chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cellulitis at injection site started within four days.  Expanded over the next week.  Started first course of Cefdinir on Jan 16.  Took for four days before seeing my PCP.  Started 2nd course of antibiotics, 10 day course of Keflex, 2000mg/day on Jan 20, 2021.  Improving as of this date, Jan 26, but still some visible discoloration.
NVD/ emesis; nausea/ NVD; NVD; Visual/Neuro concerns; Visual/Neuro concerns; SOB; lightheadedness; funny taste in mouth; Tachycardia; flushed; This is a spontaneous report from a non-contactable other healthcare professional. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7534) via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that during her 15 originally but ended up for 30 due to how she was feeling waiting period after the injection, the patient began to experience lightheadedness and nausea with brief "funny taste in mouth". She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling. + Nausea: + Lightheaded Tachycardia present. Flushed. Treatment included: water and Pepcid, Zofran. Follow up response to treatment. Patient discharge: Transported to ED by ambulance. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Patient was unable to tolerate PO fluids. Emesis frequency not changed. Discussed with patient about options, she wished to be taken to ED. Husband and daughter will meet her there. ED manager updated. Outcome of the event vomiting was not recovered while unknown for the other events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: There is a reasonable possibility that the event vomiting was related to BNT162b2 based on known drug safety profile.  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.
I received my shot at about 7:30PM Friday Jan 22, about 8 hours after that my shoulder had pain where I received the shot and had started to get a headache.   4 hours later awoke with extreme headache with pain in my joints,  also this is when diarrhea started.  Took Aleve and tried going back to bed an hour or so later chills started and couldn't sleep with the pain and diarrhea.  Kept trying to sleep but was difficult with these problems a couple hours later tried stretching and doing a little stretch and flex to see if this would help but it did not.  So approximately 18 hours after the shot the diarrhea was done (nothing left in me) I was dehydrated and consumed water constantly.  A couple hours after this I did not have anymore chills but my head felt like a balloon that was being over inflated and was going to pop.  By this time my sister was at my house keeping an eye on me, I had called her earlier.  I couldn't really feel the pain where I received my shop because of the pain in all my joints (shoulders, knees, hands etc.) but the worst was my neck and head.  Slept rough during the night drinking large quantities of water all night.  Started feeling a bit better mid morning the next day, got appetite back but was extremely fatigued and pretty much napped in bed until 6pm Sunday the 24th.  That's when I started feeling normal again eating like a pig and still couldn't get enough water in me.   Now I'm scared about getting the 2nd dose of Moderna in a month. Thank you t
itchy, red, and raised area appeared 8.5 days after vaccination, will use topical and/or oral antihistamine treatment if itching gets worse.
Pain in right shoulder and neck since about 4 hours or so after receiving the vaccination and has not gone away to this point; Pain in right shoulder and neck since about 4 hours or so after receiving the vaccination and has not gone away to this point.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non- pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the right arm on 09Apr2021 at 09:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. 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. Concomitant medications included unspecified medications; from an unknown date for an unknown indication and unknown if ongoing. On 09Apr2021 at 14:00, the patient experienced pain in right shoulder and neck since about 4 hours or so after receiving the vaccination and has not gone away to this point. It was unknown if the patient received any treatment for the events. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain in right shoulder and neck since about 4 hours or so after receiving the vaccination and has not gone away to this point was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Low grade fever, body aches, lethargy, chills and chest cough.   Fever and chills are gone, but cough and muscle ache below and around right shoulder blade still persist.  Some lethargy also continues.
A PSA TEST INDICATED A CONCERN AS THE LEVEL HAD RISEN TOO HIGH.  THE LEVEL OF PSA TOTAL AT THIS TIME IS 6.1.  NO ACTION WAS TAKEN AT THIS TIME.  HOWEVER, THE NEXT TEST TAKEN ON 04/19/2021 SHOWED A LEVEL FOR PSA FREE OF 6.9.  A BIOPSY WAS THEN TAKEN OF THE PROSTATE ON 07/07/2021 (12 SAMPLES ALL INDICATED "HIGH RISK CANCER').  THEN TWO PELVIC SCANS PLUS A BONE SCAN ON 08/03/2021 INDICATE THE CANCER HAS SPREAD WIDELY TO THE BONES. A CONINUOUS SERIES OF SHOTS OF ELIGARD (EVERY 3 MONTHS) WAS INITIATED AT DR. OFFICE ON 08/12/2021 AND A NEW DAILY MEDICATION OF BICALUTIMIDE (50MG) WAS STARTED.  A VISIT TO AN ONCOLOGIST WAS RECOMMENDED AND IS SCHEDULED FOR 09/02/21.  SEE MORE LAB HISTORY IN ENTRY 19 BELOW.
Lower back pains, shoulder pains, elbow pains and leg pain. Never had this until I received the Lymerix shots.
This spontaneous report as received from a pharmacist refers to 6 patients of unknown demographics. Pertinent medical history, drug reactions or allergies were not reported. Since February 2014, the patients may have been vaccinated with improperly stored doses of ZOSTAVAX 19,400 unit, 1 standard package vial of 1, (dose and lot numbers were not reported). No adverse effects reported. Additional information has been requested.
Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from Other health care professional via Health Authorities under reference 575268. This case involves a 11 years old male patient who experienced likely arthus reaction, redness and swelling at vaccination site, while he received vaccines ADACEL and GARDASIL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Apr-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site. On 20-Apr-2015, the patient received a dose of suspect GARDASIL (lot number and Expiry date unknown) via unknown route in unknown administration site. On 22-Apr-2015, the patient developed a serious likely arthus reaction (type iii immune complex mediated reaction) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and GARDASIL. This event was assessed as medically significant. On 22-Apr-2015, the patient developed a non-serious swelling at vaccination site (vaccination site swelling) and redness at vaccination site (injection site erythema) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and GARDASIL. (Other relevant tests included no lab data.) Final diagnosis was redness and swelling at vaccination site and likely arthus reaction. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.; Sender's Comments: This case involves a 11 years old male patient who experienced likely arthus reaction and redness and swelling at vaccination site, while he received ADACEL and GARDASIL VACCINE. Time to onset is compatible with the role of vaccine. However, further information including concomitant medications excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
autoimmune disease; M spike protein Elevation/Mag Igm auto antibodies=2350; M spike protein Elevation/Mag Igm auto antibodies=2350; This is a spontaneous report received from a contactable reporter(s) (Nurse).  An 80-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "autoimmune disease"; MONOCLONAL IMMUNOGLOBULIN PRESENT (non-serious), AUTOANTIBODY POSITIVE (non-serious), outcome "unknown" and all described as "head M spike protein Elevation/Mag Igm auto antibodies=2350". The patient underwent the following laboratory tests and procedures: Autoantibody test: 2350; Monoclonal immunoglobulin present: Elevated. The patient was having issues that were not related to vaccine but needed to have a neurology work up and head M Spike protein elevated with mag Igm auto antibodies = 2350. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events autoimmune disorder, monoclonal immunoglobulin present, autoantibody positive and the use of suspect product BNT162B2 cannot be fully excluded. The case will be reassessed once further 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 RAs, Ethics Committees, and Investigators, as appropriate.
Patient reported to another pharmacy for her second covid vaccine and reported she was in the hospital for covid (went in hospital on 04/10/21)when her original second dose appointment was scheduled.
Patient with single J+J COVID vaccination who admitted to hospital for behavioral health needs.  Asymptomatic for respiratory issues during stay.  Incidental finding on admission testing.
Patient states that within 9 hours of 2nd dose of SHINGRIX she had a fever, muscle aches, general body aches, and headache that lasted 36 hours. After that time, she felt fine and had no further symptoms, states that she is feeling well at this time. This only occurred with the 2nd vaccine, with first SHINGRIX she just had muscle soreness at injection site.
This spontaneous report as received from a physician refers to a female patient of unknown age. The physician reported that the patient received the second dose of GARDASIL (lot# was not reported) in January 2013. It was not specified when the first dose of this vaccine was given. The patient was hospitalized on 01-MAR-2013 (and was still there) for intractable seizures on 01-MAR-2013. The patient sought medical attention in hospital. Treatment was given for adverse event. The patient in a ventilator. At the time of reporting, the outcome of the patient was unknown. The primary reporter considered intractable seizures as Significant Disability. Additional information has been requested.
pt recvd vax; devel localized rxn of erythema, swelling & pain w/in 24 hrs p/ vax; tx augmentin;
Child had a febrile seizure on 6/16/15-had PREVNAR, Hepatitis A and Hib vaccines on 6/15/15.
Patient reported shingles symptoms starting 1 week after vaccination. She has an itchy rash and pain under her breast that was diagnosed 5-31-18 as Shingles from her doctor.
Pt awoke this morning running fever of 101, dyspnea, hear rate up to 130 at home and severe body aches. Pt took motrin pta and temp down to 98.5 once arrived
Given GARDASIL 9 and MENACTRA at WCC 6/27/18. GARDASIL 9 given in the right deltoid and MENACTRA given in the left deltoid. Injection site of the GARDASIL 9 very painful at the time of the injection - more painful than the left arm. Arm continued to be painful x 1 week. On 7/8/18 she woke up with a very swollen right arm and went to the Emergency room and was diagnosed with phlebitis and cellulitis of the right arm. Prescribed ibuprofen 600mg QID and cephalexin 500mg QID.
Discovered after vaccine given that it was past expiration date of 06/26/2020. Informed mother by phone,. Mother said child had some increase in intestinal gas that night. Denies other changes or concerns.
Pt developed SOB the evening following vaccine dose, worsened significantly the next day.  She reports using albuterol rescue inhaler much more frequently following vaccine.  This lasted approximately one month.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 18-MAY-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose, route and lot # not provided), when he was indicated for ZOSTAVAX. No adverse experience was reported. Additional information has been requested.
Patient complained of chest pain in the middle of the night the night after vaccination, daily nosebleeds, stomach pain, and chills.
Patient felt discomfort in left arm approximately 2 hours after vaccine. Subdermal bleeding due to Warfarin use with excessive swelling and bruising.
Information has been received from a physician concerning a female who on 22-APR-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast). On 23-APR-2008 the patient experienced nausea, vomiting, dizziness and an unspecified rash. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Additional information has been requested.  This is in follow-up to rpeort (s) previousl submitted on 07/15/2008. Information has been received from a physician concerning a 20 year old female with no illness at the time of being vaccinated who on 22-APR-2008 was vaccinated with a first dose of GARDASIL into the left deltoid. On 23-APR-2008 the patient experienced nausea, vomiting, dizziness and an unspecified rash. The patient sought unspecified medical attention. At the time of the report the outcome was unknown. Follow-up information was received. The patient required emergency room treatment. The patient recovered from nausea, vomiting and dizziness. Lab test included: vital signs with normal limits (WNL), hepatic profile (normal), chemical profile (normal), urinalysis test revealed ketones + bacterial). Complete blood cell count (CBC) and Lipase were normal. Additional information is not expected.
PATIENT WAS GIVEN FLUAD DAYS BEFORE THEIR 65TH BIRTHDAY.
Sore Throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided. Treatment information does not provided.
BLOOD IRON DECREASED; ALOPECIA; STRESS SYMPTOMS; DEPRESSION. Information has been received from a health professional concerning a 35 year old white female patient care assistant with asthma and no known drug allergies who on 19-JUN-2003 and 31-JUL-2003 was vaccinated with the first and second doses of hepatitis B virus vaccine rHBsAg (yeast) (lOT 643395/0429m). There was no illness at the time of vaccination. Concomitant vaccinations on 06-JUN-2003 included a dose of tetanus toxoid. After the second dose of hepatitis B virus vaccine rHBsAg (yeast), the patient experienced alopecia the size of a half dollar and it has increased to a gold ball size. The patient was seen by her physician, and the physician "does not feel it is associated with the vaccination". Unspecified medical attention was sought. There was no product quality complaint. Follow up information from the patient indicated that she was stressed over losing a job in May 2003, and start4ed a new job in June 2003. On 06AUG2003, the patient's hairstylist noted hair loss on the patient. The hair loss continued to become bigger and more noticeable. On 26SEP2003 the patient presented to the physician's office with complaints of being stressed and depressed, and also complained of a bald spot on the right side of her head. Labs were drawn and the iron count was low at 11.1. All other laboratory data are listed below. The patient was prescribed alprazolan (XANAX)(0.5mg q12h), iron supplements, an injection of B6/B12 every 2 weeks, and a multivitamin. The outcome was reported as not recovered. No additional information is expected.
Shortness of breath, chills, diarrhea, shaking, migraines, fatigue, exhaustion
Received first dose of Vaccine on January 24th (About 50 days ago) and has not received; A Spontaneous report was received from a health care professional, concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine and has not received the second dose.  The patients medical history was not provided. Concomitant product was not provided by reporter.  On 24-JAN-2021, the patient received their first dose of two planned doses of mRNA-1273(lot number unknown) via unknown route for COVID-19 infection prophylaxis and is yet to receive second dose. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was Unknown.  The outcome of the event, Inappropriate schedule of drug was resolved at the time of the report.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #  unknown  with no associated Adverse Events.
In February 2020 I became very sick with a heavy cough, chest and sinus congestion. I was sick for approximately 2 weeks. In the second week I began experience a tingling sensation on the left side of my neck behind and below my left ear and radiating into my left shoulder. I recovered but the tingling sensation persisted. Muscle tightness and pain accompanied the tingling.  Several hours after my first Covid vaccine, I awoke with extreme sharp pain in my neck in the same area. I began alternating Advil and Tylenol. Over the next few weeks the pain subsided, but I began experience shortness of breath and labored breathing. My doctor began testing for blood clots and heart issues which were being reported at the time related to the vaccine. Nothing was found. On 04/26/2021 I received the second dose of the Moderna Vaccine. With 24-48 hours all the neck pain and tingling sensations disappeared. The breathing issues have persisted. Tests have shown no cause. My doctor prescribed Spiriva but I did not respond well and discontinued. My breathing has very slowly improved over time but I still get winded much more easily than I used to prior to the first vaccine.
Pt was given 0.2 undiluted dose of the 2-5 yr COVID vaccine. The Nurse manager called and spoke with mom, mom stated that pt had some soreness at the injection site, but no other symptoms.
feel sores under my lip; area had spread to the size of a soft ball; hot and red area at injection site started to disipate; Didn't feel well; injfection site hot spot; injection site red spot; chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel well), VACCINATION SITE WARMTH (injfection site hot spot), CHEILITIS (feel sores under my lip), INJECTION SITE REACTION (hot and red area at injection site started to disipate) and RASH (area had spread to the size of a soft ball) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced MALAISE (Didn't feel well), VACCINATION SITE WARMTH (injfection site hot spot), INJECTION SITE ERYTHEMA (injection site red spot), CHILLS (chills) and PYREXIA (slight fever). On 12-Apr-2021, the patient experienced INJECTION SITE REACTION (hot and red area at injection site started to disipate). On 13-Apr-2021, the patient experienced CHEILITIS (feel sores under my lip) and RASH (area had spread to the size of a soft ball). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LORATADINE at an unspecified dose and frequency. On 12-Apr-2021, CHILLS (chills) and PYREXIA (slight fever) had resolved. At the time of the report, MALAISE (Didn't feel well) and INJECTION SITE REACTION (hot and red area at injection site started to disipate) outcome was unknown and VACCINATION SITE WARMTH (injfection site hot spot), CHEILITIS (feel sores under my lip), RASH (area had spread to the size of a soft ball) and INJECTION SITE ERYTHEMA (injection site red spot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  Treatment medication included cold water and non itching stuff on it.
Information has been received from a physician concerning a 9 year old female who was vaccinated with Gardasil vaccine (lot# not reported) for prophylaxis. On 24-OCT-2007, the patient felt slight dizziness, saw spots and got a little cold. The patient did not "pass out". Subsequently, the patient recovered. Additional information has been requested.