chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blurred vision; dizziness; metallic taste in mouth; chills; vaccination site rash; nauseating feeling in stomach; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurred vision), DIZZINESS (dizziness), DYSGEUSIA (metallic taste in mouth), CHILLS (chills) and RASH (vaccination site rash) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VISION BLURRED (blurred vision), DIZZINESS (dizziness), DYSGEUSIA (metallic taste in mouth), CHILLS (chills), RASH (vaccination site rash) and NAUSEA (nauseating feeling in stomach). On 13-Apr-2021, VISION BLURRED (blurred vision) had resolved. On 15-Apr-2021, RASH (vaccination site rash) outcome was unknown. At the time of the report, DIZZINESS (dizziness), DYSGEUSIA (metallic taste in mouth), CHILLS (chills) and NAUSEA (nauseating feeling in stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Currently pregnant when I received the first dose of the Moderna Vaccine on 1/22/21. At the time I was 6 weeks pregnant. My estimated dat of delivery is September 15, 2021.   The evening of 1/22/21 I experienced mild chills and tenderness around the injection area. 1/29/21, 7:30pm I experienced itchiness around the injection site. 1/30/31, 8:00am I checked my left shoulder and noticed that it was swollen and red in a 3x4 inch size around the injection area. As the day progressed I experienced more red patches that were itchy pop up at different areas of my body, including on my hands and wrists, on my butt and thighs, and on my knees and feet. I took a benadrly 25mg at around 8pm that evening. 1/31/21, 7:00am I woke up with facial swelling and numbness of both my upper and lower lip. I also felt itchy on my left hip. I went to the urgent care and I was advised to continue taking Benadryl as needed. Around 1pm I noticed more itchy spots had popped up near the injection site and on my butt. I took a benadryl around 2pm. My bottom and upper lip are still mildly swollen, however the swelling and numbness has decreased (3:25pm).
After 1st dose: Pregnancy-mimicking symptoms including enlarged breasts, tender nipples, bloating of abdomen lasting two weeks until the next menstrual cycle, which occurred just prior to the second dose.  After 2nd dose: The same pregnancy-mimicking symptoms as above (enlarged breasts, tender nipples, bloating of abdomen), but also including breakthrough menstrual bleeding/spotting at mid-cycle still continuing as of this reporting one week later.
Information has been received from a female who in 1973 was vaccinated with MMR II. The pt reported that she subsequently developed celiac disease. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Upon internal review, celiac disease was determined to be an other important medical event (OMIC). Additional info has been requested.
Previously healthy male presented with chest pain 4 days after his second COVID vaccination. He had left chest pain for a few hours yesterday which resolved, then recurred today. Pain was constant and radiated to armpit, worse with deep breaths.    CRP mildly up at 8.5. Troponin elevated at 465, CK up at 520, and AST mildly up at 62. Repeat troponin 1.5 hours later was 511.    Patient did have fever for one day after his second COVID vaccine, and has otherwise been afebrile.
An 80-year-old female patient was taken to the incident observation area for her first dose of MODERNA at 4:18pm. At 4:25pm the itch began which intensified in the head, arms, legs and chest. Then, the vital signs were taken which were: 130/80mmHg, 18 resp., 50 Pulse and 92 DXT. The case was consulted with Dr., who indicated that BENADRYL 25mg be administered and that it be left under observation while the treatment progresses as required. At 4:46pm BENADRYL 25mg is administered in the upper left external buttock and Famotidine 20mg p.o. as both are H1 and H2 antihistamines for allergy relief. At 4:50pm he was administered Famotidine as H2 receptor at 4:55pm. On the other hand, at 3:22pm, the patient is offered to be transferred to a hospital and indicates that it is not necessary and that if she feels bad that she has BENADRYL not to get better, she would go to a hospital.
got the flu 3 years in a row; Initial information was received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves patient (age and gender unspecified) who experienced flu 3 years in a row (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu 3 years in a row (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Patient developed constellation of fever, chills, profound fatigue, and neck swelling 24 hours after dose 1 which improved with Tylenol and advil but persisted for nearly 4 weeks resulting in 6 day delay in his 2nd vaccination.  During this time, he saw ENT for a chronic cough pre-dating his first shot and underwent CT to rule out sinus disease which revealed bilateral cervical lymphadenopathy. He then underwent 2nd dose and had exact same constellation of symptoms along with worsening of cervical lymphadenopathy and has persistent lymphadenopathy on exam at the time of consultation with infectious disease 3/16/2021) albeit symptoms and lymph nodes are improving.
On 9/13/21 pt. received Trumenba vaccine at her well child exam.  She was given no other vaccines at  that time.  On 9/14/21 she felt vaguely ill and had a  few loose stools.  On 9/15/21 pt. awoke with puffy lips  and broad areas of urticaria on her cheeks and arms. Mom gave her Benadryl, 50mg, orally and the swelling resolved.
Light headed and dizzy without fainting. Patient laid flat with legs elevated approximately 30 minutes, was then able to travel home in personal vehicle with driver.
Received shot in left arm and somewhat sore shortly thereafter.   Next morning my left hand was stiff and fingers swollen.  Now my left hand thumb  Locked and trying to move it very painful along with   no movement  at times.
Received vaccine 11/14. Mid day 11/15 noted small knot under skin wherre shot given. By the night time area was red and client had temp of 100 degrees. By Sat am temp 101 area red, swollen, warm to touch and very sore. On Sun. temp went to 102. Seen by private MD on Monday. Arm still red and inflamed and was itching. Given Augmentin and a cortisone cream.
PATIENT REFERS THAT THE LEFT ARM ITCHES AND HURTS. THE AREA APPEARS RED, WITH INFLAMMATION AND HOT TO THE TOUCH. THE PATIENT WAS EVALUATED BY DR. SHE ORDERED ARICEPT AND NAPROXEN.
Induration and swelling of vaccine injection site with extension of induration and redness further down upper arm in a triangular pattern about 4inches below site of injection. Patient complains of tenderness.
This spontaneous report as received from a Licensed practical nurse refers to a patient of unknown age gender. On 26-MAR-2016 the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX23 (Lot number reported as L010465, expiry date: 23-MAR-2016) (expired product administered). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Re-emergence of dysautonomia/POTS symptoms.; Re-emergence of dysautonomia/POTS symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: 320308D) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administration date 28Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Crohns disease" (unspecified if ongoing), notes: I have crohn's disease; "Interchange of vaccine products" (unspecified if ongoing). Family history included: "Dysautonomia/POTS symptoms." (Unspecified if ongoing), notes: -Originally dx at age 17 with POTS but have not had tachycardia or needed medication for it in the last 10 years., -My sister developed a severe case of dysautonomia/ POTS.; "Autoimmune Issues" (unspecified if ongoing), notes: Have family history of autoimmune issues. Concomitant medication(s) included: APRISO; WELLBUTRIN; LOESTRIN; VIT D [COLECALCIFEROL]. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 007M20A), administration date: 29Jan2021, when the patient was 35 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 037K20A), administration date: 01Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) all with onset 04Nov2021, outcome "not recovered" and all described as "Re-emergence of dysautonomia/POTS symptoms.". Therapeutic measures were not taken as a result of autonomic nervous system imbalance, postural orthostatic tachycardia syndrome.  Additional information: Seriousness criteria was no according Results in death, not Life threatening, did not Caused/prolonged no hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Re-emergence of dysautonomia/POTS symptoms. Originally dx at age 17 with POTS but have not had tachycardia or needed medication for it in the last 10 years. Began having symptoms again shortly after booster. Has not resolved. Have family history of autoimmune issues. I have Crohn's disease. My sister developed a severe case of dysautonomia/ POTS in Apr after completing Moderna vaccines. My other sister has a history of Guillain-Barre. No Known allergies. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not get tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
I had a routine mammogram in May 2021 and I am now undergoing chemotherapy. I am at treatment number four. I had to postpone my treatment as well due to testing positive for Covid on August 3rd 2021 as well. I was asymptomatic though.
Patient falsified DOB when registering for vaccination, stating the minor was 04/18/2005. Guardian, consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 06/18/2005 which made the vaccine a contraindication.  No known adverse reactions noted.
Patient reported on 11/3/19 that after the shot he developed a rash on both of his arms and his sternal area.  He did not specify date of onset. He also reported that after his shot he had worn multiple layers of clothing to work and did not know if the rash was related to the vaccine or the clothing.  The patient had applied Aveeno one day and then on 11/3/19 applied Noxzema to the rash.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL8982), in right arm, on 18Feb2021 as dose 2, single (Lot number: EN6198), in right arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30145BA), in right arm and on 05Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 79 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of covid-19.  Clinical course: Rebound symptoms were sore throat, nasal congestion which was started on 24Jun2022. The patient received Paxlovid from 14Jun2022 to 19Jun2022 with Lot number Fy4445 for indication of treatment of COVID-19. The patient had non known allergies. The patient did not received  other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.
ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 2/11/2023,  1/26/2023,  1/21/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Difficulty breathing; more comfortable sitting up than lying down; ended up hospitalized with pericarditis on 10/24/09 11:30 AM blood clot developed in right leg calf 11/9/09 Vaccine record received. 11/10/09 Hospital records received for dates 10/24/09. DX: chest pain Assessment: mild distress, thoracic back pain. Presented with c/o chest pain, back pain, vomiting, diaphoretic.
Vaccine was stored refrigerated, with 70 day expiration dating expired 7/3/23. Vaccine was administered 16 days past expiration.
Itching within 30 min., first day pink at inject. Third day today pink  rash the size of a half dollar with swelling and some pain. No treatment other than daily small dose of aspirin.
The first nite after receiving the shot on April 15 at 10:36 am  I had fever, chills and a headache. Couldn?t sleep all night that night.  Had one Tylenol that same night. Didn?t help. The second night I went to sleep and took two 82 mg aspirins  for the lingering headache.- it worked slept well.  Two days after the vaccine at around 2:30 pm I experienced vertigo- especially laying my head down made the sensation of spinning .  I went to sleep to take a nap and  try and sleep it off. One hour later I woke up and still had vertigo and also tinnitus- a ringing in my ear.  The vertigo has gotten better - still feel it on the third day and still have the ringing in my ear which made sleeping quite difficult on the 3rd night.
Local reaction immediately after vaccine given on L. Deltoid. Knot developed 4.5 x 4 cm, soft, no pain reported by patient. Patient was assessed by Dr. and nurse. Pt was instructed to monitor arm and call office on 10-24-16.
IMMEDIATELY AFTER VACCINATION, THERE WAS THE TYPICAL INFLAMMATION, REDNESS, AND SORENESS.  IT WAS DIFFICULT TO MOVE THE ARM.  THE INFLAMMATION AND REDNESS RESOLVED.  HOWEVER, 6 MONTHS LATER, MOBILITY NOR STRENGTH HAS BEEN RESTORED. THERE IS LIMITATION OF OVERHEAD MOVEMENT ABOVE SHOULDERS AND DRAMATIC LOSS OF STRENGTH IN THE RIGHT ARM.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillan" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported Drug ineffective and COVID-19 cannot be ruled out.
broke out in hives; Initial information received on 27-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a female patient of unknown age who broke out in hives while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination. Batch number requested.  On an unknown date the patient broke out in hives (urticaria) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (broke out in hives).  At time of reporting, the outcome was Unknown for the event broke out in hives.
Patient was administered a dose of Pfizer pediatric vaccine and immediately fainted afterwards and became conscious again right after. Guardians and Vaccination Nurse were both present, pulse was taken and paramedics were called. They chose to not transport and clear the patient
5x9cm erythema, heat, pain, swelling (L) arm onset 48 hours post Tdap administration. Afebrile. Treated with Ice and Ibuprofen.
On 12/24 I began to notice intermittent tingling along the medial edge of my left hand (in ulnar distribution). Over the next day or two I began to notice persistent weakness of the 4th and 5th digits on my left hand to abduction, adduction, flexion, and extension.  Over the weekend the weakness improved slightly, but has not improved much in the past few days.  I am also still occasionally experiencing the tingling sensation in the same distribution.
I received both dose of the vaccine and I developed asthma after the first dose and it was worse after the second dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 75-year-old female patient received first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown), both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received both doses of the vaccine and developed asthma after the first dose and it was worse after the second dose. The asthma is gone now but she had it for 2 months. The events assessed as non-serious. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received her shots, walked around the office to the waiting room where she began to fall down hit her head on desk and fainted for about 10-20 minutes.
Immediately upon withdrawing needle from deltoid, pt experienced a syncopal episode, lasting approx. 1-2 seconds, pt. fell laterally onto exam table where she rested for 15 minutes. Mom stated pt has "fainted" before when receiving injections.
I ended up in the emergency room  at 4am on 3/28.  I had 103 temp, heart racing, headache, sore throat, body chills, joints muscles hurting couldn't walk.  The ER did an EKG, chest xray, labs, respiratory swabs, and urine.  Stated all was alright.  This was an exaggerated response to the COVID vaccination.  I have had an elevated temperature the entire week.  Today my temp is 101.
Got varicella on 4/10/02 and had varivax vaccine on 12/5/96.
(1035 VAC. ADMINISTERED); 1415- RETURNED TO VACC. CENTER- C/O RT ARM VAC. SITE REACTION OF HIVES.  EMS ON SCENE.  VS:  98.5 F, 02 SAT:  96% R.A.; P:  74; BP:  159/85; 1422:  NO  C/O.  VSS.  1426:  LEFT AND WENT TO ER.
Administered flu shot 10/27/12 at 10 AM. After 20 mins, began to feel uneasy - at night felt increased fever - 100 degrees, tired, achy, sore throat, chills through night till about 10 AM 10/28/12 - still feel tired.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 19-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date on 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On an unspecified date, the vaccine experienced a temperature excursion of 47 F (8.333333333 Celsius) for 40 hours (highest recorded temperature). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Expiratory wheezeing, excessive phlegm in lungs, cleared up by morning.
Temp 104.5 max temp or about 12 hours Headache x 3 days Swollen lymph nodes in left arm for about a month fatigue for about 24 hours
Fever with seizure.  Seizure lasting at least 20 minutes requiring IV medications to stop.
No additional AE reported; expired GARDASIL 9 that was administered; Product also experienced temperature excursion; This spontaneous report was received from Pharmacist and refers to a 14-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-NOV-2022, the patient was vaccinated with an improperly stored first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T025367, expiration date: 18-NOV-2022, administered intramuscularly in the right deltoid for prophylaxis (strength was not provided) (Improper storage of product in use) (Expired vaccine used). The vaccine underwent a temperature excursion of 24.5 degree Celsius (C) for a period of 15 hours and 38 minutes. The vaccine did not undergo previous temperature excursions. The pharmacist reported that the patient did not experience any adverse event.  The medical assistant confused the date format, only saw the month and year of expiration and thought that the vaccine was good until the end of the month and the caller wanted to verify vaccine viability. The vaccine underwent a temperature excursion of 24.5 degree Celsius (C) for a period of 15 hours and 38 minutes. The vaccine did not undergo previous temperature excursions. The pharmacist reported that the patient did not experience any adverse event.  The nurse considered the event of Expired vaccine used as resolved.
4 hours after shot felt like someone had hit her right arm. At 6:30 AM the next morning definite stiffness in arm. Arm twitched that evening even when she laid on her arm: twitching continued x 24 hours. Deltoid muscle swollen and firm. Warm to touch 7/30.