chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given 5-11yr Bivalent dose when 12+ Bivalent dose was ordered. Patient and mom notified of error. No signs or symptoms of an adverse reaction.
Patient called me on Friday, 11/15/19 to inform me that she had a bad reaction to the vaccination she got at our location.  She got a flu shot in her left arm and PPSV23 in her right arm.  She reported having warmth, redness, swelling and soreness at the injection site on her right arm on 11/8/19.  The following day 11/9/19, she said was not eating  well, extremely sleepy, and that she had passed out cold on the floor of her home and was unsure of how long she had been out.  She went in to see her doctor who reported her WBC was high but she said she was not running a fever. He treated her with a week supply of Cephalexin.
COUGH; CHILLS; FEVER; This spontaneous report received from a patient concerned a 47 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and alcohol user, and other pre-existing medical conditions included the patient was healthy. patient do not have any known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination at left arm.The batch number was not reported and has been requested. No concomitant medications were reported. On 09-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced cough. On 10-MAR-2021, the subject experienced chills. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) unknown, and COVID-19 rapid POC test (NR: not provided) unknown. Treatment medications (dates unspecified) included: paracetamol, benzonatate, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and cough was not reported. This report was non-serious.
Chills, aches, headache, weakness, fever and nausea followed flu vaccine and resolved within 24 hours.
I begin chilling the next day after I received the vaccine and started running a low grade fever of 100.5-body aches, headache, fatigue and pain in the arm where I received vaccine x 2 days.
12:15PM Varivax given observed in nurses office, 12:40 c/o swollen upper lip, itching, to nurses office, 12:45 3 chewable Benadryl tablets admin orally, wheezing becoming worse. Took 2 puffs of albuterol inhaler, 12:50 1st dose Epi-pen given Left thigh, 911 called, 12:55 police arrived O2 started wheezing subsided some, 1:05 Ambulance arrived, transported to hospital.
Loud ringing in both ears. I got the shot at about 3:30. (Estimate) I sat there for 15 minutes, drove to the grocery store with the radio on in the car, shopped, went home. Arrived about 6 p.m. The house was quiet and I immediately noticed the ringing in my ears. It lasted all evening but was gone the next morning.  I need to know if I should avoid the second shot. I really wanted the J&J, and had an appointment for it on 4/17, before the pause. I DO NOT WANT A PERMENANT PROBLEM RELATED TO MY HEARING, PLEASE ADVISE!
Information has been received from a health care worker concerning a 23 year old female with drug reactions to "emytin" and Cipro who on 02-APR-2007 was vaccinated intramuscularly with a third dose of Gardasil (Lot # 657006/0188U). On 02-APR-2007 the patient developed a lump on her right arm after administration of the vaccine. The patient sought unspecified medical attention. At the time of this report, the patient's lump on her right arm persisted. No product quality complaint was involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Asthma" (unspecified if ongoing), notes: Other medical history: Asthma. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (30Jun2022) Positive, notes: Tested positive 30Jun; (05Jul2022) Negative, notes: Test negative 05Jul and 06Jul; (06Jul2022) Negative, notes: Test negative 05Jul and 06Jul; (14Jul2022) Positive, notes: Test positive 14Jul. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: After tested positive 30Jun2022, patient received treatment with Paxlovid from 01Jul2022 to 05Jul2022. Tested negative on 05Jul2022 and 06Jul2022. However, symptoms started again on 13Jul2022 and tested positive 14Jul2022. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Pt reported feeling like the back of her tongue was swollen. Nothing seen on physical exam. No edema of oral pharynx or uvula seen on physical during the next 45 minutes of observation. No other worrisome symptoms and able to drink and breathe normally.  We monitored for over 30 minutes while her father went and got her some benadryl.  No progression and no other symptoms.  She was released home with family observation and instructions to call 911 or go to the ER if she felt like her symptoms were worsening
Right Leg where Varivax immunization administered was red, swollen and warm.  Size was 2-3 inches in diameter.  Patient had difficulty walking.
Red lump on left arm for ten days, now just lump, sickness for 10 days, muscle soreness on going especially in upper body, left arm hurts when lifting above head. Headaches.
pains; fever; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (pains), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (pains), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, PAIN (pains), PYREXIA (fever), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drugs were not provided,  Concomitant medicines were not included,  Action taken with mRNA-1273 in response to the event was unknown.
Reported Symptoms:  10037844:RASH; 10037844:RASH;    Narrative:  A 69yo female with PMH of DM type II, HTN, MST, Anxiety and Chronic Pain.  On January 5, 2023, RN reported the patient had a historical ADR of Influenza vaccine
Injection site sore still, radiating joint and muscle pain (hands, arms, shoulder), headaches, fever up to 100.8 >24hrs, body aches,  tingling on the face, tiring, insomnia, mouth sores
PATIENT WAS OBSERVED SLOUCHING OVER IN HER CHAIR AND WHEN STAFF TRIED TO SPEAK TO HER SHE WAS UNRESPONSIVE BUT BREATHING, NONCOHEARANT. 02 WAS 83-90, PULSE 115, BP 93/53.  EMS WAS CALLED AND SHE WAS TRANSPORTED TO THE ER IMMEDIATLY. ER PHYSICIAN WAS UNSURE IF THE MENTAL STATUS CHANGE WAS FROM VACCINE OR POSSIBLE UTI. ATTMEPTED TO OBTAIN A URINE SAMPLE AND STARTED EMPIRIC ANTIBIOTICS.
Menstrual cycle came 7 days earlier; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle came 7 days earlier) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in February 2021.    On 06-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced MENSTRUAL DISORDER (Menstrual cycle came 7 days earlier). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle came 7 days earlier) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient had no allergies and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was not taking any concomitant medication. The patient told that she has a very regular cycle and never happened this to her. Her menstrual cycle came 7 days earlier and she was very concern about it. She said that was a red flag for her.  The AE did not cause patient to seek medical care at the moment but she will go. She did not experienced a similar event in the past, always been spread out. No treatment medication was provided.
Cellulitic redness/warmth/induration/pain around injection sites left upper arm.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date between 06-APR-2017 and 01-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M016193, expiration date 24-APR-2018, intramuscularly (dose was not reported) in immunization series. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 1 hour and 53 minute and of 34.7 degrees Fahrenheit for 1 hour and 25 minutes. There were no previous temperature excursions reported. A Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007705: US-009507513-1705USA007707: US-009507513-1705USA007708: US-009507513-1705USA007709: US-009507513-1705USA007710: US-009507513-1705USA007711: US-009507513-1705USA007712: US-009507513-1705USA000781.
Small blisters and red hardened skin on palms of hands and arches of feet.  Issue started roughly 3 weeks after vaccine and hasn't gone away.
Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster).    No concomitant medications were reported. No treatment details were reported. It was reported that total 3 Adult patients received Moderna's monovalent Pediatrics for primary series 6 to 11 years instead of Moderna's Bivalent booster dose.   This case was linked to MOD-2022-662872, MOD-2022-662904 (Linked Report).; Sender's Comments:  MOD-2022-662872:Adult-1 MOD-2022-662904:Adult-2
broke out in hives on rt arm, chest;went to intermediate care ctr;given DPH & cortisone inj IM;given rx for tapering pred & DPH;mild SOB;
This spontaneous report as received from a pharmacist refers to a 'newborn infant' patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-MAY-2016 at 07:00, the patient was vaccinated with RECOMBIVAX HB lot # L038018, exp. 13-SEP-2017, 0.5 ml, intramuscularly and then another dose of RECOMVIVAX HB lot # L038018, exp. 13-SEP-2017 intramuscularly at 07:45 on 05-MAY-2016 (coded as overdose). There was no adverse event reported. The outcome of the event was not reported. Additional information has been requested.
Patient transferred from outside facility s/p PEA arrest and renal failure. Outside facility name is: Hospital. Of note, unclear what provider cared for the patient at this hospital from the electronic health record. Patient originally admitted for worsening dyspnea onset 2 weeks prior to arrival at hospital (8/8), developed hemoptysis and was admitted for acute hypoxic respiratory failure 2/2 COVID pneumonia vs. acute on chronic HF. Patient was initially placed on IV abx, dexamethasone and remdesivir.  Noted poor tolerance to BiPAP and was found on the floor in PEA  on 8/28. Subsequently intubated. Had pressor requirement, but has since been weaned off. Developed oliguric AKI with uptrending creatinine and volume overload prompting transfer to bigger hospital for further management of his HFrEF and Renal failure. Patient had a complicated hospital course. On discharge, patient was stable on minimal ventilator settings. Discharge Disposition/Condition. Disposition: Long Term Acute Care facility (LTACH) (specify), Condition: Stable (s/sx potential problems absent or manageable)
had no problems was being given prophylactic APAP; mom left pt to get APAP & when returned pt was quiet & blue, turning white & unresponsive; mom pushed on site of inject & pt cried; called local ER;
Client in drive thru vaccination for 2nd dose of Pfizer vaccine on 4/6/2021.  Reported to the triage nurse that he had been experiencing vaccine induced tinnitis since first vaccine.  Tinnitis worse when eating high sugar foods and caffeine. Client told triage nurse that he had tried to do a VAERs report but did not have success submitting report. Called client on 4/7/2021 and left vm asking for additional information for VAERs report.  Did not receive return call by the end of the business day so submitted VAERS with info I was given.  Client did not receive the 2nd Pfizer vaccine.
Incorrect flu immz administered. Patient received FLUZONE greater than 3 YO plus dose.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine type meds).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided   This case was linked to MOD-2021-027385 (Patient Link).
Facial swelling, mouth swelling, eyes bloodshot, trouble breathing, racing pulse, increased blood pressure, difficulty swallowing, difficulty breathing.
Patient fainted after receiving 1st dose of the Pfizer vaccine. Once vaccine was administered in the pharmacy area, patient moved to the waiting area near one of the aisles. She was in the aisle with her father when she fainted, and father brought her to one of the nearby chairs where she sat down. Patient was conscious and stated she was feeling dizzy, no other symptoms, and did not want us to call 911. She drank some water and remained seated for 30 minutes. Pharmacist checked on her every 10 minutes to make sure she was still feeling okay. Patient stated that she was "really nervous" to get the vaccine. She denied feeling any other symptoms, and after sitting down said she was feeling better.
pt recv 2 doses of hepta B.  after 2nd vax, pt ex h/a, nausea, vomiting, and upper quadrant pain accomp. by general malaise of one week duration.  upper GI series and sonogram were normal.
Received first dose on 1/2/22 and started my menstrual cycle the following day (1/3/22) which was one week early. My next menstrual cycle started early again on 1/28/22 and on my second day (1/29/22), I was 30 minutes into a run/walk on my treadmill when I began bleeding profusely and had to stop. I bleed for another 30 minutes very heavily in which I began passing large blood clots that continued for the next 12 hours. I went to see my OBGYN the following day.
The day after the vaccine patient reports rash developed on left and right side of waist. He states it is itchy which comes on and off. Patient reported the symptoms to his doctor on 9/26/13 and doctor recommended hydrocortisone cream which patient states helps the itch. Symptoms present now for 2 weeks.
chest tightness/spasm in right pectoral muscle; monitored; resolved 5 mins
blisters on lips developed the next morning and persisted for days, swelling in arms and lymph nodes, neck and tongue
they gave him 6 times the amount of the regular dosage; pharmacist made a mistake.; This is a spontaneous report from a contactable consume reported on behalf of (her fiancee). A 25-years-old male patient (medical student) received  the first dose of bnt162b2 (BNT162B2, Lot Number Unknown) via an unspecified route of administration on  05Feb2021 as a Single Dose  for covid-19 immunisation.  The patient had no known medical history.  There were no concomitant medications. Reporter does not have his vaccine card with her therefore could not provide the Lot Number or Expiration Date. On 05Feb2021, the patient experienced they gave him 6 times the amount of the regular dosage. The patient received a call from (Specialty Pharmacy name) informing him  they gave him 6 times the normal dose. They said '1.8 and 0.3 was what he was supposed to get'. The patient was not given any details about how this occurred they just said the pharmacist made a mistake. The patient feels fine but customer service at (Specialty Pharmacy name) did not provide the patient with a lot of information. Consumer inquired Do they basically just monitor him? The reporter was unsure if (Specialty Pharmacy name) reported this incident to Pfizer.  The clinical outcome of the event accidental overdose and product administration error was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Information has been received from a physician concerning a 9-10 yr old male who was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Subsequently, the pt experienced minor case of chicken pox with a few scattered lesions on his trunk area. No treatment was given and the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
fever 101.5; fatigue; Headache; Chills; left arm pain from my shoulder to fingers; Nausea; Body aches; hazy feeling; This is a spontaneous report from a contactable other health care professional, the patient. A 48-year-old non- pregnant female patient, received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 23Mar2021 at 09:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypertension, Inflammatory bowel syndrome (IBS) and migraines. The patient did not have allergies to medications, food, or other products. Unspecified concomitant medications were taken by the patient. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route in the left arm on 03Mar20221 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 23Mar2021 at 14:00, the patient experienced fever 101.5 (units unspecified), fatigue, headache, hazy feeling (hazy vision), chills, left arm pain from her shoulder to fingers, nausea, body aches. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcomes of fever 101.5, fatigue, headache, hazy feeling, chills, left arm pain from her shoulder to fingers, nausea and body aches were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
ON THE COACH TODAY THE ALL DAY; VERY TIRED AND EXHAUSTED; SLIGHT HEADACHE; THE INJECTION STING A LITTLE BIT; VERY DROWSY; SLEPT FOR 9.5 HOURS LAST NIGHT AND DID NOT WAKE UP TILL 9:30 MORNING; This spontaneous report received from a patient concerned a 62-year-old male of unspecified race and ethnic origin. The patient's weight was 200 pounds, and height was 69 inches. The patient's past medical history included: guillain-barre syndrome (GBS) (and cannot have the flu vaccine), and concurrent conditions included: diabetes (type II), alcohol use (3 beers per week), non-smoker, and blood pressure abnormal. The patient had no history of drug abuse or illicit drug use.  The patient experienced diarrhea and throwing up when treated with potassium citrate, and sick and very nauseous when treated with cefalexin. The patient received vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, and batch number, expiry were not reported ) dose was not reported, 01 total, administered on 09-APR-2021 for prophylactic vaccination. No adverse evets reported. No adverse event reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: 1855194, and expiry: 09-APR-2022) dose was not reported, 01 total administered on 22-NOV-2021 at 10:00 hours for prophylactic vaccination in right arm. No concomitant medications were reported. The patient was on blood pressure pill. On 22-NOV-2021, 3 hours following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2) the patient had slight headache, very tired, exhausted and was very drowsy. He slept for 9.5 hours last night (from the day of reporting) and did not wake up till 9:30 this (day of reporting) morning. He stated that, injection sting a little bit and the pharmacist told him that it was expected because it would go into the muscle. He was on the coach today the all day. The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable. The patient had not recovered from very tired and exhausted, slight headache, and on the coach today the all day, and the outcome of very drowsy, the injection sting a little bit and slept for 9.5 hours last night and did not wake up till 9:30 morning was not reported.  This report was non-serious. This case, from the same reporter is linked to 20211154670.