chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no titers present in blood work; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 2-year-old patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis, Hib (Hiberix) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix, the 2nd dose of Hiberix, the 3rd dose of Hiberix and the 4th dose of Hiberix. On an unknown date, unknown after receiving Hiberix, Hiberix, Hiberix and Hiberix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hiberix, Hiberix, Hiberix and Hiberix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's gender was not known. The patient completed the entire Hiberix series and had completed blood work on an unknown date. It showed no titer for Hiberix was present in patient's blood. The reporter consented to follow up. The reporer did not have any patient information or vaccine information available at the time of reporting and stated that the questionnaire could be sent to her.
ITCHY HIVES ALL OVER BODY, NECK, FACE EVERYNIGHT FOR PAST 2 WEEKS, SINCE THE DAY OF THE FIRST COVID VACCINE.
The patient had seizures; This spontaneous report was received from the patient's parent referring to his/her son, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis and on an unknown date, he experienced seizures.  At the reporting time, the patient was not recovered from seizures. The causality assessment was not provided.  Upon internal review, seizure was considered a medically significant event.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA008006:
initial fatigue and pain at injection site, next day developed a fever, chills and mild neck pain Narrative:  1/13/2021, developed a fever
3/26/21 Patient presented to the ED w/several days of fever, chills, body aches, SOB, and fatigue. He had a + COVID-19 test several days prior. His RA pulse ox was 83%. He was started on BiPAP, decadron and remdesivir. Acute Hypoxemic Respiratory Failure ARDS secondary to COVID-19 pneumonia Oxygen requirement improving, Antley on 4 L of oxygen Status post 10 days of dexamethasone.  Status post remdesivir. Continue incentive spirometer use.  Breathing treatment as needed. Ct chest- CT chest images personally reviewed and notable for chronic changes consistent with evolving ILD/fibrosis + areas of consolidation which are consistent with a bacterial pneumonia  Agree with pulmonology starting patient on  IV Zosyn and IV vancomycin  Agree with MRSA PCR from and starting Steroids and plan on a 6 week taper. Repeat OP imaging. Patient desaturates with activity  Patient was discharged on 4/21 and was readmitted on 4/22 Patient is a 87 y.o. male patient with a history of hypertension, hyperlipidemia, CLL GERD, vitamin D deficiency, with a history of TIAs who was recently admitted to Hospital with COVID-19 pneumonia requiring remdesivir and steroids.  After a protracted hospitalization the patient was deconditioned and on 4/21/2021 the patient was admitted to hospital for aggressive rehabilitation.  The patient had been doing well over the past week and was making good progress however today during her visit the  Daughter noticed at 11 AM when she came to visit him that he is unable to speak and that his gaze is to the right and there is left facial droop.  Nurse confirmed this finding had a stroke alert was called.  A CT scan was completed and patient is moved to emergency room department.   Upon the virtual neurologist's evaluation, patient is alert and oriented without any aphasia or dysarthria.  There is no gaze deviation.  Extraocular movements are full.  There is no facial weakness.  There is no drift in any of the extremities and there is no reported sensory loss and there is no appendicular ataxia.   The neurologist reviewed the images of CT head and it showed no acute intracranial abnormality.
2hrs after vaccine she started having migraines, gums became swollen and sore, legs are very weak, having hot and cold flashes, dizziness
Tested COVID positive, symptoms include chills, chest pain, and nausea/vomiting.
Guillain-Barre Syndrome;  61-year old male received an injection of Influenza Virus Vaccine. Two weeks later, he developed parasthesias and those types of symptoms.Pt was hospitalized & tx w/ IV immunoglobin w/ no response.
6 days p/vax pt had red swollen firm arm w/a rash & one bump had yellow fluid in it;
For about 3 days: fever up to 101, body aches, headache, chills, very fatigued, lethargic.  No treatment. Still felt tired and had a headache a couple of days longer, but then felt fine again.
7/23/08-2 inches redness on injection site R leg observed by parent.  RN observed on 7/27/08 1 1/2 inches redness, slight warmth.
received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021). On 11-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received their first COVID vaccine on 19JAN2021 and second dose on 11JUN2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated additional contact information.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 with no associated AEs. However, for the event Inappropriate schedule of product administration of mRNA-1273, causality is not applicable.
Patient had flu shot on 10/25.  Immediately felt "flushed" and developed a headache.  Headache lasted a week, and then (11/1) she developed emotional lability and then seizure-like activity (tonic clonic full body movements).  Was hospitalized 11/1-11/3.  EEG and neurology consult pending.  (History of hemorrhagic stroke with seizure activity in 8/2013, 10 years ago)
anxiety attacks; feeling nervous; nausea without vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of ANXIETY (anxiety attacks), NERVOUSNESS (feeling nervous) and NAUSEA (nausea without vomiting) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (anxiety attacks), NERVOUSNESS (feeling nervous) and NAUSEA (nausea without vomiting). The patient was treated with LORAZEPAM for Anxiety, at an unspecified dose and frequency. At the time of the report, NERVOUSNESS (feeling nervous) and NAUSEA (nausea without vomiting) outcome was unknown.            No concomitant medication was reported.   This case was linked to MOD-2021-100492 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received: Outcome of anxiety was updated.
March 28, 2019 - 1st pregnancy, live birth, c-section, 5lbs 6oz, 42 weeks March 7, 2021 - 2nd pregnancy, miscarriage, approx 7 weeks March 30, 2021 - first dose of COVID vaccine April 27, 2021 - 2nd dose of COVID vaccine May 7, 2021 - positive pregnancy test May 26, 2021 - 3rd pregnancy, miscarriage, approx 5 weeks, thyroid blood test normal August 27, 2021 - 4th pregnancy, positive test September 22, 2021 - prenatal visit, ultrasound & heartbeat October 6, 2021 - prenatal visit, ultrasound with no heartbeat October 7, 2021 - D&C approx 10 weeks, chromosomal analysis normal
pt recv vax MAY97 & 30SEP97 pt devel varicella zoster on arm;
Weak; Dizzy; Doesn't have an appetite; Head is hurting bad; Chills; Fever; Slept the whole day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BENAZEPRIL and HCTZ for an unknown indication.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Slept the whole day). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ASTHENIA (Weak), DIZZINESS (Dizzy), DECREASED APPETITE (Doesn't have an appetite), HEADACHE (Head is hurting bad), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Slept the whole day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 11-Feb-2021, the patient received their second dose of vaccine and slept for the whole day. The patient was very weak and experienced fever, chills and felt dizzy. The patient also reported that they don't had an appetite and their head was hurting bad.  Treatment medication included Tylenol which helped.   This case was linked to MOD-2021-035003 (Patient Link).
DEVELOPMENT OF CELLULITIS. Patient had received vaccination in the morning and called back in the afternoon because her arm was starting to feel slightly warm to the touch.  The pharmacist who had administered the vaccine instructed her to go see a doctor if symptoms persist or worsen over the next 2 days. Patient called again on 06/22/19 because her arm was warm and red. I instructed her to go to an urgent care clinic for antibiotics. Patient came in later that day for a prescription for oral antibiotics.
PCM consulted HC for assessment of the patient's chest pain after the SPV. Per pt on 3/3/10 during a PT run which lasted 1 hour and 15 minutes the pt experienced left sided chest pressure (3/10) and a sensation that his "heart was beating out of sync". For the first hour after the run the pain continued but was a 1/10. The pt stated that he felt like he had run 30 miles instead of just 4 miles. The pt had no N, V or SOB or diaphoresis (other than from exercise). The pain subsided after one hour of rest. On 3/5/10 during a 45 min. run the pt experienced chest pressure/discomfort, 1/10, no palpitations, no N, V, SOB. The pain lasted for 20 minutes after he stopped running. During a PT test on 3/8/20 the pt did not experience chest pain/pressure or palpitations. The pt was evaluated by cardiology on 4/19/10 and had a normal physical exam. The pt had been asymptomatic since 3/5/10. It was determined that the patient's chest pain was non-cardiac in nature (does not meet the case definition for myocarditis or pericarditis) and patient was returned to full duty without restriction. Pain, chest NEC(786.59), Palpitations(785.1).
Low grade fever and body aches for 24 hours, then headache and swollen lymph node under armpit on side of injection. Swollen and sore injection site.
Pt presented with fussiness and fever. Pt. temperature in office was 101.5. No other symptoms noted. Pt admitted to hospital due to age.
PATIENT HAD RECEIVED INTIAL DOSE OF JYNNEOS SUBCUTANEOUSLY  IN LEFT UPPER ARM ON 8/12/2022. PATIENT RETURNED ON 8/30/2022 AND RECEIVED DOSE  -( 19 DAYS AFTER THE FIRST DOSE - OUTSIDE OF GRACE PERIOD, GIVEN TOO EARLY,)
On June 01, 2020 during morning hours, my left eye was starting  get watery and the upper eye lid felt heavy. Also the left side of my mouth commissure started to feel weak and hanging down.. The left border of my tongue was numb and I had a stabbing like headache on the left side of the back of the head. My left hand, finger number 4 and 5, felt numb and in my left foot I felt constant electric shocks. I also was having balance disorders, making me almost fall many times.
Vaccines had undergone several temperature excursions and administered to patient; No adverse event; Vaccines had undergone several temperature excursions and administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with or tested positive for COVID-19.     On 04-Aug-2022 at 6:18 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Aug-2022 at 6:18 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccines had undergone several temperature excursions and administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines had undergone several temperature excursions and administered to patient).    No concomitant medication was provided.  Patient received Dose 1 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The vaccine had undergone several temperature excursions and might got administered to patients.  The patient received Dose 2, Dose 3 and Dose 4 of Moderna vaccine intramuscular in deltoid muscle.  The vaccines were stored in the Refrigerator. There were 2 unbroken cartons with 20 vials. Date vial was moved from freezer to refrigerator on 07-Sep-2022. Vials were not visualized for Visual inspection.  It was reported that refrigeration excursions identified, vaccine was housed in these units. There were excursions noted.    It was reported that no adverse reactions were reported to their knowledge for the patient.  Treatment medication was not provided by the reporter.
Around 7:00 pm I started having aching joints, particularly my knees; had slight chills; and in general felt like I was coming down with something. My temperature was 99.2 at bedtime   These feelings lasted until I went to bed aroung 10:30 PM.  Whatever I had I sweated out overnight.  The next morning I felt fine.  I'm not convinced this is COVID related but thought I should let you know.  NOTE:  I was unable to complete #8 in the additional section below. It should read: Brilinta-60mg. Tamsulosin-0.8mg
Red circular rash approx 3 inches around inj site with lighter 1 inch circle around that. Slightly warm to touch. Soreness at local site, somewhat less today than yesterday.
Shot caused pain, fever, and redness around injection site the size of a baseball. I developed flu-like symptoms about 10 hours after the shot. I have sore throat,fatigue, horrible body aches even in my eyes like I have the flu.
Bilateral hands and wrist region edematous, reddened and warm to touch. Pt relates history of connective tissue disease which triggers unexpected inflammatory responses. Ice to affected area, vital signs monitored, Pepcid 40 mg PO and Benadryl 25 mg PO per personal choice. Observed for 50 minutes. O2 sats 95 - 98% for duration. BP at onset 190/110, 164/110  P: 62 - 68,  Resp 20 throughout. Swelling almost completely resolved at 50 min interval.Discharged to home per husband. Advised to consult provider for further recommendations or proceed to ED if worsening, SOB, chest pain or irregular, rapid HR. Phone F/U next day. BP: 120/98 which she relates is within her normal range. No further swelling to hands. Sxs resolved. Provider advised client to refrain from 2nd dose.
Initial information received on 13 October 2011 from the patient, who is also a health care professional. A 53-year-old female patient received a first intramuscular dose of FLUZONE (manufacturer Sanofi Pasteur), lot number not reported, in the left deltoid on 19 September 2011. The specific formulation of the vaccine was not reported. Three days later, on 22 September 2011, the patient woke up and had a sore throat, hoarseness, and laryngitis. Eight days post-vaccination, on 27 September 2011, she had severe joint pain affecting the foot, ankle, wrist, knuckle, and shoulder. The pain was described as "like arthritis". She was unable to walk due to foot and ankle pain. By 28 September 2011 she was unable to make a fist or open and close her hands due to severe pain. She was seen in the emergency room that day and was treated with SOLU-MEDROL. She was "okay" for 36 hours before her symptoms returned. She was treated with a MEDROL dose pack. Her symptoms appeared to be cyclic. She would have no problems during the day, but would experience pain and inability to walk by evening. She continued to have symptoms, which were reported to be resolving at the time of this report. The patient has not recovered from the events. List of documents held by sender: none.
This spontaneous report was received from a nurse practitioner referring to a 8 week old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On approximately 15-JUN-2017, the patient was vaccinated with GARDASIL 9 lot # reported as M004798 and expiration date on 31-OCT-2019 (dose and route of administration were not provided) for prophylaxis. The reporter stated that the patient was inadvertently administered the vaccine, due to human error and no adverse effects were reported.
A few minutes after injection pt stated she didn't feel well. Pt put head down between legs, c/o nausea. Pt looked up and was completely pale, c/o blurred vision, ringing in ears, dizzy, clammy, lightheaded. Assisted pt to car and transported to ER. Was dx as pre-syncope and drink fluids was discharged at 15:00
Patient was light headed after receiving vaccination. Patient was sitting on bench and appeared to have  fainted and fall off of bench onto concrete ground. Patient was unconcious when attended to by immunizing pharmacist for approximately 15-30 seconds. 911 was called and patient was roused to consiousness. Patient was dazed but alert. Patient was assesed for any difficulty breathing and returned to seated bench position.  Patient had sustained 2 minor cuts to the face presumably as he fell off bench. Applied pressure and stayed with patient untill EMS arrived. EMT's arrived and checked patient out and determined that no further treatment was necessary. Patient refused transport to hospital and allowed pharmacist to apply bandages to 2 small cuts and clean face of blood.
The evening of the 7th day after the injection I started getting a large red itchy rash. I was approx 3" from side to side and 4.5" from top to bottom. Little painful and little swollen. It lasted about 4 days and went away. Then 14 days after the injection the same rash reappeared. The reappearance started yesterday, and I still have it today.
Pt went to E.R. due to pain/inflammation of shoulder & body pains. Headache, chills. Patient received Rx for Antibiotic in ER.
Itching on injection site for1 week  Red streak about an inch along injection site Small lump at injection site
no adverse event; Non case: No stability data available in temperature excursion case no adverse event with no medication error case
First 48 hours had injection site pain and swelling. Muscle pain. Joint pain. Tiredness. Fatigue. Skin felt painful. Headache. Still having tiredness and headache today 1/8/2022
This spontaneous report was received from a certified medical assistant and refers to a 6 months old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-APR-2016 (also reported as 26-APR-2015) at 9:52, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. The patient had no illness at the time of vaccination. Administered vaccine experienced temperature excursion of 34 degrees Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Has been seizure free for 4-6 months (longest she?s been seizure free). The week of the 1st dose she had pretty significant seizures.
Dizziness, Sedation, Fever, Head pressure, Weakness, Chills, Skin hypersensitivity,  Narrative: Received 2nd dose on 1/26/21. Shortly after noted arm pain - and head pressure, weakness and dizziness within hours. Also developed fatigue, fever/chills and skin hypersensitivity day of injection. Awoke with a fever (100) the next morning. Missed work x 1 day. Symptoms improved over the next few days with complete resolution 1/30/21. Had prior positive COVID test 11/20, buat asymptomatic.
Cranky, low grade fever (98.9F) temp, mild (5-10 spots) papular lesions (face and trunk).
Patient broke out in a rash on her face and spiked a fever of 100. She was given 1.25 mL of Banophen. She was monitored for 20 minutes before leaving. Patients father advised to continue giving patient Benadryl as needed and come back if symptoms worsen or do not improve.