chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe covid arm lasting just under 2 weeks from onset to full recovery from itching and redness. This was followed by an approximate 6 week issue with eczema break outs and generalized fibromyalgia pain and fatigue.
55-year-old male had Moderna COVID vaccine 28Oct21 started noticing minimally tender bruises which are unexplained with bruising to left upper medial arm as well as right medial thigh and right anterior lower chest; patient's left upper arm medial aspect just proximal to the elbow has a few cm diameter minimally tender ecchymosis, right medial distal thigh as several centimeter diameter ecchymosis, right anterolateral lower chest as 3 separate areas of ecchymosis each 1-2 cm in diameter also minimally tender without surrounding erythema
ELEVATED BLOOD SUGAR LEVEL 446; This spontaneous report received from a patient concerned a 72 year old  female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic, and other pre-existing medical conditions included the patient reported that he has 128-138 mg/dL as normal range for blood sugar. The patient was previously treated with prednisone for drug used for unknown indication.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAY-2021, 15 minutes after having lunch the patient experienced elevated blood sugar level 446 mg/dL. She reported that she had meatballs, butter noodles, and angel fruit cake with cabbage, also for beverage had ice-tea with no sugar. Laboratory data included: Blood sugar abnormal (NR: not provided) 446 mg/dL. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from elevated blood sugar level 446 mg/dL. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210537343-Covid-19 vaccine ad26.cov2.s - Elevated blood sugar level 446. 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: MEDICAL HISTORY.
Shortly after patient exited the imz booth he sat down and a couple minutes later started to loose consciousness. Pharmacist was alerted and quickly went to aid patient. When pharmacist arrived patient was unconscious and trying to take a breath. A few seconds later the patient took a breath and slowly came back around. Patient was pale, cold, clammy, and sweaty. Patient stayed seated for 30 minutes after the incident occurred but felt better after about 5 minutes.
Severe urticaria - local and generalized. TX: PO BENADRYL, Prednisone.
I was fine at first but after 11 hours, I began to get a bad headache within 30 minutes I also had nausea and severe pain all over my body to the point I did not want to move at all. Ibuprofen did not help. I was so tired, I could not move. It lasted through the night and would wake me up. I slept most of the next day until about 1:00pm.  I finally began to feel better about 12 hours after it began and within 24 hours I was back to normal other that the sore shoulder.
After leaving pharmacy, patient said she experienced slight trouble breathing and faintness, dizziness and stated that symptoms lasted less than 2 hours and reports feeling fine after that.
Received 2-dose Modena COVID-19 vaccine on 12/30/2020 & 1/27/2021 (same lot and hospital administration).  Developed shingles on 7/31/2021 at age of 52.  Morning of 8/1/2021, evaluated within 12 hours of onset.  Given prescription for Valtrex 1000mg twice daily for 7 days.  Given Gabapentin pills and lidocaine cream for nerve pain.  Rash spread to cover 4" swatch from middle of back/spine to middle of front/midline just under shoulder and armpit.  Rash resolved after 7-10 days.  Nerve pain continued.  Refilled lidocaine cream on 8/23/2021.  Nerve pain still continues now 6 weeks after diagnosis.
Patient filled out consent form and answered that she had not received the COVID-19 vaccine, when in fact she had received her 1st dose in March and 2nd dose in April
Redness and warmth started morning of 10/2/16 7cm by 7cm measuring. Pt started on Cephalexin 500mg qid x 7 days.
pt recv vax thru ER for laceration & 2-3 days later devel erythema localized & a knot @ inj site only;no systemic sx;instructed to put heat to it & all sx resolved w/in 1-2 days x/small knot;
10 days after the 2nd HPV administration the patient developed sudden onset of a left facial nerve palsy.
After I got the second dose I started feeling really ill, chills, fever, throwing up and real dizzy. Being real sick and weak dizzy and vomiting  resolved after about four days.  Still having fevers and chills
approx 5 hrs p/vax pt awoke crying, redness/swelling @ inject site approx size of orange; given APAP & apply ice to rt leg cont APAP;
Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm). At the time of the report, PAIN IN EXTREMITY (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
Patient was under-dosed and given 0.25mL rather than the 0.5mL required dose.
hearing loss; Roaring in ear; Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat; Nose has been running; Eyes tearing up; Headache that felt like severe pressure; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 30-Oct-2015. Concomitant products included VITAMIN D NOS from 01-Jan-2010 to an unknown date and CALCIUM from 01-Jan-2010 to an unknown date for Bone disorder, ZEAXANTHIN (LUTEIN [ZEAXANTHIN]) from 01-Jan-2008 to an unknown date for Eye disorder, MAGNESIUM from 01-Jan-2010 to an unknown date for Muscle disorder.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), TINNITUS (Roaring in ear), EAR DISCOMFORT (Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat), RHINORRHOEA (Nose has been running), LACRIMATION INCREASED (Eyes tearing up) and HEADACHE (Headache that felt like severe pressure). At the time of the report, DEAFNESS (hearing loss), TINNITUS (Roaring in ear), EAR DISCOMFORT (Could feel fluid in ear and when she bent over it felt like it was going in to her head and coming up her throat), RHINORRHOEA (Nose has been running), LACRIMATION INCREASED (Eyes tearing up) and HEADACHE (Headache that felt like severe pressure) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. Very limited information regarding the date of the events in relation to the date of vaccine administration have been provided. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient demographics updated. Patient medical history updated. concomitant medications added. Start date for the events were added. Outcome for the events updated ( from unknown to not resolved) On 30-Jun-2021: Follow up information was received from initial reporter: New event Deafness was added.  This case was upgraded from non-serious to serious due to the addition of new event Deafness; Sender's Comments: Very limited information regarding the date of the events in relation to the date of vaccine administration have been provided. Further information has been requested.
This spontaneous report as received from a physician via a field representative refers to a 65 year old female patient with none pertinent medical history. On an unspecified date in 2009, the patient was vaccinated with a dose of ZOSTAVAX, single shot, subcutaneous (lot# and expiry not reported). On an unknown date, the patient developed "a severe case of shingles on the right side of her face down to her neck." "This patient was hospitalized and had to be intubated." The physician noted "this was a life threatening event." The outcome of the events was now recovered on an unspecified date. The patient sought medical attention. Therapy with ZOSTAVAX was also reported as continued. Upon internal review, "had to be intubated" was considered as medically significant. This is one of several reports received from the same source. Additional information has been requested.
48 HOURS LATER, EXTREME TINNITUS BOTH EARS (NO PRIOR HISTORY); CHILLS, NIGHT SWEATS; ELEVATED BLOOD PRESSURE
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age. On an unknown date in 2004 (reported as at least 8 years ago) the patient had completed the hepatitis b vaccine (recombinant) (manufacturer unspecified) (lot number, expiry date, route and dose were not reported) vaccination series the patient had a titer test which was nonresponsive for hepatitis b surface antibody approximately on an unknown date in November 2012 (reported as within last month). No concomitant medications were reported. The patient sought medical attention (contacted the pharmacist). No adverse event reported other than the non-responsive titer test for hepatitis b surface antibody. The patient's outcome was unknown. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUZONE for prophylaxis. On 31st August 2018, the patient received SHINGRIX and FLUZONE (INACTIVATED INFLUENZA VACCINE). On 1st September 2018, 1 days after receiving SHINGRIX, the patient experienced fever, malaise, pain and lip blister. The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the fever, malaise, pain and lip blister were recovered/resolved. It was unknown if the reporter considered the fever, malaise, pain and lip blister to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX and a dose of FLUZONE and the following day the patient stated they developed fever, malaise, aches, lip blisters. The patient sought medical care on 7th September 2018 that included steroid treatment. The patient's symptoms were resolved in a couple of weeks. The reporter consented to follow up. The reporter did not have vaccine information for this adverse event.
Vaccine Administration Error: 12 y/o individual was administered with  Moderna COVID-19 vaccine. No adverse event during 15 minute observation period.
patient experienced an injection site reaction; unsure which products were administered intramuscularly and subcutaneous.; This spontaneous report was received from a pharmacist referred to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not provided.      On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, lot# and expiration date were unknown) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, lot# and expiration date were unknown) for prophylaxis. The reporter was unsure which products were administered intramuscularly and subcutaneously (subcutaneous injection formulation administered by other route).     On an unknown date, the patient experienced injection site reaction.      The outcome of injection site reaction was unknown. The causality between injection site reaction and varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Patient and spouse inquired on bivalent vaccine. Patient did not have her vaccine card with her. We have a check-in staff that is to lookup patients on database for vaccine history. Patient was sent back to the vaccine station and RN explained process  and asked required history questions. Vaccine was administered. Check-in staff stopped other staff member from vaccinating the patients spouse as he already received a bivalent dose. Both patients explained that they have received all their COVID-19 vaccines together. RN accessed a computer and was able to retrieve vaccine history on database. Check-in staff used just the last name and no results were found. RN tried a couple of different searches and record populated when just entering "name". Supervisor was notified right away and explained to staff if anyone has difficulty with pulling up a chart to notify another staff member. The Physician assistant on site spoke with patient after dose was administered. Patient was asymptomatic during her 15 minute post-vaccine administration.
Very sore arm/neck/shoulders developed around 8:15PM.   Chills/aches all night into next day.  Minimal redness at site.  Further soreness of left arm and into armpit next day.   Achy upper back/neck all  next day.  Chilled.   I had no symptoms prior to 8:15PM other than mild soreness at site of injection.
I had the same reaction to first dose, but more severe with second shot. Rash with first dose did not occur until day 7.  Second dose:   Within 2 hours: Rash at injection site that continued for 4 days; swollen, painful, fevered injection site for 5 days;  Within 12 hours:  Stress response from body, headache, neck ache, nausea, Intermittent heart pain, eye pain, unable to sleep, chills
Tdap administered on 7/11/08.  On 7/14/08 seen in healthcare ED for urticaria, onset 7/13/08.  Also had localized itching and red rash with distribution to neck, upper extremities, back and chest.  Treated with Solu-Medrol 125 mg and famotidine 20mg IV.  Doctor put on Prednisone 60 mg qd v 3 plus Zyrtec 10mg BID x 10 days.
Headache, Dizziness, Torso skin Rash evident 40 hrs. post injection
left eyes painfull and very red...left side of forehead and left top of head very tendor to touch and bad headache. since march 25th
Client reported she was evaluated early April with complaint of ringing in ears and recieved a referral to see ENT. No official diagnosis but client has 'self-diagnosed' as having pulsatile tinnitus and requested report to VAERS.
Arm hurt; swelling on the left arm at injection site; This is a spontaneous report from a contactable consumer (Patient, self-reporting). A 57-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm left on an unspecified date in Mar2021 at 01:30 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. Medical history included manage bursitis in right hip and mild inflammation soreness. Patient had no past drug history. Concomitant medication included naproxen (NAPROXEN) 1 or 2 (500MG) tablets taken for an unspecified indication, within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 13Mar2021 at 14:30, the patient experienced arm hurt, swelling on the left arm at injection site. Arm hurt after first shot in march and there was swelling on the left arm at injection site. Pain and swelling was still present when she received the second shot. It was now over 3.5 months past the second shot and I still have pain at injection site and swelling. Patient often have stabs of pain shooting from the site down the length of arm. Tender at site to pressure and had some mild inflammation soreness in shoulder 1 month prior to shot from working at home poor ergonomics. Since the shots the shoulder also went into a chronic pain. About 8 weeks after receiving vaccinations she got a Cortizone shot in left should to help eliminate pain and had 12 sessions of PT. Very painful when pressure was put on injection site. Physical therapist reported an increase of cases with people who had old shoulder injuries were coming in with flare ups and do not know if the two are related but she was hoping the symptoms would have subsided after 90 days. Some times it is just a chronic ache at injection site. Facility where the most recent COVID-19 vaccine was administered was other only. The outcome of events were not recovered.  Follow up information is excepted. Further information is requested.
tingling or "pins and needles" in fingers for weeks after the vaccine injection (this is unusual and not something I've had after a vaccine or shot before), still ongoing local soreness (normal for vaccines including flu shots I've had before), this resolved after 48 hours
Diarrhea with multi bowl movements several time a day, nausea, bloating, and headaches. Went to Urgent Care and ER. Diagnosed with Gastroenteritis.  Later tests reveled low enzyme levels. Diagnosed with Pancreatic Insufficiency.  Now taking medicine for the low enzymes. Enzyme levels at 15, normal enzyme level are near 200.
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was mentioned that the vial was initially refrigerated on 12-Nov-2021, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  Treatment information was not provided.
This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, non-smoker, and sulfa allergy, and other pre-existing medical conditions included the patient had no relevant medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced headache. On 26-MAY-2021, the subject experienced bruising all over body (left arm and the left thigh). Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and had not recovered from bruising all over body (left arm and the left thigh). This report was non-serious.
This spontaneous report was received from a Licensed Practical Nurse referring to a currently 15 years old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 30-JUL-2015, the patient received a dose of GARDASIL Lot number K006191 for prophylaxis (dose, route of administration, anatomical location and expiration date were not reported). On an unspecified date in 2017, the patient received a dose of GARDASIL 9 Lot number N001533, expiration date 16-OCT-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). However, no adverse effects were reported.
Shaky, abdominal pain, chills, myalgia, arthralgia, pelvic cramping, vaginal bleeding (menses).  Rx: Motrin, imodium
paralyzing effects of their muscles; aching arm; muscles gave out which continued until Oct of last year/muscle weakness; started laying down a lot and noticed it when I put the dog out for a walk and couldn't walk very longer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Mar2021 (Lot number: EM6203) as dose 1, single and administered in arm right, administration date 09Apr2021 (Lot number: ER8727) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoimmune disorder" (unspecified if ongoing), notes: Autoimmune disorder resulted from an exposure to chemicals. Concomitant medication(s) included: THYROXIN taken for autoimmune disorder, start date: 19May2018. The following information was reported: PARALYSIS (medically significant) with onset Oct2021, outcome "recovering", described as "paralyzing effects of their muscles"; PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "unknown", described as "aching arm"; MUSCULAR WEAKNESS (non-serious) with onset 21Mar2021, outcome "recovering", described as "muscles gave out which continued until Oct of last year/muscle weakness"; GAIT DISTURBANCE (non-serious) with onset 21Mar2021, outcome "recovering", described as "started laying down a lot and noticed it when I put the dog out for a walk and couldn't walk very longer". The patient had very little side effects other than pain in arm for first two doses. A few days after, she mentioned her muscles gave out and this persisted or continued until Oct2021. By Oct2021, it started getting better. She mentioned she got another two extra shots, so 4 shots in total of the Pfizer COVID 19 vaccine. She also ended up sick again on Dec2021, due to COVID, and described symptoms as being massively bad. He thinks she is referring to the COVID. She also mentioned that her main concern was weakening of muscles. She, as well as associates, were self quarantining and could hardly go to the bathroom due to the paralyzing effects of their muscles. She had been given astronomic amounts of magnesium and plenty of potassium as a muscle relaxant. She also had a COVID virus. She later stated that she caught COVID virus in 01Jan2022. At the end of Oct2021, 2 days after, it looks like she started feeling sweating and muscle tightening. After she came down with COVID virus, she said she can hardly walk from her apartment to her car. Therapeutic measures were taken as a result of paralysis, pain in extremity, muscular weakness, gait disturbance.