chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received an adult Engerix-B/ inadvertently received an adult Engerix-B; an adolescent patient inadvertently received an adult Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 18-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   On 16th August 2021, the patient received the 1st dose of Engerix B adult. On 16th August 2021, unknown after receiving Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.  Additional details were provided as follows: The office manager of provider's office reported that, an adolescent patient inadvertently received an adult Engerix-B for their first dose, which led to accidental overdose and adult product administered to child. The patient received correct pediatric dose for their second dose in September 2021. The reporter consented to follow up.
Right arm was hyper sensitive to touch / increased sensitivity in arm; Numbness in her arm; Tingling in her arm; Cannot move arm or straighten it; Winced in pain when she touched it; This case was reported by a nurse via sales rep and described the occurrence of touch sensitivity increased in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB02BA, expiry date 26th February 2022) for prophylaxis.   Co-suspect products included Hepatitis A vaccine for prophylaxis and Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Bexsero .5 ml, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season. On 15th October 2020, 2 days after receiving Bexsero, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm. On an unknown date, the outcome of the touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm were unknown.   It was unknown if the reporter considered the touch sensitivity increased, numbness of upper extremities, tingling of extremity, mobility decreased and pain in arm to be related to Bexsero, Hepatitis A vaccine and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were as follows: The age at vaccination was not reported. Nurse reported that patient got first dose of Bexsero on 13 th October,on right arm. and on same day patient received the Hepatitis A vaccine and flu vaccine in left arm. On 15th October patient complaint about events like right arm was hyper sensitive to touch and experienced numbness and tingling in her arm.  It was reported that nothing visible to eyes and looked normal, no redness or swelling also she stated that patient had been keeping her elbow in flex position and not able to move arm or straighten it. The physician also reported hyperaesthesia (increased sensitivity in arm and patient winced in pain when she touched it). The doctor told her to lay low for a couple of days. The reporter consented to follow up.
day after the second vaccination I was sick in bed all day with fever, chills, muscle painand fatigue.  For next week,I was very tired and had to push myself to get anything done.  Then I started feeling my heart pounding which lasted for about for about 10 days 24/7.  I saw a new Dr on March 30th, and she sent me for lab work and an Echo.  All tests so far are negative.  The pounding is no longer 24/7, but the episodes which feel like adrenaline rushes come daily anywhere from 2-12 hours leaving me exhausted.  I am currently wearing a  heart rate monitor and will have a stress echo in May to rule out heart disease.  Also looking into tests to see if the problem comes from the adrenaline glands.  I was in top shape and feeling wonderful before the 2nd shot.
Changes with monthly Menstrual . Dose 1 (04/30/2021) after pzifer vaccine, heavy period  came the same day after I was injected and it came 1 week early. And now dose 2 (05/21/2021) of Pzifer vaccine heavy cramping  period came immediately after vaccine as well 1 week early. menstrual is always on time never early nor painful. seeing immediate changes after these 2 doses.
3 days after vaccine paresthesia in arms, hands, legs, feet and face. After 3 days symptoms seem to be resolving. No more weakness.
Developed rash/hives on face within 2-3 hours of administration went to Urgent Care; treated with BENADRL.
Localized reaction: Pt reported lt deltoid area swelling and pain one day after receiving Tdap IM injection. Pt was evaluated by PCP. Mild swelling to lt deltoid area. Treatment ibuprofen and BACITRACIN.
product storage error; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 18-DEC-2020, the patient received improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037501, expiration date of 12-NOV-2021, subcutaneous in the left arm , varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date of 21-MAY-2022, subcutaneous in the left arm for prophylaxis  The vaccines experienced temperature excursions with a total of 29.5h.   This is one of several reports from the same reporter(US-009507513-2101USA011364).
Pt c/o soreness, pain, redness and heat at injection site that started 24 hours after Tdap was given. Pt states that the pain and soreness have continued to spread and is now affecting her neck, back and entire arm.
Pulmonary fibrosis; COPD; got sick; bloating; shortness of breath/ Even if lying down, he has difficulty breathing; ulcer; This is a spontaneous report from a contactable nurse (reporting for her husband). A male patient of an unspecified age (reported as Age: 67, unit: unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided) via an unspecified route of administration on 22Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter would like to know if the COVID vaccine is less effective if administered more than 21 days apart. She also reported that her husband (patient) received his first dose on 22Feb2021 and got sick on an unspecified date. Pulmonary fibrosis and COPD, for which he currently requires prednisolone. Last weeks, he had complaints of bloating and shortness of breath which was observed until Sunday (unspecified date). Even if lying down, he has difficulty breathing. He takes Symbicort. She rushed him to the emergency this morning (unspecified date) at 12:00. Although he has had similar complaints before, they still did an endoscopy and found ulcers. For his COPD exacerbation, he is taking prednisolone to lessen the inflammation. Now he's okay. She read on the Prednisolone information that it diminishes vaccine efficacy. The second dose of the COVID vaccine was supposed to be today but was moved on an unspecified date. The outcome of the events was recovered on an unspecified date.; Sender's Comments: Based on the temporal gap between the vaccination and the event onset and considering the product's known safety profile, there was not a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the events pulmonary fibrosis and chronic obstructive pulmonary disease (COPD). The events were most likely due to the patient's underlying conditions. 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.
Headache, Myalgia, Arthralgia, Fever,  Chills, Fatigue, Injection site pain Narrative:
Patient was given Fluzone vaccine (Lot UT499AA Exp 6/30/12) IM at approximately 11:35am at a worksite health fair.  This was his first time receiving a flu vaccination.  After approximately 10 minutes, patient reported having a heaviness in his chest and tightness in his throat.  He also complained of feeling short of breath.  No signs of rash, swelling of tongue or throat, and patient was alert.  We had him sit for a few minutes and monitored his symptoms.  At approximately 11:55am, the ambulance was called, and patient was taken to hospital.  He was treated with prednisone and Allegra, then released.  I was not able to reach the patient for further follow up.
Patient was experiencing fever, hives and Itching (allergy) was there for 2 days. Patient was fine after 2 days and she had her regular doctor visit on the 3rd day.
pt recvd vax & exp fluttering in chest, diaphoresis,fever & chills;5DEC94 pt was advised by MD that if sx cont,a cardiology referral could be made,if pt wished;pt has not called MD since that time;pt is scheduled for 3rd dose of vax
Per employee's report , on 6/21/23 employee awoke with body aches and later in day developed headache and fever (100.0 F), and mild cough.  Treatments included Excedrin (acetaminophen, aspirin, and caffeine), Advil (ibuprofen), sleep, and "lots of water" with only body aches lessening  with next 2 days (6/23/23) and fever and headache remaining.
Local swelling and erythema to right thigh starting about 24 hours after vaccine administration.
2/15/2018: presented at ED with hives, dizziness, nausea, and facial swelling. Symptoms treated and discharged. 2/17/2018: brought to ED by EMS for evaluation of syncopal event, fever, chills, fatigue.  Labs and ECG done, symptoms treated, and discharged. 2/18/2018: presented at ED with continued dizziness and weakness, hives. Labs done, symptoms treated, and discharged. 2/21/2018:  presented at ED with lower abdominal pain, vomiting, fatigue, headache. Labs and x-ray done, symptoms treated, and discharged. 2/28/2018:  appointment with PCP for ED follow up:  since BEXSERO #2 on 2/14/2018 continues with racing heart, fatigue, muscle aches, lightheadedness. Further testing pending.
Pt to ED 1/1 for sudden onset of shortness of breath. Pt COVID+ 1/1, on 2L NC, oral Decadron ordered. 1/2 pt is A&Ox4 with clear speech. Respirations are regular and unlabored, skin is warm and dry. Plan of care discussed, patient verbalized understanding. Pt on room air, verbalized improvement in breathing.
Source of report and patient demography: This spontaneous case was initially received on 16-Mar-2016. The case report was received from a Health Professional and concerns a 34 year old female, pregnant patient. The last menstrual date was 29-Dec-2014 and the expected date of delivery was 10-Jul-2015 (ultrasound confirmed dates). Ultrasound was performed during the pregnancy and the result was normal nuchal translucency. There was no failure in contraception. Weight: 66 kilograms, Height: 170 centimeters. Linked Case ID(s): US-BEH-2016060371 (Mother-child pair). Concurrent medication condition(s), medical and drug history: The patient has a medical history of Smoking, G2P1 and a missed abortion. Concomitant medication included prenatal vitamins only. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s): The patient received AFLURIA in early pregnancy on 11-Feb-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: not provided, site: left deltoid. Additional suspect drug(s): No additional drugs suspected. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA the patient experienced Numbness in throat (non serious, outcome: Recovered / Resolved), Metallic taste (non serious, outcome; Recovered / Resolved), Numbness in her mouth (non serious, outcome; Recovered / Resolved), Numbness radiated down the right side of her teeth (non serious, outcome; Recovered / Resolved), Pregnant patient was vaccinated (non serious, outcome; Recovered / Resolved), Tingling in mouth (non serious, outcome; Recovered / Resolved), Tingling in throat (non serious, outcome; Recovered / Resolved). The mother delivered a baby boy (weight 3.85 kg) via the normal vaginal delivery at full term. The Apgar score was 9 at 5 minutes and 9 at 10 minutes. The mother had no maternal complications or problems related to birth. On an unspecified date, the infant patient developed bilateral fetal pyelectasis (mild) on ultrasound. The patient was seen by urology after birth and was reported normal. In Feb-2016, the patient was seen by urology and no further follow-up was needed. The 'innocent heart murmur' was to be evaluated by paediatic-cardiology in March 2016 (see case 2016060371). Reporter's assessment: non-serious, did not require hospitalisation, not life threatening and not medically significant. Causality - not suspected in relation to AFLURIA. The Health Professional considered the event(s) Numbness in throat, Metallic taste, Numbness in her mouth, Numbness radiated down the right side of her teeth, Pregnant patient was vaccinated, Tingling in mouth, Tingling in throat as non-serious and unrelated. 23-JUN-2016 (System Update): Linked Case ID(s): US-BEH-2016060371 (Parent-Child Link).
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-031890, MOD-2021-032239, MOD-2021-030077, MOD-2021-032129 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Outcome of the event was updated to recovered.
I had the typical soreness about 12 hours after the injection. No worries there. The next morning, on the 10th, around 11:40 AM, I started feeling extremely dizzy. The room started spinning. I was standing at the time, and I kept standing, but other than that, I had no control. My hearing starting going fuzzy, starting with ringing in my ears until it sounded like I was underwater. My vision started blurring, as well, eventually going completely black. For a solid 5-10 seconds, I could neither hear clearly nor see at all. I was conscious, because I could think relatively clearly, and I could feel my eyes blinking and could wiggle my fingers, but that was it. Once the episode passed, I immediately sat down. About a minute later, I started having excruciating abdominal pain. The pain was wracking my whole body, causing me to go pale (as I later saw once I could hobble to the bathroom) and making me sweat. After about twenty minutes, the whole thing passed and I was left with minor dizziness and slight nausea. Now, three days later, I still have some of the dizziness, but none of the blindness, deafness, or pain has returned. All other side effects, such as soreness, have completely left.
three days later from each time, I had horrible, horrible reaction; vertigo; so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction), DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to) and VERTIGO (vertigo) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to). On an unknown date, the patient experienced VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction) and VERTIGO (vertigo). At the time of the report, VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction), DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to) and VERTIGO (vertigo) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-311397, MOD-2021-311050, MOD-2021-311042 (Patient Link).
soreness to shoulder where vaccine was given. The following day, lymph nodes in the armpit were swollen and painful.
extreme fatigue/wealness, difficulty concentrating /stay on task, nausea, chills, equilibrium is off
Sore arm immediately that lasted for 3 days. First night painful could not sleep. As of this date I continue to experience fatigue, headaches, light pressure back of the head, appetite is improved over the last couple of days. Energy level is low especially if I move around or try and exercise. One night difficulty swallowing.
This spontaneous report as received from a consumer refers to herself, a female patient of unknown age and no reported medical history. On an unknown date the patient was vaccinated with ZOSTAVAX (route, dose and lot number unknown). No other suspect therapies or concomitant medications were reported. On an unknown date the patient experienced may have been improperly stored. Noted that she received ZOSTAVAX withiout any proper storage instructions but was not administered the dose but that these other doses of ZOSTAVAX dispensed by this pharmarcy may have been improperly stored and administered to other unspecified patients on unspecified dates. Consumer requested AE follow up report be sent to the owner of the pharmacy. Please note the consumer did not want AE follow up report sent to her physician. No adverse effect reported. Please note that PQC filed on possible missing prescribing information for ZOSTAVAX packaging. The primary reporter, reports that she has not received the improperly stored dose of ZOSTAVAX. She is reporting an improper practice which may affect unspecified numbers of unspecified patients. Additional information has been requested.
09/07/2005 12:50 called patient -LM to return call. 09/08/2005 1:55 called patient she was going to class and could not talk, asked to return call after class. 09/09/2005 return call from patient. Asked to relate incident to me. Stated has 8:30 appointment, She was not aware that she had to wait 20 min in waiting room. She saw other students walking out and though it was OK if she left. She felt slight dizzy while walking to car, got into car and drove home she was on her street when she blacked out she came to when she hit the curb. She wasn't sure what happened unsure of time of accident. Did not seek medical Rx after accident.
Pt had a COVID test due to requiring psychiatric admission.  The test was positive and the patient was found to have COVID pneumonia and required admission.
Patient stated he had diarrhea and vomiting (1 time) 4 days after receiving vaccine.  He also stated he is having "gastric upset and pain".  I recommend he contact his physician to be evaluated.
pt recvd vax 15JUN93 & devel bumps on both cheeks of face 6 hrs later which were not itchy or red; pt given DPH;
UrticariaPruritus itchy, warm, throb, lymph node swelling Narrative:  pt w tattoo on inj site; day 8 - site got itchy, warm, throbbing, noted lymph node swelling in axilla of inj site arm; day 9 - symptoms still persisting
3 months after having the vaccine, my shoulder started to have a pain. I was unable to move my arm from right to left or back. It has improved but I am still having issues moving the arm backwards. I have not seen a doctor. I have taken ibuprofen and Tylenol but nothing works. I had a cold and warm massage and the hot pack improved the symptoms. On a Saturday around 1:00PM, I was not feeling well and my daughter told me to take a COVID-19 test because I was tired and feeling crappy. I took the test and it was positive on June 25, 2022. I called an advice nurse and the doctor prescribed me Paxlovid. When I took the medication, my throat had started to hurt. I believed it was from the medication so I did not take it the next day. I took just Tylenol and ibuprofen. My symptoms improved with 12 hours. I continued to isolate for 5 days.
infection; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No relevant medical history was provided.  The patient's past medical history included COVID-19 in October 2020. Concomitant products included METFORMIN, LISINOPRIL, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FISH OIL, INSULIN GLARGINE (LANTUS), NITROGLYCERIN, ATORVASTATIN, METOPROLOL TARTRATE, ISOSORBIDE MONONITRATE (ISORBIDE [ISOSORBIDE MONONITRATE]), TICAGRELOR (BRILINTA), DEXLANSOPRAZOLE (DEXILANT), EMPAGLIFLOZIN (JARDIANCE), CYCLOBENZAPRINE HYDROCHLORIDE (CYCLOBENZAPRIN), ESTRADIOL, MAGNESIUM and TRAZODONE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (infection). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Infection, at a dose of 1 dosage form and AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) for Infection, at a dose of 1 dosage form. At the time of the report, INFECTION (infection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient finished taking Augmentin antibiotic for an infection on 04Apr2021 and completed Medrol dose pack steroid last week.
Asthma flair -  6 hr till 36 hrs after shot. Fever 101.1  24 hrs after vaccine  Body Aches  Site of injection  Red, welt,  hot  Itchy.  Took Asthma medication,, Tylenol
Fever of 101 F-103 F, lethargy, loss of appetite for 3 days.