chrisvoncsefalvay/vaers-outcomes huggingface dataset:
leg heaviness; fever; knee pain; cellulitis; malacia; sore throat; being lethargic; This spontaneous report was received from a consumer, a currently  70-year-old female patient reporting on herself. The patient's concurrent conditions included hypertension, blood cholesterol increased and gastrooesophageal reflux disease (GERD). She had a history of a drug reaction with unknown cholesterol medication. The patient's was under therapy with concomitant medication, but refused to provide.  On an unknown day in 1998, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (dose, route of administration, lot # and expiration date were not reported) for pneumonia.   After vaccination on an unknown day in 1998, the patient experienced side effect of severe reaction including cellulitis, fever, knee pain, malacia, sore throat and being lethargic. The symptoms lasted for 2-3 weeks and on the same year, the patient recovered. The patient was unsure of the provider, who administered the vaccine. The patient also reported experiencing leg heaviness from taking unspecified cholesterol medication. She was unsure of the medication names. There were not laboratory tests or studies performed. The patient sought medical attention. The patient sought information on pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) ingredients in comparison to COVID-19 vaccine ingredients. No additional information was provided.  The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the occurrence of the events was not provided. Upon internal review, the event of cellulitis was determined to be medically significant.
first dose of Shingrix in September 2018 / forgot to receive the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in september 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient forgot to receive 2nd dose of Shingrix. Till the time of reporting,the patient did not received the 2nd dose of shingrix which led to incomplete course of vaccination. The reporter did not consent to follow up.
Cried; Injection site pain; This spontaneous report has been received from a physician, concerning a 2-month-old female patient, via Company representative.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) as prophylaxis.  On an unknown date, after receiving pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), the patient experienced injection site pain (Vaccination site pain) and she cried (Crying).  At the time of reporting, the outcome of both events was unknown.   The causal relationship between the vaccination site pain and crying with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was not reported. No further information provided.
A serious report of congenital anomaly, thyroglossal duct cyst, has been received from a study concerning a 47-month-old male participating in a post-marketing study for FLUMIST, MI-MA162. This case is submitted in accordance with manufacturer post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The subject's medical history included thyroglossal duct cyst, peanut allergy, resolved event of heart murmur, eczema, and hypoplastic enamel in dental procedure under anesthesia. No concomitant medications were reported. On 03-Sep-2009 the subject received FLUMIST, 0.25 ml per nostril. He received a total of one dose of FLUMIST before onset of the event given on 03-Sep-2009. Prior one year to August 2009, the subject was diagnosed with midline neck mass, which has grown slowly during this time. The subject experienced mild discomfort with palpation and movement of mass. There were no dysphagia, shortness of breath, voice changes, hypo- or hyperthyroid symptoms, drainage, or infection of lesion. Ultrasound test was performed and indicated thyroglossal duct cyst. On 12-Aug-2009, it was recommended to remove the cyst. On 03-Sep-2009, the subject was cleared for surgery at preoperational exam. On 08-Sep-2009, the subject was admitted to the hospital, and surgical procedure (Sistrunk procedure) was performed under general anesthesia. After the procedure, the subject was transferred to postanesthesia care in stable condition. The subject was discharged from the hospital in stable condition. Discharge medications included acetaminophen with codeine, amoxicillin, and bacitracin-polymyxin. Pathology results were also performed and supported the diagnosis. On 15-Sept-2009, the subject was seen for follow-up exam. He was experiencing no pain. Parents reported that he was eating well, and there was no drainage from the wound. The event of congenital anomaly, thyroglossal duct cyst, was resolved on 09-Sep-2009. The investigator assessed the causality for the event of congenital anomaly, thyroglossal duct cyst to FLUMIST as none. The severity of the event was mild. The alternative etiology was congenital. The sponsor assessed the causality for the event of congenital anomaly, thyroglossal duct cyst, as not related to FLUMIST.
A report has been received from a Health Professional concerning a 12 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 20-Jan-2014. It was reported that expired FLUMIST QUADRIVALENT was given to 42 patients which started on 20-Jan-2014. The outcome of the event of gave expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Received vaccine at 8:20am on 1/13/2021.  At 5pm had tachycardia HR up to 150-160.  Resting HR 120-130. Work up in ER F/U with Primary in 1-2 days.
Information has been received from a registered nurse concerning a 63 year old male who on 05-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck). On 29-JAN-2009 the patient called the office and reported that as he was leaving the office on 05-JAN-2009 after he received ZOSTAVAX (Merck) he started to have shortness of breath, heart palpitations but no chest pain. The nurse reported that on 18-FEB-2009 the patient called back and stated that he still was having two to three episodes a day but not enough to wake him up while he was sleeping. The patient had gone for a follow up chest X-ray but the result was not provided. The patient called the office for medical attention. Additional information has been requested.
Lightheaded, facial pressure, "feeling like something stuck in throat" - Evaluated by EMS-Cleared
Information has been received from a 29 year old white female, a smoker, who on 3/5/99 was vaccinated with MMR. In March, 1999, the pt experienced vomiting, felt sick, and "throat is killing me". The pt's symptoms persisted. Subsequently, the pt was found to be pregnant. LMP was 3/25/99. EDD is 12/30/1999. No further information is available.
Pain at injection site when raising arm above shoulder and bruising from injection site to below the elbow.
Daily headaches for past 7 weeks, fatigue for about 5 weeks, brain fog, dizzy at times,  butted vision at times
Information has been received from a physician concerning a male who two weeks ago was vaccinated with 0.5 mL second dose of VARIVAX, subcutaneously. On 01-JUL-2009 the patient returned to the physician's office because of a varicella-like rash and papules on the face. At the time of this report the patient had not recovered. Follow up information received on 31-JUL-2009 from a health professional indicated that the patient was a 5 year old female with pharyngitis at the time of vaccination and no medical history or drugs allergies, who on 11-JUN-2009 at 09:30 was vaccinated with a second dose of VARIVAX (lot # 661975/0188Y), into the left arm.  On 01-JUL-2009 at 09:00 the patient developed rash-erythematous papules, vesicle, crusted/scabbed erosion (perioral/back). The patient's outcome was not reported. No further information is available.
Left upper arm, shoulder to hand, ear, sided face red, itchy, warm to touch, swollen. No individual hives. No respiratory symptoms. Was very tired acting. By 2:30 pm when seen by medical provider redness was gone. Still some swelling. 12/8/09:  Primary care records received from 11/18/09.  Dx:  Allergic reaction to H1N1 vaccination.  Presented with redness, itching, warmth and swelling of L arm, ear and side of face.  +HA, no fever.
SWELLIN OF THE HANDS AND FEET AND LEGS; SWELLIN OF THE HANDS AND FEET AND LEGS; SWELLIN OF THE HANDS AND FEET AND LEGS; This is a spontaneous report from a contactable, consumer. A 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6206) 1st dose on 11Mar2021 at 09:45am, solution for injection in the right arm, via unspecified route of administration for Covid 19 immunisation. Medical history included diabetes. The patient had a history of codeine allergy . The Patient has tested as negative and the test name was not provided on unspecified. Since the vaccination, the patient had been tested for COVID-19. On 12Mar2021, the patient had swelling of the hands and feet and legs. The patient has recovering from the event of swelling of the hands and feet and legs at the time of reporting. No follow-up attempts are needed. No further information is expected.
Headache, treated with acetaminophen 750 mg, asa 250 mg, caffeine 65 mg, ibuprofen 800 mg, fluids, headache lessened in severity
After the shot, I got chills and fever; the Saturday following the vaccination, my temperature dropped and I had chills and body ache. On Monday, I went work because I was pretty fine; and Tuesday morning, my ears and my head was hurting pretty bad. There was a swollen across the bridge of my nose, and my lymph node was swollen on my right side. I couldn't breathe through my nose. Dizzy. My whole body was aching. Temperature 100, loss of taste and smell on Wednesday, coughing, fatigue.
Syncope Pt immediately passed out, started snoring with his head down as I supported his weight in the chair.  I revivied him with smelling salts after 15-20 seconds.  He remained pale for a few minutes while I monitored him.  He sat and rested for 10 minutes then felt better and left with his mother.
This spontaneous report was received from another health professional regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (lot # K021935 expiry date 20-NOV-2016) (dose and route unknown). No adverse events were reported. Follow up information has been received from the reporting C.M.A. during a phone call on 04-NOV-2015. The medical assistant reported that she would have to research the request made for patient identifiers, lot numbers, expiration dates and dates of vaccination. This is one of the two reports received from the same reporter. Follow up information has been received from the C.M.A via other source on 24-NOV-2015 concerning a patient of unknown age and gender. The reporter stated that the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) on 01-MAY-2015. This was one of several reports received from the same reporter. Additional information has been requested. Reporter information, patient demographics, therapy start date, event onset date and narrative were updated.
received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer); This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 5047B21A) for COVID-19 vaccination.    Co-suspect product included non-company product BNT162B2 for COVID-19 vaccination.    No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient started BNT162B2 (unknown route) at an unspecified dose. On 13-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer)). On 13-May-2021, INTERCHANGE OF VACCINE PRODUCTS (received 2 different brands of vaccine (1st - Moderna, 2nd - Pfizer)) had resolved. 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 and treatment medications were reported.  HCP called in to report that they have administered a Pfizer dose to a patient who was supposed to be getting the 2nd dose of the Moderna vaccine.on 13-May-2021.
This case was reported by a physician and described the occurrence of glucose elevated on a 9-year-old female subject who was vaccinated with Havrix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included diabetes. Concurrent medications included Insulin via a paradigm pump and Poly-Vi-Flor + iron salt. On 12 June 2007 at 15:00 the subject received 1st dose of Havrix at 0.5 ml in the right arm. That night, 12 June 2007, after vaccination with Havrix, the subject experienced glucose elevated to  518 and was seen in emergency room. Alkaline phosphatase was 318 and the subject had no ketones. She was hospitalized for treatment. At the time of reporting the event was said to worsening.
Wants to report breakthrough case. Received vaccine 4/2021, then came down with COVID in October 2021.
Patient was given a booster dose of Pfizer 5-11 vaccine when patient should have received Pfizer 12+ vaccine since patient is already 12.
Vaccine administration not in accordance with VFC recommended childhood and adolescent immunization Schedule 2005. Administration of vaccine not licensed for Adolescents.
About 5 mins after receiving the vaccine, my right arm started itching at the injection site. The itching then spread all the way down my arm to even my fingertips. There were also small bumps on my arm. The tip of my tongue had also started itching. After 15 mins I reported this and the NURSE PRACTIONER on site gave me 25mg of BENADRYL. I continued to itch. I left the site ABOUT 30mins later. Later that evening about 745pm when I Was home my arm started itching again and bumps started appearing. The tip of my tongue and my lips also started itching. I took another dose of benadryl at home. The itching subsided about half hr to 45 mins later. I then fell asleep. I woke up at bout 2am. The next day I had no itching but I had a headache and felt lethargic(malaise). I saw my primary care on 8/26/21. On that day I still had a slight headache and still felt generally really tired(lethargic).
allergic reaction; Initial information received on 18-Feb-2021 regarding an unsolicited valid non-serious case from a consumer via Regulatory authority (under reference number: 00482313).  This case involves female patient of unknown age who experienced allergic reaction (hypersensitivity), after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   In 2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  In 2010, the patient developed a non-serious allergic reaction (hypersensitivity), (approximately in the same year, exact latency unknown) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was not reported for the event hypersensitivity.  Also reported that: Reporter wanted to know what were the components of that vaccine. Consumer was referred to her administering physician. Consumer stated she will check the website and she will call back tomorrow to speak to a supervisor. AE (adverse event) information not obtained due to long hold with consumer, and her main concern was just knowing the product composition of that FLUZONE HIGH-DOSE in 2010. Consumer was referred to the website and to her health care provider. She stated that she will call back tomorrow to speak to a supervisor.   There will be no information on the batch number for this case.
pt recvd vax & devel high f,fatigue,h,n,d,sweating,achiness,chills,flushed,v,abdo cramps,no appetite,dizziness,rash, back pain,stiff neck,jt pain,chest discomfort,palpitations,iritability,inc liver enz,blood-shot eyes,tachycardia,visual dis
thigh became swollen & hard; pt could not walk for several days because of severe pain; pt treating MD stated that this type of reaction was not uncommon & did not feel it was necessary to see pt;
Redness; swelling; large knot at injection site; swollen lymph nodes in armpit in injection; tingling down to fingertips of arm injected; shortness of breath and heart palpitations.
Itching, Redness, Tenderness. I put ice on the arm. I also had to use anti-itch cream to stop the itching.
Within 4 hrs of receiving first HPV vaccine, she became confused, dazed, acting as if intoxicated. This behavior change lasted 48 hrs. She also had headache and dizziness develop immediately after the vaccine, which has persisted. Taken to local ER. No treatment given.
On May 29, 1999 the patient experienced chickenpox with > 70 lesions.
Heart palpitations starting about two weeks after the second dose, lasting to the present. It varies day to day and week to week, but I get about three or four noticeable palpitations per day on average. I usually get them when I'm calm and sitting down, not during exercise. I don't drink caffeine.
Breakthrough case of Covid sx began 06/06/2022. Positive test 6/07/2022. Sx began later in the day of 6/06/2022 with sneezing a lot. By the next morning, 06/07/2022 I woke up feeling terrible. Over the course of the night, I had a fever (without use of thermometer as I did not have one handy) but I know my body. I had coughing and congestion, I also had a terrible headache. I booked a PCR test which came back positive, and a rapid home test was also positive. My PCP. Things got worse before they got better, I am fatigued, I was still had a fever of 102.5 - 102.9. I was taking TYLENOL and MOTRIN alternating and did not go down. My SpO2 was getting into the 80s and I was feeling over all crappy. My PCP prescribed PAXLOVID. I improved by 06/10/2022, my sense of smell and taste have been altered slightly but are starting to comeback. I am grateful for the vaccine, I feel it could have been worse.
Headache on 01/22/21. Fever of 101.7 on morning of 01/23/2021. Cold sweats and clamminess on 01/24/21. Later woke from resting with a elephant on my chest type pain. Rushed to ER for difficulty breathing. Ran EKG , chest xray and blood levels. All negative, sent home advised to take Tylenol. When I left er the pain felt like a brick sitting on my chest and my rib chest area felt lots of pressure. On 01/25/2021 still had feeling of brick on my chest and fullness in the rib cage. My physician called in a zpac, steroid and inhaler. Also noticing brain fog since I had the 2nd dose. 01/28/2021 if the first day I don't feel the brick on my chest.
60-80, possibly more, administered expired moderna doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (60-80, possibly more, administered expired moderna doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (60-80, possibly more, administered expired moderna doses). In November 2021, EXPIRED PRODUCT ADMINISTERED (60-80, possibly more, administered expired moderna doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The expired doses were administered from 08-NOV-2021 to 22-NOV-2021 It was reported that the vial didn't undergo any temperature excursions. The reporter reported that on 08-Nov-2021 13 doses, on 09-Nov-2021 5 doses, on 10-Nov-2021 6 doses, on 11-Nov-2021 5 doses, on 12-Nov-2021 5 doses, on 15-Nov-2021 5 doses, on 16-Nov-2021 8 doses, on 17-Nov-2021 5 doses, on 18-Nov-2021 23 doses, on 19-Nov-2021 3 doses, on 22-Nov-2021 3 doses of expired doses were administered. All 81 doses were booster doses.    Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Primary reporter details were added. Suspect drug dose number was added. On 01-Dec-2021: Follow-up was received with list of administration dates and number of dosage given on each day.
Unsure what flu shot I received. Headache and low fever on 12/1, rash on both arms 12/2 more severe on right arm
c/o lt upper arm swollen and red, warm to touch. Pt received 11 y/o boosters on 11/16/19. Father has been applying ice packs to area WCC sat, left arm received Tdap and meningitis. Using ice and 1/2 tab ibuprofen given last night some itching noted, seems worse 11/18/19 than yesterday.
Pt recvd vax & exp fever, chills, inc in SOB, t101, resp rate 32-40/min; chest exam revealed rales-poss pneumomia; BP dec in ER to 60 systolic ; WBC count on admission was 11.2; delusions, psychosis, psychotic, pulmonary emphysema;
Pt. experienced syncopal episode with mild seizure activity lasting less than 5 seconds immediately after receiving 4 immunizations, no loss of consciousness. Alert and oriented x3. Moving all extremities x4. B/p 140/90/pulse 80/respirations even and unlabored, color slightly pale. Within 15 minutes, client appeared recovered. B/P 120/82/pulse 72, respirations even and unlabored, color pink. Client denied any chest pain/tightness through episode. Able to walk out of Clinic accompanied by Mother. Mother and client counseled to advise future healthcare providers of syncopal hx. prior to any venipunctures or vaccinations.
Patient became pale, weak and hypertensive within 3 minutes after administration, colleagues noticed confusion with conversation. Experienced numbness inside nose which resolved spontaneously.   Initially refused ER but then throat became scratchy. He was seen in the ER approximately an hour after administration and was given IV fluids, benadryl and dexamethasone. Home prescriptions given of loratadine 10mg po daily and prednisone 40mg po qd x 4 days starting 12/31/2020.