chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine used; Excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported. On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.They used the excursion from their freeze on 01-Oct-2021.It was reported that the storage condition at the time of the excursion was frozen, vial size was 7.5 ml.  Product was storage minimum -4.2 degree and maximum 5.7 degree F. Excursion duration was 6 minutes . All vials are used up. 10 vials are impacted.  The vials were thawed before administration and there were no color changes of any things  abnormal. No concomitant medication were reported.No treatment drug were reported.This case was linked to MOD-2021-383410 (Patient Link).Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-NOV-2021 updated patient demographics.
Began with fever at 1030pm and continued with fever over 104 and lower back pain for 29 hours. Fever did not go below 102.9 with both motrin and Tylenol. Fever finally broke completely on 1/14 at 330am. At 300pm I spiked a fever at 104.6 within 5 minutes and had vigorous rigors and horrible lower back pain.  I was at work in the hospital and turned blue as per other nurses and doctors. I was evaluated b/p 144/100 HR 130 lactate 4.9. I am 120lb and have never had a b/p higher then 120. After NS Tylenol 2 liters of Lactated ringers my fever was 103.3 and the rigors stopped. I never had elevated wbc and my covid they did in the ER was negative. I went  home. For the next 24 hours I continues with intermittent fevers. The next day I began with runny nose and sneezing. Since then I am very congested with headaches all day relieved partially with Motrin but never fully relieved.
Vaccine administration error, related to temperature excursion, associated with an adverse event. The clinic explained prior to thawing and administration of the vaccine, it was stored in frozen temperatures for longer than recommended by the manufacturer. Outcome: Staff attempted contact x 3 and mailed letter to vaccine recipient.
patient was in observation and stated that she was ahe started to feel flushed. Notified medics and vital signs were taken blood pressure was elevated at 197/92, pulse 82 an d oxygen saturation 96%. Patient stated that she had " white coat syndrome" and was nervous. Patient refused further evaluation at the hospital and states that she was feelig well after a few minutes.
This spontaneous report as received from a pharmacy intern refers to a 68 years old female patient with unknown medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX on 24-SEP-2012. Lot number H011331 (in validation), expiration date 09-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. After vaccination, at the site of injection and around it (about a couple of inches) the patient had redness, not raised and itching that went down the arm a little bit (2-3 inches down from the injection site). No treatment was given. No laboratory test was performed. At the time of reporting, the patient had not recovered from the events. Additional information is not expected.
Resident displayed with confusion/shaking at 1400, condition worsens at time went.  Resident unable to state where he is, knows his name.  can tell you he does not feel right.   Temp 97.3, p 88, O2 91%, Bp 214/116  Transferred to ED with fever, temp of 103, and shortness of breath, admitted to ICU  Positive COVID-19 test at hospital. Diagnoses include acute COVID-19 pneumonia and hypoxia. PO had confusion,  fatigue, weakness, hypoxia, increased BP
Chief complaint: Syncope.   The patient was seen on paramedic arrival to room #2 with the above chief complaint.  She is a very pleasant otherwise healthy 38-year-old woman who had been in her usual state of health.  Today she felt a little lightheaded, laid down on the floor in her kitchen, and had a syncopal spell.  This occurred roughly an hour prior to arrival and lasted just a few minutes.  When her mother arrived she stated that she had witnessed the spell and that the patient was tonic but not having seizure-like activity.  She was completely unresponsive and confused afterwards but not incontinent.  She is describing nausea but no chest discomfort.  She has had no vomiting or diarrhea and no diaphoresis.  She denies prior similar symptoms and has no history of seizure, heart disease, VTE, or reactive airway disease.  She does feel like she has a dry mouth and also feels improved at this time.  She is not on medications chronically.  She did have her second COVID-19 vaccination yesterday with some mild arthralgias but nothing else.  She was seen by the paramedics and noted to be having dropped beats.  An EKG was obtained and during transport she went into a complete heart block with resumption of sinus rhythm afterwards.  The EMS rhythm strip was reviewed by myself and does reveal transient complete heart block.       DETAILS OF HOSPITAL STAY   Hospital Course Summary Patient is an 38 y.o. female w/ no significant PMHx who presented to the ED via EMS after a syncopal episode.  She was standing in the kitchen, felt lightheaded then fell to the floor and passed out.  Her mother subsequently arrived and witnessed an additional episode of of unresponsiveness.  EMS subsequently caught on telemetry multiple episodes of complete heart block.  The longest of these lasted 20 seconds.  She was referred for admission.  The interested reader is referred to the complete admission history and physical.   Patient is admitted to the hospital.  Pacer pads were placed.  On monitor she had no further symptoms nor pauses.  Cardiology consulted.  Echocardiogram was performed and was normal.  It was ultimately felt that the patient most likely experienced a vagal event with marked suppression of AV conduction.  Of note, patient received her second Pfizer COVID-19 vaccination the day prior.  Cardiology has recommended discharge home with a Zio patch.  Lengthy discussion has been held with patient regarding importance of immediately activating EMS should she have recurrent symptoms similar to what brought her in.   Patient was also noted to have a microcytic anemia.  Iron studies returned remarkable for severe iron deficiency.  She received 1 dose of IV iron in the hospital and is discharged with twice daily oral iron.  She is to follow-up with her PCP for ongoing monitoring and evaluation.  In addition, she should lay down immediately.
The patient was administered the Janssen COVID-19 vaccine at age 17, when it has only been "approved" for adult patients 18 years and older. The patient and her mom have been made aware of the error, and will monitor her for adverse effects.
NOTE - I do not know which Rabies vac was used - it's not on my paperwork -   While one in a billion chance of obtaining rabies from bat spit out of the air when near a roosting site, my irrational mind went to the hospital when I awoke with what felt like flu symptoms in my arms and legs and I started immediate rabies treatment. 36 hours later I felt a sensation in my bladder that instead I may actually be having a UTI which would explain the odd arm/leg flu type chills I was having along with a very hard issue concentrating. I did have a UTI without bladder feeling before but it hit the kidney first with massive pain and while there was no pain this time, the aftermath felt familiar. I had also not slept very well for 60 hours.  Regardless, I started rabies treatment with the 2 shots in the legs of immunoglobulin and first dose of rabies vac in the arm. Type is only shown as purified chick embry cell (5/21/2020). I was also test for covid-19 the same morning as initial symptoms but came back negative.  After receiving my first pass at this vaccine, I woke up after a restless sleep the next morning feeling as if my skin was on fire. That lasted 20-30 minutes and subsided. Later that evening  is when I felt my bladder feeling weird and a home test shows elevated leukocytes so I went the next day to the local clinic to be tested. Initial quick test was negative but all my symptoms fit. I had no cough and temp has never gone over 100.1 and hovers around 98.9 and 99.1 - My baseline is 97.9. I've had on and off feeling of weird tension in my arms/legs but figure it was the shots themselves. By the evening, it was gone and I felt great.  I started Macrobid while awaiting a 3 day longer culture grow tests on my possible UTI and immediately started feeling better.  Finally started sleeping again. Energy and mental clarity returned. Went for my next booster of rabies on 5/24/2020 in the arm at the same hospital. Within 30 minutes I felt the whole upper body skin burning sensation again but not as bad. The whole day I felt great.  Appetite which was non-existent the first 3 days returned finally too.   Today (5-26) I awoke feeling a little shaky again, arms and legs do feel off/strange - but no pins/needles in feet/hands or any other symptoms - the sensations comes and goes. As the day goes on it seems to slowly resolve.  Is this normal behavior of the vaccine? Temp is 99.1. I feel fine otherwise.
My  first vaccine shot  was on 1/11. 10 days after (1/21) a 2 inch red, slightly itchy, warm to the touch rash appeared at injection site. By 1/24, the rash appears less red but has expanded to 3-1/2 to 4 inches.  On 1/21 and 1/22,  I took Allegra (180mg) but as of 1/23, I switched to OTC Benadryl (25 mg 4 times a day) and 1% Hydrocortisone Cream. I have NOT  had, thankfully, any "severe side effects" (like Difficulty Breathing, Swelling, Fast Heartbeat, Dizziness, Weakness or Widespread Rash). Rather my rash appears to be a delayed reaction. I plan to continue with the Benadryl and Hydrocortisone Cream
Severe itching in arm. Then fatigue, headache and progessive weakness in all extremities. Continues to worsen after 3 days.
Pt.'s Mother states that after receiving the 1st dose of Phizer 11/15/2021, started experiencing symptoms 11/17/2021 of a rash (Hive-like) developing under the arm of injection site. At one site of the blemish has began to develop into an opening (sore-like).  No noted Primary visit/communications.
pt recv vax 17FEB97 & 17FEB98 pt devel 40 skin lesions all over body;there was no fever @ this time;approx 1MAR98 pt recovered;
No adverse event noted. Client, administered H1N1 Medimmune outside age age indication. Please note information in VAERS system for future reference if needed.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 54 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Diabetes, HTN, hyperlipidemia; "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing).  The patient had no known allergies. Concomitant medication(s) included: FARXIGA; ROSUVASTATIN; IRBESARTAN; OZEMPIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: Treatment of COVID-19; (04Sep2022) positive, notes: Rebound positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 03Sep2022 to 07Sep2022 and the patient had rebound positive test on 04Sep2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Burning pain internally for over a week; weakness on the left arm; This is a spontaneous report from a contactable Nurse (patient). A 44-years-old female patient received second dose of  bnt162b2 (BNT162B2), intramuscular on 15Jan2021 08:00 at SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications was none. Historical vaccine at 44 year old included product=COVID 19, brand=Pfizer, lot unknown=False, administration date=25Dec2020, administration time=08:45 AM, vaccine location=Left arm, dose number=1} for covid-19 immunisation. No Known allergies. No covid prior vaccination. No other vaccine in four weeks. The patient experienced burning pain internally for over a week, weakness on the left arm on 15Jan2021 09:00 with outcome of not recovered. Still on pain 10/10 throbbing pain Tylenol, ibuprofen, ice packs, heating pad have not reduced the pain. The patient underwent lab tests and procedures which included pain: 10/10 on 15Jan2021, Covid test post vaccination: covid test type post vaccination=Nasal Swab: negative on 22Jan2021.   Information on the Lot/Batch number has been requested.
Noticed small pimple/blister like bumps on her head, by next day had approximately 20-30 similar bumps.
body felt like it was sleepy and sore; body felt like it was sleepy and sore; chest pain; heavy and putting pressure on her chest; difficulty in her movement and walking coordination and her brain was "not working; difficulty in her movement and walking coordination and her brain was "not working; difficulty in her movement and walking coordination and her brain was "not working; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. This 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on 14Apr2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation; Solution for injection, lot number and expiry dates were not provided) via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. On 14Apr2021, about after 12 hours, half of her body felt like it was sleepy and sore. She also had chest pain, which felt like there was something heavy and putting pressure on her chest. She also mentioned that she had difficulty in her movement and walking coordination and her brain was "not working". She was asking if this is common or something that she needs to go to the doctor to. She mentioned that her friends who got the vaccines had fevers but no chest pain. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever 24 hours. Seizures and tic. Would not sit up for a long time; always laying down even when he plays with toys. Cries a lot. Violent temper tantrums. Stopped talking; plays along. Blinking of eyes. Per follow up report received 05/13/2005:  Patient is still not speaking and he is stil on Keppra for seizures.  Patient is still Autistic. Medical Records received stated patient experienced eyes rolling back.  He is still Autistic - unable to function like a normal child.
He got his vaccine, had not reaction then at 6:00 AM he had muscle pain, fever, nausea, diarrhea, headache, weakness.  Those symptoms are still prevalent today but are better.  He has taken Motrin and Tylenol for his symptoms.
Received vaccines on 02/01/04. On 02/23/04, daycare provider noted a large red warm area on upper left arm that was 7x5cm. Patient complained of soreness but had no fever.
Pt got vaccine Wednesday & Thursday at 1am pt got fever & then (Rt) upper arm painful redness/swelling. Treated for cellulitis.
Hives to legs MOSTLY right left and left wrist ( 1 ) and left mid arm(1)
6 year old girl complaining of her arm hurting, vomiting this morning, and mom says she had a fever last night. Pt was here yesterday for immunizations. Pt has a fever of 100.1 when she was checked in today.
Rash on arm, large red circle around injection site, 6? in diameter, hot to the touch, very sore
Patient given Pneumo vaccine on 11/15/04 PM of 11/16/04. Patient developed redness and pain at injection site associated with temperature, chills, and sweats. Patient called on 11/17/04 and was scheduled an appointment. Started on Keflex for cellulitis. Appointment on 11/18. Patient was given Rocephin 2gms IV and sent to ER. Diagnosis: Sepsis
High pitched screaming/inconsolable 1-2+ hrs. Fever (5 days, TYLENOL every 4-6 hrs). Drooling/limp body. Swollen lymph nodes/joint pain. Back arching/pain. Startle reflex returned.
1.  Nauseous & achy DAILY for 5 weeks. 2.  Day 6 after Booster, woken from sleep by R hand & wrist extreme, pain, swelling, inability to close fist, fingertip numbness, burning, & tingling. 3.  Day 10 after Booster, the same symptoms present in L hand, wrist & fingertips. 4.  These symptoms are present all day to the present day (1/30/2022).
Painful, erythema, swelling localized reaction. Treatment: Zyrtec 10 mg daily.
Employee reported having itchy eyes and mouth approximately 30 minutes after receiving the Flu vaccine. She felt like her face was swollen but this was not visible when she looked in the mirror. She did have red hives on her face. She had Benadryl 25mg on her person, she proceeded to take to tablets with relief. 10/4/18 she states have no further symptoms.
Had vomiting and diarrhea. Left arm started aching, experienced fever. Since then both arms hurt from shoulder down to fingers, fever on and off at night.  Occasionally short of breath at night, continue to feel weak all the time.  Take Tylenol or Advil occasionally also occasionally use a topical ointment like BenGay. Did see PMD he told her her lungs and heart were healthy and to continue taking the Tylenol or Advil and advised her to call back if symptoms got worse.
my lungs hurt when i breathe in; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (my lungs hurt when i breathe in) and VACCINATION COMPLICATION (COVID arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (Hospitalized for 2 weeks) in 2019.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (my lungs hurt when i breathe in) and VACCINATION COMPLICATION (COVID arm). At the time of the report, PULMONARY PAIN (my lungs hurt when i breathe in) and VACCINATION COMPLICATION (COVID arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.
RAPIDLY LOSING WEIGHT; LARGE CLOT IN ABDOMINAL AORTA (40 PERCENT BLOCKAGE); CLOT IN LEFT LEG; SPOT ON ADRENAL GLAND; This spontaneous report received from a parent concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: Unknown and expiry: Unknown ) dose was not reported, 1 total, administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in 2021 patient developed severe abdominal pain ninety days later to vaccination (APR-2021 or MAY-2021) for which patient went to urgent care, ran tests, took images and found large clot in abdominal aorta, 40 percent blockage. Upon further testing patient found another clot in left leg and a spot on adrenal gland. On an unknown date in JUN-2022 patient started rapidly losing weight and patient was put on blood thinners. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from large clot in abdominal aorta (40 percent blockage), spot on adrenal gland, rapidly losing weight, and clot in left leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220846125-covid-19 vaccine ad26.cov2.s -Large clot in abdominal aorta, clot in left leg. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related.
Information has been received from a certified medical assistant concerning a reportedly healthy 61 year old male with no medical history and no allergies who was vaccinated with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot 650084/0605P). Concomitant therapy included an unspecified blood pressure medication. Subsequently the patient developed swelling and redness at injection site. The patient sought unspecified medical attention. Subsequently, the patient recovered from swelling and redness at injection site. The reporter indicated that something must be wrong with the lots since the patient was vaccinated before without any problems. The records of testing prior to release of this lot have checked by Quality Assurance and found to be satisfactory, the lot complies with the standards of Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Some tiredness; Swollen lymph nodes in both arms and neck by the both shoulders; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Some tiredness) and LYMPHADENOPATHY (Swollen lymph nodes in both arms and neck by the both shoulders) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation.     Concurrent medical conditions included Blood pressure increased. Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for Cholesterol, ALPRAZOLAM (XANAX) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (Some tiredness) and LYMPHADENOPATHY (Swollen lymph nodes in both arms and neck by the both shoulders). At the time of the report, FATIGUE (Some tiredness) and LYMPHADENOPATHY (Swollen lymph nodes in both arms and neck by the both shoulders) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.