chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; patient came in for a typhoid fever vaccine but was given yf-vax intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a nurse.  This case is linked to cases 2023SA326767 and 2023SA326868.  This case involves a 38 years old male patient who came in for a Typhoid fever Vaccine but was given Yellow Fever Vaccine - [Yf-Vax] intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (hepatitis b vaccine) for Prophylactic vaccination.  On 20-Oct-2023, the patient received 0.5 ml total (Dose 1) (1 X) of suspect Yellow Fever Vaccine - Solution for injection (lot number: UJ819AA, Expiry date: 18-Apr-2024) (Strength: standard) (Frequency: once) via intramuscular route in the arm nos (not otherwise specified) for immunisation.  On 20-Oct-2023, the patient came in for a typhoid fever vaccine but was given Yellow Fever Vaccine - [Yf-Vax] intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (wrong product administered) (latency: same day).  It was reported, Nurse called to advise that patient came in for a typhoid fever vaccine but was given YF-VAX intramuscularly instead of subcutaneously.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient noticed that her dystonia has gotten worse since the COVID vaccine. She said she is falling more often now - once or twice a week when she used to fall less frequently (once a month).
I started to experience sinus congestion. My husband tested positive so I decided to take a test. On 12/23/2021, I took a rapid test and it came back positive. I ended up with fever, chills, cough and extreme fatigue. For about a day, I had stomach issues. About a week after I tested positive, I lost my taste and smell. I took some Theraflu and some allergy sinus medication and it did not help my symptoms. I tested a couple weeks later and the test came back negative.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).   An elderly male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Single, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: DIZZINESS (non-serious), ASTHENIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Two days of dizziness, weakness, and a sore arm.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2/19/03, developed small lesion on coccyx, some itching & burning, has hx of shingles. This was similar to flare-up 1 1/2 years ago. At that time she was tx'd with Valtrex. On the evening of 2/19/03, started tx with valtrex. In 24 hours site on coccyx improved. Vaccination site had some redness, swelling & itching on 2/19/03 but improved and cleared by 2/20/03.
pt had fever to 105 & was very irritable for 24-36 hrs then resolved; telephone follow up 5SEp92 doing well;
Patient was given a dose of Rotavirus vaccine and she shouldn't have recieved it because she was over the age of 12 weeks and this was her first dose.  The patient had no signs or symptoms of an adverse event, but received a vaccine that they shouldn't have.
Initial report was received from a health care professional on 08 February 2012. An 8-month-old patient (gender not reported) had received dose three of DAPTACEL (lot number, route, site and date of administration not reported) and the "next day", the patient's mom reported the patient was lethargic and slept for six hours. The patient's medical history, concomitant medications, illnesses at the time of vaccination and adverse event following prior vaccinations were not reported. The reporter declined to provide further information or contact information. No further information to provide. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Rash developed within 48 hours after second vaccine dose. Rash is on forearms, thighs, and legs. He has seen an allergist and blood was drawn for lab tests. Biopsy of rash is planned.
developing digestive issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (developing digestive issues) in a  patient of an unknown age and 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (developing digestive issues). At the time of the report, DYSPEPSIA (developing digestive issues) outcome was unknown.            Concomitant medications were not provided. No treatment information was provided.   This case was linked to MOD-2021-288736 (Patient Link).
This spontaneous report as received from a nurse practitioner refers to a 17 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 23-DEC-2014, the patient was vaccinated with the dose of GARDASIL lot # K006191 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. No information about medical histories, concomitant medications, concurrent conditions or drug reactions and allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (doses, routes and sites of vaccinations were not reported, lot number K011081, expiry date 08-AUG-2016). It was reported that all of the vaccinations were administered prior to the expiration date. Digital Data Logger was involved. Doses of vaccines underwent temperature excursion of -14.2 degrees Celsius for 2 hours. Previous temperature excursions were reported as follows: -14.2 degrees Celsius for 2 hours, -11.5 degrees Celsius for 3 hours, -11.0 degrees Celsius for 3 hours and 30 minutes, -12.4 degrees Celsius for 3 hours, -12.4 degrees Celsius for 3 hours, -12.6 degrees Celsius for 2 hours 30 minutes, -14.2 degrees Celsius for 30 minutes and -5.7 degrees Celsius for 13 hours and 30 minutes. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 6/24/21 Lot# EW0196;  Pfizer 7/15/21 Lot# E0196
noticed sores in oral cavity & lesions on the floor of mouth which devel w/in 7 days of MMR vax;
Pt received a full moderna shot on 09/21/21 and got a moderna booster on 1/11/22 which is too early from the recommended 5 months
10 min after the shot was given he lost vision, fainted, eyes rolled back, moaning , and started to shake
This case was reported by a nurse via sales rep and described the occurrence of shingles in a female patient who received FLUARIX Tetra. On an unknown date, the patient received FLUARIX Tetra at an unknown dose. On an unknown date, 14 days after receiving FLUARIX Tetra, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to FLUARIX Tetra. Additional information provided as follows: The nurse was agreed to take follow up. The nurse had two patients in the hospital. The nurse wondered if this could have been triggered by vaccine. This case has been linked with US2017GSK175535, as reported by the same reporter.
12/5/2022 Started in the afternoon with a scratchy throat and coughing.  Went to Urgent Care with symptoms but no tests were positive.  Advised to monitor and come back if things got worse as no tests were positive.  12/11 Went to Urgent Care Tested positive on a Rapid COVID-19 Test.  Doctor Proscribed Prednisone for 5 days.  The symptoms gradually got better over the next 4 days, with the sore throat clearing up the first day.  Couch lingered for a month or more and sense of taste was not correct for about the same length of time.
Pt received Pfizer 1st dose on 3/30/21. Pt became COVID + on 4/6/21. Pt was hospitalized d/t COVID on 4/7/21
Received yellow fever vaccination in left arm over August Unit Training Assembly.  Patient did not experience any problems until approx 1 hour later.  He ate lunch returned to work and felt a generalized weakness in his body, he denies any ringing in the ears but states that he did see stars.  Patient was sent to the MC and given fluids (PO) and no further treatment was provided and symptoms did not recur.  He was released back to full duty and considered worldwide ready and able to perform assigned tasks.
A second dose of Pfizer Covid-19 vaccine pediatrics 5-11 years was administered on 10/29/22 with a short-dated/expired/recalled vaccine manufacture date 10/2021 with a 10 weeks expiration date after the date of receiving was 11/4/2022 (actual expiry date: 9/30/2022). Called the patient's parent to see how the patient is doing and if there is any side effects after the vaccination to follow up but no answers. Left a voicemail message and will try to call back.
Information has been received from a registered nurse who was reporting on her 15-month-old child who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Twenty-four hours after vaccination the patient experienced a fever of 104.5 degrees. At the time of the report the patient's status was unknown. A product quality complaint was not involved. No further information is available.
This spontaneous report was received from a certified medical assistant referring to a 35 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 16-NOV-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot number L024993 and expiration date of 17-OCT-2017 for prophylaxis (dose and route of administration were not reported).
About 21 hours after receiving my second shot, I started to run a fever and feel a little achy. Temperature got up to 100.8°. Fever broke about 0700 the next morning. No other symptoms. Patient feels fine and is back to normal. Patient had a sore arm for 2 days after both shots.
A report was received from a health professional on 16Oct02, concerning about 20 vaccines between the ages of 6-35 months who were inadvertently administered Fluvirin between 14-16Oct02. Between 14-16Oct02, about 20 vaccinees between the ages of 6-35 months were inadvertently administered 0.25ml of the Fluvirin vaccine in the vastus lateralis. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. There was insufficient information to determine the reporters causality assessment. Update 1 27Dec02: A report received from a health care professional indicated that a female vaccinee of unk age inadvertently received Fluvirin vaccination on 15Oct02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300021, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300027, PJP200300028, PJP200300029.
Patient reports a chronic pain/ache in heart.   Also she had an increase in her heart rate while at rest that lasted for approximately 1 hour
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was reported regarding concomitant medications, medical history of concurrent conditions. On 28-JAN-2019, the patient was vaccinated with an expired PROQUAD recombinant Human Albumin, lot # N020010 with expiration date on 13-JAN-2019 for prophylaxis (dose and route of administration were not reported).
patient received only about 1/2 to 3/4 of the Quadracel vaccine because the child was moving; Initial information received on 23-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 5 year old child patient who vaccinated with 1/2 to 3/4 DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] since the child was moving.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and AESCULUS HIPPOCASTANUM (VARIVAX [AESCULUS HIPPOCASTANUM]) for Immunisation.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-May-2019, the patient received a 0.5 ml once dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (formulation: unknown, lot number C5500CA, expiry date 16 Aug 2020) via unknown route in unknown administration site.  Today's Quadracel dose was the patient's fifth in the DTaP series, and the fourth in the IPV series.  It was a case of actual medication error due to vaccine underdose (patient received only about 1/2 to 3/4 of the quadracel vaccine because the child was moving.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Anaphylactic reaction; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, less than 2 years after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.   It was unknown if the reporter considered the anaphylactic reaction to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had an anaphylactic reaction t o an unknown influenza vaccine that was administered in a previous season. Health care professional (HCP) did not provide any further details regarding patient or vaccine administered. The patient did not consent to follow up.
Severe pain to arm within 4 hours Next symptoms were on 4/30/2021 Fever started at approximately 2am 103.7 Vomiting/Nausea 5am Bodywide pain noted at 5am Tylenol 1000mg taken at 5am Symptoms continued for the duration of the day. Fever reduced to 100 for most of the day. Shortness of breath started at 1pm with cyanosis during exertion. Positive cough as well.  Returned to bed after 3rd dose of Tylenol. Unable to take Motrin due to increased bleeding issues. 5/1/2021 symptoms Woke at approximately 1am to severe nausea and vomiting. Bodywide aching noted to have returned. Fever of 101.7 SOB continued however cyanosis abated Tylenol 4th dose taken. Fever remained at 101 at 5am. Motrin 600mg taken due to no reduction of fever or pain with Tylenol. Pain and SOB tolerable at this time. 10am
rash, breathing, feet swelled 1 hour post shot then 3 hours later heart raced, breathing got worse. Today R arm swollen with rash, weak, high fever, migraine
Day after shot left side of tongue swelling beginning gradually  End of second day  left side of  tongue  visibly swollen  arm  was red and slightly swollen below shot site Treatment: ice on tongue then took two Tylenol went to  bed Third day, in the morning,tongue less swollen  and by mid morning swelling almost gone  Arm still slightly red and tender below shot site
12/31/20 fever, cough, diarrhea, congestion, runny nose, fatigue, difficulty breathing, chills, HA  12/31/20 Tested positive for Covid
Week one- swollen, sore injection site and nasal congestion. Fexofenadine 180mg was taken Dailey and Flonase nasal spray Dailey. Symptoms continued into week 2 with delayed onset urticaria occurring at day 10 after Moderna Covid booster. The urticaria was spontaneous and moved around various locations of the body.  Back of neck, torso, underarms, spine, hands and palms of hands.  Tightness of throat and difficulty swallowing food.
Shortly after receiving the vaccine my left tricep / bicep starting to hurting.  I have limited movement in my left arm compared to my right.      If i move too far I have a sharp pain.  The pain doesn't last long, maybe 15-20 seconds.   this pain discomfort in my arm has yet to subside.
RED; SWOLLEN; warm; itchy; Uncomfortable; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (RED), VACCINATION SITE SWELLING (SWOLLEN), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE DISCOMFORT (Uncomfortable) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (RED), VACCINATION SITE SWELLING (SWOLLEN), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE DISCOMFORT (Uncomfortable). At the time of the report, VACCINATION SITE ERYTHEMA (RED), VACCINATION SITE SWELLING (SWOLLEN), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE DISCOMFORT (Uncomfortable) outcome was unknown.        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 relevant concomitant medications were reported. No treatment details was reported.
(5/18/2021) Thyroid nodule, was determined to be cancerous, No other symptoms. Ongoing (07/21) Surgery, Levothyroxine.
Received Moderna booster on 11/5/21 at 11am. During the night, Patient tried to get out of bed to go to the bathroom and couldn't stand. She fell and laid on the floor with her head on the corner of a dresser drawer until 8am on 11/6 when her niece that she lives with found her. Patient had slight standing issues (tried a few times to stand due to muscular soreness and weakness in legs) since shortly after her first Moderna shot on 2/11/21 at Pharmacy. Her 2nd dose was on 3/11/21 same place. Standing became increasingly harder but she was able to stand on her own then walk fine with no assistance anytime. Less than 24 hours after her booster we found her on the floor, unable to stan unable to stand on her own and with much muscular pain in her legs and back. We called 911 & went to Hospital around 8am on 11/6/21. They did a CAT scan to rule out stroke & bloodwork. She was discharged with a walker around 2pm same day. Doctors suspected covid booster shot reactions and said they were seeing many patients with covid shot reactions.  Patient was unable to stand at all, even with 3 adults trying to get her up and she was still having muscular pain. She stared and did not act right. The top of her thigh and hip area were extremely swollen. We called 911 again around 10pm on 11/6/21 to return to same hospital because she was totally immobile, unable to stand and barely walk even with a walker. A hip xray, covid test, more bloodwork and ultrasound were done - all negative. Doctors suspect Moderna booster reaction. She will be receiving physical therapy, IV antibiotics (slightly elevated white count) and oral Ibuprofin for inflammation. On 11/7 she was doing better. Patient is still having a hard time standing but more alert and able to walk better with a walker. She is still hospitalized on 11/8.
Very swollen, tight, red, low grad fever, welt on arm. On anti-biotics twice had blood work done everything is high.
w/in 12 hrs p/DTP/HIB/OPV pt exp urticarial rash wich was more prominent on the lower extremities & trunk; also had itching but was afebrile; tx included DPH & hydrocortisone;
T103.5-103.7 leg very swollen;cried uncontrollably didn't want to be held-touched or hot touched;MD prescribed erythromycin for a cold @ this same time;
Tinnitus; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 17Jan2021 at 11:15 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib), type 2 diabetes, and hypertension (HPTN). 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. The patient received unspecified concomitant medications. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. On 19Jan2021, the patient experienced tinnitus. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of tinnitus which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not resolved at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 07Feb2021 at 13:15 (at the age of 80-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.