chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; Information has been received from a lawyer referring to a 72 years old female patient. Information about concurrent condition, history condition and concomitant medication was not reported. On 21-AUG-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for prophylaxis. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer Bell's palsy on or about 12-FEB-2015 including any and all of it sequelae. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s defective design, the patient suffered severe and permanent physical injuries, including but not limited to Bell's palsy, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event Bell's palsy was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events Bell's palsy to be disability.   Upon internal review, Bell's palsy was determined to be medically significant.
cold sore 20 days after #1 covax; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown expiry date: unknown) via an unspecified route of administration on an unspecified date as first dose single dose for COVID-19 vaccination. The patient medical history and concomitant medication were not reported. After administration of the first dose the patient had experienced cold sore 20 days after 1 covax on 09Feb2021. The reporter pharmacist if there would be a drug interaction with a patient getting second covax today and on acyclovir. The patient was on it for cold sore developed 09Feb last dose will be on 13Feb and he is to get the second dose today, first covax was 21 days ago. The outcome of event was unknown.   Information on the Lot/Batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. Patient has never been diagnosed or tested positive for COVID-19. Allergies to medications, food, and other products none. Patient had no acute illness at the time of vaccination and up to one month before. Concurrent medical conditions included Deaf, Hypertension, Diabetes mellitus and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, GLIMEPIRIDE and METFORMIN for Diabetes mellitus, LISINOPRIL and AMLODIPINE for Hypertension. On 06-Apr-2022 at 10:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dispensed 28 doses of expired Moderna Covid-19 vaccine.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The date of the vial was initially stored in the refrigerator was unknown. It was reported that the vial had no temperature excursion  It was reported that the patient was deaf and through typing back and forth, described zero adverse events to the booster on 06-Apr-2022. No treatment information was provided by the reporter. This case was linked to MOD-2022-541343 (Patient Link).
Extreme pain at injection site 2.5 hrs after shot. Nausea, headache, general malaise for 2 days.
WHOLE BODY WAS COVERED WITH SEVERE ECZEMA AND RASH INCLUDING THE PENIS AREA. THE CHILD CRIED NON-STOP, CONTINOUSLY AND HAD A HIGH FEVER.
I was pregnant and received the Tdap vaccine on 10/24. On 10/29 my daughter was stillborn.
2 days, post vax, pt had vomiting, diarrhea, loss of appetite and decreased activity. 4-5 days, post vax, more marked decrease activity, more sleeping and said head "hurts". Better by day 6.
13year old female who passed out after receiving her vaccination. She was responsive an attended to by medical staff on team. She struck her head on the floor when she fell EMS was called individual was checked and all vital signs were normal. Both parents present and did not want to go to hospital for further evaluation.
Varicella vaccine was administered intramuscularly instead of Subcutaneously into the Left Deltoid.  No know adverse reactions known currently
Patient stated she woke up about 1:30 am on 04/16/2022 from sleeping and felt dizziness and lightheadedness and felt like she was about to pass out. That is when she called 911 to come and assist her.
8PM pt appeared fussy & hurt all over according to mom;to ER 930PM lethargic w/o LOC, pale, moderate SOB, t99;Ibuprofen given in ER-adm to peds for observation-no further problems-d/c on 21FEB97;MD dx as immunization rxn w/apneic spell
Pt received his 2nd covid 19 vaccination on 3/31. Presents on 4/26 with 3 days of nausea, vomiting, diarrhea, fever, chills. admitted with severe sepsis and gram negative bacteremia of unknown etiology. being treated with ivf , zosyn and supportive care
Numbness and tingling in bilateral hands and legs/feet. Headache, muscle weakness, vomiting, lightheadedness.
really bad hot flushes; sweats all the time; rash started on her neck/rash all over/rash keeps getting worse; This spontaneous case was reported by a nurse and describes the occurrence of HOT FLUSH (really bad hot flushes), HYPERHIDROSIS (sweats all the time) and RASH (rash started on her neck/rash all over/rash keeps getting worse) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013C20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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 HOT FLUSH (really bad hot flushes), HYPERHIDROSIS (sweats all the time) and RASH (rash started on her neck/rash all over/rash keeps getting worse). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, HOT FLUSH (really bad hot flushes), HYPERHIDROSIS (sweats all the time) and RASH (rash started on her neck/rash all over/rash keeps getting worse) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included inhaler for allergies.  The patient thinks maybe her rash started since she began using a mask but around March it exacerbated. It started on her neck and now it's all over and keeps getting worse. She has been to her family doctor and her gynecologist, nobody seems to know what's going on. They keep saying it's contact dermatitis.   She thinks it may be her menopause or a fungal infection as she has really bad hot flushes and sweats all the time. The doctor gave her hormone replacement therapy about three weeks ago. She also received Prednisone. She will visit an allergist in October. She takes vitamins and has an inhaler for allergies as needed.
shaky still; Pressure went to 176 systolic; Heart rate was 126; she turned very red; difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), NERVOUSNESS (shaky still), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126). On an unknown date, the patient experienced NERVOUSNESS (shaky still). The patient was treated with EPINEPHRINE ongoing since an unknown date at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) ongoing since an unknown date at an unspecified dose and frequency and ALBUTEROL [SALBUTAMOL] ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ERYTHEMA (she turned very red), DYSPNOEA (difficulty breathing), NERVOUSNESS (shaky still), SYSTOLIC HYPERTENSION (Pressure went to 176 systolic) and TACHYCARDIA (Heart rate was 126) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 120 (Inconclusive) blood pressure is 120's systolic. On 20-Jun-2021, Blood pressure measurement: 176 (Inconclusive) blood pressure went to 176 systolic. On 20-Jun-2021, Heart rate: 126 (Inconclusive) heart rate was 126 ..         Concomitant product were not provided/unknown. Treatment product includes fluids were reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
The evening of my dose 2/15- around 8:00 PM I started to experience a burning in my mouth.  It wasn't horrible and I attributed it to something I ate.  The next day, the pain intensified - I bought some products to alleviate the pain andin scomfort - mouthwash.  Seemed to help. Wednesday it was more uncomfortable. I called the Health on Thursday and they suggested that I call the vaccination center to let them know. Today, I spoke to the vaccine center and they suggested that I fill out this form.
VARIVAX given right arm sq on 4-26-10 also had HEP B in left deltoid & PPD on RFA intradermal. Seen in office today to check PPD - site with no RXN but pt. has area > 5cm of redness and warm to touch at VARIVAX inj. site.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered Moderna vaccine while temperature excursion assessment was ongoing) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
pt recv vax 4NOV96 & 11NOV96 pt exp a fever;devel a rash on 13NOV96 & 14NOV96 pt presented to MD office w/a morbilli-like rash;devel no koplik spots;it was noted fever/rash not typical dry rash;
Suspected vaccination failure; I got the shot about 4 or 5 months later I caught shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 4 and 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Apr-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient heard how horrible the shingles was so he/she got the shot, about 4 or 5 months later, the patient caught shingles. The patient stated that it was such a minor case, enough to let him/her know he/she had it but no serious effects. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details were available.
red circle on her left arm at the injection site/Pinkish red and warm to touch at injection site/red circle around injection site; Pinkish red and warm to touch at injection site; Soreness at injection site; 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 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2021 (Lot number: EN6205) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported VACCINATION SITE ERYTHEMA (non-serious) with onset 09Mar2021, outcome not recovered; VACCINATION SITE WARMTH (non-serious) with onset 09Mar2021, outcome not recovered; VACCINATION SITE PAIN (non-serious) with onset 09Mar2021, outcome not recovered.  The patient stated that on Monday 08Mar2021 she received her second vaccine and she noticed the next day she developed a red circle on the left arm where she got her injection and she continued to say she did not have that problem the first time with her vaccine. The patient did have some redness and soreness at the injection site. She stated the red circle area started about the size of nickel and was probably quarter size at the time of reporting and was red but not bright red, it was more of a pinkish red and it was not hot to touch but more like slightly warm to the touch. Patient remarked that it may not be spreading but actually spreading out and dissipating.   No follow-up attempts are possible. No further information is expected.
Three days after second vaccine, the skin on my back and under my left arm is sore. Shot was on left side. Soreness is now on upper left back and under left arm.  Has lasted now for 8 days.
One day post vax, the pts mother reported that the pt developed one chickenpox-like at the injection site. She also notice two pimples that did not look like pox. Additional information has been requested.
Rash about 10 days later, on upper right arm where shot injected.  Rash on and off for days afterwards.  NOT serious, just reporting since so much later than shot.  No other reason known for rash at that time. Otherwise, just a bit sore at injection site for 1 week after injection.  Nothing serious to report, just for public database.
VOMITING; This spontaneous report received from a patient concerned a 22 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. 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 13-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting. This report was non-serious.
A few hours later after receiving the vaccine I had redness, swelling, pain, and itching at the injection site. That lasted through Monday for about a week. For a few days I had chills, headaches, and body aches. Friday and Saturday I was feeling good again, but on Sunday the chills, headaches, and body aches came back. I also started to get a cough. Monday morning I woke up and felt awful. I had a pounding headache, fever, chills, and a cough. I took a COVID test that came out positive. I went to a family medical health center to get another test did. They gave me a steroid shot and antibiotic shot in each hip. I was given a high dose Tylenol of 2,000 mg to take every 4 hours, a Z-Pak for a week, another antibiotic for 5 days, Ivermectin for 5 days, Hydroxychloroquine for 5 days, Vitamin C, Vitamin D, Zinc, Melatonin, and Quercitrin. The doctor I saw was Dr. I am feeling better. The body aches and headaches aren't as bad, but I still have the painful cough. The fever isn't as high.
High BP/BP 195/95; Blurry vision; Dizzy; Weak; Spacy; Headache; Mouth began getting dry; Very sore arm with lump and redness; Very sore arm with lump and redness; Very sore arm with lump and redness; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Mar2021 12:45 (Batch/Lot Number: EP6198) as UNKNOWN, SINGLE for covid-19 immunization. The patient past Medical history included High BP, obesity, bronchitis, occasional asthma and covid-19(If covid prior vaccination Yes). The allergy includes Thimerosol and Bacitracin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 10Mar2021 at 13:00 15 min after vaccination, the patient experienced BP 195/95 probably from high BP, Blurry vision, Dizzy, weak, spacy and after 20- 15 minutes later mouth began getting dry, Very sore arm with lump and redness & a little soreness still present. The patient did not receive any other treatment. The event outcome was Not recovered for Very sore arm with lump and redness and for rest of the events recovered on unspecified date.  No follow-up attempts are possible. No further information is expected.
Within seconds after VARIVAX booster vaccine being given, patient complained of throat itching and vomited. Became very pale - was given Epinephrine and Benadryl.
Got Covid after 2 doses of vaccine; Got Covid after 2 doese of vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 intramuscular, administered in Arm Right on 23Feb2021 (Age at the time of vaccination 39-year-old) as DOSE 1, SINGLE, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 2 intramuscular, administered in Arm Right on 16Mar2021 (Age at the time of vaccination 39-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history includes drug allergy. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had tested for COVID-19. Patient visits Doctor or other healthcare professional office/clinic for Adverse events. On 14Nov2021 the patient experienced got COVID after 2 doses of vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test positive, on 15Nov2021 Nasal Swab. No hospitalization and no treatment received.The outcome of event was recovering.  Follow-up (22Nov2021): Follow-up attempts completed. No further information expected
rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May; Wisdom teeth Pulled; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May) and TOOTH DISORDER (Wisdom teeth Pulled) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May) and TOOTH DISORDER (Wisdom teeth Pulled). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (rescheduled his 2nd dose appointment on 2 July 2021 because he's having wisdom teeth pulled/first dose on 27 May) and TOOTH DISORDER (Wisdom teeth Pulled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.
low level of fatigue; shoulder is sore in one certain spot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (low level of fatigue) and ARTHRALGIA (shoulder is sore in one certain spot) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 FATIGUE (low level of fatigue) and ARTHRALGIA (shoulder is sore in one certain spot). At the time of the report, FATIGUE (low level of fatigue) and ARTHRALGIA (shoulder is sore in one certain spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact