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 a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 1:59 PM,  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. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.53 for dose administered on 20-MAR-2021.  No concomitant medications were reported.  Batch number 031A21A underwent temperature excursion 20-MAR-2021 with temperature 34 degrees Fahrenheit at 09:00 AM and 37 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 09-MAR-2021 and beyond use date for the vial was reported 08-APR-2021. Product moved to clinic on 20-MAR-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
I just got a breakthrough case of COVID on 9/4/21, about 8 months after my first vaccine. And I am experiencing exactly the same vertigo-like and dizzy symptoms that I experienced two weeks after receiving my first dose. I did not want to blame the vaccine for my symptoms 8 months ago. I remember I went to get my second shot and needed a wheelchair because I was so dizzy, experiencing vertigo. But I never thought of blaming the vaccine until now that I have COVID and the same symptoms have returned. Besides vertigo/dizziness, I also have roving superficial pains that migrate from one part of my body to another, then randomly go away. Exactly like I experienced after the vaccines were administered. My dizziness has varied in severity and will drop and rise every now and then. I began with extreme tiredness, sore throat, fever for 8 days that never went beyond 101, and it would come and go when I had covid. I had gastro intestinal issues, lost sense of taste and smell and hair profusely as well. The dizziness kicked in around day 5 and was extremely bad. Brain fog came about and is causing me to forget many things as well. This is causing me to struggle with work as well. After covid I had blood tests done and this discovered hemoglobin A1C as high which I had never had before. It showed a high D-Dimer test as well and they thought I had a blood clot occurring, however I had covid pneumonia. I also had the oxygen level drop severely and then the next day I felt better.
I gave the Dtap Guadracel  when I should have given Dtap Daptacel
This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-SEP-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # N023828 with expiration date reported as 25-JUN-2020 (dose, frequency and route were not provided) for prophylaxis. No adverse effects reported. The vaccine was stored at a temperature of 47 Fahrenheit degree to 77 Fahrenheit degrees with a time frame of 1 hour and 10 minutes and previous temperature excursion of 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 27 minutes and 47 Fahrenheit degree to 77 Fahrenheit degrees for 1 hour and 5 minutes. Digital Data logger was involved. This is one of eight reports received from the same reporter. Sender's Comments: US-009507513-1809USA013685: US-009507513-1809USA012930: US-009507513-1809USA013687: US-009507513-1809USA013684: US-009507513-1809USA013688: US-009507513-1809USA013682: US-009507513-1809USA013683.
Within 8 hours of vaccination employee began to experience aching and swelling at vaccine site, swelling spread up shoulder and a small knot formed above clavicle; other symptoms within 24 hourse included fever; no symptoms of anaphylaxis reported; physician seen and diagnosed as local reaction to flu vaccine, prescribed naproxen, symptoms subsided by 10-20-06.
DVT; This is a spontaneous report from a contactable consumer reporting for a patient. An 88-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation, at 88 years old. Medical history included High blood pressure from an unknown date. No COVID prior vaccination. Not tested for COVID post vaccination. No known allergies. The patient received the first dose of BNT162B2 (Lot number el9264) on 03Feb2021 for Covid-19 immunization. Concomitant medication included simvastatin (ZOCOR); terazosin; carvedilol; ranitidine, taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Lower right leg swelling was noted beginning approximately on 01Mar2021 without injury or pain that worsened through 04Mar2021. Patient was taken to ER on 05Mar2021 when DVT was diagnosed. Therapeutic measures were taken as a result of DVT includes XARELTO. Outcome of the event was recovering.
This case was reported by a pharmacist via call center representative and described the occurrence of dizziness in a 26-year-old female patient who received ENGERIX B adult (batch number 53P39, expiry date 12th February 2020). On 4th October 2017, the patient received ENGERIX B adult 1 ml. On 4th October 2017, less than a day after receiving ENGERIX B adult, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved. The reporter considered the dizziness to be unlikely related to ENGERIX B adult. Additional details were reported as follows: The patient received ENGERIX B adult in left arm.
I started having a head cold nasial compression and a postnasal drip. I had a slight fever 100.1. I called the doctor because I was awakened by my wife, and she thought it would be best to test because she had just tested positive for COVID-19 as well as my grandchild. I was 100 % positive for COVID-19, and I have other health issues that pushed me to reach out to my primary doctor. The doctor called in a prescription for Paxlovid, and it helped because I didn't get any worse.
MMR given with rash/conjunctivitis and fever developing after vaccine. Question secondary to attenuated measles virus. Eval on 8/5/02.
Nurse reported the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug allergies, reactions, or concomitant medications were not provided.  On 26-MAY-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally, for prophylaxis (lot number 1660704 which has been verified to be valid, expiration date reported and validated as 20-MAR-2021) (dose and vaccination scheme frequency were not reported).   The administered dose of the vaccine experienced a temperature excursion of 12.1 degrees Celsius for 16 hours and 11 minutes, as recorded by a data logger. There was no previous temperature excursion.
Unknown adverse drug events at this time - patient received expired medication on 6/16/2023 - expiration date of Lot is 6/10/2023
poor response to Haemophilus influenzae type b; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 14-year-old male patient, referred for lymphopenia, recurrent herpes stomatitis, and recurrent otitis media. He had a vesicular eruption with fever after varicella vaccination and developed shingles at age 3. He had chronic rhinitis and cough with negative testing to environmental allergens. At age seven he had serum immunoglobulin G (IgG) at 1400 mg/dL, serum immunoglobulin M (IgM) at 19.5 mg/dL and serum immunoglobulin A (IgA) at 43.1 mg/dL. The patient also had marked diminution in all lymphocyte subsets as provided below. At the age of 4, the patient had the following test results: CD3+ lymphocyte T cells: 193 per milliliter of blood, CD3+ lymphocyte T cells/ CD4+ subset: 84 per milliliter of blood, CD3+ lymphocyte T cells/ CD8+ subset: 113 per milliliter of blood, CD19+ B cells: 80 per milliliter of blood, CD3- CD16+ CD56+ Natural killer (NK) cells 87 per milliliter of blood, antigen proliferation (Candida) : 1.3, SI was low, however, basal proliferation was high, skewing interpretation of results. At the age of 10, the patient's mitogen proliferation - phytohemagglutinin (PHA) test was normal.  On an unknown date, the patient was vaccinated with Haemophilus b Vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot number and expiration date were not provided). At the age of 14, the patient had the following tests results: CD3+ lymphocyte T cells: 137 per milliliter of blood, CD3+ lymphocyte T cells/ CD4+ subset: 47 per milliliter of blood, CD3+ lymphocyte T cells/ CD8+ subset: 90 per milliliter of blood, CD19+ B cells: 33 per milliliter of blood, CD3- CD16+ CD56+ Natural killer (NK) cells 75 per milliliter of blood. Abnormal neutrophils were apparent by light microscopy. Large vacuoles were present in many of the neutrophils as well as some lymphocytes. These vacuoles were clearly seen by transmission electron microscopy. The patient had also "toxic vacuolation" on a manual complete blood count. His cells showed enlarged macropinocytotic vesicles in lymphocytes as well as neutrophils. On an unknown date (also reported as "at age 14"), the patient had normal to elevated IgG (1110 mg/dL), low IgM (11.9 mg/dL), and normal IgA (53.6 mg/dL), with marked diminution in all lymphocyte subsets.  On an unknown date, antibodies to tetanus, varicella, and a few pneumococcal serotypes were adequate with poor response to Haemophilus influenza type b. Targeted in-house immunodeficiency gene panel at Hospital identified de novo heterozygous RAC2 c.184G.A, p.E62K. The outcome of the decreased therapeutic response to Haemophilus influenza type b was not provided.  The reporter considered the event to be related to Haemophilus b vaccine (manufacturer unknown).    This is one of two reports derived from the same literature article and concerning the same patient cross-referenced with case MARRS# 1907USA003039).; Sender's Comments:  US-009507513-1907USA003039:
Interchange of vaccine products; This non-serious case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 13-year-old female patient who received Men ACWY-CRM NVS (Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine) for prophylaxis.   Co-suspect products included MENACTRA for prophylaxis.   On 21-SEP-2018, the patient received the 1st dose of Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine. On 04-MAR-2019, the patient received the 2nd dose of MENACTRA. On 04-MAR-2019, 164 days after receiving Meningococcal polysaccharide groups A, C, W-135, Y conjugate vaccine, the patient experienced interchange of vaccine products (Verbatim: Interchange of vaccine products).  The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 The nurse reported clinic had a patient that received a dose of meningococcal conjugate, and a dose of Menactra on.  Now stated that school system was saying this patient needed another dose since she did not have a dose after age 16 yrs. The patient received Menactra after protentional GSK  meningococcal conjugate vaccine, which led to interchange of vaccine product. At the time of reporting, another dose has not been administered. The reporter consented to follow up.
Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (dose, unit, route unknown, lot # L045956, expiration date 17-NOV-2017) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.
Immediately after injection was given pt. became light headed, faint, and nauseated. Pt. had not eaten or drank anything. Given Powerade, crackers, and laid down on exam table. Vasovagal rxn. lasted approx 15 minutes. Pt. fully recovered.
Severe full body rash, Onset 6 days post immunization. Mother described it looking like "a burn. No temperature or other untoward symptoms. Seen by family physician on 07/02/02. Child treated with comfort measures only. Rash duration of 5 days.
fever, myalgia, insomnia, arm pain, swelling, redness.  Took benadryl, and alternated taking ibuprofen & tylenol.
Shaking, shivering. Feeling very cold, not related to shaking. Intense headache, extreme pressure at temples. Dizziness. Feeling faint.  Extreme nausea. Disorientation.  Intensified as day progressed. Unable to stand. Stomach pain. I called my doctor who advised me to go immediately to the emergency room.  I was unable to afford this.  Went to sleep, had my husband check on me. Symptoms lasted for approximately  4 days, less intensity as time went on. I also lost time at work because of this.
patient  fainted and had some symptoms such as flu like symptoms, disoriented the day after the vaccine was administered.
Headache, nausea, fever, pain at injection site, swelling at injection site, fatigue.
FEVER 9/15. HIVES, FEVER 102 9/16. TYLENOL, ADVIL AND BENADRYL GIVEN. 9/17 RESOLVED FEW HIVES NO FEVER RESOLVED BY AFTERNOON.
Pt received ZOSTAVAX on 1-19-13. She called us at the pharmacy on 2-26-13 to report a rash that appeared on 2-25-13 on her chest & collarbone on the left side.
Patient instructed to wait in waiting room for a minimum of 20 min where she noticed a rash that was red and beginning to puff up around 1130 ten minutes later she noticed hives locally around the injection site. Patient verbalized no respiratory, or cardiac emergent complications.
DAY AFTER IMMUNIZATION PATIENT'S INJECTION SITE SWELLED UP MORE THAN AN INCH HIGH AROUND ENTIRE DELTOID AND THE ENTIRE DELTOID AREA TURNED BRIGHT RED ACCOMPANIED BY SEVERE PAIN AT INJECTION SITE, REDIATING DOWN THE ARM AND AROUND THE BACK UP THROUGH THE NECK. HE SUFFERED A HEADACHE.  AT 6 DAYS POST VACCINE HIS ARM STILL ACHES AT NIGHT AND HAS BRUISE ACROSS ENTIRE DELTOID.
On or around March 19 developed a dry cough with shortness of breath.  Was hospitalized on March 23  and diagnosed with interstitial lung disease and is currently on a ventilator.  The diagnosis is unknown but suspected amiodorone toxicity or Sjogrens.  Both are rare  side effects.  He is on high dose steroids and  antibiotics but  no improvement.   Has never had lung issues prior to the shot.  He has never smoked.  Onset of disease was rapid and progressed quickly.   Is it possible shot triggered the acute lung disease?
7-24-13 received phone call from client stating he had a fever (but he did not get a temp reading) for 2 days after receiving PNE vaccine on 7-9-13. His arm was also red and "he was very sick". He did go to his Primary Care Physician and was diagnosed and treated for a sinus infection (BACTRIM). He had received PREVENAR 13 on 2-6-13 per current recommendation.
Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg,  and  ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing  in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.
The participant passed out and had seizure-like activity, then would arouse and be coherent.  No history of seizures.  Several brief episodes occurred.  EMS called.  B/P  and pulse un-obtainable.  EMS arrived and assessed participant.  Taken to  Medical Center E.D.
This spontaneous report was received from a pharmacy student and refers to a patient of unknown age and gender. There was no information regarding patient's concomitant medications, drug reactions or allergies provided. On 19-NOV-2014 the patient was administered PREVNAR 13 (dose and route not provided) and on 09-JAN-2015, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (route of administration, lot number and expiration date were not provided). There was no adverse effect reported. There was no product quality complaint involved. Additional information has been requested.
approx 5 hrs p/vax started screaming & would not console for 4 hrs; both thighs red & swollen, t102 & 104 R; recvd APAP;
Next day and every day thereafter he started getting more symptoms of feeling sick. The arm pain began the next day after injection. Followed by runny nose, sore throat, croup sounding cough, shortness of breath, gasping, chest pains, vomiting, back of the skull pain. He described the head pain as a square from the base of the back of his skull to the crown of his head and back down. Felt more like a pressure in the bones of his skull and less like a standard headache. The chest pains are sharp and come on sporadically. At first they were accompanied by hacking cough but then progressed to sharp chest pains at random times especially when lying down.  He has difficulty sleeping and staying asleep. Also, lower abdominal pain but no vowel issues.
Flu like symptoms, fever, chills muscle ache about 6 hrs after vaccination and lasted about 12 hrs.
Patients mother called 4-4-07 at 11:00 am to report redness and swelling in arm where varicella was given. States "It's hot to the touch and he complains its sore. I plan to take him to ER." 4-4--07 2:00 pm mother and patient came by health dept and said ER said it was infected and gave antibiotics." Slight swelling at injection site noted, redness from shoulders to elbow noted.
pt recv vax 24JAN97 & that evening c/o bad h/a & temp ( no thermometer available in home), inj site swollen & painful, dec appetite;pt sent to clinic tx w/ATB for cellulitis;
A week later around 04/27/2021 pt started experiencing pain from back to left arm and noticed swelling on back (under shoulder blade and medial), pt took baby aspirin and put ice on swollen area, symptoms resolved around 05/04/2021, lasting a week. Around 05/04/2021 pt noticed swollen neck glands, which resolved around 05/13/2021. Pt was seen by doctor on 05/11/2021, prescribed Amoxicillin, and finished antibiotic regimen. About 05/13/2021 pt noticed facial swelling, localized on the left side from the jaw to the eye, resolved around 05/20/2021, pt also noticed hands swollen around 05/20/2021, resolved next day 05/21/2021. Around 05/21/2021 pt noticed tenderness and swelling in left upper leg from knee to hip. Pt seen again by doctor on 06/03/2021, and was told leg swelling should resolve in a couple of days. Pt denies any allergies. Pt takes Zolpidem (Ambien) for sleep and Diazepam (Valium) for PTSD twice a week. Pt was recently prescribed and finished treatment of Amoxicillin for swelling. Pt was advised to go to urgent care for imaging of the leg in order to determine the cause and proper treatment of swelling and tenderness.
Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 10-Aug-2022; No adverse event; Patient administered vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date), PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 10-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (Vial was initally stored in refrigrator of 08-Jul-2022 and was adminstered on 10-Aug-2022).    No concomitant medications was provided by the reporter.  The vial did not undergo the temperature excursion.   The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment medications was provided by the reporter.
Clammy patient has hx of vaso vagal episodes Vitals: Blood pressure 140/80 HR: 62 O2Sat: 95 Skin signs: warm and dry. Actually clammy warm and dry  Circulation: Cap refill <2sec Resp: Breath Sounds Clear Bilaterally Juice given
pt recv vax & exp being seronegative when tested for antibodies;no further details were provided;