chrisvoncsefalvay/vaers-outcomes huggingface dataset:
April 25th (within 24 hours of vaccine) I felt the typical fever, severe chills, fatigue, etc that I'd often reported. No soreness. This was gone by the end of the day. April 26th I began feeling some light-headedness and feeling faint. My heart was fluttering every time I stood up, my vision went blurry, and I was very unstable (had to hold something to keep from falling). This feeling was bad enough to cause me to become uncoordinated and fall down the stairs while home alone. That evening I went to the ER where they verified that I was "stable" and checked for bigger issues, and sent me home without treatment.  These symptoms continued for the next week. Improving a little each day.  It is now May 10th and I am still experiencing some light headedness and clumsiness. Still needing to rebalance myself on something if I stand up quickly. At some point over this time, I've started making mistakes in my words and sentences. Just odd things like omitting words from phrases or confusing "up" with "over" etc. I did not notice this at first, but my co-workers did. Before the vaccine, this is not something I ever did. Correlation?  Causation?  Regardless, I'm still a little unwell and a little worried. But the ER seemed unconcerned, so I've been continuing about my life.
Information has been received from a physician concerning a 21 year old female who on 08-May-2007 was vaccinated intramuscularly with 0.5 ml of Gardasil lot #657617/0384U, and felt pain after receiving vaccine.  The pain was initiated at the injection site and radiated down to her 3rd and 4th finger.  There was no visual redness or swelling.  This was her second vaccination.  She did not have any reaction on her first vaccination.  Unspecified medical attention was sought.  As of 14-May-2007, the patient has not recovered from her pain.   No further information is available.  Additional information has been requested.
Initial information received on 05-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA252194, 2018SA252181 and 2018SA252204 (same reporter). This case involves patient (age and gender not provided), who was given expired vaccine PENTACEL (lot number: C5384AA and expiry date: 30-JUN-2018) (dose, dose in series and route of administration were not reported) in the left leg on 13-Jul-2018. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR and ROTAVIRUS VACCINE (Lot number, dose, route and site of administration not provided) on an unknown date. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
pt recv vax & exp dizziness & profuse sweating, hypotension, tachycardia (>126bpm);pt exp build-up of clear fluids in lungs;breathing is painful & diff (asthma-like);exp pain in hips, knees, & toes;devel skin rash ;
This spontaneous report as received from a healthcare worker refers to a 15-year-old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # reported as L011846, expiration date was reported as 16-JUN-2017) (dose, route and site of administration were not provided). Concomitant medications were not reported. No adverse effects was reported. This is one of several reports from the same source. Additional information has been requested.
2 hours post vaccination patient called with complaints of dizziness, lightheaded, and heart racing. Per patient, she has had a similar reaction when given the high dose flu shot. She says something happens every time but this time it seemed to be more severe.
Headache, Myalgia & Fever Narrative:  Per nursing report "Employee took 2nd dose of COVID 19 vaccine on 1/29/21 and reports symptom of slight fever, flu like symptoms and headache that has progressively worsened. Employee called in on 2/1 and 2/2/21."  Other Relevant History:
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 10/12/2021. PATIENT FULLY VACCINATED ON 03/18/2021. PATIENT RECEIVED MONOCLONAL ANTIBODY INFUSION ON 10/14/2021.
G1P0, currently pregnant at 12w3d (EDD: 02/21/2022) with fetal hydrops, patient not delivered
PATIENT RECIEVED VACCINATION.  NO ISSUES DURING MONITORING.  THREE HOURS LATER SHE DEVELOPED RASH W/ERYTHEMA MULTIFORM SPREAD TO WHOLE BODY.  MILDY ITCHY, BUT OTHERWISE ASYMPTOMATIC.  BENEDRYL GIVEN WITH NO EFFECT.  ISSUE RESOLVED ITSELF.
Temperature excursion for high dose flu vaccines. The manufacturers recommendation was to not use them after it had been administered to patient.
?COVID arm?  delayed cutaneous hypersensitivity;  Firmness day 1-2, a lot more painful than initial injection pain, redness that increased/spread over 3 days, painful to touch, slightly raised and swollen, started really painful ? itchy days 2-5. Took photos.
Patient reported a bump forming at injection site approximately 3 to 4 days after vaccination. Also reported pain at site of injection, stated pain was greater in comparison to previous vaccinations. Spoke to pharmacist at another pharmacy for counsel on 9/26/22, observed and thought this could have been due to the vaccination administered too low in shoulder muscle.  Scabbing and irritation has also developed around site.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: FH8C20) at the age of 45 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013L20A), in left arm and on 12Feb2021 as dose 2, single (Lot number: 016M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ALTAVERA, start date: 01Jan2006. Past drug history included: Benzocaine, reaction(s): "Known allergies: Benzocaine".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, and indication was treatment of COVID-19.
Loss of consciousness during sleep at 1:00 AM on 4/6/2021 about 8 hours after vaccination. Loss of consciousness lasted approximately  20 seconds. Diarrhea has persisted since 4/6/2021 and has affected daily activities including work
BODY ACHE; CHILLS; HEADACHE; LOW GRADE FEVER; FATIGUE; 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced body ache. On 31-MAR-2021, the subject experienced chills. On 31-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced low grade fever. On 31-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, chills, low grade fever, fatigue and body ache was not reported. This report was non-serious.
Swelling under left arm pit and breast area; Swelling under left arm pit and breast area; Slight Fever (Low grade); Tiredness; Dry throat; Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips; Skin warm; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), BREAST SWELLING (Swelling under left arm pit and breast area) and PYREXIA (Slight Fever (Low grade)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herpes NOS.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), PYREXIA (Slight Fever (Low grade)) and FATIGUE (Tiredness). On an unknown date, the patient experienced BREAST SWELLING (Swelling under left arm pit and breast area) and LYMPHADENOPATHY (Swelling under left arm pit and breast area). On 30-Mar-2021, DRY THROAT (Dry throat), PARAESTHESIA ORAL (Tingling in the Mouth and on the Lips, Feels like Cold Sores popping out inside her mouth on the back of lips), SKIN WARM (Skin warm), PYREXIA (Slight Fever (Low grade)) and FATIGUE (Tiredness) had resolved. At the time of the report, BREAST SWELLING (Swelling under left arm pit and breast area) and LYMPHADENOPATHY (Swelling under left arm pit and breast area) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: low grade fever (High) low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     .   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow-up information received on 14-MAY 2021 contain new events(Lymphadenopathy) and (Breast swelling). Out come of all the events has been updated to recovered.
This spontaneous report was received from a Nurse refers to a patient of unknown age. On an unknown date, the patient was vaccinated with VARIVAX (merck) Lot # J007028 (Expiry: 05-JUN-2015) (0.5 ml once) subcutaneous was stored at 1C for 150 hours. No adverse effects reported. No further information provided. This case is linked to the case 1405USA000004 and 1405USA000973 (Same reporter link). Additional information has been requested.
Extreme tightness and pain in the arm surrounding the injection site. Pain still present three days after injection.
Patient is a 77-year-old man with history of COPD (severe; 6 L NC at baseline), CAD, non-small cell lung cancer (preivously underwent round of chemotherapy in 2019, but not actively undergoing treatment), AFib, and diastolic heart failure who presented to the ED with hypoxia and shortness of breath.     Patient was on BiPAP at the time my assessment and was difficult to obtain full history.  History is supplemented by review of EMR and discussion with patient's daughter via telephone.   Patient has required multiple admissions related to hypoxic respiratory failure and pneumonia over the last year.  He was last hospitalized in 11/2021 with hypoxic respiratory failure.  He was noted to have Pseudomonas pneumonia with associated bacteremia that admission.  He responded appropriately to antibiotics and was able to be transition to his baseline oxygen requirements.  Palliative Care has evaluated patient on multiple admissions.  Patient is thought to be hospice appropriate, but patient and famly have continued to request full medical support and usual medical care.   Patient was last seen in the ED on 1/15 after he experienced a fall at home.  CT head and C-spine did not show any acute findings.  He had a forehead laceration that was repaired  He was able to be discharged back to his home in stable condition.   On 1/21,  he worked with home health PT and started to have worsening shortness of breath. His family reported that he was starting to become more hypoxic during this time.  His family believed that his home oxygen concentrator was malfunctioning and that this was contributing to his ongoing hypoxia.  Patient developed an episode of dizziness and weakness one day prior to admission.  On the day of admission, patient was noted to be much more ill according to family. He was noted to be more lethargic and struggling to breathe.  EMS was then summoned.  Patient was noted to have significant hypoxia with O2 sats in the 70's was placed on BiPAP.  He was then brought to the ED for further evaluation.     Upon arrival to ED, patient was noted to be hypoxic and required BiPAP support.  He was noted to be tachycardic in the low 100's and normotensive.  Admission lab work was notable for WBC 24.  ABG showed hypoxia and mild hypercarbia on BiPAP.  Patient tested positive for COVID-19.  CXR showed diffuse airspace disease bilaterally, stable from prior studies.  CTA chest showed no PE, but shows stable dense consolidation in LLL, and partial consolidations in RLL and RML.  It also showed persistent mediastinal lymphadenopathy.  Patient was started on broad-spectrum antibiotics in the ED. Hospitalist was then contacted for admission.     Of note, patient was vaccinated against COVID-19 and completed an mRNA vaccine series in 2/2021.  He had not received COVID-19 vaccine booster.  I spoke with patient's daughter and expressed concerns regarding his severity of illness and his prognosis. She affirms that patient wishes to be full medical support at this time.  She was upset that she was not able to visit patient while he is in the COVID unit.   PT IS INPATIENT AT THIS TIME.
Began with a horrible coughing spell that lasted about 30 minutes.  My voice changed, got hoarse, then throat and windpipe began closing up and felt like I couldn't breathe.  I began to feel dizzy, like I was going to pass out, weak, and nauseous.  Nausea has yet to go away, 24 hours after shot.
A report had been received from a Health Professional concerning a patient of unknown gender, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The reporter stated that FLUMIST QUADRIVALENT not stored properly might have been administered to patients. The outcome of the event of FLUMIST QUADRIVALENT not stored properly might have been administered to patients was unknown. The reporter was considered to be non-serious.
Pt experienced transient joint pain and swelling in the knees, wrists, shoulders and ankles.  Pt indicated that the condition comes and goes and is not everywhere all the time.
This spontaneous report was received from a pharmacist and refers to a non-pregnant 65 year old female patient with no pertinent medical history. Concomitant therapies included NORVASC, TOPROL XL, LIPITOR and ACCUPRIL. On 24-SEP-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscularly for prophylaxis (anatomical location, lot/batch # and expiration date were not reported). On the same date, she developed large swelling and redness from shoulder to elbow. It was reported that the patient received treatment (unspecified) for the events and not lab diagnostics were performed. The patient did not need hospitalization or intervention to prevent serious criteria, as did not present disability or a life threatening event. The outcome of peripheral swelling and erythema was reported as not resolved. The causality assessment between peripheral swelling and erythema with the therapy with PNEUMOVAX 23 was not reported.
pt recv vax & 1mo later pt exp positive antibody for hepatitis core antigen;
Pain at administration site. The pain got worse and the patient sought treatment. They were given an unknown antibiotic and naproxen. x-ray and ultrasound was performed. Patient was given an injection of lidocaine/cortisone. Patient was instructed to follow up in two weeks.
No additional AE reported; vaccine administered after temperature excursion; Temperature 9.6 C; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.    On 12-JUL-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number: U007860, expiration date: 14-JAN-2022) 2 mL administered orally. The vaccine was stored in temperature 9.6 degrees Celsius for 11 minutes (product storage error temperature too high). There was no previous temperature excursion. Digital data lodger was involved. No adverse event was reported.
Fainted; Anxiety; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and ANXIETY (Anxiety). At the time of the report, SYNCOPE (Fainted) and ANXIETY (Anxiety) outcome was unknown.            No relevant concomitant medications were provided the reporter.   Patient had anxiety and fainted. Patient had received the second dose and was fine. No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to Patient Link.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 17:00 (Lot number: 301458A) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 301308A, Location of injection: Arm Right, Vaccine Administration Time: 10:00), administration date: 29Sep2021, when the patient was 30 years old, for Covid-19 Immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 19Oct2021 06:00, outcome "unknown", described as "Brain fog". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other medications within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Cough, difficulty breathing, tight throat, severe wheezing on auscultation. Treated with Epi-pen autoinjection, oxygen via mask
LEFT ARM BELOW DELTOID AND ABOVE ELBOW SWELLED. VERY RED AND HOT. PT ALSO COMPLAINED OF HIGH FEVER OF ABOUT 102F WITH NAUSEA AND VOMITING. PT STATED SHE WENT TO DOCTOR ON MONDAY 10/10/16 AND WAS ADMINSTERED A STERIOD SHOT BY PHYSICIAN.
INJECTION GIVEN ABOUT 1224 -REPORTED WITHIN 15 MINUTES OF INJECTIONS THAT TONGUE WAS FEELING NUMB AT THE TIP,  SIDES OF THROAT FEEL THICK-WATER DRINKING WAS NOT HELPING, AND SLIGHT ITCHY CHEEKS. AT 1253-25MG BENADRYL ADMINISTERED. 108 PM-REPORTED SOME IMPROVEMENT OF TONGUE SYMPTOMS AND ITCHY CHEEKS.
Approximately 6 days after the vaccination date, the injection site started to itch and get a red ?splotch? around it. Pressing the area feels denser than the surrounding tissue and is slightly tender.   Reported to my immunologist even though she did not administer the vaccine. Treating at home with Benadryl and ice packs.
Information has been received from a nurse concerning an 8 year old patient who on an unspecified date was vaccinated with at least one dose of VARIVAX (Merck) (Lot # and route no reported). The nurse reported that the patient on an unspecified date came down with chickenpox. At the time of the report, the patient outcome was unknown. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
HARD LIKE A LUMP AT SITE OF INJECTION, REDNESS, SORE, AND WARM TO TOUCH, NO FEVER. PATIENT TOOK ONE ALEVE 200MG. (RECOMMENDED COLD COMPRESS BUT PATIENT HAS NOT HAD A CHANCE TO DO THAT YET).
This spontaneous report was received from a female certified nurse assistance of an unknown age, with type 1 diabetes mellitus and no allergies or drug reactions reported, referring to herself. The nurse assistance reported that, on 3-NOV-2016, while she was drawing up the vaccine into the syringe, PNEUMOVAX 23, (lot # and expiration date unspecified), a very small amount squirted into her eye. She flushed her eye with water, denied pain, and would be seen by her primary care physician. No treatment for the adverse event was given. No laboratories were performed. At the time of the report, the outcome of the patient and the causality between PNEUMOVAX 23 and Occupational exposure to product were unknown. Additional information has been requested.
Breakthrough case admission after 2 vaccines Pfizer 4/22/21 Lot# ER8735;  Pfizer 5/13/21 lot# Ew0179
Information has been received from a physician concerning a 44 week old female who on 31-MAR-2008, was vaccinated with a second dose of ROTATEQ, oral, (lot number not reported). The patient never received the third dose of vaccine. The patient experienced inappropriate schedule of vaccine administration with no adverse effects reported. No product quality complaints were involved. Additional information has been requested.
First varicella vaccine 9/14/2016 local reaction - HA since first injection. #2 12/7/16 Varicella - Induration at site 4 cm. dizzy, lightheaded. Migraine HA.
Pt returned to office accompanied by mother. Mother reports child started having a few bumps on 9/26/03, late in the evening and by 9/28/03 it had spread to entire body. Cortisone cream applied by mother prior to 9/30/03, Benadryl prescribed every 6 hours.
I have had ringing in my ears ever since I received the shingles shot. This was the first round of the shot. I haven't informed the Doctor's office as of yet but I am going to do that next.
Syringe leaked at the hub between the needle and syringe, another dose given to vaccine recipient
Later the night after the vaccine I developed a bad headache, fever of about 100, body aches and severe fatigue so I took a mixture of Vitamin C, D and Zinc and Aspirin to help with the symptoms. I also took Tylenol and Ibuprofen as well and within less than 24hrs all symptoms had subsided. My arm at the injection site was sore for a few days also.