chrisvoncsefalvay/vaers-outcomes huggingface dataset:
For about 2 months I experienced brain fog, dizziness ranging from a couple of minutes to 1-2 15 minute spells; For about 2 months I experienced brain fog, dizziness ranging from a couple of minutes to 1-2 15 minute spells; I had a couple incidents when I did not recall something I had done at work; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6203) at the age of 61 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Gluten intolerance" (unspecified if ongoing), notes: Known allergies: High gluten and "Dairy intolerance" (unspecified if ongoing), notes: Known allergies: Dairy sensitivity. Concomitant medications included: VITAMIN B; PROBIOTIC and CALCIUM. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EM9809; Route of administration: unspecified), administration date: 09Feb2021, when the patient was 61 years old, for COVID-19 immunisation.  The following information was reported: FEELING ABNORMAL (non-serious), DIZZINESS (non-serious) all with onset an unknown date in 2021, outcome "recovered" (an unknown date in 2021), and all described as "For about 2 months I experienced brain fog, dizziness ranging from a couple of minutes to 1-2 15-minute spells"; MEMORY IMPAIRMENT (non-serious) with onset an unknown date in 2021, outcome "recovered", described as "I had a couple incidents when I did not recall something I had done at work". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, dizziness and memory impairment.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The incident that worried her from getting a booster was a Sunday afternoon she had a 15-minute dizzy spell and had to lay down. She signed out 2 tax documents and a check - her husband called her later the next morning saying that she had put 3 different dates - they should had been the same date. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19.
This spontaneous report as received from a healthcare worker refers to patients of unknown ages. Since February 2012, GARDASIL was exposed to repeated temperature excursions as low as -9C. The GARDASIL was also exposed to temperatures above 8C multiple times. On unknown dates, doses of the vaccines (lot # not reported) (strength and total daily dose not reported) had been administered to patients. At the time of this call, the healthcare worker did not know the exact length of time that the vaccine doses were exposed to the temperatures out of range, nor was there adequate documentation of the administration of these doses to the practice's patients. It was unspecified whether the patients sought for medical attention. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Pt. received AFLURIA shot on 10/23/14. On 10/25/14 he developed sx of runny nose, sneezing, coughing, and on 10/26/14 developed fever of 101 degree F with body aches, H/A, stomach ache.
12/22 4:20 pm - Pt playing with sister turned on floor trembling and LOC. RN called. Now feels ok, lucid. H/O seizure. Dx syncope, check seizure.
Patient's mom called and stated she woke up with rash on neck, some on legs and up into her scalp. States it does itch. She went to pediatrician (appt was already in place to check her for mono). Rash was diagnosed as definitely urticaria per RN at pediatric office. No treatment was given for rash. Recommended Benadryl, but pt did not want to "get sleepy".
Area on left arm around the injection site became raised, red, hot, very itchy, and firm.  Area grew to about 8sq inches in an oblong shape .  Applied  topical Diphenhydramine 2% cream 5 hours after first signs of itching (no noticeable improvement) Took oral dose of Fexofenadine Hydrochloride 180mg 16 hours after first signs of itchiness.  Saw a slight decrease in itchiness over 24 hours.  Iced area for 20 minutes and took 2nd dose of same oral antihistamine 24 hours after first dose.  Inflamation (raised, red, firm) symptoms began subsiding slowly. Still have residual itchiness and redness and firmness 60 hrs after symptoms appeared.
Patient received flu shot on 10/04/19. Patient's mom states arm all red and got a fever 102.3  on next day of receiving flu shot 10/05/19. Unsure what time course patient had reaction.
Given the second dose 19 days after the first dose; A spontaneous report  was received from a pharmacist concerning a 76-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and was given the second dose 19 days after the first dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.     On 27 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 19 Mar 2021, the patient was given the second dose 19 days after the first dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event was given the second dose 19 days after the first dose was considered recovered on 19 Mar 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported
patient developed rash on upper chest and on arm of vaccine 10 days later after receiving vaccine her doctor is having her take zyrtec twice daily she is on day 15 rash has improved but not completely gone  her dr still would like her to receive 2nd dose and patient would also like to receive 2nd dose
Patient reports that on the late evening of 11/19 or certainly by the morning of 11/20 they experienced an itchy, red, rash at their injection site (left upper arm). The rash was reported to be 3in wide by 4-5in vertically at its largest. The patient self-administered an over-the-counter antihistamine. The patient denied any other symptoms, such as difficulty breathing, a widespread rash, lip/facial swelling, etc. The patient reports the localized rash lasted "a few days" and began to resolve." By 11/23/21, the rash is entirely resolved per the patient.
red raised rash that began @ inj site & spread to both legs, arms & abd & face w/itching noted (rash started on lt thigh);
113 Bivalent doses administered after the BUD to patients 12 and up.; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No Adverse event) in an adolescent patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No Concomitant medication was reported. No treatment information was provided.  It was reported that Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.
MMR and Varivax and PCV7 on 6/14/06. Mom noticed eye swelling, rash. Used Benadryl, went to ED on 06/20/06 diagnosed with allergic rxn/hives.
Multiple seizures, pneumonia, abnormal MRI, high blood pressure, code blue due to lack of breath, transferring to multiple facilities of medical center, on going crying, stiffness of legs.
Patient had symptoms of fever, chills, nausea, light headdness and loss of apetite.
This spontaneous report has been received from a medical assistant, concerning multiple patients' of an unknown age and gender. The patients' concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported. On an unknown date, the patients' were vaccinated with M-M-R II (lot # R000555 and expiration date 08-JAN-2020) (anatomical location not reported). The M-M-R II vaccine was reconstituted with properly stored sterile diluent. In addition, improper storage dosis of with ROTATEQ (Lot#R016790 and expiration date 20-APR-2020) taken orally, were administered to some unknown patients. Both vaccines were taken as prophylaxis. No adverse effects reported. Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger. This is a non-valid case due to the lack of a patient identifier.
Information has been received from a medical assistant concerning a 16 year old female patient with sulfonamide and azithromycin allergy who on 30-JUN-2009 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 659655/0940X). On 01-SEP-2009 the patient was vaccinated intramuscularly with the second 0.5ml dose of GARDASIL (lot# 663452/0671Y). Concomitant therapy included SPRINTEC. On approximately 07-JUL-2009 ("a week after administration of her first dose of GARADSIL"), the patient experienced fainting spells, stomach pains, weight loss of 16 pounds, swollen glands in the neck and fatigue. It was reported that the patient experienced the same symptoms but more intense after her second dose of GARDASIL administered on 01-SEP-2009. When she experienced a fainting spell, she was exhausted for the rest of the day. The patient still continued to have episodes of blacking out and stomach pain once or twice a week. The patient had been examined and had a complete work up from a neurologist, gastrologist and cardiologist. All tests were negative. At the time of this report, the patient was recovering. Follow up information has been received from the medical assistant who confirmed the dates and lot #s for the two doses of GARDASIL and reported that there were no concomitant vaccines were administered. She clarified that the events, experienced a week after the first dose, persisted then worsened after administration of the second dose. The events were considered as disabling since the patient could not attend school. It was unknown if the patient was hospitalized. The patient had not seen in their office since 01-SEP-2009. Fainting spells, stomach pains, weight loss of 16 pounds, swollen glands in the neck, fatigue and episodes of blacking out were considered to be disabling. Additional information has been requested.
4/9 vaccination. Twelve hours later, I had fast pulse over 130 BPM. Woke me up at night. My resting is at the low 60's; normal.  chest pain. I was so tired. Tried to go back to sleep. Kept having episode. I woke up husband and said we need to go to the ER. Ran tests. Referred to cardiologist. They gave me Tylenol and baby aspirin.  *Went to ER 4/10 and 4/12 4/16 appt with cardiologist; 24 hour HR monitor. Waiting on results 4/26 Echocardiogram scheduled   **Dr. (cardiologist)
After 5-6 days, itching at site. Itching is becoming more intense. Using Triamcinolone Acetonide to relieve symptoms.
Information has been received from a physician concerning a 12 year old male patient with previous exposure to mumps who on 06-FEB-1997 was vaccinated with the first dose of MMR II and on 07-AUG-1999 received the second dose of MMR II. On 03-JAN-2010 the patient experienced mumps; the date of diagnosis was 05-JAN-2010. The patient presented with left parotitis and was afebrile. On 05-JAN-2010, the following laboratory tests were performed; serum immunoglobulin M test, 1:10; serum immunoglobulin G test 8.81; serum amylase test 162. The patient's final outcome was not reported.  No further information is available.
This spontaneous report as received from a nurse refers to a 13 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 29-JUL-2016, the patient was vaccinated with a dose of PROQUAD, dose 0.5 ml, subcutaneously, lot # L031600, expiration date: 18-FEB-2017, (dose number and injection site were not reported) and a dose of VARIVAX, (dose, dose number, injection site, route of administration, lot number and expiration date were not provided) (overdose). There were no concomitant medications reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information had been requested.
Syncope - loss of consciousness for 45-60 seconds - possible seizure activity- labored breathing. Struck head on half wall and chair before falling on floor. Paramedics called but pt regained consciousness and mother refused transport to hospital.
Registered Nurse erroneously gave 0.25 ml instead of 0.5 ml.
gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Mar-2022, the patient experienced ACCIDENTAL OVERDOSE (gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.). At the time of the report, ACCIDENTAL OVERDOSE (gave 4th dose of the Moderna Covid-19 vaccine of 0.5mL instead of 0.25mL dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment information was reported.
Nurse was called to vaccination room for patient evaluation. Patient was alert and oriented x3, lying down, no signs of injury or loss of consciousness. Reports history of near syncope with vaccine administration. VS obtained. BP 100/70. Pulse 82 Respirations 16 Oxsat 97%.Radial pulse strong. Denies nasuea/vomiting, throat swelling or chest pain. Patient was moved to the post vaccination observation room. Walked himself without assistance and was observed for 30  minutes.
This spontaneous report as received from a nurse refers to 33 patients of unknown age and gender. On an unknown date, the patients were vaccinated with doses of improperly stored VARIVAX (Merck), 0.5 ml, subcutaneous. No adverse effects were reported. Additional information has been requested.
Arm pain; Shingles on torso and leg; Lump in breast; Joint pain; Throw up; Headache; Chills; Nausea; Whole body felt hot; Felt faint; Extremely cold for next 30 hours; This spontaneous case was reported by a consumer and describes the occurrence of Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, and Arm pain in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L204 and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's disease (In 2002), Anxiety (in 2001) and Blood pressure (in 2001). Concomitant products included LEXAPRO for Anxiety, METOPROLOL for Anxiety and Blood pressure high, SYNTHROID for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 18-Feb-2021, the patient experienced Whole body felt hot, Felt faint, and Extremely cold for next 30 hours. 18-Feb-2021, the patient experienced Joint pain, Throwing up, Headache, Chills, and Nausea. On 06-Mar-2021, the patient experienced Lump in breast. On 18-Apr-2021, the patient experienced Shingles on torso and leg. On an unknown date, the patient experienced Arm pain. At the time of the report, Shingles on torso and leg, Whole body felt hot, Felt faint, Extremely cold for next 30 hours, Arm pain, Lump in breast, Joint pain, Throwing up, Headache, Chills, and Nausea outcome was unknown.            Treatment information was not provided by the reporter.    This case was linked to MOD-2021-014748.
I had covid in Jul2022/Aug2022 - 1 tested positive for 2 wks; I had covid in Jul2022/Aug2022 - 1 tested positive for 2 wks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 19Apr2021 at 10:00 as dose 1, single (Lot number: EW0162), in left arm, on 10May2021 at 10:00 as dose 2, single (Lot number: EW0173), in left arm, on 01Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FE3590), in left arm and on 30Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FK9895), in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Booster dose due to a weakened immune system" (unspecified if ongoing), notes: Booster dose due to a weakened immune system; "Current or recent cancer" (unspecified if ongoing), notes: Current or recent cancer: Checked; "No/non-functioning, spleen" (unspecified if ongoing), notes: No/non-functioning, spleen or kidney failure: Checked; "kidney failure" (unspecified if ongoing), notes: No/non-functioning, spleen or kidney failure: Checked. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I had covid in Jul2022/Aug2022 - 1 tested positive for 2 wks". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: I Had several covid-19 test before hospital procedures- don't know dates- all Negative; (2022) Positive.  Clinical course: booster dose (other): 30Nov2022, bivalent lot# GT6742. prior vaccinations (within 4 weeks), vaccine name: flu, anatomical site of infection: left arm. test: patient had several covid-19 test before hospital procedures- don't know dates- all negative. patient had Covid in Jul2022/Aug2022 - 1 tested positive for 2 wks. specific relevant test for thromboembolic events with thrombocytopenia: none
About nine days after receiving my first dose of the vaccine, I took a shower and noticed a HUGE red hive or rash on my left arm at the injection site. The rash is not itchy or painful, but is worrisome based on how quickly it went from being ok to bright red and visible.
pt recv vax 4OCT96 & pt exp hives on inj arm w/in 24hr post vax, the hives spread to chest, face & back;tx w/DPH 5OCT96 & 6OCT96;sx resolved on 7OCT96;
Information has been received from a medical assistant referring to unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored oral, ROTATEQ (lot # L000569, expiration date 13-JUL-2016) (dose and route were not reported). Previous temperature excursion was reported as 1.5C for 28 minutes. Time frame was reported as 1 hour and 14 minute under temperature: +0.9C. No adverse effect was reported. Additional information has been requested.
Complete unilateral hearing loss right ear; This is a spontaneous report from a contactable nurse. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), in Feb2021 (Lot not reported) as 1 st dose, single then on 18Mar2021 (Lot not reported) as 2 nd dose, single; both intramuscular (at the age of 80-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included neoplasm malignant. The patient's concomitant medications were not reported. The reported adverse event was complete unilateral hearing loss right ear on 27Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received were PET-scan (in 2021), MRI (in 2021), hearing test (in 2021), antibiotics and prednisone. The outcome of the event was recovered with sequel in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available a causal relationship between event unilateral hearing loss right ear and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I suddenly experienced increased heart rate. I then felt like my heart was beating out of my chest. I had my fiancé check my blood pressure, which is typically in the normal range. I had a 160 over 108 with a resting heartrate of 120. That night I also experienced severe sweating.
Patient presented to the ED and was subsequently hospitalized for tachycardia, community-acquired pneumonia, gastroenteritis within 6 weeks of receiving covid booster vaccination.
pt recv vax pt kept crying;mom called from wal-mart;pt still screaming told to bring child in;pt was screaming, RVL site very red, swollen;pt had been crying from 9:20 to 2PM;cont crying into noc;
Just about 15 mins after recieving vaccination, I  experienced increased shortness of breath, feeling weak, slight headache, and my heart seemed to race.  When I shared this with the pharmasist, she did not offer to take vitals nor seemed concerned.  She suggested that I was experiencing anxiety, and that it was not a typical reaction to the vaccine.  However, each day since vaccine I have continued to have episodes of shortness of breath.  Today, 3 days after the vaccine, I had more shortness of breath than I had since first contracting Covid-19(which was on 10th of Dec).  I also was having to stop walking several times every 5 mins or so in order to catch my breath, feeling weakness and fatigue.  My sense or taste/smell is gone as well. I was so short of breath today, work was worried anough about me they urged me to go home and call my doctor.  I now have a tele-visit set up with my doctor today.