chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In April I started having strange spotting. I?ve never had spotting issues before. It spotted a bit, and my cycle was delayed. In May it spotted again mid cycles and delayed. It skipped June and July. I did not get another cycle until late august. I went to my primary care, and they said as long as I had my cycle currently, I should be fine as long as no more symptoms continue. They had heard similar cases of other vaccine recipients. I intend it get it checked at an OB/GYN.
Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; This is a spontaneous report from a contactable nurse (patient).   A 55 years old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142/expiration date: MAR-2021) on an unspecified date  at single dose via an unspecified route of administration on deltoid Right for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. The patient reported that since an unspecified date right arm, where the vaccine was given, swelled up to the soft ball size; It was a reaction, hardness, warm at the patch, redness and it kept expanding. The patient did not receive treatment for the events. At the time of the reporting events outcome was unknown.
Pt received the flu vaccine in within a minute was gagging, coughing and turning blue. Her lung exam did not reveal wheezing but she was quite restricted with poor air flow. We laid her down with slight improvement in color but still breathing fast and tachycardia. Epipen JR was administered with immediate improvement in symptoms. Albuterol was also given. EMS called and taken to ER. In route to ER she was given benadryl. She was monitored for 4 hours and then sent home.
PUNCTURED VIAL OF THE JNJ COVID-19 VACCINE LEFT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, and expiry: UNKNOWN) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-OCT-2021, the patient experienced punctured vial of the JNJ covid-19 vaccine left at room temperature for more than 2 hours, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial of the JNJ covid-19 vaccine left at room temperature for more than 2 hours and out of specification product use was not reported. This report was non-serious.
Lingering Sore jaw (left side) - painful to bite down lasting 3 days after injection. Chills and aches one day after injection, but faded next day.
Has had sore arms from flu shots / Has received multiple flu shots in the past; This case was reported by a other health professional via other manufacturer and described the occurrence of pain in arm in a 60-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included sjogren's (diagnosed 10 years before the reporting date). Previously administered products included flu shot (received multiple shots in the past).   On an unknown date, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient was 60 years old at the time of her latest flu vaccination. The patient experienced pain the arm after the vaccination. The patient received Pfizer Covid 19 vaccine on 5th March 2021 and experienced swelling and itching.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR066243:Same reporter US-GLAXOSMITHKLINE-US2021AMR066247:Same reporter. US-GLAXOSMITHKLINE-US2021AMR066243:Same reporter
Ran fever, had chills, lots of sweating (started) while sleeping. Gone next day. None, was gone by next morning.
About June 1st, 2021 My joints started hurting starting with my hips, back, ankles, now shoulders.  Basically all joints.  Had an appt set with primary care dr Oct 4th, 2021 but had to reschedule to Dec 23, 2021.  So dr is unaware of these symptoms until my appt.
25 y/o WM ADSM is referred from a study for evaluation of previous local reaction to AVA #2.  Symptoms:  Edema @ injection site 50-120mm, Pain, Erythema.
Anthrax #5 July 31, 13. Swollen arm, tender, red, muscle aches, headaches, nausea, extreme fatigue, profuse periods of sweating, nausea.
Dx w/ COVID at urgent care just PTA. Was on abx and albuterol. Completed vaccine 6/2021. Vit-C, Vit-D, zinc, steroids. Rapidly improved and discharged home with O2.
So-full blown flu attack last night around 9pm Body aches; So-full blown flu attack last night around 9pm Body aches; headache; chills; exhaustion; I woke up around midnight and was awake for hours; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 15Feb2021 10:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation. The reporter stated that so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion on 15Feb2021 21:00. I took extra strength Tylenol and went right to bed. I woke up around midnight and was awake for hours! I took 2 more Tylenol and eventually went back to sleep. I feel much better this morning not 100%. I took an ALEVE. Therapeutic measures were taken as a result of so-full blown flu attack last night around 09PM Body aches, headache, chills, exhaustion and I woke up around midnight and was awake for hours and included treatment with Tylenol and ALEVE. The outcome of the event was reported as recovering.   Information on the lot/batch number has been requested.
Arm pain, feeling of hot lead in area of injection site, injection site swelling and pain, fatigue, joint pain, feeling unwell, heaviness and lethargy.
Around 10 hours out started to develop a fever. Body aches, headaches, chills and uncontrollable shaking. Fever peaked at 101.7 and lasted for 7 hours at that temp. During that time heart rate was resting at 110bpm. Also experienced ear pain in both ears. Still have fever of 100 degrees more than 24 hours after the shot, so symptoms ongoing. Used ibuprofen to help, but had mild impact. Tepid shower. Lots of fluids. At no point did the fever ever cause me to sweat.
a) First cold sore ever - 3 wks b) Flu the next day for 2 days
ischemic stroke; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. ON or around 06-OCT-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose the prevention of shingles (herpes zoster). Approximately on 13-OCT-2015, reported as one week after zoster vaccine live (ZOSTAVAX) vaccination, the pt suffered an ischemic stroke. As a direct and proximate result of use zoster vaccine live (ZOSTAVAX) use, the pt's symptoms had resulted in physical limitation not present prior to vaccination. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX) use, the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental, anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of use zoster vaccine live (ZOSTAVAX) use, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.   Upon internal review the event of ischemic stroke was considered to be medically significant.  The event of ischemic stroke was considered to be disabling.
Blood pressure high, hearing ringing in ears, pain injection site, poor tolerance for bright lights, unable to comprehend words.
Developed large red welt like spots on trunk of body (front and back) and legs. No itching. Remained afebrile.
patient filled out our consent and release form indicating he has NOT received any prior covid vaccination.  when we later in the day processed it thru, his insurance indicated that he HAD received the J & J formulation back on 4/8/21.  I called that administered it to confirm all patient info was the same and it was.  we will not give final dose when patient returns
Suspected myocarditis and diagnosed tachycardia when seen by physician days later.  Tachycardia lasted for period of 3 weeks.
Child experienced fever, passed out. Mother took her to ER. Child's temp in ER was 104.8. Redness at site on right arm
It started on Friday with slight tickle and scratch in my throat with head congestion.  I felt really tired.  My asthma did not kick in.  The first three nights I took cold medicine and was able to sleep.  I started feeling better on the fourth day.  I tested negative with my home test on Saturday and retested Monday and was positive.  I was unable to get into the doctor.
A spontaneous, non-serious report of headache and sore throat has been received from a consumer concerning a 12-year-old female patient subsequent to FLUMIST use. Medical history and concomitant medications were not reported. On 04-Sep-2009, the patient received FLUMIST. On 05-Sep-2009, the patient developed a headache, sore throat without fever over the weekend. The patient still did not feel well, so she was sent home from school. No further information was available. The outcome of the events of headache and sore throat were ongoing.
Headache, Myalgia, Fever, FATIGUE Narrative:  MISSED PART DAY OF WORK  Other Relevant History:
2 month shots given--6 days later pt hospitalized for sz & question of vax react raised; 10JUn94 12 month HIB was given & pt was re admitted for inc in sz;
101 degree fever about 12 hours after shot, treated with tylenol, subsided; 100 degree fever about 24 hours after shot; Chronic pain flare-Up for about 36 hours after shot which decreased as fever decreased.
3/9/2023- Resident had increased confusion, SOB, low 02% and was hypotensive. Labs done on 3/7/2023 indicate low sodium levels with elevated BUN. Sub Q fluids initiated on 3/9/2023. Symptoms worsening throughout the day. Sent to ED on 3/9/2023 at 23:00. Notified by Hospital on 3/10/2023 that patient passed away.
Minimal effect immediately following vaccine. But a week later developed what I learned is commonly referred to as covid arm-large red oval around injection site, itchy skin in that area, swelling and firmness and area was hot and red.  I?m now in my 3rd day with these symptoms. Used ice to reduce swelling on/off. That helps, but as soon as you take ice off, warmth & redness return.  Swelling and firmness have started to subside.
Minor burning, red quarter size round  raised with some rash on  upper arm. Muscle soreness  minor.  Benadryl and anti itch cream  Lasted only 2 days .  Recieved 2nd dose today No Reaction
Tdap administered in left deltoid, student obese-large arms 24 hrs after vaccine given, site is warm, red, slightly raised 3-4 in diameter of left deltoid cool compress applied.
Pain at injection site. Swelling of upper arm. Red welt at injection site with redness spreading away from injection site over the course of the following 2 days. Warmth at injection site and surrounding areas.
Started noticing in June that my arms felt heavy upon waking. Since then, heaviness as well as aches has worsened to include forearms, upper arms, shoulders neck and hands. Also intermittent burning sensations on hands forearms shoulders neck and face have occurred. MRI of brain and cervical spinal cord done on October 17th we?re normal.
Information has been received from a certified medical assistant concerning an 81 year old female with hypertension, arthritis and iron deficiency, noted to be overall healthy who on 1/27/05 was vaccinated with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot # 650084/0605P). Concomitant therapy included lisinopril. On 1/27/05 the patient called the doctor's office complaining of redness and soreness at the injection site. The office told her that was normal. The patient was then seen later in the office with a red, hot, and swollen arm. Her whole left arm swelled from injection site down. The patient was noted to have developed cellulitis. The patient was started on a week of steroid treatments and a week of antibiotics and required a few office visits. Subsequently, the patient recovered from cellulitis. The reporter indicated that something must be wrong with the lots since the patient was vaccinated before without any problems. The reporter felt the patient's cellulitis was considered an other important medical event (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released.
JUST GOT SICK LIKE HAD THE FLU; This spontaneous report received from a patient concerned a 34 year old female. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced just got sick like had the flu. The action taken with covid-19 vaccine was not applicable. The patient recovered from just got sick like had the flu. This report was non-serious.
No other signs or symptoms noted; patient was given expired PEDVAXHIB; This spontaneous report has been received from a nurse regarding to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 19-JUL-2021, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R027322, expiration date 09-JUL-2021 (strength, dose and route of administration were not provided) for prophylaxis ( expired product administered). No other signs or symptoms were noted (no adverse event). Additionally, No previous temp excursion were reported. No further information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on fingers, arms, stomach, neck, and knees), PERIPHERAL SWELLING (fingers seem swollen) and PYREXIA (fever) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 0486B21A) for COVID-19 vaccination. No Medical History information was reported. Concomitant medication was not provided. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PRURITUS (itching on fingers, arms, stomach, neck, and knees) and PERIPHERAL SWELLING (fingers seem swollen). On 21-Apr-2021, the patient experienced PYREXIA (fever). On 21-Apr-2021, PYREXIA (fever) had resolved. At the time of the report, PRURITUS (itching on fingers, arms, stomach, neck, and knees) and PERIPHERAL SWELLING (fingers seem swollen) outcome was unknown. Not Provided. Concomitant medication was not provided. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Dizziness that lasted for about an hour.  Weakness, extreme fatigue lasted the rest of the day.
Tenderness, soreness, difficult to move (R) arm, warm to touch along with fever. Took Advil on yesterday, that did help with fever. Swelling still present.
Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GM9694) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Lot number: FM8030) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 027A21A) and on 27Mar2021 as dose 2, single (Lot number: 028A21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Covid-19 treatment from 12Jul2023 to 17Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263627 same patient, diff drug/event;
I had a runny nose on Tuesday 22nd, then got a headache that afternoon (took Tylenol). When I got home from work I ran a low grade fever 100.9. I called my work and they set me up for a covid test in the morning. Ended up testing positive in the morning.
No signs or symptoms reported/ No other AE or PQC reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a physician via a healthcare business professional referring to a specified patient of unknown age or gender.  On 01-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032318, expiration date on 22-SEP-2022, after a temperature excursion occurred, for prophylaxis (dose, route, location were not reported). No signs or symptoms were reported. The record of the temperatures were: 15°F to 46°F (30.3F) for 6 hours 30 minutes and 0 seconds; 6°F to 14°F (14.1F) for 5 hours 0 minutes and 0 seconds; 15°F to 46°F (16.6F) for 14 hours 0 minutes and 0 seconds; 15°F to 46°F (19.7F) for 1 hour 0 minutes and 0 seconds. Time frame of 26 Hours 30 Minutes 0 Seconds (cumulative). There were no previous temperature excursion and the call was done because of a data logger.
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 26 Oct 2021; 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 (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 26 Oct 2021) in a 63-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 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 26 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 26 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vaccine placed in refrigerator on 26 Oct 2021. Vial did not undergo temperature excursion. No adverse event reported.  Treatment medications were not reported.
injection site seemed to be like a mosquito bite; itching at the injection site; swelling that is a bit raised at the injection site; redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE VESICLES (injection site seemed to be like a mosquito bite), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE VESICLES (injection site seemed to be like a mosquito bite), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE VESICLES (injection site seemed to be like a mosquito bite), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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.
Child received 6m-4year Pfizer COVID vaccine instead of 5y-11year COVID vaccine