chrisvoncsefalvay/vaers-outcomes huggingface dataset:
episodes of 4.5 seconds with non pulse; she experienced a basal artery blood clot stroke; lightheaded; This is a spontaneous report from a contactable consumer (patient's son). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 14:30 (at the age of 100years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history was not reported. Concomitant medication included furosemide taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had medical issues starting within hours of the first dose of Covid vaccine. Prior, the patient was in independent living, no medications (as reported), walking about 1/2 daily and completely lucid. Immediately thereafter (after the vaccine, 11Jan2021 16:00), she experienced lightheaded, a hospital stay, and episodes of 4.5 seconds with non-pulse. A pacemaker was installed. During rehab, the patient experienced a basal artery blood clot stroke. The patient is still in rehab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized on an unspecified date for 8 days. Treatment received included pacemaker, numerous medicines (e.g. AFIB). The patient had Covid test post vaccination: Nasal Swab on 15Jan2021 with negative result. The outcome of events was recovering.  Information about lot/batch number has been requested.
swollen gland on neck under jaw on the right side of their neck; swollen gland under the jaw; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm), SWELLING (swollen gland on neck under jaw on the right side of their neck) and LYMPHADENOPATHY (swollen gland under the jaw) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cosmetic surgery and Dental implant user since an unknown date. Concomitant products included PARACETAMOL (TYLENOL A) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Jan-2021, the patient experienced SWELLING (swollen gland on neck under jaw on the right side of their neck) and LYMPHADENOPATHY (swollen gland under the jaw). On 24-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, SWELLING (swollen gland on neck under jaw on the right side of their neck) and LYMPHADENOPATHY (swollen gland under the jaw) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, X-ray: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills; Body aches; Fever of 101.4; Headache; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL7249; Expiration date was not reported), intramuscularly on the left arm, on 12Jan2021 (17:30) at a single dose for COVID-19 immunization at the hospital. Medical history included migraine headache and arthritis of knees. Concomitant medication included topiramate (TOPAMAX). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported) on the left arm on 22Dec2020 for COVID-19 immunization (when the patient was 43 years old). The patient was not pregnant at the time of reporting. On 13Jan2021 (12:00 AM), the patient had chills; body aches; fever of 101.4 (unit was not reported); and headache. It was unknown if the patient had received treatment for the reported events. The outcome of the events, 'chills', 'body aches', 'fever', and 'headache', was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
PATIENT STATE HER MOUTH WAS SWELLING. PATIENT APPEARS IN NO APPARENT DISTRESS. PATIENTS VITALS CHECKED WITHA BP OF 137/62, HEART RATE OF 63 AND A 97% O2 SAT. PATIENT OBSERVED AN ADDITIONAL 15 MINS. PATIENT STATES FEELS FINE AND RELEASED.
missed his second dose appointment due to being in the hospital for a "heart problem"; Second dose not received in allowed time window; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (missed his second dose appointment due to being in the hospital for a "heart problem") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (missed his second dose appointment due to being in the hospital for a "heart problem") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window). At the time of the report, CARDIAC DISORDER (missed his second dose appointment due to being in the hospital for a "heart problem") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window) outcome was unknown.        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.   No concomitant medications were provided by the reporter.                                                                                              No treatment medications were provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a registered nurse and refers to a multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in 2017, since January 2017, the patients were vaccinated with VARIVAX  (route of administration, lot number and expiry dates were not reported). No adverse effect was reported. Data logger was involved. At the time of the report, temperature excursion and time frame of temperature excursion were not known. There was no previous temperature excursion. Thi is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1703USA011830:
Redness at injection site; Left wrist tingling; Joint pain; Muscle pain in thighs; Nausea; Fever; Tiredness; This is a spontaneous report received from a contactable healthcare professional, the patient. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203), via an unspecified route of administration in the left arm on 19Mar2021 at 10:15 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time of vaccination. Concomitant medications included ADDERALL 20 mg and ritual prenatal vitamins (MANUFACTURER UNKNOWN), for unknown indications and taken from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 19Mar2021 at 10:45, the patient experienced left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site. The clinical outcomes of the events left wrist tingling and joint pain, muscle pain in thighs, nausea, fever, tiredness and redness at injection site were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
8 month old receiving a dose of Flublok vaccine, no adverse event; Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/non-health care professional via media Information (under reference number 00820516) in a specific country.  This case involves a 8 months old, unknown gender patient who was administered with the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age) .  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (same day latency).  It was reported "Voicemail received on 19Oct2021 at 6:55 PM. More information in the Event Information field. Placed in proxy. Hi my name is <Redacted> I I am calling from <Redacted>. Wondering um what the safety risk are for <Redacted> receiving a dose of Flublok vaccine. If you could call me back, again my number is <Redacted>. Thank You."  At time of reporting, no adverse event was reported and the outcome was unknown for the reported event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
Patient was administer 0.3 mL of undiluted Pfizer Vaccine.  Pt. offered MD exam to include EKG and troponin levels with follow up.  Pt complains of headache and muscle aches both improving.
Child lost consciousness in clinic room after receiving three vaccines. She turned pale/green. Her hands were cool to touch and after regaining consciousness she had rapid breathing, tremulous legs and arms, and reported back pain. Water and juice provided. EMS called.
Low grade fever, muscle aches, chills, nausea, swelling right deltoid area  Started within a few hours after administration of vaccines. Symptoms resolved by 11/9/2020.
Patient received the first dose of the Moderna Vaccine at Walmart on 7/15/2021.  States that day and the following day she had a golfball size area that was red and tender.  This resolved.  One week later on 7/23, she developed swelling, itching, redness where the vaccine was given.  The area has continued to spread.  This morning she had hives on the left forearm that has since resolved.  Patient treated with Decadron 10mg IM and will take antihistamine at home.  She will follow up if her condition worsens in any way.
02/23/2022 A Day after my vaccine, I noticed brain fog, weakness, and fatigue like no energy at all. Coughing along with a headache as well. The entire time I have never had this amount of fatigue before and it has continued since. Headaches were very intermittent and coughing is still currently going on. 03/16/2022 I went to the ER, where the doctors established, I was in A-Fib. I then went to my doctor and had a heart monitor ordered and am currently wearing the heart monitor.
Within 24 hours of MCV4 ran fever of 103, nausea/vomiting, arm swollen and red at injection site. Parent states reaction to pertussis containing vaccine much worse. All four of her children cannot tolerate pertussis. Saw PMD - ordered BENADRYL, fluids and rest.
Patient reported bruising around injection site, and rash extending below the injection site. Patient said she had to treat with ice and over the counter medications. Reporting that rash is resolving after visit to urgent care.
Patient received intranasal H1N1 vaccine at approximately 10:30 AM. At approximately 1:05 PM, she called the health department explaining to RN that she was experiencing neck swelling and itching. RN immediately referred her to the emergency department. RN called the patient at approximately 1:30 and got no answer. When RN called the Hospital, there had been no patient admitted. Unable to determine course of treatment and/or outcome. Per nurse, the patient called and stated that she had swelling and pain in her neck and the patient was weak but did not go ER or dr office. The patient is not taking and medication for the reaction.
I passed out about 5 hours or so after and could not awake or stay coherent. My body took 2 days to heal and recover. I was unable to stand or eat. I could barely drink water when I could stay awake long enough. I have not been able to focus since then. I forget things that should be very common.
The first vaccine date (07/07/2021) was overlooked, and pt was given the Moderna COVID Vaccine #2 too early. Pt was oberved in clinic >15 mins, pt tolerated the shot and left clinic stable.   07/22/2021, pt was contacted. She reported pain to injection site and some chills but improved with tylenol. Pt to follow up with primary care provider on 07/26/2021 or sooner if needed.
Hospitalization due to COVID-19  Reported per Pfizer COVID-19 Vaccine EUA
6 to 7 weeks post vaccine, 03/01/2021, I started having swelling of my upper and lower lip, the corner of my mouth were cracked. I went to the doctor. The doctor recommended to switch mask to start were the surgical mask instead of the fabric mask, and that went away. That stopped. 09/15/2021 I started breaking out in hives. It was sporadic hives, they popped up in different places. They itched like crazy. They were hot. The hives were on my head, back, torso, bottom of my feet, they were everywhere. If I used an alcohol patch on the raised welt, it would go away, and pop up in an hour they continued they got larger, and they stopped going away. I went to see the PA on 09/27/2021. The PA prescribed: prednisone tapered scheduled, but as soon as I stopped taking the prednisone they returned and Allegra and Zyrtec. They referred me to an Allergist. He did blood work, tested for food and deficiencies, everything came back normal. A little bit low on the thyroid, but nothing to extreme, nothing that needs to be treated. I am constantly breaking out as of today, 02/01/2022. The Xolair injection are ready for me, but I have not scheduled that visit yet. Whether or not  the doctor recommends this, I cannot afford 1,000s of dollars if the insurance does not pay. The prednisone does keep it at bay, but it raises my heart rate. So they are trying to figure out what to do with that.
This spontaneous report as received from a pharmacist refers to a 90 year old female patient. On 13-MAR-2014 (reported as today), the patient received expired dose of PNEUMOVAX 23 injection 25 / 0.5 Y, (lot number H012650, expiry date 27-FEB-2014), dose and route of administration were unspecified. Concomitant therapy was unspecified. The pharmacist did not know if this dose of PNEUMOVAX 23 was the patients first dose. It was reported that the patient has not reported or demonstrated any adverse effects. The dose of PNEUMOVAX 23 was administered as part of a long term care facility admission protocol. No product quality compliant was involved. No further information was provided. Additional information has been requested.
Arm swollen from elbow to shoulder. Extreme pain. Can't lift arm more that 10 degrees.
This spontaneous report was received from a healthcare professional who reported that on unspecified dates, an unspecified number of doses of VAQTA (Intramuscular injection, dose number, batch and lot #, expiration date not reported could have been administered to an unspecified amount of patients. No adverse events reported. Further information was not provided. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M006729, expiration date 08-FEB-2018; lot # M017292, expiration date 07-APR-2018; lot # M010484, expiration date 01-MAR-2018, dose and route were not reported). No adverse symptoms were reported. This is one of several reports received from the same reportedr Additional information has been requested.
Sneezing, whole body itching, throat itching and erythema to injection site throughout the day.
About 45 moments later, I had a Fibromyalgia flare up. I was so achy I had to take ibuprofen and lay down.  A couple weeks later, I had a flare up with my endometriosis as well. I started getting bad pain in my pelvis area. I went to the gynecologists' because the pain was so bad. The pain was off and on for several weeks. The doctor gave me pain meds and performed an ultrasound. They found a cyst.  These symptoms continued on, during, and after my second dose. I received surgery to remove the cyst and some scar tissue.
At time of injection, warm sensation at site spreading downwards for approximately 3-inch.  Sat for 30-minutes with no other symptoms. Warm sensation gone, just site discomfort. Released back to work. 1-hr post injection mild headache forms. 2-hrs post, heightened sense of smell which was making me nauseous.  3-hrs post,  headache, nausea, body aches starting. Loss of appetite.  8/20/2021 Approx. 2am woken from dead sleep with entire right leg numb. Was sleeping on back as is normal and this has never happened before. Took about 5-mins before leg returned to normal. Went back to sleep. Called out sick as I had a headache, nausea, body aches, tire, running hot and cold. Loss of appetite.  8/21/2021  Headache, body aches, running hot and cold, tired.  Loss of appetite. 8/22/2021  Tired, get the "sweats" from just walking to the bathroom.  Still not much of an appetite.  Late afternoon, 3:30-ish, starting getting intermittent tingling sensations running up and down both left and right arms; sometimes simultaneously.   8/23/2021  Returned to work.  Some fatigue and "sweats".  Intermittent tingling sensations continue in both arms.  Contacted primary care physician and am awaiting recommendation.
colds; chills; body ache; This is a spontaneous report from a consumer (patient) via a Pfizer-sponsored program.   A male patient of an unspecified age received first dose of BNT162B2 (solution for injection, Lot number: unknown), via an unspecified route of administration on an unknown date, as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects such as colds, chills, and body ache. The outcome of the events was unknown.  Information on lot & batch number of the suspect drug if available.
Initial report received from a healthcare professional on 10 OCT 2013. A 36-year-old male patient was given ADACEL intramuscularly on left deltoid on 27 SEP 2013. Patient had left deltoid pain that radiates down the arm and numbness and tingling in the left hand on 27 SEP 2013. The events were not recovered. List of documents held by sender: none
SEVERE REDNESS AND BLISTERING TO HER SKIN THAT STARTED ON HER SHOULDERS AND HAS NOW SPREAD TO ENTIRE TORSO FRONT AND BACK.
Tiredness and aching, much more than with usual vaccines; fever (99.1 at midnight on day of vaccination, 99.4 the next evening).  Unable to sleep first night, unable to go to work the next day.  A painful lump underneath left arm (not at site of injection).  Most symptoms gone by Aug 6 (2 days after vaccination), but lump under arm remained a few more days.  On Aug 6  I discovered a discoloration, reddish and later bluish like a bruise, under the left arm but farther down from the lump.  The lump was gone and the discoloration much reduced by Aug 9.  I called my doctor to report this but don't remember if I mentioned the lump.  Did not visit doctor.
Temperature elevated- as high as 103.9. Had seizure at 102.9- and was taken by ambulance to ER. Just observed, given TYLENOL & ibuprofen. Sent home. Returned next PM for high temp-ordered ZITHROMAX & oral steroid (to ER).
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimotos" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: experience rebound affects after testing negative for two days; (unspecified date) Positive; (02Aug2022) Positive, notes: Rebound started the following Tuesday 2Aug with a positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:The patient experienced rebound affects after testing negative for two days with no symptoms. Rebound started the following Tuesday 2Aug with a positive test. A day later fever and congestion set in and loss of taste and smell. The patient had no known allergies. No other medication within 2weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported lingering swelling at the injection site several days following injection. She also reported pain that radiated up into the shoulder causing restricted range of motion.
received flu and a TDAP and noticed red spots 10/8/19 received shot 10/7/19 no fever all over back & chest and stomach hives