chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 2:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 2:57 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 83.94.  Concomitant products were not provided.  On 28-Feb-2021, Excursion time was 9 AM, temp was 27 and at 1 PM temp was 26; total doses given for the day was 152, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vial was moved to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration At 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM : 26, 2 PM : 37, 3 PM: 43 and 4 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
I FIRST HAD SYMPTOMS  WEDNESDAY EVENING MAY 11TH, THEY WERE MILD AND FELT LIKE A COLD. I KNEW I HAD BEEN EXPOUSED. ON THURSDAY I STILL FELT LIKE I HAD A COLD HEAD ACHE AND CHEST CONGESTION. I DID A COVID TEST AROUND 3PM AND IT CAME BACK POSITIVE. I WAS EXETERMLY TIRED AND COULDNT GET OUT OF BED.THEY HAD TO BRING ME MEALS. I WAS REALLY TIRED AND HAD ALOT OF SYMPTOMS LIKE HEAD ACHE AND CHEST AND HEAD CONGESTION. ON THE 16TH I STARTED FEELING I HAD ENOUGH ENERGY TO GET OUT OF BED. I WAS STILL TESTING POSITIVE. ON TUESDAY I STOPPED ISOLATING AND I WORE A MASK BUT I DIDNT GOT OUT I STAYED IN THE HOUSE. AND WOULD MEET FAMILY MEMEBERS OUTSIDE. I STARTED GOING OUT WEDNESDAY AND I REALIZED I GOT TIRED FAST AND THAT HAPPENED FOR THE NEXT FEW DAYS. SO NOW AM JUST TAKING IT EASY BECAUSE I STILL FIND MYSELF BEING TIRED AND SHORT OF BREATH. ON FRIDAY THE 20TH I THOUGHT I WAS RELAPSING BUT I WAS NEGATIVE. AND I ALSO HAD A FEVER WHILE I WAS IN BED AND ON THE 20TH BUT THAT HAS GONE AWAY.
numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain with walking left leg; This is a spontaneous report from a contactable nurse reporting for herself.    A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm  on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation (Age at vaccination 78 years).  The patient medical history was not reported.  On 04Feb2021 the patient received the first dose of BNT162B2 and experienced sore arm.   The patient's concomitant medications were not reported.  The patient experienced pain with walking left leg  on 28Feb2021 with outcome of recovering , left leg swelling/ it got so swollen/left foot swelling  on 03Mar2021 with outcome of not recovered , numerous blood clots below the knee  on 04Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood test: unknown results,  ultrasound joint: numerous blood clots below the knee   on 04Apr2021   , vital signs measurement: unknown results.  Course of the event: The patient  waited for the timeframe after the second dose and had no problems. 4 days after, she experienced pain with walking in her left leg.  She took Aleve for a few days.  It got so swollen, she should have gone then to her Primary Medical Doctor, but she did not go until 25Mar2021. She was sent to  Hospital for an Ultrasound of her leg on 04Apr2021.  After the Ultrasound, she was taken to the Emergency Department at the hospital. The doctor told her she had numerous blood clots below the knee.  Was prescribed Eliquis 5mg.  She was instructed to take 2 tablets or 10mg twice a day, 8hrs apart for 1 week and then 1 tablet twice a day for the remainder of the 74 tablets. She completed that. She was out of them and got a refill of Eliquis 5mg on 26Apr2021. She received 60 tablets and can refill for 5 times. She is really concerned. The swelling is still so bad and so that could that mean blood clots are still in there. The ER doctor told her that the medication is dangerous.  It thins the blood and can cause bleeding and the blood clot can go to her heart.  Follow up information has been requested.; Sender's Comments: The causality has been assessed as related to bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm  on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization, based on temporal association and profile of the product.,Linked Report(s) : 2021499984 same patient/drug, diff dose/event
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot number M046133, expiration date 26-SEP-2019 (dose and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA004510: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005550: US-009507513-1707USA005551.
Day 2 reports a red streak on his arm, and his arm is vary painful Day 2-4 Fevers, Sweats, pain all over body.
Severe local pain in left arm (could not lift arm for 2 days), fatigue, fever, diarrhea. Took ibuprofen with no relief. Symptoms lasted 2 days. Missed 1.5 days of work.
Given monovalent vaccine inadvertently. Should have received bivalent. No side effects noted by patient
From initial information received on 10Jun04 from a health care professional, regarding an adverse event occurring, it was reported that a 16 month old female pt received an Acthib vaccination, lot number UE215AA, administered IM in the left thigh, an IPOL vaccination, lot number X0771, administered IM in the right thigh, a Hep B vaccination, lot 0466N, admin IM in the right thigh and an Infanrix vaccination, lot 590B9, administered IM in the left thigh, on an unspecified date. The pt's mother reported that the pt developed generalized hives about 12 hrs after vaccination. Benadryl was given. The rash was still present when the pt was seen in the physician's office on 09Jun04. The pt's recovery status was reported as unk.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages who on an unknown date, might have been vaccinated with a dose of VARIVAX (Merck) (lot number 0690Y) (dose and route not reported) that was expired. The lot reported had expiration date on 15-MAY-2011. No adverse symptoms were reported. Additional information has been requested.
Continual vomiting, intense shivering (teeth chattering), intense joint spasms, feeling extremely fatigued.
temperature reaching 104 degrees and high temperature staying elevated with fever reducing medications.  Severe joint pain and muscle aches with the feeling of my joints having been hit with a hard object.  Injection site hot to the touch with axilla lymph node reaction the size of a golf ball with pain that radiated into chest wall.  Symptoms still evident after almost 72 hours post injection
Woke up in the evening with vertigo.  This has persisted throughout the morning.  No previous history of vertigo in my lifetime.  Vertigo is listed as a side-effect on the insert.
Pt. called stated he had flu shot about 10 days ago at pharmacy. C/o tingling effects to (L) arm & shoulder, dull HA, lethargic, spasms or cramps to (L) arm, sl. SOB, stuffy for past 2 days & indigestion.
After I received my first dose I started to experience my first symptom on March 30, 2021. I noticed that I had a small lump on the left side of my rib cage beside my left breast which was about the size of a sausage link. The area wasn't painful, slightly tender to the touch and soft. By 4/3/21 the area has expanded to the upper portion of the scapula and it was no longer located on the side of my rib. It was about the size a pear and it was inflamed and very tender to the touch. I couldn't raise my arm and it was pertruding from my clothing and preventing me from sleeping at night on that side. By 4/5/21 the mass had turned into a different shape and direction and it was no longer just primarily on my scapula.. This current shape favored a boomerang and it started on my lower scapula and wrapped around my arm going directly into the middle of my arm pit.. It was about an 1.5 inches wide, inflamed, painful and wouldn't allow me to fully lift my arm or lay on it.. The mass was hard and didn't move, I visited a prompt care and they couldn't decipher what it was. I began to take tylenol and use cold compress and over a few days the mass began to decrease in size and I was able to increase my range of motion obtaining full extension on 4/17/21. The mass is now smaller than a pencil on 4/22/21 and hardly noticable but it was quite an experience.
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Apr-2021 and was forwarded to Moderna on 21-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of APHTHOUS ULCER (whole mouth broke out on canker sores) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Medical history were diabetes - pacemaker - heart valve replacement, as provided by the patient.  The patient's past medical history included Pacemaker insertion (cardiac) (heart valve replacement).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced APHTHOUS ULCER (whole mouth broke out on canker sores). On 19-Mar-2021, APHTHOUS ULCER (whole mouth broke out on canker sores) had resolved. 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.   This case was linked to US-MODERNATX, INC.-MOD-2021-083076 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083076:First dose
information has been received from a physician concerning a male at risk patient in his mid sixties who, a couple of years ago, in approximately 2003, was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast). A couple of years ago, in approximately 2003, the patient experienced a swelling of the air passage and breathing trouble. The patient went to the emergency room and was treated. It was reported that the patient recovered. No other information was provided. Swelling of the air passage and breathing trouble were considered to be immediately life threatening and disabling by the reporter. Additional information has been requested. This is an amended report, tracheal oedema has been changed to oropharyngeal swelling. This is a corrected report as amended. Oropharyngeal swelling is considered an expected event, and as a result the report no longer meets the criteria for expedited submission.
On 9/19 he developed a large, red, itchy area around the vaccine administration site which was hot to the touch.  He was seen at an Urgent Care .   The area increased in size and discomfort and was seen the following day in the emergency room.  He was given an oral steroid, a Rocephin injection, and antibiotic was changed to Keflex.  He was discharged on oral Prednisone and Bactrim. He was seen again in the office on 9/21/20 when the site was slightly improved and complained of more itching than pain.
Distinct lump at injection site (initially 2 inches around, one-half inch deep at center, when first noticed, 12 hours after injection). Injection was given by pinching my arm at injection site (thick pinch). My arms are both muscular and fat. At present, 5 days later, the lump is beginning to soften and reduce in size. Within the first 24 to 48 hours after injection, my arm was both sore and itchy, but that is starting to diminish at present.
Reports on the morning after vaccine given, she removed band aid to shower and noticed red spot (  dollar size) and found it to be itchy. Reports site lessened in itch and redness over the course of a couple days. No s/s by Tues 4/20. ? Reaction to bandaid/adhesive.
This spontaneous report as received from a medical assistant refers to a 17 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 03-JAN-2017, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis. On the same date, the patient was also vaccinated with improperly stored doses of  MMRII (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) and VAQTA with lot number M027879 and expiration date of 24-JAN-2018 (strength, dose, route of administration and anatomical location were unknown) for the same indication. The vaccines were stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: Original Case : 1701USA004150 US-009507513-1701USA007912: Original Case : 1701USA007906 US-009507513-1701USA007922: Original Case : 1701USA007910 US-009507513-1701USA007881: Original Case : 1701USA007910 US-009507513-1701USA007913: Original Case : 1701USA007910 US-009507513-1701USA007882: Original Case : 1701USA007916 US-009507513-1701USA004150: Original Case : 1701USA007916 US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007915: US-009507513-1701USA007848: US-009507513-1701USA007849:
Patient experienced extreme pain swelling and redness around the injection site from shoulder to elbow reaction 1 hour of receiving vaccine. Patient was seen by her physician and the doctor stated that the patient experienced an allergic reaction to vaccine. She was treated with fluid and steroid shot.
This spontaneous report as received from  a healthcare professional refers to a patient of unknown age and gender. On 13-JUL-2017 the patient was vaccinated with an improperly storage ZOSTAVAX lot # M040623 for prophylaxis. The patient did not experience any adverse event. The outcome of incorrect product storage and no adverse event is unknown.
No hearing in left ear, not able to hear on phone, any sounds. Went to ENT on 11/2/09 @ 09:30 am. Had examination and audiogram. Audiogram showed severe sensoryneural hearing loss left ear, right ear normal. Started on Prednisone 60 mg po daily. Had MRI on 11/4/09 which was normal. Over next two weeks hearing gradually improved accompanied by notable tinnitus. Seen again by ENT on 11/18/09 at medical center. Hearing clinically improved but still not at baseline. Continue Prednisone at 40 mg po Q day x 2 more weeks. Follow-up audiogram planned in about 2 weeks.
Death within 48 hours, post vax; Myocardial Infarction.
was very lethargic for about a year; This spontaneous report as received from a receptionist at a provider's office via a company representative refers to an adolescent female patient of unknown age (reported as 13 or 14-year-old). No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration, lot # and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (the company representative was unable to determine which one it was).    On an unknown date, the patient was very lethargic for about a year.  The outcome of the event was unknown.  The relatedness between the event and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Pt passed out after Tdap administration ambulance were called. Pt stated he always pass out after injections. Pt stated NKDA and no health conditions prior to adm. Pt refused to be taken to hospital.
Pts mother, called reporting on 11/18/02 that patient was very weak and had temp of 102.5 over the weekend of the 15th through 17th.  On 11/19/02 Dr. called to report patient was ok.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild
Sudden confusion, in the form I know what I want to say but it feels as if I suddenly forgotten how to articulate, I stumble on words.
Temp of 101.4.  Mild chills, loss of appetite, mild muscle aches, lethargic   No treatment except rest, fluids and Tylenol
received the Shingrix vaccine/wonders if this is shingles/ suspected vaccination failure; wonders if this is shingles/ suspected Shingles; Itchy rash; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On 10th September 2021, between 1 and 2 years after receiving Shingrix and more than a year after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and itchy rash. The patient was treated with hydrocortisone (Hydrocortisone Cream). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient received last dose of Shingrix 1 and 1/2 years before the date of reporting (no further details remembered). After receiving Shingrix, the patient experienced an itchy rash on her body. The itchy rash covers from above her knees, both thighs across her stomach and around to her back.  The rash started about 3 weeks before the date of reporting, then pretty much cleared up after 1 week and now as of day of reporting it was back again, in the same locations on her body. The pharmacy told her to put hydrocortisone cream to help with the itching. The hydrocortisone cream does help stop the itching.  The reporter wonders if this itchy rash was shingles. The patient was referred to healthcare professional (HCP). The reporter did not consent to follow-up. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Hospitalized (10.21.21);  COVID-19 positive (10.21.21);  fully vaccinated  Admission Date: 10/21/2021 Discharge Date: 10/24/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute renal insufficiency [N28.9] Severe sepsis (HCC) [A41.9, R65.20] Acute cystitis without hematuria [N30.00] COVID-19 [U07.1] UTI (urinary tract infection) [N39.0] Urinary tract infection [N39.0] HOSPITAL COURSE: 76 y.o. female who presented with urinary tract infection, severe sepsis complicated by acute hypotension.  Given appropriate fluid repletion in the emergency department.  Briefly placed on norepinephrine IV for pressure control.  No further evidence of hypotension at this time.  Weaned off norepinephrine within 24 hours. Placed on IV Rocephin for positive urine culture of E coli.  In addition blood culture positive for Haemophilus influenzae sensitive to ceftriaxone.  Overall much improved at this time. Today on October 24th she is feeling much better.  Denies fever, chills, sweats.   Plan on discharge today.  She has persistent leukocytosis.  White blood cell count was 47000 yesterday.  Today is 36,000. This is likely secondary to infectious process in conjunction with IV Decadron.  Patient has received 4 days of IV remdesivir in addition to 4 days of IV Decadron. Patient will be discharged on oral Ceftin.  In addition will continue additional days of orally Decadron.  Advised to follow-up with primary care physician this week to re-evaluate elevated white blood cell count.