chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tongue paresthesia Narrative:  Immediately following administration of first dose of Pfizer COVID19 vaccine, patient reported pruritus, bumps on sides of R then L neck, and tingling/stinging sensation of the R side of her tongue without swelling of tongue/lips elsewhere. Patient took personal supply of diphenhydramine 50mg and was transported to ED for further evaluation. Upon arrival to ED, no additional symptoms reported. She denied any areas of urticaria/hives at that time and stated the neck is the only area of rash she noted, and she currently has pruritus only around the neck area and still notes small bumps. Her tongue felt improved but not normal and she denied any tongue/oral swelling, wheezing, dyspnea, chest pain, syncope, LH, palpitations, confusion, n/v/d/abd pain HA, focal neurological complaints, seizures, or any other acute symptoms. Patient had an extensive history of multiple other allergies. Diagnosis included early angioedema and second dose not recommended by ED provider. Methylprednisolone and famotidine administered in ED. Patient discharged from ED with prednisone and famotidine. Previously prescribed epinephrine for anaphylactic seafood allergy.
About one week post-vaccination, I noticed itching and when I scratched, I noted a lump where it itched. This was Feb. 11th at about 2pm. When I got home, I removed my shirt and noticed I had a red blotch and lump at the vaccination site.  It no longer itches, but I still have the red splotches and a slight lump under the skin.  I want to know if it is safe to get the second vaccine. I already plan to get it in the opposite arm.
Vaccine admin on 11/7/14 - within minutes profuse rhinorrhea; 30 min itching (diffuse), then headache, dizziness; within a few hours paresthesias in fingers and toes progressed to hands and feet. Weakness elbows to fingers and knees to toes bilat. Complaints of entire body feeling "heavy". Redness and induration at injection site slightly larger than a quarter. At 48 hours, weakness and paresthesia (in fingertips/toes) continues.
Had C:Pox vaccine 4/10/07, presented today 4/12/07 a large red whelp C shaped with 4-5 cm induration mild erythema and mildly warm to touch.
Patient experienced a syncopal episode after receiving dose. He fell as he was walking to the observation area . The episode was witnessed .  Patient became diaphoretic.  Recovered uneventfully EMS were on scene . Patient did not require transport to ER.
I got the shot on Satruday and then that evening, my arm was sore as expected. I had a little something under my eye. Looked like a little bite. On Sunday, on my face I had what looked like sunburn under each of my eyes and on the side of both of my face. It felt tingly. The redness was there day into Sunday night. I took some Benedryl. On Monday, the red was gone but my eyes were puffy and had some swelling to my face and still had tinglng in my face. I called my PCP and she asked that I come in and see her. On Monday, I had a visit with my PCP, there was stil some swelling around my eyes. She was going to report it and would let  me know if I could take DOSE 2. I was advised to not take DOSE 2. It was all better by Wednesday.
Intense, local allergic reaction at administration site with swelling, redness, and itching. Symptoms lasted 8 days treated with antihistimine by mouth.
This spontaneous report was received from a registered pharmacist via a company representative regarding a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, intramuscular (dosing regimen and lot number unspecified). On an unknown date the patient experienced injection site reaction which included injection site soreness, injection site itching, injection site swelling and patient was given ZOSTAVAX by the intramuscular route. Patient sought medical attention. The outcome of injection site reaction, injection site soreness, injection site itching, injection site swelling and medication error were unknown. Causality assessment was not provided. Additional information has been requested.
Patient noted to be diaphoretic, tachypneic at regular rhythm, increased work of breathing, rales LUL, vocalizing with end expiration, O2 Sat 67% - was placed on 15 L nonrebreather with O2 Sat recovering to 96% - sent out via EMS to hospital where admitted  for acutehypoxic  respiratory failure from aspiration event. treated for possible PNA with IV antibiotics and discharged on oral antibiotics - on admission had elevated troponin to 0.9 with no EKG signs of acute ischemic changes and quick trending downward of troponin - treated with IV heparin but low suspicion for acute coronary syndrome and diagnosis of demand ischemia (type 2 NSTEMI) - discharged on aspirin chewable 81 mg daily
Muscle Twitching  Hypersensitivity to Noise  Numbness and Weakness in Arms and Legs (predominantly right side) Brain Fog Joint Pain Inflation / Reactive Arthritis  Off-balance
Pulmonary Embolus  Insidious onset of dyspnea on exertion with her daily walks, stairs, muscle fatigue the week after her vaccine Initially attributes sx to donating blood ( 3 days after vaccine) When sx persisted came to office for eval. D Dimer positive Chest CTA shows RLL PE No hypoxia, no chest pain, clinically stable Plan is for oupt tx with Eliquis and stop OCP
dizziness 11/11/09 and 11/10/09 upon awakening in am, nausea 11/10/09 upon awakening in am.
This spontaneous report as received from a registered nurse refers to a 54 years old female patient with intermittent bronchitis, carcinoma, abnormal blood pressure and no known drug allergies. The patient's medical history included hysterectomy for uterine cancer. The patient was vaccinated subcutaneously in the right deltoid with lot # (672428/1599AA), 0.65 ml dose of ZOSTAVAX on 16-OCT-2012. No other co-suspects were reported. Concomitant medications included an unspecified blood pressure medication. The registered nurse reported that within 24 hours of receipt of the dose the patient contacted the nurse and reported that she was experiencing redness, swelling and lumpiness of the injection site, her right deltoid. On 18-OCT-2012 the patient appeared to be developing a vesicular rash. The patient was given BENADRYL and was applied cold compresses as treatment for the events. No lab diagnostic tests were performed. At the time of the report the injection site appeared to be worsening. The relatedness for vesicular rash, lumpiness, swelling and redness of the injection site was not provided for ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 11 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On 06-APR-2018, the patient was vaccinated with GARDASIL 9, intramuscular, to prevent human papillomavirus (HPV) (strength, dose, frequency, lot#, expiration date were not reported). On the same day, 15 minutes of receiving the dose, the patient felt dizzy, fell, and hit her head on the ground. It was unknown if the patient received any treatment or if diagnostic laboratories were performed. The patient recovered on the same day. The causality assessment between aforementioned events and GARDASIL 9 was not provided.
Immediate: Dizziness, numb face, itching throat and nasal passage, itching tongue (slightly swollen) with lead like feeling, bruising on chest. 3 Days Later:  Itching throat and nasal passage, itching tongue with lead like feeling and chest pain. 4 Days Later: Itching throat and nasal passage, itching tongue with lead like feeling and off-on chest pain.
Upon asking questions on the COVID-19 Immunization Consent Form on 3/12/21, it was noted that the patient could have possibly had a mild anaphylactic reaction to her first Moderna vaccination 28 days ago. She received the first vaccination to her left deltoid, and states that she had moderate swelling at her injection site. She also reports she still has left breast pruritus, mild swelling of her left arm, mild swelling of her bilateral hands, and swelling of her bilateral legs, ankles, and feet. She also had a runny nose after the vaccination, but that has resolved. Patient was sent to ER by her PCP.
Rash was blistering; She had a terrible rash; Had open sores on her body; Heart palpitations; On her arms she has scar tissues from the first dose; Her eyes were going to pop out of her head from her migraines; Her eyes were going to pop out of her head from her migraines; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 041C2A and expiration date was not reported), via an unspecified route of administration on 11Aug2021 at dose 1, single for covid-19 immunization. She never had issues with migraines except when she was pregnant and also has infertility issues. The patient's concomitant medications were not reported. Patient who was surgical technologist, had a terrible rash and having heart palpitations after the first dose, she felt like her eyes were going to pop out of her head from her migraines in Aug2021. Reported that her rash was blistering and she had open sores on her body, not like hives, almost like shingles but she did a shingle test and it was negative. On her arms she has scar tissues from the first dose, skin was still raised and healing in that area. She has been in and out of ERs getting steroid injections in her butt and having to be on high doses of steroid pills because of this. She had to get her second dose on 08Sep2021 to be compliant for school. The patient underwent lab tests and procedures which included Shingles test: negative in Aug2021. Therapeutic measures were taken as a result of events (rash was blistering, had a terrible rash (rash), had open sores on her body, on her arms, has scar tissues). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101275965 same patient/vaccine, different dose , similar events
I had 2 adverse reactions to the Janssen Covid-19 Vaccine EUA: AE #1) Roughly 15 minutes after receiving the vaccination, the lower half of my face went numb for approximately 3 hours. The people who administered the vaccine made me stay at the site for about an hour and a half to make sure that the reaction did not get worse. AE #2) 10 days after receiving the vaccination, the lower part of my left leg began to swell significantly. I went to the emergency room on 4/13/2021. When I was there, they did tests and confirmed that I have a blood clot behind my knee. To treat the blood clot, the emergency room doctor gave me lovenox 110mg and warfarin 5mg. Since then, I have followed up with my primary doctor who has me taking warfarin 10mg ( 1x daily) and lovenox (as needed).
Patient was given Combination vaccine Dtap/Polio that is labeled use for children less than 7 years old, patient was 7 years old at time of vaccination. No adverse reactions.
on 23Apr, I spotted and had terrible cramping and lower back pain; on 23Apr, I spotted and had terrible cramping and lower back pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 14:00 (Lot number: EW0164) at the age of 53 years as dose 1, single and administered in arm left, administration date 04May2021 13:15 (Lot number: EW0176) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID; PROGESTERONE; ESTROGEN. Past drug history included: Levaquin, reaction(s): "known allergies: Levaquin", notes: Levaquin; Compazine, reaction(s): "known allergies: Compazine", notes: Compazine. The following information was reported: MUSCLE SPASMS (non-serious), BACK PAIN (non-serious) all with onset 23Apr2021 07:00, outcome "not recovered" and all described as "on 23Apr, I spotted and had terrible cramping and lower back pain". The event "on 23apr, i spotted and had terrible cramping and lower back pain" and "on 23apr, i spotted and had terrible cramping and lower back pain" was evaluated at the physician office visit.  Additional information: My first vaccine was on 13Apr2021.I have not had a period in 9 years. On Apr23, I spotted and had terrible cramping and lower back pain (as if I was going to have a period) The cramping was on and off and ended around 02May. On 04May I received the second covid vaccine. The cramping and lower back pain began again the next day. The symptoms have been on and off but quite severe on 09May and still continue.   No follow-up attempts are possible. No further information is expected.
Chicken pox lesions onset 11/13/2001, afebrile, itchy, symptomatic treatment.
pt recv vax & approx 10 days later devel some lesions on back;p/3 months devel new lesions on face & elbow;
Little discomfort in the ribs; Sore ribs; Dizziness; Blood sugar going down; I am feeling like reluctant to put food in my mouth and because it does not seem to be agreeing with me; I got horribly sick to my stomach and it cause me to throw up; I got horribly sick to my stomach and it cause me to throw up; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 71-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration on 23Feb2021 (at the age of 71-year-old) as dose 2, single for covid-19 immunization. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications patient stated as yes, she took a lot of medication, well there was awful lot of them.".Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on 02Feb2021 as dose 1 single for COVID-19 immunization. On 24Feb2021 the patient got horribly sick to her stomach and it cause her to throw up, on an unspecified date she experienced little discomfort in the ribs; sore ribs, dizziness, blood sugar going down, she felt like reluctant to put food in her mouth and because it does not seem to be agreeing with her. The patient underwent lab tests and procedures which included blood glucose: going down on an unspecified date. No treatment received for blood sugar as the patient stated her blood sugar was fine. Outcome of the events Little discomfort in the ribs; Sore ribs, Felt like reluctant to put food in her mouth and because it does not seem to be agreeing with her were not resolved, outcome of the event Blood sugar going down was resolving and Outcome of rest of all the events were unknown.  Follow-up attempts completed. No further information expected.
11 year old patient was vaccinated on 02/04/2022 for his second dose of COVID and was administered adult dose 0.3 ML with the above mentioned Lot. A family member is called to verify the minors health status.
Patient was given a Moderna vaccine full dose. Pt is 14 yrs No adverse reaction
pain, redness and swelling, headache, shivering, tiredness.  Last 24 hours. Tylenol 500mg/twice a day
Client very anxious prior to vaccines given. After administering vaccines client became pale and c/o feeling dizzy and loss of vision. Client became limp and lowered to floor with knees elevated. Client remained conscious and talking. Cool compress applied and juice given.
STARTED TO HAVE REDNESS AND HOT , NOT ITCHY  AROUND 2-3 INCHES IN SIZE ON SUNDAY ,
no adverse effects; patient received varivax on10/20/2006 after receiving MMR II on 10/10/2006; This spontaneous report was received from a nurse regarding a patient of unknown age. Information on the patient's pertinent medical history, other concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 10-OCT-2006, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) and on 20-OCT-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route of administration, batch/lot # and expiration date were not provided) for prophylaxis (inappropriate schedule of product administration). Other suspect therapies included sterile diluent. No adverse event reported. No product quality complaint (PQC).
severe stabbing-shooting lower back pain; severe stabbing-shooting lower back pain that radiated to both legs; Pricking, pins and needles sensations in the hands and feet; numbness; weakness to both legs but mostly the right leg; Coordination problems, unsteadiness; Coordination problems, unsteadiness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscular on 20Dec2020 08:00 at single dose at left arm for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications in two weeks included multivitamins. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. No known allergies to medications, food, or other products. On 22Dec2020 at approximately 19:15, the patient experienced sudden onset of severe stabbing-shooting lower back pain that radiated to both legs. Pricking, pins and needles sensations in the hands and feet. Coordination problems, unsteadiness, numbness, and weakness to both legs but mostly the right leg. The patient underwent lab tests and procedures post-vaccination which included nasal swab for covid test: negative on 30Dec2020 (Antigen Test). Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. Patient received pain medication, steroid dose pack, MRI (pending), and physical therapy (pending) as treatment. Outcome of all events was not recovered.; Sender's Comments: Based on the compatible temporal association, a contributory role of vaccination with BNT162B2 in the onset of the events cannot be excluded. 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.
"Tickling" in throat, dizziness, headache, anxiety.  Vital signs:  12:12pm 124/80 83 18;   12:18pm 120/74 78 18;   12:22pm  120/82 74 16;  12:29pm  122/80 60 18;   12:37pm  120/80 72 18;  Pt. states she feel better. Will take ibuprofen and benadryl at home.  Instructed to follow up with ER or  PCP if symptoms worsen.  Patient left at 12:37pm.
8/3/2021 patient reports testing positive for COVID-19 3 weeks ago (7/19/2021) at outpatient dialysis center.  Patient reports he was asymptomatic at that time but decided to get tested due to having a sick contact, despite already being vaccinated.  Patient states over the last 2 weeks he started developing symptoms of shortness of breath, productive cough with white sputum, feeling tired, fatigued and also reports associated symptoms of having occasional sore throat, abdominal tightness from coughing and a headache.  He is denying any fevers, chills, nausea/vomiting, diarrhea or chest pain.   Patient received Pfizer vaccine, last dose April 2021. 8/5/2021: Patient discharged home
Was getting ready for bed, I believe it was a seizure; I  Lost all blood pressure, fell to floor. Had convulsions for awhile, couldn't speak out for help. nausea, couldn't hold bowels. After that episode of about 45 min. Felt sick and week for a few days. Did not call a doctor.
I'm legally blind./I started to lose my vision,; I felt the needle hit my bone; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (I'm legally blind./I started to lose my vision,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (I'm legally blind./I started to lose my vision,) (seriousness criterion medically significant) and VACCINATION SITE DISCOMFORT (I felt the needle hit my bone). At the time of the report, BLINDNESS (I'm legally blind./I started to lose my vision,) and VACCINATION SITE DISCOMFORT (I felt the needle hit my bone) outcome was unknown.            No concomitant medication information was provided. Patient had her third booster back in July/ August. In December 2021, her doctor said it was probably from the booster since she didn't  have any health problems. No treatment medication was provided.  Company comment:  This is a spontaneous case concerning  a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Blindness and expected non-serious event of Vaccination site discomfort. The events occurred on an unknown date, after the third dose of mRNA-1273 Vaccine.  No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of Blindness and expected non-serious event of Vaccination site discomfort. The events occurred on an unknown date, after the third dose of mRNA-1273 Vaccine.  No further details on clinical course, lab test results and treatment received were reported. Outcome of the events was not resolved at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Information has been received from a registered pharmacist (R.PH) concerning a 69 year old retired female with diabetes and no allergies who 22- May-2008 was vaccinated subcutaneously in the left arm with a dose of ZOSTER vaccine live (lot# 659411/0293X). Concomitant therapy included SITAGLIPTIN phosphate (MSD), PANTOPRAZOLE sodium (PROTONIX), SIMVASTATIN, METFORMIN, VERAMPRIL, CLONIDINE, SPIRONOLACTONE and HYROCHLOROTHIAZIDE (+) VALSARTAN (DIOVAN HCT). On 23-MAY-2008 the patient developed itching and tingling over the whole body. The itching and tingling were described as strange feeling over the whole body, not related to the injection site. There was no rash, but the skin was described as itchy. The itching and tingling were not constant, but went away and then returned and had continued and not improved since starting. At the time of this report, the patient did not recover. The patient contacted pharmacist. No product quality complaint was involved. Follow up information was recovered from a pharmacist concerning the patient did see her family doctor and recovered. Additional information is not expected.
Day 1 following vaccine c/o low grade fever, nausea, chills and body aches. Also acquired a rash over R side of chest which has spread to full chest and back (this is day 10). Rash is somewhat itchy, using topicals for itch.
had a high temperature, tachycardia, high blood pressure, severe dizziness, weakness .  Lasted a week