chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient did not receive the second dose of SHINGRIX; This case was reported by a other health professional via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th July 2020).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 24-Oct-2022 Reporter's comment: The caller was a health-care professional called to report an adverse event for Shingrix.  The caller reported that a patient did not receive the second dose of Shingrix as recommended.  There was no additional information provided.  There was no additional adverse event reported.  There was no pharmaceutical product complaint reported. The permission for consent to follow-up was denied. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 26-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 7-decade-old female patient of an unspecified ethnicity received PREVNAR 13 , via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported back to her doctor that after receiving her pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) shot, that she ran a fever and was nauseous on an unspecified date. Outcome of the events was unknown. The information on the batch number and expiration date has been requested.
Shingrix 1st dose 2 years ago but never completed the series; This case was reported by a consumer 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 (received 1st dose on an unknown date, 2 years before the time of reporting).   On an unknown date, the patient received 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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccination. The patient never completed the series. The reporter disconnected abruptly and did not provide any additional information.
Right after the vaccine my throat became itchy and mild lip swelling followed by nausea and vomiting about 4 hours later.  I had a mild headache and soreness at the injection site
pt recvd vax; crying uncontrolable for 2 hrs straight; would not eat well; inc t; to er 3x; viral infect,wheezing & coughing uncontrolably;
The pt experienced a fever of 106, limpness, headache, dizziness, and eyes rolling. This started approximately 2 hours post vax. The 2nd episode 10 hours later and then was sent to a local hospital.
had an adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had an adverse event) 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 ADVERSE EVENT (had an adverse event). At the time of the report, ADVERSE EVENT (had an adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
fever onsetted 2pm 24th of June and lasted until 6am June 29th. Irritability and loss of apetite
This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 23-NOV-2015, the patient was vaccinated with improperly stored GARDASIL, lot # K011215, expiration date 05-MAY-2017, (dose, dose number, route and anatomical location were unspecified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine (Tetanus) given on 11/15/00, so was (TB tine test) Friday, 11/17/00. TB was checked it was negative, the Tetanus was swollen and red. On Saturday, 11/18/00, it blistered half the diameter of swelling.
This spontaneous report was received from a registered nurse, concerning multiple unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses ROTATEQ lot # M043669 and expiration date on 15-JUN-2018; and lot # N005617 and expiration date on 03-OCT-2018 (strength and dose were not reported), administered for prophylaxis. The storage temperature was 9 to 25 degrees Celsius (°C) (9.8 °C), for a timeframe of 20 minutes and 9 to 25 °C (8.5 °C) for 7 minutes . There was previous temperature excursion at 9 to 25 °C for 3.31 hours. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA015077: US-009507513-1709USA013515:
Cough; Runny nose; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and RHINORRHOEA (Runny nose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Sneezing. Concurrent medical conditions included Chronic cough.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced COUGH (Cough) and RHINORRHOEA (Runny nose). The patient was treated with CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN WITH CODEINE) at an unspecified dose and frequency and CODEINE PHOSPHATE, PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE WITH CODEINE) at an unspecified dose and frequency. At the time of the report, COUGH (Cough) and RHINORRHOEA (Runny nose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.     This case was linked to US-MODERNATX, INC.-MOD-2021-226183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-226183:Dose 1 case
Initial unsolicited report received from nurse via pharmacist on 03 Oct 2017. This case is linked with 2017SA192800 and 2017SA195913 (Same lot number). This case involves female patient (Age was not reported and reporter thinks that gender was female) who was vaccinated with a dose of FLUZONE QIV (batch number: UT5936LA, expiry date: 30 Jun 2018, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, following the vaccination patient had arm swollen, welps and spots on arm, area warm and dizzy. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.
The next day injection site swelled and I felt awful, hot, and severe chills. I had diarrhea and slept a lot. Two days post vaccination I broke out in a rash that continued to get worse. I was told by my allergist to double up on ZYRTEC. A week after I was then prescribed prednisone which did not work. I could not sleep and I would wake up continuously scratching my skin. I then went to my primary care and was given a stronger dose of prednisone and hydroxyzine. As of now, my symptoms of the rash flares up when I make contact with the site and clothes. The rash seems to be reducing in color, however, it varies throughout the day how intense the symptoms feel. It is extremely uncomfortable. The higher dose of prednisone and hydroxyzine seem to help however it still will come back. I am no longer experiencing the diarrhea or arm swelling. The rash is pretty much everywhere on my body except my head.
The patient received the vaccine on Wednesday 3/7/2018. On Friday morning 3/9/2018 the patient felt soreness, was febrile (up to a temp of 102F degrees). He also experienced a red "soft ball" sized rash at the injection site. It persisted thru Sunday 3/11/2018 which he also perspired for most of the day. Throughout this episode he self-medicated with additional ibuprofen and stayed hydrated with Pedialyte. Today 3/12/2018 he states that the soreness and rash are gone. The patient was told to follow up with his PCP.
The vaccination was given to her when she was still 15 years old, however, she will be 16 years of age on 3/25/21 which will be the date she is planning on receiving her 2nd Pfizer COVID vaccination.  We verified with our district manager that we needed to report the incident, but that we should proceed with the continued dosing schedule.
Pt was administered 0.1ml of the Typhoid vaccine, intradermal, in the Left forearm instead of PPD for a tuberculin skin test.
My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; My arm is hard, swollen and tender and it's not getting any better; This is a spontaneous report received from a contactable consumer or other non hcp (patient).   A 38-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration on 17Jun2021 at 16:00 (age at vaccination 38years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient did not take any other medical condition. The patient did not take any other vaccine after covid vaccine. The patient previously received BNT162B2 dose 1 on 27May2021 16:00 AM (at 38 years of age) (Batch/Lot number: EW0185) via unspecified route of administration for COVID-19 immunisation. The patient experienced arm was hard, swollen, and tender and it was not getting any better on 18Jun2021. The patient did not receive any treatment for the events. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable pharmacist (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 28Dec2020 at 18:00 at a single dose for COVID-19 immunization.  Medical history included diabetic and blood pressure high, both from 10-15 years.  There were no concomitant medications. The patient does nursing homes and assisted living facilities and also the employees of the nursing home. The patient received the first dose of COVID-19 vaccine on 28Dec2020 at 1800 PM in the left arm. He tested negative on 27Dec2020, 04Jan2021, and 08Jan2021 and tested positive for COVID-19 on 11Jan2021, which was 2 weeks after the administration of the vaccine. He reported no severe symptoms, all he got from the COVID-19 infection was a little bit of chills, temperatures rising to a maximum of 100 degrees Fahrenheit (temperature back and forth), body aches, oxygen levels at 95%, and no cough. His oxygen saturation has always been good between 95% and 96%. The patient asked what caused the positive test and asked if he was going to have protection after receiving the first dose of COVID vaccine. The patient is due for the second dose of the COVID vaccine on Monday, the 18th (18Jan2021), in which he will still be under isolation. The patient asked if he should wait until he gets out of isolation to receive the second vaccine. The patient asked if that is part of the vaccine to test positive for COVID or if he actually does have COVID. The patient also asked if he can have the second dose. He will be unable to receive second dose of the COVID vaccine at the 21-day mark due to being in isolation from the COVID virus. The patient was recovering from the events.   Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
I contracted Covid19 on 4/24/2022 with symptoms headache, congestion, fever of 102.9. After returning to work 05/02 by 05/06 I began coughing, experiencing chest tightness, shortness of breathe, fatigue, and went to urgent care where I was given 40mg of prednisone for 4 days, received a nebulizer treatment, and rescue inhaler. My PCP prescribed 10more days of 40mg of prednisone, qvar inhaler, antibiotic ZPAK, continued with rescue inhaler. I am still experiencing shortness of breathe and having asthma issues.
pt recv vax 1DEC78 & DEC78 & JAN79 noted inc numbness & weakness of feet w/diff walking & occasional numbness of hands;hosp 16JUN79;rt sural nerve biopsy revealed perinural fibrosis;dx profound mixed sensorimotor peripheral neuropathy;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-OCT-2014 the patient was vaccinated with ZOSTAVAX lot # H019038 and expiry date 17-JAN-2014, dose 1, 0.65 milliliters, subcutaneous. On 29-OCT-2014, the patient received expired dose. The patient experienced no adverse effect. A product quality complaint has been filed. The outcome of received expired dose and no adverse effect is unknown. The reporter considered received expired dose and no adverse effect to be not related to ZOSTAVAX. Additional information has been requested.
nurses administered expired PENTACEL to a patient with no reported adverse event; Initial information received on 05-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old female patient and it was reported nurse administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] to a patient 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 A vaccine (hepatitis A) for Prophylactic vaccination.  On 05-MAY-2023, nurse administered an expired 0.25 mL (Dose 4) of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)] suspension for injection (batch/lot number: UJ672AAA; strength: standard; expiry date: 27-Apr-2023) to a patient via intramuscular route in the thigh NOS for prophylactic vaccination (immunization) with no reported adverse event (expired product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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 states she had swelling and redness all through the upper deltoid region to her elbows. Also said her neck itched. Told her to call her MD. MD prescribed Prednisone and ZYRTEC.
According to patient, admitted to hospital for pneumonia. Received shot in morning and in the afternoon had a fever with chills.
Swelling pain and itching of the shot site, its Monday and its the same. Beginning the night of the shot, nausea, extreme chills, muscle aches all over, very tired and lethargic, diarehea still on Monday after.
I had to go off of the medication for my COVID shot and I had a flare up; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced that she had to go off of the medication for her covid shot and she had a flare up on an unspecified date. Therapeutic measures were taken as a result of events with XELJANZ 10 mg tablets. Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
19 days after varicella vaccine developed serum sickness type reaction with rash, itching, swollen hands & feet. Treated with steroids with improvement.
Cold, waves of chills, slight fever (avg. 99 deg), body aches- all began the night following the injection.  Chills and fever dissipated by morning but body aches remained for the rest of the following day.
I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 1/12/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I24.8 DEMAND ISCHEMIA 1/12/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I21.3 ACUTE ST ELEVATION MI, UNSPECIFIED 1/12/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I24.8 DEMAND ISCHEMIA 1/12/2022 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
p/vax pt exp local erythema extending to neck & chest on rt side; nausea; anxiety; pain to site & rt side; also h/a
Patient states that she had "a bad pain" in her arm. She was not able to extend her arm fully. She had a difficult time completing some normal tasks.
vomiting x6-7 including dry heaves for 2 hours starting approximately 8 hrs after shot
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Oct2023, outcome "not recovered", COVID-19 (medically significant) with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 07Oct2023 to 11Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Moderna vaccine was administered outside of the clinic - reported by patient ------------------------------------------------------------------------------------------------- ACUTE RESPIRATORY FAILURE 4/8/2021 MITRAL VALVE REGURGITATION    UNSPECIFIED ANXIETY ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/9/2021 MITRAL VALVE REGURGITATION    UNSPECIFIED ANXIETY ACUTE RESPIRATORY FAILURE 4/8/2021 CHF, STAGE C, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/9/2021 CHF, STAGE C, UNSPECIFIED ACUTE RESPIRATORY FAILURE 4/8/2021 LEFT HEART FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/9/2021 LEFT HEART FAILURE ACUTE RESPIRATORY FAILURE 4/8/2021 HYPONATREMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/9/2021 HYPONATREMIA
When I woke up on Friday, I had a tooth ache. By Friday night, my right ear started hurting. Saturday I also had a headache. I went to my dentist on Monday, who prescribed me antibiotics. I started to form a rash on my chin and lip first and by Friday it had spread up around my face and around my ear. I decided to go to urgent care, and they told me I had shingles and prescribed me Valtrex.
Pt was given his 2nd dose of Pfizer vaccine at pharmacy on 6/3/21 at 1:20pm.  Minutes after the vaccine pt developed headache, stiffness of neck, dizziness, fatigue and SOB. Epipen was brought out but never administered, pt was there for about 45 min.   Was sent home and took Advil 400mg.  Was playing badminton with lots of running 30-45 min prior to vaccine.  No other vaccines given in the past year.  Since the vaccine, pt has had  fever up to 102. Continued headache, neck stiffness.   1st night 6/3/21- bad headache, throbbing headache all around head but worse back right side and then "spikes" on left side (like someone was hitting him with an axe) and fell asleep d/t sever pain, trouble breathing in the next few days 2nd night 6/4/21- neck pain and stiffness was really bad, he looked pale and almost disoriented.  Had fever.  Slow to respond.  Would get rush of bad headache if he moved his neck too fast.  Afraid he would fall down if he moved too fast.   3rd night 6/5/21 - (called 911) chest pain, difficulty breathing, vomited stomach acid, pain radiated down chest to the left, pain only when breathing in and went away the next AM  6/7/21 Chest still feels sore on Left side. Biggest issue right now is headache.
Itching, stinging rash on arms, bump above injection site with swelling on left arm, throat thickening but not closure