chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was inadvertently administered a dose of Pentacel that had expired with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via medical information (Reference number- 00685292) and transmitted to Sanofi on 16-Jul-2021.  This case involves a 15-month-old male patient who inadvertently received a dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that had expired (expired product administered).  The patient had DTaP and polio vaccine doses as past vaccination.  Medical history, medical treatment and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE, VARICELLA ZOSTER VACCINE (MMRV).  On 15-Jul-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [lot UJ337AAA, expiry date: 05-Jul-2021] via an intramuscular route at the right thigh for prophylactic vaccination. (expired product administered) (Latency: on the same day)  It was a case of actual medication error due to expired vaccine used.   It was reported that, "Upon transfer, physician (MD) asked how to proceed if a patient was administered an expired dose of Pentacel. MD also asked for any safety information on giving an expired vaccine or repeating the dose. MD did not have available the number dose in the series that this Pentacel dose was to have been, because the patient was born overseas and just came here in June".  At the time of report, no adverse event reported.   Outcome of event was unknown.   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 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.
Pt. states that after receiving the 1st dose of Phizer 03/12/2021, started experiencing symptoms of pain at injection site, with bruising. Primary visit 06/2021 with referral to Orthopedics (Appt. 07/15/2021 X-Rays preformed). Bruising lasting estimated 4 weeks and pain still continuing spreading down the Left arm. (Recommended it was possibly Tendonitis of the Rotator Cuff) Physical Therapy has been setup up.
Left arm pain; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 42-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Apr2021 10:00 (Lot number: ER8733) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021, outcome "recovering", described as "Left arm pain".  Additional Information: The patient experienced left arm pain worse than second dose within minutes of 10:00. The patient did not receive additional vaccines on same date of the Pfizer suspect. No emergency room or physician's office required. The patient had no prior vaccinations within 4 weeks and no adverse events following prior vaccinations. No relevant test was done by the patient.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481071 Same patient and drug, different dose and events.
persistent cough, pain in joints, nausea, chills, heart arrhythmia
I was hospitalized for a week in severe pain. My existing diseases worsened and I had to get a hysterectomy
Patient noted a blister like lesion in the area of the vaccination on the left upper arm.  First noted a day after the vaccination.  Did also have expected soreness and erythema to the area.  Seen two days after the vaccination and a 0.5 cm flaccid blister noted lateral to the injection site but in the area of the part of the bandaid. Dad states blister is bigger today than it was last evening
Patient awoken by joint pain, primarily of  hip and knees, progression to wide spread neuralgias, focal kidney pain, temp 99.9 degrees, emesis x 12, loss of appetite, paresthesia of hands and feet, headache and sinus headache (worst headache pain of life, pain scale 9), sinus drainage, photosensitivity, inability to focus eyes to read, extreme fatigue lasting 30 hours. headache and paresthesia unresolved at time of this report.  UC worsened.
Diaphoretic, states can not see, Dropped BP, monitored for 30 minutes, BP improved, no loss of vision
7OCT98 2PM fever, nauseated, lt arm hurt, swollen, T104, arm throbbed hot & cold packs 7 ASA taken;soup 10PM from elbow up lt arm bright red;T99 in Am swelling down;feels much better;
This patient had brachial plexus neuropathy occurring without injury. Started after the flu vaccine was given.
This spontaneous report was received from a nurse practitioner and refers to a 40 year old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 20-JUL-2017, the patient was inadvertently vaccinated with a pediatric dose of VAQTA intramuscularly in to right deltoid (lot # M039202, expiration date: 11-MAR-2018, dose was not provided) for prophylaxis. No adverse effects were reported.
Diagnosed with Wells Syndrome, took days to resolve, had never had a bad reaction to vaccine before.
This spontaneous report was received from a healthcare worker referring to a 9 week old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
numbness complete lt side more so in face w/eye, hose effected, swelling lt side-felt like being pushed into ground like something heavy on tope of head-metal taste in mouth
Mom called office 4/24/13 to report right thigh redness, warmth, swelling and pain after shot received 4/22/13. Mom advised to return to office for evaluation ASAP, mark borders of redness to track extension, give ibuprofen for pain relief. Go to urgent care facility or ER of fever develops, pus oozing from site or further extension of redness. Assessment 4/24/13 went to U.C. Dx: Cellulitis.
allergic type, itchy rash on full body. treated with dexamethasone and vistaril.
Breakthrough case admission after 2 vaccines Pfizer 7/21/21 lot# FA6780;  Pfizer 8/1/21 lot# FC3180
Gave an additional dose of Shingrix (3 doses), pt is feeling flu like symptoms and is lethargic
PATIENT ASKED TO RECEIVE H1N1 VACCINE.  PATIENT WAS THROUGH TRANSLATOR IF SHE HAD ALREADY HAD VACCINE.  PATIENT STATED "NO."  ABOUT 20 MINUTES AFTER RECEIVING PREGNANT DOSE ON H1N1, PATIENT AND HER SISTER CAME TO TELL US SHE HAD THE SHOT IN DECEMBER.  NO COMPLICATIONS NOTED WHILE PATIENT WAS STILL IN CLINIC.
Patient experienced tingling in mouth (roof of mouth, lips, and some in tongue) and back of throat.
The patient recently saw the nurse practitioner and told her she thought the injection was high, close to joint. Practitioner didn't think there was any nerve damage but that patient did complain of pain with motion.
Patient seen by staff member lying on floor in 1st floor lobby. Patient was conscious, but had moved to the floor (did not fall or hit head) when he was not feeling well after getting a covid vaccine upstairs. A code white was called. Patient was with Mom (). Mom said he was diagnosed today with vasovagal syncope. Patient was able to sit up. @433pm Vitals Temp 97.8, pulse 79, O2 98%, R 16, BP 108/60. Patient able to drink water, color looks good, breathing without difficulty. @438 BP 104/56, @443 BP 103/59. Patient's Mom states they were told to go to the waiting room downstairs after getting the vaccine to wait 15 minutes and this is when the situation transpired. Patient feeling fine and Mom is comfortable with taking him home
Past recommended interval received first dose mid May; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Past recommended interval received first dose mid May) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past recommended interval received first dose mid May). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Past recommended interval received first dose mid May) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Immediately after felt pain on left arm, then started having tingling and numbness on left arm only
Very rapid heartbeat, headache, nausea, fever, light headedness, pressure in chest, chills for 7 hours, sore at injection, itchy eyes, muscle aches, and fatigue.
Received Moderna COVID-19 Vaccine EUA. The 2nd dose resulted in headaches, fever with chills and tiredness. Fever registered at 100.8 at 7 am. Symptoms were less at this time. I suspect the 4 am symptoms of severe chills and hot skin was a much higher degree of fever.  Took Tylenol at 7 am. Temperature returned to normal within a couple of hours and no recurrance of fever. Very tired rest of the day. Slept on and off all day. Back to 100% the next day, April 22nd.
I experienced a stroke on 07/14/2021 and had to be rushed to be hospital on 07/15/2021. The ER doctors checked me in and I was there for 3 to 4 days. A series of tests were performed and they confirmed that I suffered a stroke. I have been in physical therapy, speech therapy, and occupational therapy that has been ongoing since I suffered the stroke.
Information has been received from a medical assistant concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL. There was no concomitant medication. The medical assistant reported that about two weeks after receiving the dose of the vaccine, the patient experienced  a bee size lump at the injection site. No lab diagnostics studies were performed. Patient sought unspecified medical attention. Additional information has been requested.
received a vaccine booster and today they are running a fever of 99.9°F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (received a vaccine booster and today they are running a fever of 99.9°F) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced PYREXIA (received a vaccine booster and today they are running a fever of 99.9°F). At the time of the report, PYREXIA (received a vaccine booster and today they are running a fever of 99.9°F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2021, Body temperature: 99.9 (High) 99.9°F.         No concomitant medication details was reported. No treatment medication details was reported.
Had minor pain at injection site beginning 4 hrs after ijection, resolved after 24 hrs.  No other side effects until 7 days late (19 Mar).  Moderate chills, moderate fatigue, moderate headache began 7 days after first injection, persisting with little change now 80 hrs after onset.  One instance diarrhea 60 hrs after first injection.  No fever. No joint pain or swelling.   Have consulted PC nurse who advises I report this, and self-quarantine while await PCR results.  I will report to ER if symptoms significantly worsen, otherwise will check back with PC physician Monday 22 Mar.
Severe Red Rash developed on abdomen,  back, arms and  neck with severe pruritus Diagnosed by infectious MD as Leukocytoclastic Vasculitis
Patient came to me 9-28-15. Complained of nausea since the vaccination, also had fatigue. I believe she stated she missed a day or so of work.
Injection site swelling, redness, rash and heat lasting since time of injection (~2 weeks).
Post immunization client developed hives that itched until she scratched and drew blood. They covered neck to toe of her body.
Sore Arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 02:30 (Lot number: EN6202) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 ([{product: COVID 19, brand: Pfizer, lot number: EN6202, lot unknown: False, administration date: 14Mar2021, administration time: 02:30 AM, vaccine location: Left arm, dose number: 1}]), administration date: 14Mar2021, for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Apr2021 02:00, outcome "recovered" (Apr2021), described as "Sore Arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. No Covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Erythematous papules over bilateral arms, back, and thighs which started the day after receiving pneumovax. Initially itchy. No SOB, chest pain, lightheadedness/dizziness. Given Loratadine and Triamcinolone 0.1% cream with improvement.
This literature marketed report has been received from the authors of a published literature article, concerning a 12-year-old female patient. No information regarding the patients' medical history or concurrent conditions was provided. The patient was a part of a retrospective analysis that studied the impact of 7-valent pneumococcal conjugate vaccine (PCV7) on the incidence of invasive pneumococcal disease (IPD) in cancer patients, along 20 years. The patients included were registered with at least 1 visit between 01-JAN-1992 and 31-DEC-2012. Unique patient-visits (UPV) (inpatient or outpatient) per calendar year, age, and cancer type were obtained from hospital databases. However, non-cancer patients were also included. Patients <15 years were considered "children", and at least 15 years old were "adults". Children 0-4 years were referred to as "vaccinees", and patients at least 5 years old were "non-vaccinees". The IPD incidences were categorized as "before PCV7" (occurred between 1992-2000), "after PCV7" (2001-2010) and "after PCV13" (2011-2012). The authors observed an abrupt decline in the incidence of IPD in 2000, coinciding with the introduction of PCV7. It remained relatively stable through 2010. The IPD incidence declined after PCV7 in children 0-4 years (vaccinees) and in at least 5 year old patients with hematologic malignancies (non-vaccinees). This suggested an indirect effect of routine childhood immunization with PCV7. They suggested that continued surveillance is warranted to characterize the burden of IPD in the era of PCV13 and optimize preventive strategies in highly immunocompromised patients. On 06-JAN-1993, the patient was vaccinated with a dose of PNEUMOVAX 23 injection (dose and route of administration were not reported). There were no concomitant therapies reported. On 28-DEC-1993 ("before PCV7"), the patient was found to have invasive pneumococcal disease (type 6; one of the vaccine serogroups). The patient was hospitalized due to the event on an unknown date. No prescription drug treatment was required, however it was reported that the patient required unspecified medical/surgical intervention to prevent one of the serious outcomes. She recovered from the event on 12-JAN-1994. The authors considered the event of invasive pneumococcal disease to be medically significant, life-threatening and related to the vaccination with PNEUMOVAX 23. The physician stated that no further information was available. It was a study done via chart records from over 5 years ago, and those records were no longer available at the time of contact. This is one of several reports derived from the same literature (linked reports MARRS# 1802USA000459, 1803USA007152). Sender's Comments: US-009507513-1802USA000459.
not feeling well; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-096728), for BNT162b2.  A female patient of an unspecified age received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 24Sep2021 as dose number unknown (Booster), single for COVID-19 immunisation. Medical history included endometrial cancer from unknown date to unknown if ongoing. The patient previously took Keytruda infusions. Concomitant medication included lenvatinib mesilate (Lenvima) at a dose of 20 mg, once daily, taken for an unspecified indication from 20Jul2021 to an unspecified stop date. On 24Sep2021, after the vaccination, patient was not feeling well and stated that it hit her like a sledgehammer. Patient did stated that she was waiting to receive CT scan. The outcome of the event was unknown.  Lot/Batch number was not provided and will be requested during follow-up.
Syncope after MENACTRA vaccine, fell and had 3 lacerations on face, sent to E.R. for stitches.
Reactivating of herpes virus; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for similar events for two patients. This is the second of two reports.   A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration on left arm on 13Jan2021 05:30 at a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Facility type vaccine was in nursing home/senior living facility. No other vaccine in four weeks. No COVID prior vaccination. The patient had no known allergies. The patient medical history was not reported. Concomitant medications (medications in two weeks) included calcium and colecalciferol (VIT D3). The patient experienced reactivating of herpes virus on 15Jan2021 05:30. No treatment was administered for the event. The patient was not COVID tested post vaccination. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021032647 same report/drug/event, different patient
Patient presented with swollen, red area where vaccination given 48 hrs prior. She claimed it was hot to touch. MD stated it was "cellulitis: gave KEFLEX.
Muscular twitches all over the body. They will happen every so often and could be anywhere. One focus site is the right leg above the knee. At times it will all of the sudden feel very hot and there will be many muscle twitches in the area. It is not pink or swollen, and does not feel hot to the touch. Also receiving the feeling of pins and needles in different places like the right leg, the shoulders and the neck.
pt recv vax & 4hr p/vax pt became nauseated, then vomited;intermittent vomiting cont for the following 2 days;pt seen in ER on the evening of the 2nd day p/vax;pt had some trouble breathing;
Fever, aches, chills, slight chest pain one day after vaccine Mild chest pain, shortness of breath two days after vaccine
Started 5 minutes after injection with a bad salty metallic taste in mouth, then wave of heat and lightheadedness. Sweaty and flushed, nauseated, felt like I was going to faint, then tachycardia and shortness of breath. Nurses told me this was a normal reaction, took my vital signs, and watched for everything to return back to normal, and told me I could report experience to VAERS. Most of it went away within 10 minutes of onset. I still felt a little dizzy and lightheaded and weak for a couple of hours, and had short spurts of tachycardia the rest of the evening.
Initial information received on 14-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 73 years old female patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 12-Jan-2019, the patient received a 0.5ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine, prefilled syringe, lot UI809AB, expiry date 02-Mar-2018 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient was expired FLUZONE HD (expiry date 02-Mar-2018) on 12-Jan-2019. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 documents held by sender- none.
Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; Severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling; This is a spontaneous report from a contactable Nurse (patient). A 34-years-old female patient received second dose of bnt162b2 (BNT162B2 lot number=EK9231), via an unspecified route of administration on 08Jan2021 08:00 at SINGLE DOSE on arm left for covid-19 immunisation. The patient medical history was none. Known allergies: None. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d3 (VITAMIN D3), zinc (ZINC), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and Multivitamins. The patient previous received product=COVID 19, brand=Pfizer, Lot number=EL0140, Administration date=18Dec2020, Administration time=08:15 AM, Vaccine location=Left arm, Dose number=1. On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. After the second dose, the patient experienced severe muscle ache, joint pain, fatigue, cold sweats, chills, injection site swelling on 08Jan2021 19:00 with outcome of recovering. No treatment was received. The patient had no covid prior vaccination; no covid tested post vaccination.