chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness of left arm noted on 10/22/2006 (also 23 after vaccine), diameter at 3 cm (also swelling and pain).
High temp after vaccine.  8/28/07 ER medical records reviewed which reveal patient had laceration of 2nd & 3rd fingers of left hand that occured out of state in AM & seen upon return home in PM after no medical care rendered out of state.  Lacerations felt to be superficial w/small avascular flap attached.  No stitches done.  Dressed w/antibiotic ointment & Tdap given before release to home.  No labs done.  T/C to ER to check recovery status of patient.  No additional records for patient other than initial visit on 7/21.  Multiple calls to patient home to check recovery status unsuccessful.
Metallic taste in mouth, causing nausea. Symptoms subsided after approximately 15 mins.
pemphigus; This is a spontaneous report from a contactable pharmacist reporting same event under the same suspect product for six patients. This is one of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. It was reported that while consulting her (reporter) dermatologist, she was informed that there are 6 patient who had pemphigus after receiving COVID vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021615653 Same reporter/drug/event, different patient
I am unsure if the lateral neuropathy of my daughters left leg is related to the GARDASIL vaccine, but after reading reports of numbness I feel obligated to report the numbness in her left leg. She has seen a neurologist who confirmed the lateral numbness and states there is no cure. 7/7/09 NCS report received DOS 4/8/09. Assessment: Left lateral femoral cutaneous neuropathy. Patient presents with loss of pain and temperature sensation of the left lateral femoral cutaneous nerve.  8/18/09 PCP medical records received DOS 7/21/06 to 4/6/09. Patient presents with leg pain, going numb & "probs' X 3 years. Paresthesias (L) lateral thigh.
I had a very, very severe headache and was nauseous for over 24 hours. I could not sleep even though I was tired, would get out of breath easily, and had chills. After 24 hours I just felt run down for the next 24 hours.
Sinus tachycardia; Edema; I had a 'tremor' and both of my legs; My heart rate has been a 140 ever since then; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: I38731) via an unspecified route of administration, administered in right arm on 21May2021 (at the age of 44 years old) as a single dose for COVID-19 immunization. Medical history included Long COVID, cardiac arrest (twice), bilateral pulmonary embolism, four upper extremity DVT (deep vein thrombosis), blood clot from an unknown date and unknown if ongoing. No family medical history of adverse effect. Concomitant medication included apixaban (ELIQUIS) 2.5 mg tablet in the morning and night to prevent blood clot, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW6955) dose 1 via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization and it made her sick. The patient reported that she had a vaccine reaction that just needed to report. The patient had long COVID, tested positive in January. The patient waited for 90 days before she could be vaccinated for her first vaccine. The patient got her 2nd vaccine on 21May2021 4:30 in the evening and her heart rate had been 140 ever since then. She had a tremor and both of her legs. She went to cardiologist and doctor told to call and let Pfizer know about tachycardia. The patient stated that she woke up Saturday morning 22May2021 with tachycardia. He had done an EKG (electrocardiogram). It was just normal sinus tachycardia, there was no arrhythmia, heart rate was 68 to 78. The patient reported that it was the side effect of the vaccine. The patient stated that her cardiologist said there was nothing that can be done. The doctor told her to wear compression stroking for the edema which she had done since she follow him and her heart rate was coming down and it was down to like 120's now but doctor told her that it will eventually come down on its own, there was a medication and there was nothing to do. The doctor did have her on a heart monitor, so he can watch her rhythm and heart rate but stated there was a medication. The patient underwent lab tests and procedures which included electrocardiogram: normal on 28May2021 Normal sinus Tachycardia, heart rate: 140 on 28May2021, Cardiac magnetic resonance imaging: unknown on 28May2021. The clinical outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Flu-like s/s.. Fatigue, nausea, congestion, body aches.
It started the same day at 7pm. Aches in my joints particularly on all my fingers, Fever 101, body aches and headaches and unable to sleep. It all lasted 15-18hours. The first week of 3 June 2021, my stomach was irregular, every 5 to 6 days I would have multiple bowels movements and urge to go and a burning sensation after each bowel movement. My butt was achy. June 28 reported to doctors. Was told to lay off certain foods, I would get cold sores ongoing off and on until today and in tongue.   2 episodes on June 2021 - lightheaded. Twice at lunch time for 10-15 seconds. On 1st July lightheadedness was severe. I had diarrhea and vomited violently and had vertigo. I went to the ER 1 July and had to be transported in the ambulance.
not feeling well; not feeling well; lost of appetite; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MALAISE (not feeling well), the second episode of MALAISE (not feeling well) and DECREASED APPETITE (lost of appetite) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 002A21A) for COVID-19 vaccination.     Concomitant products included CICLOSPORIN (RESTASIS) for Dry eyes, RIVAROXABAN (XARELTO), DILTIAZEM HYDROCHLORIDE (CARTIA XT), FLECAINIDE, ESTRADIOL (ESTRADIOL SANDOZ), LEVOSALBUTAMOL TARTRATE (XOPENEX HFA) and FLUTICASONE PROPIONATE (FLOVENT) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced the first episode of MALAISE (not feeling well), the second episode of MALAISE (not feeling well) and DECREASED APPETITE (lost of appetite). The patient was treated with HISTAMINE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. In February 2021, last episode of MALAISE (not feeling well) and DECREASED APPETITE (lost of appetite) had 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.   This case was linked to MOD-2021-215308 (Patient Link).
(197/101) high blood pressure; Blood sugar was up to 196; Extreme dizziness; Could not get warm (chills); Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ((197/101) high blood pressure) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ATENOLOL, LISINOPRIL, METFORMIN, SIMVASTATIN, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GLIMEPIRIDE, ANASTROZOLE and AMLODIPINE for an unknown indication.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 25-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED ((197/101) high blood pressure) (seriousness criterion medically significant), BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), DIZZINESS (Extreme dizziness) and CHILLS (Could not get warm (chills)). On 26-Mar-2021, BLOOD PRESSURE INCREASED ((197/101) high blood pressure) and DIZZINESS (Extreme dizziness) had resolved. At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar was up to 196), PAIN IN EXTREMITY (Sore arm) and CHILLS (Could not get warm (chills)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood glucose: 196 (High) high. On 25-Mar-2021, Blood pressure measurement: 197/101 (High) High. On 26-Mar-2021, Blood glucose: 190 (High) high. On 26-Mar-2021, Blood pressure measurement: (normal) normal.         No treatment was provided.; Sender's Comments: This case concerns an 83-year-old female with a serious unexpected event of increased blood pressure, and nonserious unexpected dizziness, pain in extremity, glucose increased and expected chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
had loss of appetite; Extreme chills; muscle pain; headache; insomnia; This spontaneous case was reported by a nurse and describes the occurrence of INSOMNIA (insomnia), DECREASED APPETITE (had loss of appetite), CHILLS (Extreme chills), MYALGIA (muscle pain) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and VITAMIN D NOS for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Injection. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced INSOMNIA (insomnia), CHILLS (Extreme chills), MYALGIA (muscle pain) and HEADACHE (headache). On 16-Feb-2021, the patient experienced DECREASED APPETITE (had loss of appetite). At the time of the report, INSOMNIA (insomnia), DECREASED APPETITE (had loss of appetite), CHILLS (Extreme chills), MYALGIA (muscle pain) and HEADACHE (headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment mediation included acetaminophen.
Initial solicited report received on 25 April 2018 from an investigator participating in study. This case involves a 91-year-old male subject who had Bell's palsy during the study participation. The subject's medical history and concomitant therapies were not reported. On 12 April 2018, 169 days after receiving a single 0.5 ml intramuscular dose of blinded therapy on 25 October 2017 for seasonal influenza prevention (site of administration and batch number not reported), the subject had Bell's palsy. The subject's weight was 67.2 kg and height 168.9 cm. Subject visited the ER after 6 days of left forehead weakness and several months of left ptosis. The working diagnosis was Myasthenia gravis vs. Bell's Palsy. Lab tests for Myasthenia were done. The subject was diagnosed with Bell's Palsy. The event was considered as non-serious by the investigator, however it was upgraded to serious by the company based on IME list. Lab tests for Myasthenia were negative. It was reported that the subject continued on home regiment of oral steroids. The subject was recovering from the event of Bell's palsy at the time of the report. According to the investigator, the event was possibly related to the study vaccine or trial procedures. Relationship to investigational product according to company: not associated. List of documents held by sender: none. Sender's Comments: A 91-year-old male subject had Bell's Palsy five months after receiving a dose of study vaccine. This is a listed event. Investigator considered the event as possibly related. Based on limited data available, the sponsor assesses this event as not related to study product or trial procedure.
pt recv vax DEC97 & exp a swollen arm w/a fever of 102;pt required a visit to ER;@ time of report pt had not yet been administered a second dose;
3/16/21-Obtained vaccine at 0800.  At 1pm same day, began with cough then an asthma attack, chest tights, couldn't catch breath.  Required rescue inhaler and Advair inhalers. by 3pm same day, fever 100.3 po, severe body aches, horrible neck pain, extreme fatigue, ringing in ears, 'brain fog'.  Went to bed 5pm- slept 7 hours. Woke up midnight, fever broke, still horrible aches and extreme fatigue. Slept another 7 hours. 0730 on 3/17 woke up face was "red" like a sunburn- no fever, very weak, no appetite. called primary, told to rest, tylenol, fluids and go to ED if worse symptoms. revisit in person 4/19.      From 3/17-3/26 fatigue, brain fog- had eye exam for employment on 3/26 and vision in left eye had changed- could not see the chart. By today 3/31, still poor vision right eye- will see physician 4/2- less fatigue and improving brain fog, occasional tinnitus. This was my 1ST  in the series of Moderna vaccines. Concern- should I get the 2nd on 4/13?
Fever,  chills, muscle ache, joint pain,  bones ache, headache.
Patient was complaining of a weight on his chest and difficulty breathing including gasping for air.  BP was 136/90  and Epipen was administered.  Following epipen breathing improved
This spontaneous report as received from a consumer refers to her daughter, a 13 year old female patient. No information regarding the patient's concurrent conditions was provided. In 2004, the patient was vaccinated with the first dose of varicella virus vaccine live (manufacturer unknown), (dose, injection site, route of administration, lot number and expiration date were not reported). The second dose was administered in 2007. On an unknown date (reported as "recently"), the patient had a varicella virus antibody test performed which revealed that she did not have sufficient antibodies to the varicella virus, thus necessitating the booster. On 07-JUL-2016, the patient was vaccinated at her pediatrician's office with the third dose of varicella virus vaccine live (manufacturer unknown), in the arm, (dose, route of administration, lot number and expiration date were not provided). There were no concomitant medications reported. The reporter stated that on 08-JUL-2016, she noticed a large red bump on her daughter's arm where the vaccine was administered. The bump was 1.5 inches wide by 2 inches long. The patient sought medical attention via visiting her pediatrician, who believed that it was an injection site reaction. The outcome of having insufficient antibodies to the varicella virus and developing a large red bump on the arm where the vaccine was administered was unknown at the time of the report. The relatedness between the events and varicella virus vaccine live (manufacturer unknown) was not reported. Additional information has been requested.
Patient was admitted on April 16, 2021 with at least 1 week history of worsening of progressing severe shortness of breath associated with mild dry cough, no sputum production.  The patient had the first dose of Moderna vaccine on March 31, 2021.  He thinks, after he got the vaccine he initially developed some shortness of breath which went away, but then over the last week he developed above-mentioned symptoms.  He denies fever, chills, diarrhea.  He also his presents with generalized weakness and very poor appetite and poor oral intake.   On admission he was found to be in severe hypoxemic respiratory failure with multiple infiltrates in both lungs on chest x-ray.  He had elevated D-dimer on admission and CT angiography revealed acute right lower lobe pulmonary embolism.  COVID-19 PCR also came back positive.  Internal medicine service was consulted.  The patient was placed on BiPAP, will start with remdesivir, dexamethasone, levofloxacin for possible superimposed pneumonia and therapeutic doses of Lovenox.  Letter Doppler study revealed nonocclusive left popliteal vein DVT. Patient remains hospitalized for continued treatment due to COVID19 infection, right lower lobe PE, L popliteal DVT, severe hyperglycemia.
5 minutes after vaccine given, client experienced diaphoresis and ightheadedness.  Ice pack and water given, client admits to not eating lunch and had been a little bit since eating/drinking anything.  Initial B/P  70/60 HR 63.  After 25 minutes B/P 145/91, HR 61, no respiratory distress or difficulty breathing. Pt felt 100% better after 35 minutes.
Prolonged nap more than normal for our child, woke up very irritable and cranky..Continued fussiness with runny nose.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 31-DEC-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001529, expiration date 07-NOV-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Immediately-Severe pain. After two days 11/12 redness and swelling traveled down 1.5 inches away from injection site, severe pain radiating from upper left arm through elbow halfway down forearm AND up through shoulder and armpit area into left side of chest and left side of neck, experienced fatigue after simple tasks walking to vehicle etc feeling hard to catch breath. 11/14 and 11/15 experienced abdominal pain and diarrhea 11/16 experienced low grade fever and itching.   redness and inflammation increased to 2x2 inch circle by 11/17/2021. At this current time, missing period by 4 days, no possibility of pregnancy
Patient is 11 years old received GARDASIL shot #1 6/10/11 and GARDASIL #2 8/23/11. Patient has been depressed since July 11 and has thoughts of suicide. No attempts.
Severe chills for 60 hrs Swelling of lymph node under armpit, baseball size day 2 Swelling of face and upper body 4 days after, rash on left arm where shot was give
On 3/29/00 at 11:00 AM the pt received a TD vaccine. The pt returned to the ER on 4/2/00 with cellulitis - 3.5 inches on the lateral upper arm. Pt was afebrile. Keflex and Darvocet were prescribed.
Moderna COVID?19 Vaccine; significantly swollen lymph node (left arm pit near injection site
After second dose patient experienced severe swelling, redness, and heat extending through their left arm approximately for a week. Then a lump/fluid filled mass appeared on the left side of their neck extending from their shoulder. Patient is being seen by physician. Physician wants them to have an MRI to deteremine the cause but believes it to be the vaccine
Case number PHEH2014US011642 is an initial spontaneous report received from a consumer on 09 Jun 2014. This report refers to a patient of unknown demographics. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1309401, expiry date: 30 Apr 2014) on an unknown date. On an unknown date after vaccination, the patient experienced swelling of lips and tearing of the eyes. The outcome, causality and seriousness were not reported.
This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L033693 with expiration date 31-MAY-2017, orally; dose and dose number were not reported. No adverse effects were reported and a product quality complaint (PQC) was not involved. IT was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Sedation, Myalgia, chills and fatigue. pain, redness and swelling at the injection site.
cold; which progressed to a middle ear infection; rhinitis; ear pain; Fever; pain in limbs; Rash on both legs of unclear origin; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02170 (Moderna).  A female patient received BNT162b2 (COMIRNATY), on 07Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (SPIKEVAX), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "RRMS" (ongoing). Concomitant medication(s) included: OCREVUS intravenous taken for relapsing-remitting multiple sclerosis, start date: 16Mar2018; TENOFOVIR. Vaccination history included: comirnaty (2ND DOSE), administration date: 30Jun2021, for COVID-19 immunization; comirnaty (1ST DOSE), administration date: 09Jun2021, for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset Jan2022, outcome "recovered" (Apr2022), described as "Rash on both legs of unclear origin"; PYREXIA (non-serious) with onset 11Apr2022, outcome "recovered" (15Apr2022), described as "Fever"; PAIN IN EXTREMITY (non-serious) with onset 11Apr2022, outcome "recovered" (15Apr2022), described as "pain in limbs"; NASOPHARYNGITIS (non-serious) with onset May2022, outcome "recovered" (May2022), described as "cold"; EAR PAIN (non-serious) with onset May2022, outcome "recovered" (May2022); RHINITIS (non-serious) with onset May2022, outcome "recovered" (May2022); EAR INFECTION (non-serious) with onset May2022, outcome "recovered" (May2022), described as "which progressed to a middle ear infection". Therapeutic measures were taken as a result of rash, pyrexia, pain in extremity, nasopharyngitis, ear infection, rhinitis, ear pain.  Additional information: the patient was missing Sars-CoV-2- antibodies after the four dose of vaccination. The patient had Rash on both legs of unclear origin from early Jan2022 to Mid-Apr2022. Treatment included various creams (names cannot be remembered on request). The patient had Fever (felt; patient did not measure this) and pain in limbs from 11Apr2022 with a duration of 4 days. Treatment included ibuprofen 400 mg as needed. Patient sees relationship to fourth vaccination with Spikevax (11Apr2022). The patient had a cold (rhinitis, ear pain) from early May2022 with a duration of 2 weeks, which progressed to a middle ear infection. Treatment included antibiotic for 6 days (1-0-1; name not remembered on request). The events were not life threatening, disabling/Incapacitating or Medically Important. Hospitalization is not required.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.