chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Highest temperature 72-73 Fahrenheit degrees. Total excursion time was for 5 1/2 hours with no AE; Initial information received on 13-Dec-2021 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves unknown gender patient for whom it was reported "the highest temperature 72-73 Fahrenheit degrees. total excursion time was for 5 1/2 hours" (product storage error) after receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot U7140BB, expiry date: 07-Nov-2022] via an unknown route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to product storage error [Latency: on the same day].  It was reported "Caller stated that she left the product out".  At the time of report, no adverse event was reported.  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.
Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown.  Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .
pt recv vax 20MAY97 & pt devel chickenpox w/8 lesions;
Patient called us stating that she had severe arm pain and developed a welt  roughly the size of a tangerine after receiving her 2nd Shingrix dose. She states that the swelling has been going down and the pain has been gradually getting better.
Patient was 17yrs old at the time of her first dose of Covid vaccine and received Moderna.
History of Present Illness:  This is a 53-year-old male with significant past medical history of cerebral palsy, mental retardation, decubitus ulcer,  recent left loculated pleural effusion with empyema status post catheterization line placement by IR at outside hospital.  Patient is A&O times 2-3 at baseline.  This patient presents with recent fall associated with right shoulder pain, decreased range of movement and minor bruise to forehead.  Per report from nursing home patient was also altered and slightly confused.  Due to concern for intracranial process patient was transferred to the ED for further workup.   In the ED, vitals were remarkable for mild tachycardia.  Patient was noted to be hypoxic on room air an  Additional information for Item 18: Patient was noted to be hypoxic on room air and placed on 3 L oxygen via nasal cannula.  Initial labs show leukocytosis 28.6.  For concern for sepsis blood cultures obtained patient initiated on antibiotics vanc and Zosyn.  Status post 2 L IV fluid bolus.  Inflammatory markers elevated patient tested for COVID-19 infection.  CT brain negative for fracture.  CT abdomen showed nonspecific thickening of the colonic wall may represent colitis in appropriate clinical setting.
Rash resembling mild case of chickenpox. 8-10 red dots on face, trunk and legs. No fever.
1st dose then exp itching, stomache & back hives, swelling on face & eyes puffy; had it for 4 days; dull h/a; suspect poison oak & cats; discontinued vax;
Exactly 72 hours after Pfizer shot, pt had loss of appetite and severe fatigue (she barely had enough energy to walk to her bathroom). She is slowly recovering; still experiencing loss of appetite and fatigue. Her son and doctor are not certain if the COVID vaccine caused these adverse effects.
SLIGHT SHORTNESS OF BREATH; TIREDNESS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced slight shortness of breath. On APR-2021, the subject experienced tiredness. On APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness, nausea and slight shortness of breath was not reported. This report was non-serious. This case, from the same reporter is linked to 20210429237.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Two days after receiving the shot, in addition to soreness at injection site, both my arms and hands suddenly started tingling, like pins and needles. That was on Feb. 11th, and now, March 19th I still have tingling everywhere from my neck down to my feet. Mostly arms and legs. It has gotten worse at times, then is milder, I notice it most when I try to fall asleep. The paresthesia keeps me awake or wakes me up. It also makes my heartbeat increase, along with hot flashes. I've been to the ER two times, have taken antihistimines but they do not agree with me. My doctor thinks it's a neuropathic reaction to the virus and will go away but it's been over 5 weeks and is still there. I will see a neurologist soon to rule out other possible causes, but I've never had paresthesia  before, so think it must have been the Pfizer vaccine.
High temp, mother gave Tylenol 1.25mg po, abnormal breathing pattern.  Was seen in ER, CXR normal, infant stable.  No treatment, resolved.
PATIENT BECAME NAUSEOUS, ACQUIRED AN INSTANT HEADACHE, HER LIPS WERE TINGLING, SHE HAD A BURNING FLUSH THAT STARTED IN HER CHEST AND ROSE UP TO THE TOP OF HER HEAD, AND SHE WAS LIGHT HEADED AND WEAK, WHICH ALL BEGAN WITHIN FIVE MINUTES OF RECEIVING THE VACCINE.
"Periods of light headedness lasting 2-3 minutes, occurs a few times per day."
Patient registered for Pfizer vaccine and was advised he would be getting dose of Pfizer COVID vaccine.  Pt was vaccinated with Pfizer and provided vaccine card where first dose of Moderna was given 31 days prior to today.  Pt received Moderna at a different location on 4/14/21 and was vaccinated with Pfizer today 5/15/21. Pt was monitored for 30 minutes after vaccine given with no side effects prior to leaving clinic.
Enlarged lymph node in right armpit began on 12/24/2021; painful, the size of a lime. Lasted 5 days. Then, full body hives began overnight on 1/1/2022; they started on my back and then spread to my chest/stomach/arms/legs; had extreme itching; swelling of left fingers to the point that fingers could not be bent. Full body hives lasted 3 days, took Benadryl daily during this time to manage the itching. Also had tongue itching. Have had daily bouts of less severe hives ever since, and have been diagnosed with dermatographia also.  The hives/welts will appear at random all over my body, particularly concentrated on my inner forearms, abdomen, throat, and knees. They last 20-30 minutes.
NAUSEA; HEADACHE; VOMITING; CHILLS; FEVER OF 101; This spontaneous report received from a patient via a company representative . The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) .5 ml, administered on 08-MAR-2021 for prophylactic vaccination. The batch number was not reported, Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On 08-MAR-2021, the subject experienced fever of 101. On 08-MAR-2021, the subject experienced chills. On 08-MAR-2021, the subject experienced vomiting. On 08-MAR-2021, the subject experienced headache. On an unspecified date, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the fever of 101, chills, nausea, vomiting and headache was not reported. This report was non-serious.
I received the vaccine at 3 pm and started to feel pain on my back around midnight. It felt like my skin hurt--a symptom I get when I have a fever. After sleeping for 2 hrs I awoke with severe burning in my legs, body aches all over, more severe pain in my back, and I was shivering to the point that my teeth were chattering. I took 3 extra strength acetaminophen. I was unable to sleep the rest of the night, but laid in bed anyway because I felt too awful to get up. Later in the night I developed a headache. When I got out of bed, around noon, the body aches and teeth chattering were gone, but my back still hurts, I have a headache, and a fever of 100. My usual temperature is around 97. It is never as high as 98.6. I would have to guess that during the night my fever was well over 101. I am shocked that there was no verbal warning given to me at any time regarding the potential side effects other than a sore arm! I feel that everyone who gets this vaccine should be warned to have no other commitments or plans for the next several days as they may feel like they have the flu--fever and all.
Nurse reported that the patient developed a fever and an injection site reaction characterized by redness and swelling. The patient recovered. This is 1 of 3 patients from this facility who experienced an adverse event following receipt of Acel-Imune lot 464-307.
Vasovagal Syncope.  Awake within 3 seconds, kept her legs elevated, pushed fluids and a snack. Patient was given the Moderna Vaccine and is under the age of 18
That evening, I had body aches and a headache. And a scratchy throat and post  nasal drip.  Next day, (8th), I had a fever - 100.6 (after I took aspirin); body aches; fatigue; dizziness. And ear pain/pressure. That first week, symptoms didn't go away so I went to Urgent care on Friday January 15. I didn't have any sinus issues or infections. For ear pressure/pain and dizziness - they put me on a MEDROL dose pack. I was taking Sudafed and Mucinex and Claritin for it prior to this to help it. In two days, I went to ENT  (1/17) and  on 1/18, I got on 6 days of Prednisone and they also put me on Flonase nasal spray which still didn't help the ear pain/pressure/popping and dizziness. I went to February 3 ENT physician because it hadn't helped and he   another six days of Prednisone - Eustachian Tube Dysfunction > February - 25. The intermittent dizziness f and ear pain/pressure finally went away (almost 7 weeks later). I still have ear popping even today (which isn't usual for me). I'm still taking Flonase because I have the popping ear problem still.
Herpes zoster infection in child without history of varicella infection. No other known risk factors.
1150: employee received her #2 Pfizer vaccine.  1224: employee complained of some dizziness and a headache.  1231: headache continues. She was brought into the conference room for monitoring  1235: employee states that she has an increase in lightheadedness and dizziness. She states that her throat feels itchy.  She denies any pruritus, shortness of breath, wheezing, nausea, or abdominal cramps. BP: 135/88 HR 66 O2100% 1238: Benadry 50mg PO given 1244: employee starts to have bronchospasm with constant coughing. BP 145/92 HR 110 O2 94% 1245: Doctor notified of epi administration. 1st dose of epinephrine 1:1000 given IM  1249: Doctor arrived to conference room O2 98% 1250: 2nd dose of epinephrine 1:1000 given IM  1252: Rapid Response arrival 1255 BP 135/73 HR 101 O2% 99% 1258 3rd  dose of epinephrine 1:1000 given IM
Received 2 doses of Pfizer vaccine, 2 weeks after second dose, started to have tachycardia, flushing, tremors, ina bility to take deep breaths. New diagnosis of Grave's disease and enlarged lymph nodes in chest.
On 5/31/99, the pt experienced severe headache and lymphadenopathy in the occipital and posterior neck region. No further information is available.
On Friday, November 6th 2009 in the Medical Dept. the H1N1 vaccine provided by the Dept. of Health was administered to a 37 y.o. 12 week pregnant woman. She carries the diagnosis of undifferentiated autoimmune disease and had received the approval of the vaccine by her obstetrician. She lives with a 3 1/2 y.o. son who is healthy and received the first of the two H1N1 vaccines from his pediatrician. Day 1 and 2 after the vaccine the patent complained of fatigue. Day 3 coughing, sneezing and fever to 101. Day 4: she felt weak and claims to have passed out. Day 5: 103 fever, PMD advised Tylenol and cold compresses. Day 7: MD tested her in the office for influenza (regular) and was told it was negative. Placed on ZITHROMAX for possible bacterial infection of the lungs. Day 8, 9: fever broke, felt better, still fatigued.
Starting bleeding a few hours after the vaccine and severe bleeding for 10 days; Started to have severe cramps; Starting bleeding a few hours after the vaccine and started to have severe cramps and bleeding for 10 days. It wasnt even my menstrual time; This is a spontaneous report from a contactable other healthcare professional, the patient. An adult non-pregnant female patient of unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date, the patient started bleeding a few hours after the vaccine and started to have severe cramps and bleeding for 10 days. Reportedly, it was not even her menstrual time and her periods were absolutely horrible like never before. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started bleeding a few hours after the vaccine, started to have severe cramps and bleeding for 10 days and it was not even her menstrual time were not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 1 hour later, patient could not get out of bed because started coughing violently; cough productive with clear sputum. Patient reports cough has worsen and it has been like 7 days; the worst was the same day through 4/5 -4/6. Per wife, patient was delirious on first and second day. On 4/4 patient went to clinic and told them what was going on; told it was typical and would last like 3-5 days. Patient has been taking MUCINEX, sucking on cough drops, and drinking lots of water. Mouth is very dry so patient is a bit dehydrated. On 4/7, patient was concerned because started coughing blood. Patient may have irritated throat from coughing so much and has not happened since. Patient is wheezing, hard to catch breath but getting a little better. Patient cannot sleep well because coughing so much and drinking so much water. Patient feels burning on chest and stomach due to the cough probably. At night patient feels the need to have rag from sweat to wipe head--pillow is soaking wet. Patient has had no fever this whole time.
I was feeling really worn out and tired. It increased over the holiday season. In January, I went to my doctor. He asked me to have a blood test. The blood work showed my blood sugar was high. He gave me a test for diabetes. The results indicated early diabetes. It came on quickly.  I was Hyperglycemic through my earlier years, so I've always had to watch my sugar. I don't take medication. I go to a Clinic so they can monitor my blood sugar and teach me how to eat better. I'm also trying to lose weight.
Double vision and more frequent migraines with 2 week of booster #2. still have double vision but not as frequently. migraine headaches have also reduced in frequency; severe diarrhea and significant weight loss (104 to 93lbs), fatigue/lethargy starting within 2 weeks of  3rd booster.
Moderate to severe diarrhea (liquid stool with cramping 4 times the first day, 5 times the second day) beginning several hours after vaccination, and ongoing more than 54 hours later. Additionally, a 1 inch diameter purple-blue bruise at the injection site. (Additional reactions I experienced are listed as common, including low grade fever 12 hours after vaccine lasting 20 hours, chills, body aches).
This spontaneous report as received from a physician refers to a 13 months old patient. The patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot number unspecified) instead of VARIVAX (Merck) on 27-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Significant elevated heart rate for 48hrs +. Significant body chills, fever, fatigue.
very sore arm; very uncomfortable; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 26Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of vaccination. On 27Jan2021, the patient experienced very sore arm- had to have vaccine in dominant arm. The patient added that after 24 hours she was very uncomfortable. The events were assessed non-serious. The patient has not been diagnosed with Covid prior to vaccination and has not tested positive since the vaccination.  Information on the lot/batch number has been requested.
Her pneumonia titers were low; This spontaneous report was received from a physician who was also the patient, reporting on herself. She was approximately 46 years old and her ethnicity was reported as other. Her concurrent conditions included autoimmune antibodies to thyroid with normal thyroid values, and unspecified food and environmental allergies. Her medical history and concomitant medications were not provided.  On approximately 06-DEC-2020 (reported as "a full month prior, 30 days prior"), the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).   On an unspecified date, the patient's pneumonia titers were low.   The outcome of the event and the causal relationship between the event and the suspect vaccine were not reported.
Patient had temp 100.3, unable to work, numbness of hands & feet pupils dilated, moaning. BP 120/70 RR rapid 40, headache (+) Blood sugar 70. Pt came out of it at 3 pm - body aches headaches. Head CT (-).  Visual problems lasted till 6/21/09. Hallucinations (+) sore (R) arm where shot was given. 911 went by ambulance to hospital.  6/29/09 Medical records received DOS 6/18/09 Assessment: Seizure Parent states that patient had seizure. Found patient somnolent. Presents with pupils dilated, not reactive to light. Respirations 40.  6/29/09 ER records received DOS 6/18/09. Assessment: Arthralgia, myalgia secondary to vaccinations. Presents with fever, joint pain, lethargic.
Developed neurological ticks, head nodding, blinking of eyes, movement of the mouth.
Stroke occurred on 3/6/2021,  seen in ED at healthcare facility. Transferred to another healthcare facility. Right sided weakness/paralysis, altered mental status, dysphagia, slurred speech. Rehab at another healthcare facility. Now at home cared for by family.
3/13/14 Am mom noticed swelling and redness. Redness better and swelling better on 3.14.14 no fever, no fatigue.
Experienced swollen lymph nodes under his right armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication includes antihistamine. No concomitant medications were reported.   This case was linked to MOD-2022-464121, MOD-2022-464124 (Patient Link).
Information has been received from a doctor of pharmacy for the pregnancy registry of GARDASIL concerning a female patient who on an unspecified dates was vaccinated with an unknown number of doses of GARDASIL. It was reported that the patient was pregnant and the fetus had fluid in the brain and heart. It was reported that the patient had four days to decide whether to continue or terminate the pregnancy. The patient sought medical attention with the physician. Upon internal review hydrocephalus was considered to be a congenital anomaly. No further information is available.