chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable healthcare professional reported that an 18-year-old patient of an unspecified gender received TRUMENBA, via an unspecified route of administration on an unspecified date at a single dose for booster. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced body aches, chills, and headache. The patient mentioned that he took TYLENOL. Outcome of the events was unknown. Information on the batch number has been requested.
patient that received 2 doses of high dsoe, no AE; Initial information received on 26-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.   This case involves patient received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number and expiry date were not reported) (Form: Suspension for injection in pre-filled syringe) via unknown route in unknown administration site for prophylactic vaccination on an unknown date (extra dose administered)   Past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  The patient had no medical history, concomitant disease or risk factor.   It was a case of an actual medication error due to extra dose administered (latency same day).  At the time of reporting, patient had no adverse 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. 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 available on the batch number for this case.
11:30 FEELS LIPS ARE TINGLING. STATESE "SHE HAS SENSITIVE SKIN". PATIENT IS WAITING IN CAR, WILL CONTINUE TO MONITOR 11:35 DENIES SHORTNESS OF BREATH OR CHESTPAIN 11:45 PATIENT STATES SHE WANTED TO GO HOME. NO CHANGE IN LIPS. LIPS DID NOT APPEAR SWOLLEN OR RED INSTRUCTED PATIENT TO FOLLOW UP WTH PRIMARY IF TINGLING CONTINUES.
pt stood up from getting shot said felt funny, turned pale, & went limp; mom caught pt; no loss of consciousness; BP 100/62, HR regular, BP p/3mins 108/74; tired;
could hardly walk; dizzy; arm hurt; felt weak; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on 27Feb2021 11:00 (lot number not reported), as dose 1, single, for COVID-19 immunisation. Relevant medical history included disability and pain in his knee both from unknown dates and ongoing. Concomitant medications were not reported. The patient previously took tramadol for 5 years because he has pain in his knee and experienced withdrawals. The patient went off tramadol because he read to not take pain killers while taking the vaccine. On an unspecified date, the patient's arm hurt and felt weak but these went away the next day. On 28Feb2021, the patient could hardly walk and was dizzy. On 01Mar2021, the patient had no symptoms, only pain in his knee due to his condition. The patient recovered from arm hurt and felt weak on an unspecified date; and from could hardly walk and dizzy on 01Mar2021.  No follow-up attempts are possible. No further information is expected.
pt recvd vax;subsequently devel soreness & warmth at inject site,malaise & general body achiness;
530AM 12JUN98 stomachache since 4:30 Thursday;saw MD 1030AM on 12JUN98;dizzy & nauseated;labs & x-ray;BP & pulse low (amylase 180) IV;adm to hosp;very severe abd pain;
Hospitalization for fever post-treatment for UTI and tested positive upon admission  on dates 6/29/22-7/5/22. Treated with dexamethasone, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Anthrax #1 June 3, 2003 Complained of increased warmth and red face the day of his immunization.  The next day was worse with an "exploding headache", passed out with altered LOC for 45-120 minutes. He complained of a palpating chest pain - dull-sharp ache (4-5/10) that worsened with deep breaths and lying down.  Relaxing and sitting up relieved the pain.  He complained of a "drained" feeling, fatigue and "lethargy"(no energy) and generalized body weakness. He observed a knot to his left arm for one month following the first immunization (indicated tricep region as immunization site). Anthrax #2 (3-4 weeks later)Unknown Elevated blood pressure (190's systolic) 20 minutes after receiving his 2nd immunization with facial flushing headaches (10/10 scale). He continues to have "flash headaches" 2-3 times a week lasting a few moments then gone.  Gradual new onset bilateral joint pain to his shoulders hips & knees.  He describes the pain as a grinding stiffness at 6/10 scale 3 weeks after 2nd immunization. He noticed a large red circle surrounding the immunization site for a few days post-vaccination; and a knot to the tricep region of his right arm for one month. He again felt drained, fatigued with no energy.  He complains of night sweats and difficulty sleeping over 4-5 hours.   Anthrax #3 Unknown Complained of severe pain with the third immunization, like a burning hammer hit him, with redness and stripes of bright red streaks surround the injection site for a few days with resulting knot that lasted for one month.  His blood pressure rose again with similar feelings of facial flushing, redness and headaches, feelings of fatigue, lethargy and lack of energy.  His headaches, night sweats and difficulties sleeping continue.  Nurse follow up on 09/28/04 states: "Reviewed d/c summary. Final diagnosis was non-cardiac chest pain now resolved with secondary diagnosis of hypertension. Diaphoresis and SOB while c/o chest pain. "
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) frequency time 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with Covid-19 vaccine was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated: 90000187877. The suspected has been confirmed to be non-void based on the evaluation/investigation performed. This case, from the same reporter is linked to 20210801047.; Sender's Comments: V0 - 20210801102- COVID-19 VACCINE: Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Mother states that on top of her son's arm where he had gotten his vaccines his arm is now red and warm to the touch with 2 small bumps that look like pimples and it is itchy. Consulted with someone and advised mother to use a cool compress, 15 minute on and 15 mins off, until redness and itching went down. Advised mother to use childrens Tylenol for pain. Advised mother to seek medical attention if redness and itching do not get better or get worse over the next 1-2 days. Advised mother to seek mediacal attention STAT if child begins to get worse or have trouble breathing. Mother stated that pt does have a local latex reaction to bandaids but latex-free used at HD.
PATIENT REPORTS MUSCLE ACHES, FEVER, CHILLS, UPSET STOMACH, HEADACHE, FATIGUE AFTER RECEIVING SHINGRIX. ALSO STATES THAT INJECTION SITE IS WARM AND PAINFUL.
Severe flu-like symptoms starting at 12M including high fever (103), chills, severe aching; Fever down to 101 at 5AM; took aspirin after calling emergency room; fever down to 100 at 6AM; fever and flu like symptoms thru 9/25/08 evening.
Vaccine received 1/10/21 10:30am, no pain or immediate adverse reactions. By 7pm left arm very sore like punched in arm. 1/11 arm is sore to lift or to touch all the way down into forearm and thumb area of palm. By 1/14 pain is less, only sore to lift, a post work out feel. On 1/16 woke up to a more sore arm and by end of day very sore again like 2nd day after shot. On 1/17 by bedtime left arm is itchy around injection site and there is a hive like bump at the injection site and another about 2 inches straight down, about the size of pencil eraser. Entire arm feels tingly when lay down. 1/18 woke up with headache and left arm is more painful, tingly down into fingers and heavy feeling. There is redness, warmth and very itchy between the dots. Dots are part of red area. Stomach cramps, but could be induced by stress of arm reaction. Primary directed to walk in clinic. Treating as possible cellulitis. Augmentin 875mg twice a day for 7 days, topical triamcinolone, Zyrtec. Monitor for changes.
Erratic heartbeat, palpitations, atrial fib, ventricular tachycardia.
12 hrs after shot  felt exhaustion, mental brain fog, mild nausea and migraines.  In the weeks following vaccine, exhaustion and migraines have persisted at an interval of several times a week. This is abnormal for me - i do not have headaches regularly or migraines.  It has almost been 2 months and I am still having exhaustion and migraines.
Fever, extremely tired, fussy, crying, administered acetaminophen.  Fever worsened throughout night, child vomited twice, unable to administer acetaminophen.  Maintained fever of 101 for 12 hours.  Child stayed fussy/irritable for three days following.  Broke out in terrible rash over arms and legs, and face.  Rash still present a week later.
At approximately 2:10pm, staff member received his second dose of Hepatitis B vaccine Heplisav B 0.5mL in his left deltoid.   At approximately 230pm, I was notified client was having a reaction in the bathroom. When I walked in and observed him, he had redness on his body had removed most of his clothing. He complained of itchiness all over his body,  Gave client two 25mg of Diphenhydramine HCl capsules.  After 10 mins, he was not getting any relief and started to shake from his ?itchiness? and urticaria presented on his chest, back, and arms.   911 was called   While waiting for EMS, client complained that his lips were starting to tingle and were going numb. He also stated he was having some irritation in his throat and his eyes were itching uncontrollably.   Administered one 0.3 Mg of Epinephrine via auto-inject pen.   EMS arrived and at 3pm,  client  was transported him to Hospital ER for observation.   Approximately 2 hours later, client was released from the ER observation. No additional follow-up was needed or recommended.
right cheek started turning red/ spread towards the right ear, then left cheek near the nose, and turned a little bit red"; became warm to touch, felt hot inside, cheek was "warm to touch"; started itching; felt a little stingy; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 25 minutes after the first dose, the patient experienced right cheek started turning red, became warm to touch, felt hot inside, and felt a little stingy. HCPs checked and confirmed that patient cheek was "warm to touch" and that spread towards the right ear, then left cheek near the nose, and turned a little bit red. Patient received antihistamine as a treatment for the events. So, the patient started itching and she took another antihistamine, and the events went away eventually. The patient clarified that her throat didn't close up or anything like that and asked for guidance regarding her second dose. The outcome of the events was recovered.  Information about batch/lot number has been requested.
Can't print pneumonia vaccine - don't know maker or name - but that was given in left arm and is cause of problem.  Sore arm shortly after injection.  Woke during night with extremely sore arm - hot to touch and felt tight.  Following afternoon had swollen, hard nodes under arm, red streak in front of axillary area (1"x3"), unable to raise arm without pain, extremely tender arm around injecion site and chills.  Felt lightheaded.  Slept 12 hours and awoke to less tenderness - but red streak remained. Nodes are less palpable - injection site sore but not as before.
Patient reported flushed feeling, bad taste in mouth and tingling on the outside of right cheek. Administered Benadryl 25mg 0.5cc IM RD muscle at 2:46pm. Patient did not have a rash, redness, nor swelling. Patient was not in any distress. Patient left facility alert, awake at 3:20pm. Symptoms had subsided and patient had no further complaints.
Within 5 minutes of injection administered, pt became faint, lied down, twitched, sat up stating "something's really wrong", lied down again.  BP & P WNL.  Waited, OK within 15 minutes.  DC 30 minutes home.
Sore arm, lymph node in armpit is swollen of the same side as injection,  neck lymph nodes "a little swollen"
Arm is numb between the top of left shoulder and left elbow. It is so numb I have difficulty pulling my pants up on the left side. I can not shrug my left shoulder with left elbow bent.
COVID-19 DISEASE (12/19/2022) 2 days of symptoms in retrospect.  - Consider starting treatment after family has their meeting depending on goals of care.
Pt usually is scared of needles and had anxiety with every imz. After giving the shot, she said, she was ok and was with her mother. After a couple of minutes she fell down saying that she is dizzy. We took care of her and also called 911. While falling her mother caught her, so she didn't get any injuries. she felt fine after 3-5 min. EMT arrived and took care of her.
Severe Headache, nausea, stomach upset, diarrhea and overall unease. Took Advil for headache but it didn?t subside until after I fell asleep. Symptoms continued into the early AM hours when I could finally sleep.
pt recv vax 1JUN95  & 1NOV97 pt exp full blown chickenpox (covered from head to toe), fever, h/a, chills, sore throat & dysphagia;
pt recv vax & 12hr post vax pt exp fever, chills, & h/a;an ER or MD visit was required;sx subsided p/7 days;
Pt had Prevnar 20 IMZ on 3/23/22 and reported redness/warmth/swelling at site of injection abt 1 day after reaction. Pt said her husband had the same vaccine that day and he didn't get a reaction. Per pt, she took 2 benadyl capsules and symptoms seemed to be improving, but her "arm still felt warm and was red". Advised pt to continue to take benadryl 25mg capsule with max of 300mg per day. Pt's husband called back later and stated pt seems to be getting better. Counseled pt's husband to continue to monitor pt's symptoms. In addition, if symptoms do not improve or if pt has trouble breathing/experiences anaphylaxis to go to the ER. Called pt back at the end of the day and pt said the swelling went down, but area is still a little pink. Per pt, she feels fine.
This female subject was enrolled in a prophylactic open study. On 26 June 2009, she received the dose of MENINGOCOCCAL-TETANUS TOXIOD. On 12 August 2009, 47 days after the 1st dose of INFANRIX, 47 days after the 1st dose of MENINGOCOCCAL-TETANUS TOXIOD, this 18-month old subject became floppy. The subject was hospitalised and the event was life-threatening and clinically significant (or requiring intervention). The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the floppy infant may have been caused by INFANRIX and MENINGOCOCCAL-TETANUS TOXIOD. Investigator Comments: Normally healthy child 'not acting right' when she awoke from a nap at 9.00pm on 12 August 2009. On arrival at ER (emergency room) child's extremities were flaccid and she could not hold her head up. At the time she was alert and demonstrated abdominal muscle breathing without respiratory distress, although her pulse oximeter reading was 79%. Demonstrated withdrawal to pain with PIV placement, crying on assessment and during PIV placement, remaining alert. On initial exam her pupils were round and reactive, she was crying and she slightly withdrew when stuck for blood but demonstrated no other muscle action except for movements of her head. Her neck was supple at all exams. Within 30 minutes her pupils became pinpoint and she became unresponsive to touch or voice. She was intubated at that time. PO was still 100% on oxygen and she still demonstrated abdominal breathing. CV: tachycardia. Lungs - clear. Abdomen - soft. Diaper area - no trauma, no rashes. Back: few papules consistent with mosquito bites. Extremities - flaccid, no bruising, warm and dry. Neuro: initially appeared alert with appropriate cry then deteriorated to unresponsive, but was able to cry again when initial preparations to intubation occurred. CT of head without contrast - normal. CBC and BMP - normal. Anesthesia at bedside for intubation - 50mcg of PROPOFOL. Fentanyl and Versed administered post-procedure. Child with spontaneous respirations. Placed on CPAP Fio2 50% rate 25. Transferred to hospital as in critical condition without confirmed diagnosis. No further information available at this time. Additional information 14 August 2009: On the evening of August 12 the child was with grandmother and upon mom's return home she noticed that the child was not acting as usual - the ER is very close by, so mom took the child in - (child became unresponsive, POx 79% and was intubated in ER then transferred to another hospital where continues to be intubated but slowly becoming responsive; head CT was negative).
Patient complains of itchy, throat swelling after 2nd dose of Pfizer COVID vaccine. Patient took 50 mg of Benadryl at 13:15 prior to getting COVID vaccine. COVID vaccine administered and the patient stated "I am itchy all over and my throat is starting to itch." Patient complained of symptoms getting worse so epinephrine was administered in the left thigh. EMS was called and patient was transferred to a hospital.
Toward the evening and night of that same day I started to feel sick. I took some ibuprofen, and then went to bed. Around that time I started my period and it was a lot heavier. However, I did get a birth control implanted in my arm a  few months before getting the vaccine. Since then my period has gotten less and less. After about a week of getting the vaccine, I started to feel back pain with two muscles in my back that would hurt.
Facial, neck and upper arm swelling.  Most profound swelling of lip and nose.  Tenderness upper arm and neck. Applied ice.  Took Benadryl
pt administered a dose of Moderna covid-19 vaccine; at time of administration pt is 15 years old.  no adverse reactions reported
Erythematous rash at site of (L) shoulder area surrounded by small blisters. GM used to give him BENADRYL x 2 days. This rash lasted for 4 days. No residuals left.
I have irregular tenderness at the injection site. My arm started to swell and be most painful with red swollen rash spreading from my arm to my breast and stomach. Rash was hot to the touch. Went to my PCP I was given steroid medication.
Information has been received a representative at the Health Department concerning a 14 year old female who was vaccinated with a first dose of Gardasil. Subsequently the patient developed swelling in both arms after receiving the first dose of Gardasil. Unspecified medical attention was sought. Subsequently, the patient is fine and the swelling has gone down and the patient recovered. Additional information has been requested.
Hospitalized 05/10/2022-05/13/2022; COVID-19 positive 05/10/2022; fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider:  Primary Care Provider:  Admission Date: 5/10/2022 Discharge Date: May 13, 2022   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Chest pain [R07.9] Hypertensive emergency [I16.1]   HOSPITAL COURSE: A 62 y.o. male with PMHx including ESRD on HD (MWF), HTN, HOCM, CAD s/p PCIx2, not on anti-platelet therapy, presenting with chest pain and hypertensive emergency. Upon arrival to the emergency department he was noted to be hypertensive at 228/97, remainder of his vitals were stable.  Initial EKG showed some ST depression in the inferior leads.  Troponin elevated at 63, repeat 2 hour troponin 69. He was started on nitroglycerin drip for his blood pressure, with subsequent resolution of his chest pain. Repeat EKG showed resolution of the ST changes. Cardiology was contacted who recommended echocardiogram and starting heparin drip for possible ACS.     He was incidentally found to be positive for COVID, with symptoms including mild diarrhea and rhinorrhea x 1 week, myalgias, cough with congestion using OTC mucinex and coricidin.  He had SpO2 >90% on room air. He was also found to have vitamin D deficiency, and was started on vitamin D supplementation.    Cardiology recommended starting carvedilol, and patient was weaned off clonidine, and stopped metoprolol, and subsequently weaned off nitroglycerin gtt. Repeat echo with evidence of LVEF 75%, unchanged from prior, with septal thickening to 14mm. Nephrology was consulted, and he received dialysis on his scheduled days, MWF. Patient was discharged in stable condition, with chest pain resolved, in no acute distress, O2Sat >92% on room air.
Six days later on February 22, 2021 I woke up with a severe case of hives and have had them every since.  They look like pictures on the Moderna website.  They are on my legs, arms, trunk of my body, neck and even some on the face.  They are extremly itchy.  Some are a single hive and others are big patches like on my back and stomach.
The patient had two syncope episodes, assessed by staff. Decreased BP 83/56, pale skin and shaky. Paramedics were called. Patient was transported to the hospital for further assessment.
C/o nausea, LBP (but hx of), HA, arm sore at site. Temp 101. Took extra strength TYLENOL. Also dizzy. The arm was not swollen, but was little warm. Felt too dizzy to leave house to come in. 8/9/10 went to ED - CBC with diff, CMP, Lyme titer + U/A, blood culture + lactic acid done. Use antipyretic med PRN and return if worse.
Patient recevied Pfizer vaccine and shortly after noticed her throat was scratchy and felt tight.  She was given 50 mg of benadryl PO with no relief.  Was administered 0.3 mg of epineiphrine IM  and called 911.  EMS shortly arrived and transferred patient to nearest ED.  Symptoms prior to leaving in stretcher were: diaphoresis, chest pressure, throat closing sensation, scratchy throat, "I don't feel right".
It started with a sore throat on day one and progressed with fever headache fatigue then it went to congestion and cough all other symptoms had resolved by day seven or eight but mild cough still remains.