chrisvoncsefalvay/vaers-outcomes huggingface dataset:
metallic taste; back ache; Neck & back ache; sore arm 3 hours after injection; tingling skin; racing heart; sore throat; high blood pressure; lower lip swelling; hives; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the arm right on 06Mar2021 at 13:00 (at the age of 69-years-old), as a single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The medical history includes type 1 diabetes, thyroid disease, colitis, lichen sclerosis, carpel tunnel syndrome, legionnaire's disease, mixed hyperlipidemia and hx of Cdiff. Patient was allergic to PCN (penicillin), sulfa, IV iodine, codeine, blue cheese and adhesive bandage. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination she was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Concomitant medications included insulin aspart (NOVOLOG), insulin glargine (BASAGLAR), gabapentin (MANUFACTURER UNKNOWN), ibandronate sodium (BONIVA) and levothyroxine sodium (SYNTHROID). On 06Mar2021, the patient developed lower lip swelling, tingling, hives and sore arms three hours after the vaccination, tingling skin, sore throat, high blood pressure and racing heart. On the same day (06Mar2021), the patient had visited the OPD clinic and was prescribed diphenhydramine hydrochloride (BENADRYL). On 13Mar2021, the symptoms had returned with metallic taste, swelling lip, neck & back ache and went to ER (emergency room) where patient was prescribed with famotidine (MANUFACTURER UNKNOWN) and can use diphenhydramine hydrochloride (BENADRYL). On 16Mar2021, the patient met the physician and was prescribed fexofenadine hydrochloride (ALLEGRA) and montelukast (MANUFACTURER UNKNOWN) as the symptoms were the same. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment was received for the adverse events, including Benadryl/Famotidine/Allegra/montelucast. The clinical outcome of all the events was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
SORENESS AT INJECTION SITE IN LEFT ARM; MILD HEADACHE; DIZZINESS; This spontaneous report received from a consumer concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic, lupus, depression, hypothyroid, metabolic disorder, and hip disorder.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included insulin glargine, insulin human, and levothyroxine.  On APR-2021, the subject experienced dizziness. On APR-2021, the subject experienced mild headache. On 07-APR-2021, the subject experienced soreness at injection site in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and mild headache on APR-2021, and soreness at injection site in left arm on 09-APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
~21/2 hrs after vaccine, mother changed Patient's diaper and saw "welts" on buttocks. After undressing him completely, she also saw on arms & legs. Mother brought child back into office & he had macular papular large polymorphic areas of some central clearing on arms & legs. Appeared to be hives. No mucous membrane involvement. Breathing w/o difficulty. T. 99. Benadryl 1mg/kg given by mouth. Ibuprofen 10mg/1kg given by mouth. Ice packs applied. Patient was seen in office.
Arm feels dead, heavy, lifeless. Face numb. shortness of breath, shaking
(R) arm swollen and warm to touch. Affected area was app. 3 1/2 wide by 4" long upper arm. Referred to clients PCP.
21DEC93 mom found pt unresponsive father attempted CPR until rescue team arrived pronounced dead at hosp @ 137PM; was reported to SIDs center as poss SIDS; sl cold p/DTP;
After the vaccine dose 1 asked about allergies. I informed by the head of pharmacist and 7 different physicians based on my medical history was told to get Moderna vaccine. Also to bring my Epipen in case I needed to use it.I waited after 15 minutes started to ex cough I was placed on Oxygen and given a shot of Epipen .At the point I wasn't getting enough Oxygen to the brain called code blue until I was stabilized having a anaphylactic.I was discharged not to work 3 days and return to hospital for Prednisone injection. In late Jan I went to my Allergist got tested right and left arm skin test(muscular) it was PEG,Polysorbate 80 I was allergic.Im recommended to not get 2nd dose until Covid test that does contain PEG/Polycarbonate 80.
My last period was in April of 2019.  I was diagnosed with menopause over a year ago.  Experienced all the typical  symptoms...  extreme hot flashes, loss of period  over a year, etc..     This past Tuesday morning, I had my period which lasted for 4 days. It's been almost 3 years since I had a period and this came out of nowhere.
The issue started after the 2nd dose of vaccine. I had no underlying issues outside of slight hypertension. After the dose I had an episode of diverticulitis. I also was running PVC's. I went to a cardiologist and was throwing 28,000 abnormal PVC's. After the cardiologist ran all tests, he determined that I had a mitral valve regurgitation and other cardiac abnormalities. He treated me to control the abnormal beats. Atenolol and hydrochlorothiazide. I have made improvements but I am still throwing PVC's. I am having another echo done in 2 months. I am unable to do strenuous activities as I become short of breath easily when doing so. The provider already completed a battery of test but still not able to determine what the issue is.
Chills, swimmy head, extreme tiredness, soreness throughout entire body, headache, weird after taste in mouth, no appetite
Severe insomnia persisting for a week (so far, ongoing side effect), muscle twitching (most pronounced when trying to fall asleep at night, contributes so sleep difficulties and keeps me awake), bouts of racing heartbeat and sudden flashes of heat (occurs most often while I?m trying to fall asleep, then persists throughout the nights keeping me awake), dizziness/light headedness/floaty head feeling throughout the day but worse at night when it makes the room feel like it is spinning and keeps me awake.
The patient presented with the mother on 7/25/23 to receive the child's first dose of COVID vaccine. This nurse administered 0.2 ml of the vaccine in the maroon cap, blue writing, yellow-banded vial labeled "BOOSTER DOSES ONLY Age 6m-5y", but because it was the first dose the child should have received 0.25 ml of the vaccine in the blue cap, blue writing, grey banded vial labeled, " BOOSTER DOSES ONLY Multidose Vial Booster Dose: 0.5 ml or 0.25ml based on age". This resulted in the child receiving an inadequate first dose and per guidance received from our state immunization nurse consultant, the child will need an additional dose in 2-3 months. I realize this is my oversight and the responsibility is ultimately my own, however, there is absolutely no reason why we should have to be administering mislabeled vaccines. The labels both state "BOOSTER DOSE ONLY'" but only one is to be given as a first dose but not labeled as such. This is absolutely unacceptable and I hope these companies will be held to higher standards and will stop having exceptions made for their poor choices for product labeling when the reformulated fall 2023 version becomes available.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a 57 year old male patient. The patient's weight was 70 kilograms and height was 64 inches. The patient's concurrent conditions included penicillin allergy (PCN). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 1 in total administered in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-MAY-2021, Laboratory data included: COVID-19 antibody test was negative and the patient reported suspected immunological vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179796.; Sender's Comments: V0: 20210530196-Covid-19 vaccine ad26.cov2.s- Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Purple big dots/some of them are big and some are smaller/ I have spots on my arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Purple big dots/some of them are big and some are smaller/ I have spots on my arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B214 and 046AZ-A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (Purple big dots/some of them are big and some are smaller/ I have spots on my arm). The patient was treated with PARAFFIN (PENATEN [PARAFFIN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN DISCOLOURATION (Purple big dots/some of them are big and some are smaller/ I have spots on my arm) outcome was unknown.            No concomitant medications were reported.
vasovagal syncope, cold compress applied to forehead, assisted patient to lay down, vitals taken, observed patient for approximately 10 minutes, released patient to parent
Rash on both legs, stomach and top of feet; This is a spontaneous report from a non-contactable consumer (reported herself). An elder female patient of unspecified age (65 plus Years) (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown, reason: Unable to locate or read the details), via an unspecified route of administration, in left arm, on 27Jan2021 at 12:00 PM, as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine was received in four weeks. On 28Jan2021, at 04:00 PM, after the vaccination, the patient experienced rash on both legs, stomach and top of feet. The patient did not have covid prior vaccination. The patient had not been tested for covid post vaccination. The outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a certified Medical Assistant referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 23-NOV-2015 the patient was vaccinated with an improperly stored dose of M-M-R II (Lot # K024036, expiration date 26-NOV-2016) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received form the same source. Additional information has been requested.
Site of injection red and warm. Contacted MD. Advised to monitor for increasing redness/fever and to call back.
Patient has extensive history of autoimmune disorders.  Received Moderna vaccine #1 on 3/13/21.  Developed sore throat 3/15, progressing to oral lesions - went to urgent care on 3/22/21 and ED on 3/25/21 (diagnosed with stomatitis). Evaluated by ENT specialist 4/2/21 and diagnosed with oropharyngeal lichen planus. Was prescribed steroids. Hospitalized 4/2/21, 4/17/21, and 7/23/21 due to dehydration, malnutrition, and weakness. Patient opted for hospice care and died 8/10/21.
This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age. On 22-OCT-2014 the patient was vaccinated with a third dose of GARDASIL (lot number and expiration date were not reported) 0.5 ml, intramuscular. On 01-NOV-2014 the patient was determined to be 6 weeks pregnant. The patient became pregnant with last menstrual period (LMP) of 20-SEP-2014 and estimated delivery date (EDD) of 27-JUN-2015. Initial exposure to GARDASIL was at 4 week. The pregnancy outcome was outcome pending. The patient sought medical attention by visiting the office on an unknown date. Additional information has been requested.
20 hours after vaccination: significant fatigue, body aches, decreased memory function, severe vertigo, poor balance, significant muscle weakness, tremors
3/8 Red welt with mild itching . Slight arm muscle soreness. Still bothersome 3/19! 3/9 Day after shot felt like I'd been hit by a truck. Everything joint & muscle hurt! Better on 3/10.
Fever at bedtime 102F (R) on 2/6/01 and 2/7/01; 103F (R) on 2/8/01. Rash started on 2/7/01 and subsided on 2/11/01.
Immediately following vaccine dizziness, itching feeling in throat and skin, and nausea.  A few hours after the vaccine, headache, nausea, dizziness continued.  Face and left arm (vaccine site) felt like they were internally on fire.  Twenty-four hours after the vaccine, flu-like symptoms (cold chills, fever, nausea, muscle aches to the point of it hurting to move, joint pain), headache, skin itching.  Treatment was tylenol, ibuprofen, and benadryl.
Resident given High Dose Flu vaccine on 10-11-15 (L) deltoid. 10-12-15 Temp 99.3. Upper (L) arm site redden, warm to touch and tender.  Denies trauma. Warm compresses tid ordered, TYLENOL prn pain. Venous Doppler (-) neg, DURICEF 500 mg Bid x 7 days.
Dose administered after temperature excursion; Dose administered after temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Nurse reported that on the morning of 30 Mar 2022, the temperature went to 39.38 Fahrenheit for the same vaccines.  The minimum temperature was reported as 38.08 F, and the maximum temperature was reported as 46.77 F. She is unsure of the duration of the excursion.
muscle weakness and cramping and overall fatigue and chest pains still continuing after a month and a half
Swollen face; Swollen throat; Severe throat pain; Fatigue; Weakness/ no strengths to get up; No appetite; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 29Apr2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, thyroid disorder, high blood pressure and penicillin allergy. 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 vaccination. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), fluticasone (MANUFACTURER UNKNOWN) and unspecified high blood pressure drug, all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN) and prednisolone (MANUFACTURER UNKNOWN) and experienced drug allergy for both. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 08Apr2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 10:00, the patient experienced swollen face, swollen throat, severe throat pain, fatigue, no appetite, weakness/no strength to get up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swollen face, swollen throat, severe throat pain, fatigue, no appetite, weakness/no strength to get up was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
He tested positive for covid 11-05.   Was admitted with fatigue and malaise and per medical records developed pneumonia,  acute kidney injury with persistent hyperkalemia, , paroxysmal afib,  and resp failure  requiring  intubation and hypotension requiring  vasopressor support.  several specialists were involved in his care.     Placed on comfort measures  and the patient passed away on  11-12-23
Pt reports "I am unable to move my left arm", pain reported as "9.4/10 if 10 is passing out".   Pt reports "I did not feel the shot" when injection placed, "but now it hurts like a (expletive)."  Pt denies swelling, redness or heat at injection site.    Pt denies rash or SOB, swelling in the face, lips or tongue.
Patient states that a month after administration she felt tenderness in center of right deltoid. She also states a month after adminstration she feels soreness when she pulls her arm back or up. Again, she points to center of right deltoid. She has not seeked medical attention because she says it is not necessary at this point. She only wanted to let me know about tenderness and soreness in center of deltoid.
Patient coming in for approximately 9 days of symptoms concerning for Covid.  States that symptoms initially started with diarrhea he developed a sore throat, now has dry mouth, cannot smell or taste.  Reports a cough but states that he feels like this is related to his asthma.  Reports some intermittent shortness of breath.  States had fevers to 103.  He did receive two doses of Moderna vaccine at the beginning of the summer.  Reports a positive exposure at church prior to onset of symptoms.
Pt vaccinated with DTP experienced twelve hrs of hypotonia with mild vomiting & lethargy. Some loose stools.
Pain and paralysis right arm for 3 mos - still. Cough from time of injection 4 mos - still. New Cardio and Pulmonary issues never before. 3 hernias from cough, repaired in July 2018. Still no energy, a lot of fatigue. Body aches all over! Hand tremors R/hand. Pt reports still the same complaints of feeling fatigued. He is followed by Pulm and Cardio. He reports he had an ECHO and was told there's no changes. Pt maintains it was the Pneumonia shot that got him so sick last year. He wants to get the records of the vaccine, i.e., Lot# exp. date and manufacturer he needs it this week so he can give to the FDA, CD etc. Pt informed of ROI process. Voiced understanding. He said he tried to ask Medical Records and was told they couldn't locate the exact info. Chart reviewed, pt had the PNEUMOVAX 23 on 9/7/17 during his visit with PCP, pt was due to be given for Pneumonia shot per reminder and LPN gave it pt per requirement.
PATIENT STOOD UP AND STARTED ASKING QUESTIONS AFTER GETTING SHOT. THEN HE STARTED JERKING LIKE HE WAS HAVING A SEIZURE STANDING UP. I PUT MY ARMS OUT AND HELD HIM AND STARTED ASKING HIM QUESTIONS. MY TECH GRABBED A CHAIR AND PUT HIM IN IT. I WENT THROUGH SMART ACRONYM TO CHECK FOR STROKE CALLED 911. HE WAS NOT ABLE  TO TALK AND ONLY SAY YES OR NO. HE THEN ALL OF A SUDDEN STRUGGLED TO BREATHE, LOST CONSCIOUSNESS AND I ADMINISTERED AN EPI PEN IN HIS LEFT THIGH. HE CAME TO IN ABOUT 30 SECONDS AND EMS ARRIVED 2 1/2 MINUTES LATER. WHEN THEY ARRIVED HE WAS TALKING AGAIN.
2 weeks to the day after the 2nd shot, developed serious heart palpitations, anxiety,  body heat flushes that lead to the start of all the symptoms, inability to eat, entire body felt like it was tightening up inside, this lasted for 11 days...with 2 days  of feeling normal within the time period
49 year old female received Td on 02/23/07 developed cellulitis of L arm on 2/27/07. Had to take antibiotics.
An hour after my shot my left check was numb, lower left eye numb, left ear numb and left side of my tongue is numb. It is still numb as I type this.
COVID REBOUND; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned an elderly of unspecified sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced covid rebound and tested covid positive again with return of mild symptoms (Dose number in series 2). Patient was treated with unspecified drug (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 14-DEC-2022 to 19-DEC-2022 for Covid-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid rebound was not reported. This report was non-serious.