intramuscular right deltoid dose of ADACEL (lot number C3438AA) on 02 February 2009. The patient also noted swelling on the right side of the neck. The patient did not have any areas of redness. The patient was seen by a physician on 05 February 2010. The patient was not recovered at the time of the report. List of Documents held by Sender: none.
"Approximately 1 week after, I woke up in the middle of the night and was incredibly aware that I could finally take a deep breath again. Additionally I noticed that my brain fog I had been living with had mostly cleared up."; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: "EN608") via an unspecified route of administration in the right arm on 23Mar2021 at 14:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen and grass. On 11Nov2020, the patient underwent nasal swab test and the result was negative. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. On 02Apr2021 at 03:00, the patient had a positive effect to report and wanted to give a feedback of the experience of receding the vaccine because the patient thought it was truly a miracle. The patient understood that he was a "COVID long hauler". This term was given to the patient by his physician whom he consulted for shortness of breath and fatigue. He had a strange cold at the very beginning of the pandemic. At the time he was not wearing a mask. It was possible that got sick with the corona virus and had shortness of breath and poor mental clarity or brain fog since. After receiving the first shot of the vaccine, approximately one week after, he woke up at the middle of the night and was incredibly aware that could finally took a deep breath again after going through the majority of the last year not being able to take a deep breath. This was noticeable because the year before he was practicing cross fit and an amazing shape. Additionally the patient noticed that the brain fog had been lived with had mostly cleared up. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event "approximately 1 week after, he woke up in the middle of the night and was incredibly aware that he could finally take a deep breath again. Additionally he noticed that his brain fog he had been living with had mostly cleared up" was unknown at this time of report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0164) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
low grade temp;swollen area 5x6cm 8JUL96;warm to touch;ice to area;
sore right arm and headache beginning at 10:45 p.m. of injection day; body aches and fatigue beginning next morning; some tightness in throat; no fever (taken with touchless forehead thermometer)
Itchy all over my body, allergic reaction all over my body. Never experienced this in my life.  It?s been  over a month since I?ve been dealing with this and it randomly comes. My hands and feet burn and are red. I have numerous pictures. I have welts that look like lines all over my body that come and go.
Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided   11 doses from one vial was punctured on 05Jan2022 and the vial was initially stored in the refrigerator on 01-Dec-2021 the vaccine was administered on 05Jan-2022
Hives to face. No SOB, cough or wheezing. Benadryl (25mg IM)
Received first SARS-CoV2  vaccination yesterday at local store Experienced new symptoms of chills, nausea as well as worsening from baseline dyspnea at night. Wife states he had rough morning breathing and had sudden loss of consciousness and unresponsiveness and failed to respond to bystander CPR. He expired at his home.
Migraine, sleepy, loss taste (still no taste as of today), bruises on arm.
about 5 days after vaccine.  Red rash, somewhat itchy and sore at injection site  Round about 6" diameter.  Very mild barley noticed except when I saw in the mirror.  Lasted about 3 days
Tdap (ADACEL) given to LD on 1/12/15 had previous Tdap on 6/21/2012.
cried all day long, running fever 102-103.6 gave APAP used cool rags; temp for 32 hrs, cried alot, nap 10-15 mins then cried; never called MD just used APAP
Pain in shoulder, could not raise right arm.  Pain is throbbing when laying down, relief when sitting vertical.
Patient complains of pain in rt shoulder and neck for two weeks after innoculation with Hep-b #2.  States second shot felt different than first. Denies fever, redness or swelling.  Patient was advised to consult her doctor.