chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10-year-old patient received a dose of Flublok vaccine in error/ no adverse event; Initial information regarding this unsolicited valid non-serious case received from a pharmacist via Agency (reference number 00317321) and transmitted to Sanofi on 15-Oct-2020.  This case involved a 10 years old patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- QFAA2040, Expiration date- 30-Jun-2021, Prefilled Syringe) via intramuscular route in the left arm (Product administered to patient of inappropriate age) for prophylactic vaccination on 13-Oct-2020.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.  It was a case of actual medication error due to Inappropriate age at vaccine administration (Latency: 1 day). Reporter wanted to know about re-dosing and if any harmful adverse reactions to look out for.  At the time of reporting, no adverse event was reported.  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.
84 y.o. female patient of MD with history of cholangiocarcinoma, paroxysmal atrial fibrillation on long-term anticoagulation, essential hypertension, hyperlipidemia, coronary artery disease, ascending aortic aneurysm who presented with fever and cough in context of positive home COVID testing.   Covid-19 Virus Infection Date of onset of symptoms: ~8/5/2022 Symptoms present on admission: Fever, cough, sore throat, fatigue, shortness of breath. Date of covid positive test: 8/6/2022 Vaccination status: vaccinated +2 boosters Imaging: CT chest is without evidence of consolidation Oxygen requirements on admission: None Medical therapy: not indicated, was sent for Paxlovid, but this is an outpatient therapy only to prevent hospitalization Consultants following: Infectious disease, Oncology Given overall immunosuppression - MAB and Neupogen given per ID and oncology   Neutropenic fever On admission was not febrile however on day 1 had fever of 100.4 Absolute neutrophil count: 723 With known source of viral COVID infection as likely cause of fever will hold off on antibiotics for now pending ID input Hematology/oncology following ID following  Cholangiocarcinoma S/p chemotherapy (just finished earlier this week)   Atrial fibrillation with rapid ventricular response Heart rate near 130 on admission Likely due to COVID infection Continue home Xarelto, carvedilol  Continue low-dose Cardizem drip for rate control, wean as tolerated Increased BB   Essential hypertension Increased coreg given rapid HR Will continue ARB and stop hydrochlorothiazide given relative hypotension and hypokalemia on admission
Influenza dose of 3 years and older given instead of 6-35 months. Mother and provider notified of incorrect dosage, child was monitored for 25 minutes in office. No reactions noted.
Information has been received from an office manager concerning a 66 year old male patient who on 06-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot#663888/0627Y) intramuscularly in the right arm. Concomitant therapy included HCTZ (manufacturer unknown), MICARDIS, TEKTURNA, NEXIUM, famotidine (manufacturer unknown), UROXATRAL, vitamin D (unspecified), fish oil, aspirin, fexofenadine, fluticasone, ASTELIN, citalopram and CRESTOR. Subsequently, the patient experienced soreness at injection site later that evening after administration of PNEUMOVAX 23. On 07-OCT-2009, the patient experienced erythema and swelling at the injection site. He also had a fever. The patient had sought medical attention via telephone. No laboratory diagnostic study was performed. The patient was treated with anti-inflammatory and cold compresses. On 08-OCT-2009, the patient no longer had a fever but still had some erythema and swelling at injection site. At the time of the report, the patient was recovering. This is one of several reports received from the same source. Follow-up information has been received the office manager concerning the patient who on 06-OCT-2009, in the morning, was vaccinated with the first dose of PNEUMOVAX 23 (lot# 663888/0627Y) intramuscularly in the right deltoid. There was no pre-existing allergies, birth defects, medical conditions. It was reported that the patient had not required emergency room/doctor visit. On 08-OCT-2009, the patient recovered. Additional information is not expected.
Suspected vaccination failure; shingle; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient got shot and still had shingle. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided
LUE pain at injection site, muscle spasms of left arm, numbness and tingling of left hand, episode of burning across chest x 1 when symptoms first started. Brief period of muscle spasms along left neck, back left arm and left lower extremity on first day of vaccination. Brief episode of right hand numbness and tingling.   On day 2 very flushed and hot feeling, temp 37.9 at 1am on 01/12/21. Sever muscle spasms and pain from left trapezius to sternocleidomastoid, to left upper extremity,  left thorax and abdomen to left lower extremity with extreme fatigue. Headache throughout day.   Now with residual left lower extremity numbness and tingling, pain improved and muscle spasm frequency decreasing although episode of chest pain with muscle spasm did occur yesterday evening.   At this point the left lower extremity tingling is most worrisome. Muscle spasms and pain slightly improved.
4-6 weeks after this booster, I got the following symptoms about twice a month & 6 months later, symptoms tapered down: felt chill inside, soon followed by rigors, low-grade fever, hours of nausea and emesis, and then 2-2.5 days of moderately severe fatigue. MRI 7/8/21 showed multiple nodules in my lover, which at first were thought to be metastatic cancer. On the second liver biopsy ascending cholangitis was found, and a repeat MRI a couple of months later 8/19/21 showed a near clearing of nodules. There are no underlying conditions to explain this disease or its symptoms. During the last attack, I had a fever of 100.3, muscle aches, and fatigue for about 12-18 hours.  I suspect this pattern reflects an autoimmune response in my liver to the vaccine.  Dr.  Hospital, my surgeon for my Whipple surgery 7/21, and my GI physician at  to report it.
sore throat; no sense of taste; no sense of smell; fatigue; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C12A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat), AGEUSIA (no sense of taste), ANOSMIA (no sense of smell), FATIGUE (fatigue), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Treatment medication includes Excederin extra strength.
pt recv vax 24OCT96 & 24DEC96 pt devel hot & cold flashes, a sore throat, congestion & gen weakness;pt has not yet recovered;
fever 101-102 & emesis 12 hrs p/vax;duration 2 days; also myalgias, arthralgia; pt has hx SLE, no recent flares;
rash and swelling at injection site then large hard welt occurred, 1 week later redness occurred and lymph nodes under arm swelled and are still there.  Both sites are painful.
Hives on neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 09Apr2021 at 15:45 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis. Concomitant medications included unspecified medications from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 14Mar2021 at 13:30 (at the age of 50-year-old) as a single dose for COVID-19 immunisation. The patient previously took Keflex and experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 21:00, the patient experienced hives on neck and chest. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of hives on neck and chest and included treatment with Benadryl. The clinical outcome of the event hives on neck and chest was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
I received the second vaccine injection, and in about an hour felt a little warm and clammy, I was having some joint and muscle pain, and stomach upset. I had no appetite and did not eat lunch. At supper I still did not want anything, so ate cereal instead. During the night I was restless, and expelled quite a bit of gas throughout the night. Stomach still uneasy. When I awoke, about 6:00 AM, I was hungry and attempted to pour a bowl of cereal but could not due to shaking. My wife found me in the middle of a grand mal seizure and called the ambulance. The ambulance, police, and fire company all responded. They provided medical care onsite and in route to Hospital. I had a fever of 102 degrees, had been biting my tongue raw, flailing arm and hyperventilating. I was somewhat disoriented and delusional. During my hospitalization the injection site was found to be very swollen and red. Ice was applied. An MRI was performed of the head and found to be normal. Several other blood tests were also completed. I remained inpatient from 3/25/21 through 3/21/21.
Headache Migraine  Vertigo Ramsey Hunt Syndrome Shingles Tinnitus
no adverse event; Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 10-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive her second Moderna Monovalent vaccine greater than 36 days in between doses of the Moderna Covid-19 vaccine.).    No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
Rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The patients received Shingrix and had rash as an adverse reaction. The reporter asked what the range of time to resolution.
3/7/2003 Day 11 after smpx vaccination on 2/24/2003 reported temp 102-severe chills--severe fatigue and back pain--left work early 3/8/3003 day 12--temp 101-mod chills--mod fatigue--planned day off (Sat) 3/9/2003--Day 13--temp 100-mild fatigue-planned day off (Sun) 3/10/2003-Day 14--No symptoms noted 3/11/2003-Day 15--Called to report
I originally contacted the doctor's office because I had a runny nose, sore throat and a cough. 19 Also, I had been in contact with a friend who tested positive for COVID-19.   I did test positive for COVID-19 at that visit to my medical group's convenient care office.
Headache (within 90 mins), as well as fatigue, chills, fever (100.5), mild nausea which were onset approx. 6 hrs post vaccination.  Fever broke within 12 hrs, as well as chills and nausea.  Fatigue & general fogginess lasted roughly 48hrs
I got my first dose on March 27 Phizer lot number ER8730. In April 11, I saw skin allergic reaction on my skin at my leg (thighs). I got my second dose on April 17 Phizer lot number EW0162 around 3:30 pm. The same date around 7:00 pm I noticed swollen eyes. Similar allergic reaction when I had aspirin. I took Benadryl that night. Today I wake up without swollen eyes. The allergic on my thighs continues.  The intend of this report, is to provide to the organization my reaction with the vaccine.
fever 105 R, rash on back, abdo, face, rt leg, vomiting, chills;
Painful, Swollen, Red, warm  at injection site 4 days Sever tiredness 24 hours
Rash on face and itching. Rash all over bodies. No problem with breathing or swallowing. No fever child was seen in ER about 3 weeks ago with similar rash and was given an injection of Benadryl and steroids by mouth.
After receiving 1st dose of covid vaccination patient became light headed, nausea, and numbness in fingertips of right hand. Patient was placed on cot to lie down. Vitals were stable - BP 11/72, P 74, O2 Sat 98. Pt was checked by Doctor Patient declined EMS. After patient started feeling better he was released with his father who drove him. Patient instructed to go to ER if symptoms persist or worsen
Two days after injection in my left arm I have visible swelling in my left armpit. Tenderness as if I slept with my arm in a bad position. No fever or any other type of symptom.
Severe local reaction 3 1/2 x 2 1/2 inch redness/erythema and induration
Pt seen 2/25/2012-pt stated after vaccine had some redness, pruritis, swelling, pain, and warmth at injection site, had low-grade temperature of 99 last 2 days.  Has been taking ibuprofen 800 mg every 8 hours. Today redness, swelling and pain improved slightly.  Examined patient-had 5 cm area of erythema, moderate swelling, sl warm to touch.  As redness/pain improving, will do watchful waiting-continue ibuprofen, ice pack to area.  Pt to f/u at this clinic in 24 hours to re-eval site for worsening erythema or symptoms.
elevated blood pressure, slurred speech, expressive aphasia, blurred vision,headache,shortness of breath confusion.
Clamminess; muscle pain; Chills; Nausea; Splitting headache turned into body pains; splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clamminess), MYALGIA (muscle pain), HEADACHE (splitting headache), CHILLS (Chills) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (splitting headache) and MYALGIA (Splitting headache turned into body pains). On an unknown date, the patient experienced COLD SWEAT (Clamminess), MYALGIA (muscle pain), CHILLS (Chills) and NAUSEA (Nausea). On 06-Mar-2021, HEADACHE (splitting headache) had resolved. At the time of the report, COLD SWEAT (Clamminess), MYALGIA (muscle pain), CHILLS (Chills), NAUSEA (Nausea) and MYALGIA (Splitting headache turned into body pains) outcome was unknown.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received SHINGRIX (batch number 490558 ?, expiry date unknown GSK note: the reported lot number did not match with any GSK lot number) for prophylaxis. On 12th June 2018, the patient received SHINGRIX (intramuscular). In June 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. The reporter considered the injection site pain to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional stated that the patient experience soreness at injection site after vaccination which was still on going as during the date of reporting. The health care professional stated that the soreness was improving and no swelling or bruising was present. The health care professional stated that the patient said soreness occurred after vaccination but unsure of time. The health care professional provided lot number but unsure if this was correct. The health care professional unsure of outcome but stated it was improving.
high fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The reporter reported that she knows someone who had high fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain and stiffness in right upper arm from injection site to elbow. Started the night of the injection on 9/15/16 and has been consist since then. Using anti-inflammatory drugs and ice packs. Went to Dr on 10/6/16 but he cant do nothing different. Has gotten a little better but still painful at night.
FEELING UNWELL; GENERALISED SEIZURE; This spontaneous report received from a physician concerned a 21-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included absence seizures (last episode was in 2012), and asthma. The patient was previously treated with ethosuximide for absence seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-APR-2021, the patient experienced generalized seizure that lasted about 10 minutes or maybe a little longer. On an unspecified date, the patient was feeling unwell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the generalized seizure and feeling unwell was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 : 20210428279- covid-19 vaccine ad26.cov2.s-GENERALISED SEIZURE- This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
The morning after I received the shot, my stomach became distended and all my muscles and joints had pain. My joints began to swell and my tendons were tender to the touch.  This lasted for 2 weeks. I went to the doctor who ran bloodwork which revealed rheumatoid factor which I have never had before. I was sent to rheumatologist who prescribed more bloodwork and prescribed a round of steroids. I am  this day being followed by rheumatologist. The steroids reduced the pain and inflammation so that I was able to function again.
Guillain Barre syndrome, Miller Fisher sysndrome.  Symptom onset 10 days after Tdap.
Tuesday received vaccine 10am,  few hours later arm started to hurt then burning  followed by chills, nausea, headache, thru the nite into the next day Wednesday, Wednesday very tired , chills , arm hurt to touch around injection site, burning stopped, headache, nausea still very present,, Thursday am a little better not 100%,  chills, some nausea, injection site and above hurt to touch, Thursdays evening around 19:00 started feeling somewhat  normal, slept well, woke Friday feeling normal!!!,