chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 10 minutes into waiting after injection, patient stated she felt like she might "pass out".  She then experience into post-vagal posturing with no clonic activity, no loss of bowel/bladder.  After approximately 1 minute, she become coherent postictal.  BP was 138/87, pulse was 66 bpm.  She later reported that she has had a history of a "reaction to needles" but that she did not experience it when she got the flu shot last fall.
Intentional deviation from dosage regimen; Received second dose more than 36 days after first dose; Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine; Never really felt bad and if so, it was subtle; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Never really felt bad and if so, it was subtle), COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine), INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SL20A and 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Barrett's esophagus, Blood pressure high and Diabetes (Diabeties Patient take injection for diabeties.). Concomitant products included ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Barrett's esophagus, CLOPIDOGREL BISULFATE (PLAVIX) for Blood count abnormal, METFORMIN and INSULIN for Diabetes.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Never really felt bad and if so, it was subtle). On 14-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine). On 12-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose). On 12-Apr-2021, INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 36 days after first dose) had resolved. At the time of the report, FEELING ABNORMAL (Never really felt bad and if so, it was subtle) and COVID-19 (Diagnosed with COVID-19 after first dose of Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) COVID-19 positive.         Lab data includes - Patient tested COVID-19 positive on 7-jan-2021 or 8-jan-2021 Concomitant medications also included unknown blood thinner and heart medications. Treatment medication include antibody infusion for COVID-19 received around 12-JAN-2021
next day rash appeared behind her leg, behind her knee and leg it doesn't hurt but its itches; She developed a rash about 6-8 inches on the back of her right knee; This is spontaneous report received from a contactable consumer. This consumer (patient's parent) reported for a female patient (daughter) that a 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: GW0186), via an unspecified route of administration on 14May2021 (Friday) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On 15May2021, the next day on Saturday, the patient developed a rash about 6-8 inches on the back of her right knee. The next day (16May2021) rash appeared behind her leg, behind her knee and leg it doesn't hurt but its itches. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
The first thing that started was severe pain in all my joints. That was in a couple hours from the shot. I have screws in my knee and it felt like someone was trying to unscrew them. Then in the middle of the night the front and back of my head had stabbing pain. Also every tooth in my mouth was throbbing so bad that I contemplated knocking them out. I started getting numbing and tingling in my hands and feet occasionally but now it happens every morning and goes away after a couple of hours. The heart palpitations got worse and my EKG showed that it looked like I had a heart attack. I was diagnosed left anterior fascicular block (LAFB). I have a Holter monitor on that I have had to wear for seven days. I never had heart issues before. I also had blurry vision for 5 days, and I could barely see. The severe pain lasted two weeks. I still have the numbing, heart palpitations and joint pain.
on the 3rd there was swelling at the vaccination site, it was swollen and itchy and bubbling at the spot, April 10th she got a very bad cold, sneezing, sore throat, coughing, she thought it could be covid 19th and went to take a test but it came back negative
Fever of 102 in the office. Parent reports temperature of 103 at home. Cold symptoms developed.
edema/induration pain arm;tx w/medrol dose pk & Keflex great response
Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.; Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2021 as dose 1, single (Lot number: EK9231), in left deltoid and on 27Jan2021 as dose 2, single (Lot number: EL3247), in left deltoid, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Hypertension just above borderline= 140/90; "Is the patient a smoker/former smoker? : No" (unspecified if ongoing), notes: Is the patient a smoker/former smoker: No. Concomitant medication(s) included: METHYLPHENIDATE; BUPROPION; ALBUTEROL [SALBUTAMOL]; MONTELUKAST; HYZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Oct2021, outcome "recovered" and all described as "Does the patient have a positive test for SARS-CoV2?: Yes / Prior occurrence 03Oct2021 Pos.". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) 140/90, notes: just above borderline; Evidence of hypoxemia, hypercapnia (PaCO2) or acidosis (pH): (unspecified date) Unknown results, notes: Evidence of hypoxemia (e.g. PaO2/FiO2 [P/F ratio], SpO2/FiO2 [S/F ratio]), hypercapnia (PaCO2) or acidosis (pH): Checked; Oxygen saturation: (unspecified date) 92 %, notes: pulse ox brief; SARS-CoV-2 test: (03Oct2021) Positive, notes: Prior occurrence; (25Jul2022) Positive, notes: Reoccurrence RT-PCR; (24Jul2022) Positive.  Clinical course: The patient received multivitamins.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure and covid-19.
Patient presented to ED on 1/14/2021 with CC of rash throughout body after receiving COVID vaccine 3 days ago, now with red itchy rash to face, arms, back, and torso. No difficulty breathing, no chest pain. RASH: full body; dry, itchy, red; moderate severity; gradual onset; constant; worsening; new; relieved by nothing; worsened by nothing; no treatment tried. No abdominal pain, diarrhea, fatigue, fever, headache, nausea, periorbital edema, shortness of breath, tongue swelling, vomiting, or wheezing.  Patient treated with diphenhydramine 25mg PO x1 in ED with improvement. Discharged back to assisted living with prescription for diphenhydramine PO. Final diagnosis: T50.Z95A vaccine reaction, initial encounter, COVID 19; L28.2 pruritic rash. Discharged home in STABLE condition.
pt recv vax & febrile for 3 days w/t102, pain in extremity where shot given & lethargic (just lying there) x 3 days;
Patient states arm was black-and-blue after the shot.  Which began several days (at least 3) after the shot was given and was persistent over the course of 2 weeks.  Did not have pain, but had soreness the day after the shot.
13 days post vaccination patient wakes up with a slight itch in here ears.  By 4pm she reports a sudden hearing loss in her right ear.  On day 14 she proceeds to get very weak with vertigo, nausea, and anorexia. No temp or other signs of illness.  On day 15 we take her to ER and work up was negative.  On day 16 we take her to ENT no explanation of the sudden hearing loss but is told she is totally deaf in the right ear and needs a hearing aid in the left.  She did not have this prior to the vaccination and it was a sudden onset.
Severe lower back pain after first dose, started 3 days after first dose (had mild lower back pain starting day after first dose that became progressively worse). Felt like my paraspinal muscles were tightening on spine. Did not go away before second dose. The day after second dose the lower back pain became bad again. Has not gone away and it?s now 6 weeks later. Also had severe joint pain and joint swelling after second dose. And upper back tightness , spasm and knots. Muscle aches for 6 weeks as well.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 31-JAN-2016, the patient was vaccinated with improperly stored (temperature: 17 F, time frame: 15 hours) dose of VARIVAX (Merck) lot # L0103827, expiry date: 21-APR-2017 (dose, site and route of administration were not reported). No symptoms were reported. Additional information has been requested.
Tiredness; Headache; This is a spontaneous report from a contactable consumer(patient). A 28-years-old female patient received first dose of bnt162b2 (BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 24Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pregnancy, anxiety, drug hypersensitivity, urticaria, insomnia, dizziness. Concomitant medications included ocrelizumab (OCREVUS), prednisone (PREDNISONE), paracetamol (TYLENOL). On 25Apr2021, The patient experienced tiredness, headache. The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
Pt call hospital call center for consultation. After second dose of pfizer she received from outside pharmacy she had c/o of cough and headache.
BODY ACHES; CHEST PAIN; SHORT OF BREATH; 103 FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced body aches. On 2021, the subject experienced chest pain. On 2021, the subject experienced short of breath. On 2021, the subject experienced 103 fever. Laboratory data included: Body temperature (NR: not provided) 103 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chest pain, and short of breath on 2021, and 103 fever. This report was non-serious.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 26-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in June 2020. Concurrent medical conditions included Asthma (Using an inhaler). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, DOCUSATE SODIUM (COLACE) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 29-Aug-2021. On 23-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  seventeenth week of the pregnancy.  On 23-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant product was an inhaler for Asthma.  No treatment information was reported.
Swelling, redness and itching that began approximately 20 hour post-vaccination.  The swelling and itching were gone by 40 hours post-vaccination but there was still residual inflammation.
tingling of lips, tingling of tongue, numbness of left side of face, flushed face on left side. Occurred about an hour and a half post injection.  Lasted about 30 minutes.   12 hours post injection - shortness of breath similar to asthma, tongue feeling slightly swollen, slight metallic taste.  Lasted a couple of hours while watching tv - subsided.  Day 4 - noticeable fatigue, headache, slight cough, sinus like congestion, muscle and joint aches, slight dizziness, foggy feeling, sluggish, but no fever. slowly resolved over next day.
My joints ached the next couple days.; it made me very tired; My arm was sore; This case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced joint pain, pain in arm and tiredness. On an unknown date, the outcome of the joint pain and tiredness were unknown and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the joint pain, pain in arm and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient just received the dose of Shingles vaccine and experienced joints ache in the next couple days and arm soreness for 3 days. On the next day of vaccination, the patient was very tired.
Patient returns to clinic 10/21/2008 reports that shortly after influenza vaccine on 10/19/2008 had fever, swelling of face and shaking with the fever and shaking stopping and that the swelling of the face remains and sore throat - very scant swelling of bilateral eyebrow area - airway open- no respiratory distress - throat without redness, swelling, odor, exudate or post nasal drip and without visable tonsils. Cervical lymph chain without lymphadenopathy or tenderness to palpation. Referred to urgent care with instructions of need to be seen tonight and to list influenza vaccine as allergy with patient verbalizing understanding to all instruction
Mild chills, fatigue, and body ache 24 hours after vaccination.  10 days after vaccination: migrating headache of varying intensity, the longest lasting at top of head toward front, also noted at side of head toward back, with strongest intensity occurring at base of skull. All resolved the following day.
she had allergic reaction to a Merck Hep B vaccine; This spontaneous report was received from a 59-year-old female patient who was reporting on herself. The patient concurrent condition included with celiac disease, fibromyalgia and Hashimoto's disease. She had allergy to penicillin, latex, bananas and bees. Medical history and concomitant medications were not reported.  On 08-AUG-2005, the patient was vaccinated with her first part of three hepatitis b vaccine (recombinant) (manufacturer unknown) injection, intramuscularly for prophylaxis (exact dose, dose #, strength, anatomical location, lot # and expiration date were not reported). On the same date, she experienced allergic reaction and seek medical attention. As the treatment, the patient received respiratory therapy and epinephrine (EPIPEN). She had performed electrocardiogram (EKG) but results were not provided. The event resolved on the same date. The patient wanted to get the coronavirus disease 2019 (COVID-19) vaccine and wanted to know the components of that vaccine hepatitis b vaccine (recombinant) (manufacturer unknown).   The relatedness between hepatitis b vaccine (recombinant) (manufacturer unknown) and the event was considered as related.
Severe right groin pain; Difficulty walking; exercise is extremely limited; Quite painful; Weakness in legs and muscles; Very tired; heart seems taxed; Standing become laborious; Headache; Received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 05Jun2021 at 15:15 (Lot number: EL3247) as single dose for COVID-19 immunization. The patient medical history was not reported. Family medical history included thyroid med use, arthritis, increased blood pressure. Concomitant medications reported as none. None of prior vaccinations. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 15Apr2021 at 15:15 (Lot number: EL9265) as single dose for COVID-19 immunization that patient had a severe ear problem/cannot hear. On 06Jun2021, the patient experienced severe right groin pain - difficulty walking, exercise was extremely limited and quite painful; weakness in legs/muscles; very tired (heart seems taxed). This seemed to come in 'out-of-the-blue' standing becomes laborious (patient cannot seem to go on a walk anymore); headaches. One day patient would see some improvement but, the next was another story. Patient was taking Tylenol. Overall it was getting better-sort of (xtra with regular strength). Exactly 1 month to the day of 2nd vaccination (Pfizer) that this ghostly ailment came on, the right side of my body. Patient had called her GP & was scheduled for a blood test. Also, patient had scheduled an orthopaedic visit (neighbour recommended) at end of month. Patient was sleeping more, moving slow and trying to figure out how to help herself. Isometric exercise helped sometimes. Events resulted in physician office visit. Treatment received for events including Tylenol xtra strength and reg. strength. Outcome of the event "received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15" was unknown, while of the other events was not recovered. Seriousness criteria was assessed by the reporting consumer as persistent/ significant disability/incapacity.   Follow-up attempts are completed. No further information is expected.
Narrative:  Patient reached out to inquire on potential booster vaccine given previous AE after the second Moderna vaccine which was administered 2/11/2021 and 3/11/2021. Patient shared previous symptoms of slurred speech, blurry vision and diaphoresis occurring 2 days after his moderna vaccine dose #2 and during a celebration in 3/2021. Symptoms were accompanied with with diarrhea and patient went to the hospital per chart review and was monitored for arrhythmia and evaluated for CVA. The patient notes that he had similar symptoms with the first dose of Moderna #1. It is noted that the patient has had similar evaluation for sinus PVC's and pacemaker alarms even when he has not had covid boosters (12/7/2021) and noted in cardiology note 12/27/2021. Given the broad differential for the patient's symptoms and the lack of clarity to what caused the patient's episodes, consulting provider recommended a shared decision making approach with the patient regarding obtaining a booster.
Heart pounding. First ER visit 11:00 AM - 3:50pm dizzy, SOB, unable to stand, systolic B/P > 200, rapid irregular pulse, diaphoretic. Felt like passing out several times. Transported by EMT over to ER. Rx with IV. MD said it was a severe white count reaction. Second ER visit: 7pm - 11:30pm. Nausea, severe diarrhea that started at 6 pm. Unable to stand, weak, SOB, diaphoretic, felt like passing out several times. Husband called ambulance. Rx with IV, BENADRYL, prednisone. This MD said it was a reaction to the flu shot and never to have another one. Times are approximate.
This case was reported by a consumer and described the occurrence of unknown cause of death in a 70-year-old female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to FLULAVAL QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient was the relative of the reporter. The patient received the vaccine and died on an unknown date due to an unknown cause. The autopsy details were not provided. Due to the patient's death after taking the FLULAVAL vaccine, the reporter was afraid to get the vaccine.