chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left axilla soft tissue swelling; This is a spontaneous report from a contactable physician. A 39-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 14:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included back pain and COVID-19. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19, on an unknown date. Concomitant medications included diclofenac (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 08:00, the patient experienced left axilla soft tissue swelling. Therapeutic measures were taken as a result of adverse events and included treatment with antibiotics.  Since the vaccination, the patient had not been tested for COVID-19.  The event resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event left axilla soft tissue swelling was unknown at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
GRADUAL DEVELOPMENT (MILD TO SEVERE) REDNESS, SWELLING, PAIN, WARMTH TO TOUCH TO LEFT UPPER ARM 24-48 HOURS AFTER RECEIVING FLU VACCINE AND PNEUMOVAX TO LEFT DELTOID ON 11/01/04. GIVEN RX FOR KEFLEX 500MG, ADVEISED TO TAKE OTC BENADRYL, TYLENOL PRN FOR PAIN AND FEVER.
Patient immediately lost consciousness as vaccine was administered.  Her face turned red, she shook for a couple of seconds, and then regained consciousness.  She then proceeded to vomit for about 5 minutes.  She told us this type of reaction has happened many times to her before with previous vaccinations.
Initial unsolicited report received from a consumer on 21 September 2016. This case involves a female patient (age not reported) who was vaccinated with dose of Fluzone Hd (dose, batch number, expiration date, site and route of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, patient experienced allergic reaction and had severe difficulty breathing. On an unspecified date patient was hospitalized for three days. Lab data and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none. Sender's Comments: Allergic reaction and severe difficulty breathing are reported after vaccination with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Time to onset is unknown. Complementary information regarding any drug or food intake during the period between vaccination and reaction as well as allergic testing to identify the culprit antigen, time to onset and patient's history of reaction after previous vaccinations is needed for complete assessment of the case. Based on the available information role of the vaccine can not be assessed.
Body aches, weakness, fatigue, nausea, vomiting with quick onset around 10:30 pm on 5/18. Called physician and employer health line for symptom check-in. Recommended ED visit or OTC medication at home. Chills began around 11:45 pm on 5/18. Took two Advil for a total of 500mg Acetaminophen and 250mg Ibuprofen at 12:00 am on 5/19.
Generalized itch while being observed after vaccination.  No hives or rashes seen.  Resolved with dose of benadryl.
03/20/2021- I went to fashion show and had a drink, I came home and had a meal, that next morning I woke up and felt like I had pancreatitis, in severe pain, I stopped eating and went to liquids only, sent message to Doctor, had complete blood work done, I also had prostate pain. I remained on liquids such as watermelon juice and coconut water, my pancreas is still bothering me, I still get occasional abdominal pain. Have not fully recovered, I see doctor in August.
Pt began to shake during administration. stated he has had reactions to blood work and other needles. he was stating his reaction and his eyes rolled back in his head and he went limp in his chair. He was unconscious for about 1-2 minutes and became pale and sweaty. He came to and tried to stand up and was calmed down and sat back in his chair. Pt stated had not eaten today and had not gotten much sleep in last few days.  I offered him a soda. Pt  chose to climbed down off chair and sat against wall drinking soda.  EMS had been called and when they arrived they did their assessment and found 100s/60s bp, he reported normally 120/80 and that he was becoming more normal color. EMS felt he was stable, he signed off further treatment and had him stand up which we helped with. he was helped and moved to the waiting room for observation.  he asked for some candy because he felt his blood sugar was  still low.  we advised against driving and he texted his mother to pick him up. he felt 70% at last discussion. his mother came and he left.
vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the vomiting and diarrhea to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information received were as follows: The age at vaccination was not reported. A year before the reporting date, the patient received flu vaccine. The patient did not know the name of the flu vaccine. The patient had vomiting and diarrhea for 2 hours following the vaccination. They cause was believed to be a reaction to formaldehyde. Did not consent to follow-up. The patient hung up before additional information could be obtained. The outcome of the event reported in the system did not match with that reported in the source document.
Throat tightness with 5 min of receiving vaccine epinephrine given in ER.
pt with history of CLL, A Fib/flutter, CKD4, gout, recurrent pneumonia; admitted to hosp with increasing weakness and poor oral intake; hypoxic respiratory failure; positive for COVID; transferred to ICU; given steroids and Actemra; DNR/DNI; refused dialysis; pt's condition deteriorated; transitioned to comfort care and passed away in the hospital
vaccine Fluzone QIV NP was given during a temperature excursion with no reported adverse event; vaccine Fluzone QIV NP was given during a temperature excursion with no reported adverse event; Initial information received on 11-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 38 years old female patient who had experienced an event vaccine  Influenza Quadrival a-b vaccine [Fluzone quadrivalent] was given during a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine at a dose of 0.5 mL (lot UT7383KA; Expiration Date :2022-06-30) (strength, formulation: not reported) via intramuscular route in unknown administration site for immunization.   On an unknown date the patient developed a non-serious vaccine fluzone qiv np was given during a temperature excursion with no reported adverse event (product temperature excursion issue) (product administration error) (unknown latency) following the administration of Influenza quadrival a-b vaccine.  Action taken: not applicable.  At time of reporting, the outcome was unknown for the events product temperature excursion issue , product administration error.  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.
I received my first Pfizer Covid-19 vaccination shot on Tuesday April 6, 2021 at 12:25.  On Wednesday morning my blood pressure was elevated to 154/107 and pulse 75.  Readings remained the same through Thursday.  Since Friday morning readings have declined to normal levels, blood pressure 105/79 pulse 84.    I took a few blood pressure reading a couple of weeks to my Covid-19 vaccination.  They were normal.
I am currently breastfeeding my 5-month-old son. I received my first vaccine on 12/28/2020 and directly breastfed within 4 hours of receiving the vaccine. Two days after my vaccine my son was at daycare and had two large diarrhea blowouts and two large emeses followed by a 1-minute episode where he was limp with entire body cyanosis and in-and-out of consciousness. He also had a maculopapular rash on his torso. EMS was called. He was observed in the emergency department for a few hours then recovered well without intervention and did not require hospitalization. EKG was normal. He has continued to be well and back to baseline since the event.
On approximately 11/25/99, the pt experienced 5 small pox on the body. She also experienced aches and a low grade fever.
LOC about 4-5 hours post vaccine administration. Mom gave bottle 30 min prior to LOC. Was holding patient over her shoulder to burp. Noticed her go limp. Her eyes rolled back and started to look pale. Called EMS. Patient didn't regain consciousness until after EMS arrived. Mom estimates about 5-10 min total. No recurring LOC. No other s/s.
Anaphylaxis after getting a Flu shot. Patient also had her allergy shots. Allergy shots given. Patient waited 30 minutes then received Flu shot. Patient went to ER (10-27/2022) where she was treated for rash, throat tightening, light headedness, and cough.
Mom returned with infant  04/20/05 to receive vaccines. Reported high pitched crying for 26 hours afer vaccines administered on 01/14/2005. No MD visit or ER visit. Referred to Peditricain for eval.
At around 530 pm Friday I had extreme tiredness, felt feverish, was freezing.  Took advil and laid on couch.  Fell asleep, per family hallucinated.  About 1 to 2 hours later I could not smell.
12/20/2020 WITHIN MINUTES,  I STARTED TO FEEL PINS AND NEEDLES. RADIATED LEFT TO RIGHT SIDE OF ARMS, AND THEN UP TO HEAD. NUMBNESS AND TINGLING. SEVERE PROFOUND WEAKNESS, DIZZINESS AND ORIENTATION. VISION FELT 'FAR AWAY'.  HR INCREASED, HX SVT. 3 MINUTES BP  WAS 'OK' BUT I BELIEVE IT BOTTOMED OUT. HR WAS 150. STRETCHER, TX TO ER. BLURRY, 'STAY WITH US'. ALERT, AWAKE, VERY IN AND OUT OF FOCUS. FEEL LIKE 'PTSD' FROM THIS EXPERIENCE. 'WHOLE BODY WAS BUZZING'.  IV STEROIDS, IV BENADARYL, IV FLUIDS, IV ATTIVAN (NO EPI AS NO DIFFICULTY BREATHING) STILL FEELING 'DAZED' *FLU SHOT REACTION 2013 - BRONCHOSPASM, MILD. 2014 - BRONCHOSPASM,  RINGING IN EARS, INCREASED HR, DRY HACKING COUGH, USED NEBULIZER AND TOOK BENADRYL. LASTED 4 HOURS.  ALLERGIST APPT 2020 - ADMINISTERED FLU SHOT UNDER GUIDANCE; SCRATCH TEST; BROKEN UP INTO 2 DOSES. INFORMED NOT ALLERGIC TO FLU SHOW 'GOOD TO GET COVID SHOT'.  *STILL HAVE TINGLING IN LEFT THUMB
Pain at injection site (moderate to severe); general malaise (moderate); body/muscle aches (mild-moderate); body/muscle aches (mild-moderate); headache (mild); chills (mild); This is a spontaneous report from a contactable healthcare professional. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot number: EL1284; expiration date not provided), via an unspecified route of administration on 11Jan2021 10:15 at a single dose at left arm for COVID-19 immunisation. Medical history included premature ventricular contraction and sulfonamide allergy. The patient received the first dose of BNT162B2 on 21Dec2021. Concomitant medication included escitalopram and famotidine. The patient experienced pain at injection site (moderate to severe), general malaise (moderate), body/muscle aches (mild-moderate), headache (mild), chills (mild) on 11Jan2021. No treatment information was received. The patient underwent lab tests and procedures which included SARS-COV-2 test which showed negative result on 01Jun2020. The outcome of the events was recovering.
TIA followed by mild stroke 10 hours later. Hospitalized for 2 days for tests and observation.
2/5/20 PNEUMOVAX given into (R) deltoid without difficulty 2/6/20 pt called saying evening of 2/5 developed pain, swelling to (R) elbow, (R) upper arm hard red & warm to touch with limited range of motion; Urgent office Appt made. Provider recommended ice, rest & ROM exercises, provider noted. "no injection site reaction noted" 2/7/20 pt called, no improvement. Ordered Stat RUE Ultra sound which was Negative for DVT 2/10/20 I called pt to check status, states she was 100% back to normal by 2/7/20 in evening, No further pain or swelling of (R) upper arm, ROM fully returned
First dose was on 02/20/2021 and was at right arm. Second dose was on 03/20/2021 and was at left arm. The first AE happened on 03/21 at 5:30PM including severe headache and pain at injection site. The next day, pt experienced bodyache and severe headache. Pt took tylenol to reduce the AE. On the third day, pt was recovered and normal.
Erythematous lesion with central raised area (hives) noted on Right LG R><. Infant no distress; smiling laying. Rx given Benadril elixir 3.5cc PO every 4 hours PRN. No further HIB or DTaP 2 hours to reaction.
COUGH; RUNNY NOSE; BODY ACHE; LOSS OF TASTE; LOSS OF SMELL; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 20 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient is otherwise healthy and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced cough. On NOV-2021, the patient experienced runny nose. On NOV-2021, the patient experienced body ache. On NOV-2021, the patient experienced loss of taste. On NOV-2021, the patient experienced loss of smell. On NOV-2021, the patient experienced chills. On NOV-2021, the patient experienced headache. Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, cough, runny nose, chills, body ache, loss of taste, and loss of smell. This report was non-serious. This report was associated with product quality complaint.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 3/30/2022 RECTAL CANCER J96.00 ACUTE RESPIRATORY FAILURE 3/30/2022 RECTAL CANCER
PATIENT HAD SWELLING IN LIPS, TROUBLE BREATHING, PATIENT WAS GIVEN EPIPEN AND 911 WAS CALLED
Throat begin to close, minor reaction. And numbness on left side of body all the way down.
CLIENT EXPERIENCED SYNCOPE ON 11/02/09.  NO PREVIOUS SYNCOPAL EPISODES. MILD DIZZINESS 11/03/09. C/O MILD SORENESS AT SITE OF INJECTION. CLIENT EVALUATED BY PRIVATE MD ON 11/03/09 WITH NO COMPLICATIONS.
Period is very late; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient 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 26Mar2021 at 11:30 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included sertraline (MANUFACTURER UNKNOWN) taken for unknown indication and unknown start date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient was supposed to start period the day after the vaccine but the patient did not have. The patient menstrual cycle was usually very regular but period was very late and was not pregnant. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the menstruation delayed. The clinical outcome of the event menstruation delayed was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Within a month of the dose noted core weakness, difficulty in swallowing, rash to face and chest, itching to skin and scalp
Syncopal episode while driving; Crash; Became extremely warm; Sweaty; Right flank pain; A spontaneous report was received from a nurse concerning her husband, a 53-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced became extremely warm, sweaty, right flank pain, a syncopal episode while driving, and crash.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, approximately two and a half hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 11 Jan 2021, the patient felt fine for approximately two and a half hours after receiving the vaccine, then became extremely warm, sweaty, developed right flank pain, and had a syncopal episode while driving. The nurse mentioned that the patient was not seriously injured in the crash, nor was anyone else. No treatment information was provided. It was also reported that the patient had followed up with his PCP and seen a cardiologist, some diagnostics were scheduled, and plans to see a neurologist.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events, became extremely warm, sweaty, developed right flank pain, syncopal episode while driving, and crash, was unknown.; Reporter's Comments: This case concerns a 53-years-old male patient, who experienced serious unexpected events of syncope and non-serious unexpected event of road traffic accident, feeling hot, hyperhidrosis, and flank pain. The events occurred 1 day (approximately 2.5 hours) after first dose of mRNA-1273, lot # unknown. Treatment details not provided. Very limited information regarding these events has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Mom stated she took the child to the ER on 2/28/04 due to leg being hot, swollen and red. Stated the ER physician said it was infected.  Requested that mom bring child into the health department so that we could see the injection site.  She stated she would but did not.  Called the home on 3/4/04 as mom had never brought the child in and dad said that the child had a knot in his leg that did not appear to be tender and that his brother was fine.
Pt is a 15-year-old man with history of obesity, insulin resistance, mixed dyslipidemia, vitamin D deficiency, elevated hemoglobin A1c, anxiety disorder, and ADHD. He presented today to the ER with history of chest pain in the past 3 days.  This chest pain is intermittent, sharp in nature, mainly in the retrosternal area, precipitated by deep breath, partially relieved by Tylenol, ibuprofen, or laying down.  He denied any history of trauma, or recent viral illnesses.  The severity of this chest pain ranging between 4?5/10 with no radiation.  He had temperature of 38 °C on Saturday after the second dose of SARS-CoV-2 vaccine (on Thursday, 6/3/2021).  He said that he had a loose bowel movement, intermittent cough, and headache.  He denied any nausea, vomiting, nasal congestion, skin rashes, change in urine, muscle pain, or joint pain.  At the ER, he was in stable condition, afebrile, with stable vital signs.  He received 1 dose of Motrin 600 mg for the chest pain.  ER dr. was consulted and he recommended admission to the CICU for further investigation and management.  6/9/21 - Troponin levels downtrending (last 1.30). ID consulted and recommended obtaining adenovirus PCR, enterovirus PCR, GI panel, Mycoplasma IgM, COVID IgG, COVID NP, and COVID spike protein. Will follow as an outpatient. CXR normal. EKG with sinus bradycardia, while calm. Echocardiogram results normal. RPP and COVID negative. Behavioral medicine followed.  Discharged on 6/9/21.    Hospital course  CV Troponin level on admission was 2.7 and have been closely monitored. Last level obtained on 06/08 was 1.3. ECG 06/08 - sinus bradycardia. Echocardiogram 06/08 - essentially normal with trivial to mild tricuspid regurgitation and mitral regurgitation and trivial aortic regurgitation. Chest pain has now resolved and patient has good hemodynamics with good pulses, good blood pressures, and cap refill less than 2 secs. He will follow with Dr. in 1 week. No rigorous exercise for one week.
2-7-21 IMMEDIATELY AFTER 2ND COVID VACCINNATION FELT GREAT LOADS OF ENERGY NO SORENESS AT SITE RT ARM. WOKE UP 2AM ON 2/8/21 WITH A RACEING POUNDING HEART WITH A HEART RATE OF 180 AND COLD 3 BLANKETS COULDNT KEEP ME WARM. COME 8AM HEART RATE STILL RACING WITH HEADACHE AND ACHES ALL OVER MY BODY FROM HEAD TO TOE INCLUDING JAW AND FACE. ARM EXTREMELY SORE AT SITE AND HEAVY. ENTIRE BODY ACHED, FELT HEAVY AND ZERO ENERGY. AT 6PM2/8/21 I FINALLY HAD LITTLE ENERGY BUT STILL HAD ACHES CHILLS WERE LESSONING. I TOOK IBUPROFEN 800MG IN THE AM AND IT DID NOTHING TOOK ANOTHER AT 8PM WOKE UP 5:30AM 2/9/21 WITH HEADACHE AND CONGESTION AND HEART RATE 140 DIZZY IN AM.  AT 10AM ON 2/9/21 HEART RATE IS 84.  SLIGHT HEADACHE REMAINS AND STARTING TO FEEL MYSELF A LITTLE.
Fever or Chills  Cough  Shortness of Breath  Fatigue  Headache  Sore throat  Congestion or running nose
Increasing pain Left arm radiating to Left shoulder with weakness and tingling. Requiring steroids, pain meds, physical therapy, MRI and Neurology consult.
pt recv vax 15MAR96 & on 16MAR96 pt devel gen rash in the abd region;pt presented to MD;MD felt that rash was perhaps irritation from soap or pantyhose;17MAR96 pt recovered;
Was given Gardasil 9 without symptomatic recurrence of RRP/ research that secondary prevention may be achieved with gardasil 9 (on goin Trials); Literature Report  This literature marketed report had been received from the authors of a published article, titled as stated above, and referring to a 61-year-old male. The patient's medical history included COVID-19, intubation, mechanical ventilation, and tracheostomy tube insertion. The patient's concurrent conditions included nasal cannula oxygen therapy, and respiratory papillomatosis (otherwise reported as previously healthy). Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, as treatment for recurrent respiratory papillomatosis (RRP) as secondary prevention after the procedural removal of papillomas (off label use) (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported).  A copy of the published article is attached as further documentation of the patient's experience.