chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PASSED OUT; SURGES OF HEAT THROUGHOUT THE WHOLE BODY/HEAT ATTACKING THE HEART; PAIN IN THE BACK OF THE NECK UP TO THE SKULL; WHOLE BODY BURNING; LEFT ARM NUMB; LEFT ARM PAIN; PAIN ON THE LEFT SHOULDER BLADE; This spontaneous report received from a patient concerned a 26 year old female.  The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient reported that the patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 14-MAY-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported.  On 18-MAY-2021, the patient experienced left arm completely numb and painful where she got the shot, pain on the left shoulder blade, her whole body was burning. The patient also experienced surges of heat throughout the whole body, the heat started attacking the heart of the patient. Then the patient started experiencing pain in the back of the neck up to the skull. On the same day, the patient passed out and went to the hospital however, they could not find anything and advised that it was basically from the shot. The patient was discharged from the hospital after five hours. All of those symptoms lasted for three weeks and then everything resolved. As of 14-Jul-2021, the patient still had random pain and numbness in the left arm.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passed out, surges of heat throughout the whole body/heat attacking the heart, pain in the back of the neck up to the skull, and whole body burning on JUN-2021, and had not recovered from left arm pain, pain on the left shoulder blade, and left arm numb. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730970 - covid-19 vaccine ad26.cov2.s -Passed out- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient received the Covid-19 vaccine. She reports symptoms of Anaphylaxis - chest discomfort, palpitations, tachycardia, shortness of breath, feeling of tightness in the throat.  I have observed patient was mildy anxious, with shallow rapid respirations. Patient then disclosed having similar reaction after previous covid vaccination. Per the vaccinator patient had stated having an "issue" with her first vaccination, but that she had spoke with her primary and was told it would be ok to proceed" . No report of allergic reaction was reported at this vaccination. Patient described previous reaction as tightness in the chest "menthol feeling" with some shortness of approximately 40 minutes post initial vaccination lasting 7 hours.   This reaction remained mild initially. Approximately 20 minutes into observation time patient reported having increased s/sx - chest tightness and rapid heart rate, some shortness of breath and throat/tongue swelling.  Patient then reported having hx of anaphylaxis to bee stings.  Patient reported this reaction was consistent with previous allergic reactions.  Patient advised epi would be best choice - patient refused. MED TEAM called.  Patient agreed to PO benadryl, however, as medication was prepped did agree to IM benadryl and 50mg was given to patient in the R deltoid as team arrived on scene.  Patient transferred to ED via wheelchair.
Headache, Myalgia, Fever, Diarrhea, CHILLs Narrative:
Patient was awoken at 3:00 AM by sharp pain in left deltoid rated 8/10. The pain has been constant since onset. Has improved over time and is now (9:50 AM) rated 3/10 dull pain. Pain is worse when moving left arm. Patient put ice on left shoulder at 4:00 AM, which temporarily eased the pain.
Too many and too long to explain. Some: fever, cold, shaking, weakness, in bed a lot for at least 6 months, vomit, headaches, eye sight problems, heart & arteries DAMAGE, Left arm numbness ( blood flow restricted due to damage and blood clots from Vaccine), hair loss, hair thinning, could hardly move for months just enough to work remotely at desk, heart palpitations, could hardly breath for months, back pain, lung DAMAGE from vaccine worse than the COVID-19 virus previously had, extreme sleep problems (no sleep more than 20-50min at a time) for months
A report was received from a health care professional on 13Jan04, concerning a 21 month old male vaccinee who inadvertently received Fluvirin on 13Jan04. On 13Jan04, the vaccinee inadvertently received Fluvirin. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 01Mar04, follow up information received from a health care professional indicated that the vaccinee did not experience any adverse events following inadvertent Fluvirin vaccination. No follow up pending, all information received.
ABOUT 4.5 HOURS AFTER THE VACCINE, PATIENT STARTED HAVING FEVER, SORE, AND SWELLING ON THE RIGHT ARM
Patient vomited about 7 minutes after receiving vaccine. Provided the patient with a trash can and cold pack. She felt fine after another 20 minutes and left with her companion/driver
This spontaneous report as received from a pharmacist refers to a 67 years old female patient. The patient's medical history included a previous surgery (date of surgery unspecified). On an unspecified date, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # not reported). The patient developed zoster on her leg 3 days after receiving ZOSTAVAX. The location of the rash coincided with an area where the patient had had a previous surgery. The pharmacist stated that the patient was not immuno-compromised. The rash was treated by an unspecified topical prescribed by her doctor. There was no hospitalization. The outcome of the patient was unknown. Additional information has been requested.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 56 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in or out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Headache, nausea and fever for 2 days. Pain swelling at injection site.
immed fever 103, lethargic x 24 hrs; observation only w/APAP;
Fever (102.5), headache, chills, upper respiratory cough.  Everything went away in 12 hours, except cough, which lasted several weeks.
that evening I had an intense headache on the right side and nerve tension from head to tailbone on right side. Throbbing. Didn't sleep well. Sneezing the following day. Symptoms remained, becoming slightly less over the following week, but remained and led to anxiety. The improvement came after seeing a visceral manipulation provider, which I will continue to see until side effects have resolved.
Admitted on 2/4/2021 with severe multifocal COVID 19 pneumonia
Early 2013 started to feel no sensation in fingers and face. Continued to bite inside of mouth. Started to walk drop foot and had to use a cane for stability. Unable to do stairs. 9-5-13-diagnosed with CIDP-IVIG prescribed. Lifetime.
Information has been received from a nurse referring to a currently 3 to 4 years old patient. On an unknown date, the patient was vaccinated with PEDAXHIB (2 months for dose 1, 4 months for dose 2, 6 months for dose 3, dose, frequency and lot number not provided). No adverse effects were reported. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 15 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 23-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Redness began 7-11 from shoulder to elbow, hot, firm-nausea, vomiting 7-12.
Had the shot, still got shingles/suspected vaccination failure; got shingles; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The reporter stated that he/she had the shot and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Hardump at injection site, pain in upper arm, headache, dizziness, low fever, chills, lightheadedness, fatigue  Lasting 1-2 days
Rash at injection site with hives, anaphylaxis started. I took benadryl and topical cream and used inhaler  Also have extremely runny nose, congestion and fatigue
Cheeks became flushed and I had a burning across the top of my chest. The pain increased throughout the day and my chest hurt when I took a breath. By 5:00 pm, I was uncomfortable and went to an Urgent Care. Because it was chest pain, they did a couple of tests and sent me to the ER.
Dizziness/ Light headedness; Diarrhea; Headache; Fever/ Had temperature up to 101.3; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 25Mar2021 (Lot Number: ER8730; Expiration Date: 31Jul2021) (at the age of 31-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated that she was calling because she had to go to the urgent care. She got the vaccine on Friday and ever since 25Mar2021 she was having like dizziness, diarrhea, lightheadedness, headache, and she even had temperature up to 101.3, and she was still getting the symptoms on the day of reporting. The urgent care was the one who told her to call. The patient got fever, it started on Sunday (28Mar2021) she got the vaccine on Friday, but it started on Sunday. The patient went to the urgent care on the day of reporting for the events, and they advised her to give a call. They did not give her any medication. The patient asked if it was recommended that she should get the second one. She was just asking the recommendation that since she was having all these adverse reactions, so should she get the second one. The second dose was scheduled on 16Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Client awoke 8/17/02 with dollar to pea size hives on face, under arms, legs, stomach and back. Mom gave Benadryl 1t in am. At 5pm, seen at urgent care facility. Given steroid shot and Benadryl. Took Prednisolone 1r q morning and Benadryl HS. Mom stated hives disappeared morning after given Prednisolone but reappeared between 6-7pm. Hives occurred on 8/22/02 mom contacted health dept 8/31/02. Nurse advised client needed to be reevaluated by a physician . Last contact with mom was 8/27/02. Mom stated that client "was fine." Client never taken for a medical reevaluation.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:15 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 47 years intramuscular, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM]; QNASL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2023 at 01:00, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2023) Positive, notes: COVID test type post vaccination=Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid as treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
dec appetite, not sleeping well, morbilliform rash beginning in diaper area & progressing over trunk & face & proximal limbs over a 36hr period; also had a low grade tactile fever when rash began;uncomfortable -mom brought pt to MD for eval
Pt complains of itchiness, lightheaded, administered 25 mg followed by 12.5 mg. Pt stated relief. O2 10L NRB. Pt then stated she was having hard time breathing. Pt transported by Resc.
Child became extremely irritable and was inconsolable for 8-10 hrs. Pt was given Tylenol as needed.
I also have an auto immune disease that was in remission and brought them all back to flare up after receiving my second dose. The symptoms that flared up GI symptoms, Chron's disease problems with elimination. It flared up the Crohn's disease, also I have fibromyalgia and flared up all the pain I have and increased my fatigue. Brain fog, chills (these were so severe that my teeth were actually chattering and I could not control the movements of my body.) Now, I have a rash that is covering my whole body except below the knees that I am having to take Benadryl for the rash and I am now on day 3 of taking Benadryl. I also basically had the symptoms for my first vaccine.
10 minutes post shot patient was feeling light headed. Pharmacist went out to check on them and his eyes rolled back in his head and he started having a seizure that lasted for just under 1 minutes. regained consciousness, started sweating . no history of seizure. Ambulance called and came within 5 minutes
development of rash on both arms, torso,  side of face, right hand - redness, swelling, terrible itching
Headaches 1 month later, still with headaches 1 year later using PERIACTIN.
itchy skin, runny eyes & nose / sneezing / shortness of breath / swollen lips - symptoms resolved after 5 hours
Th symptom started with tingling and itching across right breast. Everything looked fine otherwise so decided to wait on upcoming mammogram. The next symptom was a sharp electric zap in a leg muscle when I would bend my left knee too far, and/or sit back on my hips. Thought that could be due to a nerve pinch, and decided to wait to get it checked out until after a 10 day vacation. This went on for a while, and about 6 weeks after the second vaccine, both legs started to have zapping and burning pains, and random muscle twitching. Shortly after that, it evolved to burning, numbness and tingling all over, including face, scalp, torso, plus both arms and legs. The areas with "zapping" and burning also have lasting skin sensitivity that feels a bit like sunburn. These sensations have evolved to fell more like prickling, and stinging. It is still ongoing. and leg muscles still get electrical jolt with certain positions.
ACHY; TIRED; HEADACHE; FEVER; SWEATING; COLD; This spontaneous report received from a patient concerned a 30 year old female. 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 not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included unspecified birth control pills.  On 10-APR-2021, the subject experienced sweating. On 10-APR-2021, the subject experienced cold. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced achy. On 11-APR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, and cold on 12-APR-2021 09:00, headache, and fever on 11-APR-2021, and had not recovered from tired, and achy. This report was non-serious.
10/28/19 Pain at the vaccine site. 11/1/19 unable to lift arm and started taking motrin. 11/7/18 unable to sleep because of the pain.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Once a week prior to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Prenatal care.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  On 07-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2020, Pregnancy test: positive (Positive) Positive. On 14-Dec-2020, Ultrasound scan: normal (normal) normal.     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.   Contact information was updated   No treatment information was provided.  Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up accepted, confirmed email. No new information; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Redness, swelling, warmth from shoulder to elbow (L) arm. Fever LT max 102.2 -> onset 1 day after injection. Rx OMNICEF.
Case number PHHY2012US055009 is an initial literature report received on 25 Jun 2012. Authors presented the importance of clinicians alertness to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. This case refers to a male patient (age not specified). The patient's medical history included of severe to profound neurologic and neurodevelopmental disabilities, including physical limitations, cerebral palsy and intellectual disability. His neurologic impairment rendered him unable to move, make sounds, or speak. He was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unspecified date during Oct 2010 to Nov 2010. On 24 Feb 2011, he developed fever of 102.2 F (39.0 C), nonproductive cough, rhonchi, tachypnea, increased tracheostomy secretions, and oxygen saturation of 84% on room air. On illness day 2, he developed wheezing and had diminished left lower lung breath sounds. He was hospitalized with temperature of 98.8 F (37.1 C), elevated white blood cell count, tachycardia, and respiratory failure requiring mechanical ventilation. Chest radiography showed hazy opacities with low lung volume. He tested positive for influenza A, and treatment with oseltamivir (75 mg once daily) was initiated. He recovered from the acute illness and was discharged to the residential facility after 8 days of hospitalization. Authors concluded that clinicians should be alert to possible influenza among children and young adults with neurologic and neurodevelopmental conditions, especially during influenza season. Prompt testing and early empiric antiviral treatment in residents with respiratory symptoms in residential or long-term care facilities is important. Influenza prevention efforts should include vaccination of residents, health-care personnel, and others who might transmit influenza to residents, use of infection control precautions, and appropriate use of antiviral medications.
Patient started feeling lightheaded while walking from vaccination station to post observation area.  Patient then started feeling nauseated while sitting in post observation area.  Patient ate breakfast this morning.  Not on any medication.  Conversing with clinic staff and wondering if feeling lightheaded is normal after receiving the shot.  Vital signs taken x2 - stable.  Offered water but declined.  Offered yoga mat to lay down but declined.  Feeling better.  Looking at phone.  Conversing with clinic staff.  Nausea resolved but still feeling "a little lightheaded."  Steady gait after leaving clinic at 10:15 am.