chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like she was going to pass out; Dizziness and lightheaded/felt a heaviness in her head; get achy`; This is a spontaneous report from a contactable consumer (patient).  A 66-year-old female patient received second dose of BNT162B2 (lot number was EL9262, expiration date was unknown) via intramuscular in left arm on 11Feb2021 around 10:00at single dose for preventative.  Medical history included ongoing autoimmune condition diagnosed three years ago, ongoing primary biliary cirrhosis diagnosed three years ago, ongoing acid reflux diagnosed 5 years ago, blood pressure abnormal, cholesterol abnormal, cardiac disorder. She had one stent.  Ongoing concomitant medication included ursodiol for autoimmune condition and primary biliary cirrhosis, simvastatin for cholesterol, ezetimibe (ZETIA) for cholesterol, losartan potassium for blood pressure, clopidogrel bisulfate (PLAVIX) since she had one stent, acetylsalicylic acid (BABY ASPIRIN) for the heart, hydrochlorothiazide for blood pressure, omeprazole for acid reflux. She received flu shot in Sep2020 or Oct2020 for immunization and she was fine. Patient received first dose of BNT162B2 (lot number was EL3249) via intramuscular in left arm on 21Jan2021 around 10:00 a.m. for COVID-19 immunization. Patient got something to eat and while she was on the phone around 12:30pm on 11Feb2021, she felt like she was going to pass out, she was dizzy and lightheaded. It lasted all night. On 12Feb2021 she felt a little better, but she still felt a heaviness in her head. It felt like pressure and the pressure was like dizziness. Her health care professional told her that it was normal, and she was told to hydrate, drink water and rest. She took her time getting up now since she was afraid. She wished she was one of the lucky ones to just get achy. Events not required visit to emergency room and physician office. There were no relevant tests. The outcome of event "Dizziness and lightheaded/felt a heaviness in her head" was recovering. The outcome of other events was unknown.
Narrative: Fully COVID vaccinated, h/o prior COVID positive 2 weeks prior, admitted with weakness, lethargy, chest tightness and COVID positive
This spontaneous report was received from a pharmacist refers to a 71 year old male patient. The patient's drug reactions or allergies were none. On 22-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # J011341, expiry date 13-DEC-2014) 0.65 ml, subcutaneous. Concomitant therapies included VOLTAREN EMULGEL, tramadol hydrochloride and LYRICA. Approximately on 25-APR-2014 (also reported as a week ago), the patient developed pain in joints of thumb, wrist and forefingers on his right side (disability). The patient was not able to grab things. It was reported that ZOSTAVAX was given on left side. There was no treatment rendered for the events. The outcome of the events were reported as not recovered. Causality of the event with suspect product was unknown. Product quality complaint was not reported. The patient sought medical attention (called pharmacy). Additional information has been requested.
Myalgia Swollen glands (armpits and neck), Injection site warm and red
Patient called 2 days after receiving immunization and complained of a red itchy rash the size of a tomatoe.
Developed swelling, redness day following administration (10/1/09). Presented to ED on 10/3/09 (Saturday) - Dx with cellulitis and Rx with KEFLEX - mother reports that improved within 24-48 hours.
After the vaccine, I had fever at night, hurt at the arm, all my joints ached during the night and headache, The headache, I had it every day from Feb to Dec 2021. In Jan 2022 I had the headache a couple times that time (2 or 3 times). Along with the headache every day I felt very off balance. I went to the doctor in March, and he did not know if it was related to the vaccine. But later on, when I had dose 5 of the COVID-19 vaccines similar symptoms came back.
Almost passing out; Very short of breath/Had trouble breathing; Coughing to the point of seeing black; Could not walk from one room to the next with out being out of breath; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 23Apr2021 16:30 (Batch/Lot Number: EW0170) as UNKNOWN, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. Medical history included asthma and sarcoidosis, drug hypersensitivity, allergies to cycline antibiotics. Concomitant medication included meloxicam (MELOXICAM) and omeprazole (PROTONIX [OMEPRAZOLE]). No Covid prior vaccination. Adverse event was reported as: Vaccine at 4:30 pm on Friday. Felt fine until later in the a.m. had trouble breathing. Very short of breath. Coughing to the point of seeing black and almost passing out. Could not walk from one room to the next without being out of breath. Adverse event start date: 24Apr2021, adverse event start time: 04:00 AM. Treatment received for events included nebulizer, rescue inhaler and Breo inhaler. The event outcome was recovering. No Covid tested post vaccination.
Initial report was received from a consumer on 05 NOVEMBER 2012. A male patient (date of birth: unspecified date of July 1961), whose medical history and concomitant medications were not reported, had received FLUZONE ID vaccine (lot number UT4463BA route and anatomical site of vaccine administration were not reported) on an unspecified date. On an unspecified date, after receiving FLUZONE ID vaccine, the patient experienced red induration which lasted for the last 6 weeks. It was larger in the beginning and had shrunk to about 80%. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovering. Documents held by sender: None.
2+ Days fatigue, nausea/vomiting, headache, muscle pain.  Severe.  Redness at injection site.  Still going on.
Information has been received from a physician concerning a female (age unknown) with a history of orthostatic hypertension, who on approximately 18-JUN-2007 was vaccinated with Gardasil. Subsequently, after receiving the vaccination the patient fainted, but it took a while to revive her. The patient sought unspecified medical attention. At the time of the report, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Developed lump in right breast approximately 1 week after vaccination. Evaluated by 2 healthcare providers. Mammogram and ultrasound showed no abnormal findings, but lump is still present today, 6 months after vaccination.
Patient presented to hospital 5/23/21 with a chief complaint unrelated to COVID19. She reports she received the moderna vaccine 1/27/21 and 2/24/21. Her COVID19 test was positive 5/23/21. She is currently asymptomatic.
Extra dose on 14Dec2022; received a dose of Menactra in 2018 and it was completed with a dose of Menveo on 18Oct2022; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA749A, expiry date 30th November 2023) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA749A, expiry date 30th November 2023) for prophylaxis and MENACTRA for prophylaxis.   On 14th December 2022, the patient received the 2nd dose of Menveo. On 18th October 2022, the patient received the 1st dose of Menveo. On an unknown date, the patient received MENACTRA. On 18th October 2022, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced interchange of vaccine products. On 14th December 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and interchange of vaccine products were unknown.   Additional Information: GSK receipt date: 14-DEC-2022 Reporter's comment: The nurse reported that the patient received a dose of Menactra in 2018 and it was completed with a dose of Menveo. The patient received an extra dose of Menveo. The reporter consented to follow up. Additional supportive information: The patient received extra dose of Menveo, which led to extra dose administered. The patient received a dose of Menactra and Menveo, which led to interchange of vaccine products.
it was rpt that in 12/96 pt vax & in 9/98 pt devel chickenpox. rpt felt chickenpox was not related to therapy w/varicella
Itching, pain, swelling redness at injection site and down to elbow.  Received penicillin injection from Dr. Pain, redness, swelling continued to about 4 inches below elbow.  5/14/16 - symptoms started to improve through the day.  Continued improvement on 5/15.
Uncontrollable shaking along with being bone chilling cold for approximately 2-3 hours; vomiting;  severely itchy mouth and nostril (on left side); dizziness; intense cramps in thighs; minor headache
Scattered papulovesicular rash in different stages from scalp to scrotum. No fever symptomatic care 3 weeks after varicella vaccine.
injection site was beet red; injection site was reallly hot; injection site was really hard; area around injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site was beet red), VACCINATION SITE WARMTH (injection site was reallly hot), VACCINATION SITE INDURATION (injection site was really hard) and VACCINATION SITE PRURITUS (area around injection site itchy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site was beet red), VACCINATION SITE WARMTH (injection site was reallly hot), VACCINATION SITE INDURATION (injection site was really hard) and VACCINATION SITE PRURITUS (area around injection site itchy). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (injection site was beet red), VACCINATION SITE WARMTH (injection site was reallly hot), VACCINATION SITE INDURATION (injection site was really hard) and VACCINATION SITE PRURITUS (area around injection site itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Developed low grade fever and GI distress (severe cramping abd pain), nausea with dizziness, extreme fatigue, diaphoresis, diarrhea, wit worsening HTN 8 days after second dose. This lasted 2.5 weeks which I then continued to experience every 7-10 days lasting about a week per episode. I eventually developed early satiety and intolerance of foods with dysphagia. Lost approx 25lbs until I initiated a AIP diet and started Cymbalta. Approx 30 days after second dose I started developing the dysphagia with essential and intentional tremors, tinnitus, fight or flight reaction which was mostly pronounced between 4-6 am. I had a full workup by neurology. Currently I have colitis type symptoms every 30 days, intermittent diaphoresis and dizziness with HTN, Tinnitus and mild tremors controlled by propanolol.
Patient face was flush.  Noticed by family after the 15 min observation.  Pt had no DIB or other complaints.  Pts BP was high and has a history of hypertension.  Unknown if this was caused by the vaccine or the patients preexisting health conditions.  Pt was transported to hospital by ambulance.
Patient became very lethargic right after giving the oral vaccine on 10-27-2021 @ 9:00am - EMS called - patient started acting more normal upon the arrival of  EMS. Parents decided to watch patient at home and will call EMS if any changes.
sore arm; heart palpatations; chest tightness; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpatations), CHEST DISCOMFORT (chest tightness) and PAIN IN EXTREMITY (sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.  Concomitant products included LISINOPRIL, APREMILAST (OTEZLA), BUPROPION HYDROCHLORIDE (WELLBUTRIN), LORAZEPAM (ATIVAN), CEFIXIME (FLEXERIL [CEFIXIME]), PARACETAMOL (TYLENOL) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PALPITATIONS (heart palpatations) and CHEST DISCOMFORT (chest tightness). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). On 28-Feb-2021, PALPITATIONS (heart palpatations) and CHEST DISCOMFORT (chest tightness) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment Medications were not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-101121 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101121:
Started to feel dizzy & weak just after rcv'd 2nd vax (Hep B). Color pale and heart rate decreased. Resolved w/out treatment. Did not loose conciousness.
muscle spasms in legs are reported in a pt who recvd flu vax approx 1 wk p/pt recvd vax devel twinges of the leg muscle which persist; pt was hospitalized on 9NOV93 & spinal tap is scheduled;
Lightheaded, dizziness, tongue tingling and "feels" inflamed (I am able to swallow.  I have had burning mouth syndrome for the past 3 years due to menopause  it seems to be worse since the vaccine), tinnitus (also a preexisting condition but seems worse since vaccine)
C/O rash with pain (R) side breast area to back. Has a relative who is pregnant. No ins. No PCP - Advised to avoid pregnant person and FU ASAP. States sx started "arounf the same time she had the flu shot and TST done.
Starting the day after the injection he had chills, fatigue and headache. Symptoms resolved on their own.
blood clots; Sjogren's syndrome; rheumatoid arthritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular, Primary immunization series completed but manufacture unknown.), administration date: Apr2021, for COVID-19 Immunization; Covid19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Route of Administration: Intramuscular, Primary immunization series completed but manufacture unknown.), administration date: Apr2021, for COVID-19 Immunization. The following information was reported: SJOGREN'S SYNDROME (hospitalization, medically significant) with onset Mar2022, outcome "recovering"; THROMBOSIS (hospitalization, medically significant) with onset Mar2022, outcome "recovering", described as "blood clots"; RHEUMATOID ARTHRITIS (hospitalization, medically significant) with onset Mar2022, outcome "recovering". The events "blood clots", "sjogren's syndrome" and "rheumatoid arthritis" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jul2022) Positive; Thrombosis: (Mar2022) lupus markers, notes: March and Apr2022 timeframe-labs showed evidence of lupus markers. Therapeutic measures were taken as a result of thrombosis, sjogren's syndrome, rheumatoid arthritis.  Additional information: Mar2022, 68 y/o female patient developed blood clots. Patient was hospitalized twice, first time Apr2022 and second time May2022. March and Apr2022 timeframe-labs showed evidence of lupus markers. Per patient's son, pt was given dx of Sjogren's adverse event patient's son, pt was given dx of Sjogren's syndrome and rheumatoid arthritis by her treating physician. Per patient's son-pt was initiated on 10,000 units of vitamin D3 qweek, methotrexate, hydroxychloroquine, and prednisone. On 15Jul2022 patient's son reported that pt had tested positive for COVID. Patient received treatment for ae. Patient had covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Kaydance was standing up and all of a sudden collapsed and fell back stiff and hit her head on the ground. She was pale in color and eyes were closed. She was NOT breathing. Wasn't breathing for about 1/2 a minute.
I noticed that for at least a year I had been losing my smell. My son inquired about my sense of smell and taste. I scheduled an appointment with my doctor. I took a test of 40 different smells and failed. I got 11 of them correct out of 40. I am doing olfactory training where I sniff common smells. The doctor provided all types of information on how to proceed. The doctor scheduled me for an MRI in a few weeks.
Fifteen minutes after receiving vaccine, patient became syncopal upon standing after his observation period.  He fell to the ground, hit his head.  Patient was diaphoretic and pale afterwards, and taken to the emergency room for evaluation due to fall.
Red, raised, hot to touch, non-painful, circle of inflammation on left anterior thigh. Approximate size is 1 3/4 inch in diameter. Fever in the morning of 101.2 degrees F. Child complains that his "leg hurts." Encouraged mom to continue Tylenol as needed. Mark with a pen the edge of redness. If symptoms worsens or any new symptoms occur to contact pediatrician.
Information has been received from a medical assistant concerning a 62 year old female patient with no known drug allergies and VARICELLA as a child who on 07-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 1556X) SQ.  Concomitant therapy included VAGIFEM.  On 27-JAN-2009 the patient developed a ZOSTER rash on her face after administration of ZOSTER vaccine live (Oka/Merck).  The patient had made telephone call for medical attention.  The patient was examined by a dermatologist and was prescribed VALTREX.  The patient was recovering from the ZOSTER rash on her face.  The patient was concerned her grandson would develop HERPES ZOSTER because she held him prior to the rash developing.  The physician may be interested in VZVID analysis.  No lab tests were performed.  Follow-up information has been received from physician via questionnaire that the patient with a history of chickenpox in childhood and no recent exposure to chickenpox or HERPES ZOSTER was vaccinated with ZOSTER vaccine live (Oka/Merck) (lot # 66334/1556X) SQ at the left side.  Nine days post vaccination on 16-JAN-2009 the patient developed ZOSTER rash near right eye on the cheek bone and on the same side of nose.  The patient also felt very tired.  The patient was seen and diagnosed by the physician who reported that she saw the patient for "this ZOSTER outbreak".  A PCR specimen was not collected, and no direct fluorescent antibody was collected.  The physician also reported that a photo was not taken.  At the time of reporting the patient had recovered from the adverse effect.  Additional information has been requested.
Patient consented to receive Moderna booster through her place of employment.  This RN verified she was to receive Moderna booster, and which arm she would like injection in.  After vaccine administered, patient stated she did not have any adverse reactions to two initial doses.  It was later discovered that patient had received Pfizer for initial doses of vaccine, and she was currently 17 years of age. Patient and her parent were notified of variance.  state immunization consultant notified of incident.
Pt reports that she experienced flu-like symptoms 10/26/14 pm that were consistent with the affects stated on the VIS for Fluzone HD. The early morning hours of 10/29/14, she experienced swelling of the tongue and ears and redness/swelling at the site of injection of Zostavax. She also experienced itchy scalp and sore abdominal muscles located below the rib cage. Patient did not previously exercise her abdominal muscles.
Sore arm morning after the injection at the site up to the shoulder and underneath side of the arm. Stuffy nose, and swollen eyes the morning after the injection. On 4/18/21 the left arm had a red ring from middle of left bicep up to shoulder. Sore and warm to touch.
Within 5 days of immunization, developed fever, abdominal pain, headache, elevated inflammatory markers, DDimers, ferritin and BNP and coagulopathy. Admitted to Hospital and evaluated for MIS-C.  Observed and treatment recommended for MIS-C with IVIG and steroids.
Stomach pain, headache, nauseated & diarrhea after injection. 12 hours after injection abd. pain then diarrhea for 24 hours.
Patient reported that the morning after the day he received his flu shot he had vomiting and diarrhea. He went to ER and was admitted to the hospital. His scans and labs showed acute pancreatitis. He was hospitalized for 4 days. (He informed the hospital that he recently received the flu vaccine but they did not say anything to reflect that it might be related in any way.)
COVID+ 1/1/23.  Vaccination status - moderna x2 BRIEF OVERVIEW: Discharge Provider: MD Primary Care Physician at Discharge: MD  Admission Date: 1/1/2023   Active Hospital Problems   Diagnosis Date Noted POA ? Cardiac arrest   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Cardiac arrest [I46.9]   HOSPITAL COURSE: Patient is a 25 year old woman with PMHx significant for Shone complext congenital heart disease s/p mechanical mitral/aortic valves, restrictive pericarditis status post pericardiectomy, congestive heart failure, ESRD on dialysis, chronic hypoxic respiratory failure status post tracheostomy/ventilator dependent who was admitted on 01/01/2023 following a VFib arrest.  Patient was transferred  in profound septic shock likely secondary to COVID-19 pneumonia with superimposed ventilator associated pneumonia leading to MSSA bacteremia.  She was initiated on broad-spectrum antibiotics overnight with worsening clinical trajectory including worsening acidosis, electrolyte derangements, and concerns for DIC overnight demonstrated on both laboratory values as well as clinical evaluation.  Extensive discussions were held with Pediatric/Adult Congenital Cardiology, cardiothoracic intensive care unit, pediatric cardiothoracic surgery, and Nephrology for discussions regarding ECMO candidacy and alterations to CRRT. On 1/2/23 AM, patient experienced a recurrent cardiac arrest following which CPR was administered and ROSC was achieved.  After extensive discussions with her family, her code status was changed to do not resuscitate and eventually comfort care. Case discussed and declined by ME office.    Medical Examiner Case Assessment Select Applicable Patient Criteria: Death within 24 hours of admission Medical Examiner Notified by: MD Name of the Medical Examiner notified:  Is the ME going to perform autopsy? : No Is the ME going to sign death certificate? : No Medical Examiner Notified by: MD Name of the Medical Examiner notified:
Large (approx 3.5 inch) red, hot, swollen circle around injection site. Swelling is going down but diameter of red circle is still increasing.  There is also a small bruise. Area is very sore and itchy