chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchiness; soreness on her arm; hives on her leg and back like mosquito bites; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites). On 13-Mar-2021, PRURITUS (itchiness), PAIN IN EXTREMITY (soreness on her arm) and URTICARIA (hives on her leg and back like mosquito bites) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  Treatment for the events included oral diphenhydramine, hydrocortisone cream, and calamine cream.  Her physician stated that she should not take the 2nd vaccine dose.
Dr. H&P- Chief Complaint: right facial droop HPI: female with medical history significant for hypertension, diabetes mellitus, dyslipidemia who presents with right facial droop of 1 day duration. Patient states that she bit right lower lip yesterday evening. Subsequently she was feeling fullness in her right ear, but denies any pain or discharge. When she woke up this morning, she noticed to have right facial droop with numbness of right side of her face. She was unable to close her right eye. Denies any difficulty with swallowing. She received her Pfizer booster couple days ago. Denies having any fever or extremity weakness. She went to ER for further evaluation. CT angiogram of brain showed occluded left intracranial vertebral artery, maxillary dental caries. EKG with atrial flutter. Patient is now directly admitted for further workup and neurology evaluation. Diagnosis: acute CVA  Former smoker: quit in 1980 Alcohol: no Assessment:  1 Isolated right facial palsy vs acute CVA 2 New onset Afib 3 Hx HTN 4 Hx diabetes mellitus, dyslipidemia  Dr. (cardiology)- Consult: The patient was seen at the request of physician, for the evaluation of new onset atrial fib.  Hx: female who presents with new onset atrial fib in the setting of stroke like symptoms (probably Bells Palsy per neuro), hypertension, diabetes, hyperlipidemia. She has a family history for heart disease in her brother. Dr. (neurology)- Consult: Hx: MRI of brain did not reveal any acute stroke. Patient evaluated at bedside. She has trouble closing her right eye. She denies any other associated symptoms. Assessment 1 acute right lower motor neuron facial nerve palsy
Developed 2 round, raised, reddish lesions 1/4cm X 1/4cm and 1/2cm X 1/2cm around injection site. Left cheek redness noted as well. Recovered with Atarax in office.
After receiving the COVID19 vaccine on Friday, March 19th at 12:30pm, I started feeling the normal side effects around 5pm. I had a low grade fever, chills, muscle aches, nausea and low energy through Saturday night around 7pm. When I woke up on Sunday morning, those side effects I no longer felt but instead I had pain in my vagina. All day, I assumed it was a yeast infection and would go to the store Monday to pick up Monistat. Monday morning, the pain had gotten worse.  My labia was very swollen and irritated and hurt when I urinated. At that point, I decided to look and found 10-15 lesions on my labia (both right and left side). I immediately called my primary care physican's office to make a same day appointment. My primary doctor was unavailable so I saw another doctor instead. She swabbed several of the lesions as she seemed to think that it was a herpes outbreak (which would have been my first). She wrote me a prescpription for Valacyclovir (10 days) and submitted my vaginal swab for HSV 1 and HSV 2 testing. Two days later I received negative test results for HSV 1 and HSV 2. I asked her for further testing as I was still in pain. I went back in for blood work: Comprehensive Metabolic Panel, CBC with Differential, Epstein Barr Virus AB Panel, Herpes Simplex Birus Antibody IGM, Herpes Simplex I/II IGG. All came back normal. I didn't have any old or new Herpes antibodies. This lead both her and my gynocologist to question whether or not this was a side effect of the vaccine.
Received flu shot/flulike symptoms began by 2:00pm w/ achy body, chills, bloody stool by 3 pm. Passed out in bathroom floor at 4:30 AM 1/19/11 after passing a large amt of blood. Was in ICU for 10 days - given 16 units of blood over 1st 6 days. Many tests - no exact GI bleed sign located.
This report was received from a physician and described the occurrence of erythema multiforme in an 18 month old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. The patient had no known allergies, no concurrent medications, and no adverse experiences following receipt of the first three doses of diphtheria and tetanus toxoids and enhanced pertussis vaccine. The patient was described by the physician as otherwise healthy. The patient received Infanrix on 9/13/03 for the fourth dose in the immunization series. On 9/17/03, four days post immunization, the patient developed a fever of less than 100 degrees F, an itchy maculopapular rash that was confluent on the thigh where Infanrix had been administered, and a lot of other urticarial, target-like lesions on the whole body. The target-like lesions ranged in size from greater than 3mm to 1.5 inches in diameter. The patient was seen by the physician, who made a diagnosis of typical erythema multiforme. She also stated that his whole set of symptoms were like a serum sickness type reaction. The physician prescribed diphenhydramine which helps with the itchy rash. The patient continued to have a fever and to get new lesions as of 9/18/03. Erythema multiforme is considered to be medically serious (OMIC). Annual follow-up report from GlaxoSmithKline (October 1,2004 to October 21, 2004).
Information has been received from a certificate medical assistant also reported as "Office Supervisor", referring to 8 unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in June 2017 (reported as "from June 1, 2017 through June 30, 2017"), the patients were administered with improperly stored vaccines of LIQUID PEDVAXHIB lot # N000237 with expiration date on 25-OCT-2019 (dose, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccines has a temperature excursion of 35.1 Fahrenheit (F) during a time frame of 3 hours. It was confirmed that no previous temperature excursions occurred or a digital data logger was involved. This is one of several reports received from the same source.
I woke up at 3am on Wednesday  the 20th and felt very dizzy. Keep on going for about an hour or so. About 4AM I started to puke my guts out. I called the doctor about 9am that morning who told me that it was an effect from the vaccine (I had a virtual visit with the doctor). I was also feeling very weak. Today I feel I better and was able to eat and even take my dog for a walk.
Injection occurred on 3/21/19 and patient had Shingles 4/2/19 (right T10 dermatome)
Initial unsolicited report received from a consumer on 19 October 2016. This case involves a female patient (age not reported) vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (Batch number, expiration date, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient experienced severe pain in the shoulder. Laboratory examinations were not reported. Corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Pt inadvertently received PPV 23 instead of Meningoccal vaccine. Error was realized and Meningococcal was also give. On 5/27/04 we got a report of cellulitis on this girl. She's being treated with Keflex.
This spontaneous report as received from a health care professional refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored doses of MMR (manufacturer unknown), (dose, route, lot number and expiration date not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
1 of 4 pts vaxed 9NOV94 pt exp red, sore, swollen arm 2 days p/vax;ATB prescribed MD thought it could be cellulitis or urticaria;
the patient had a stroke,reporter further stated that they called it a mini stroke; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206), via an unspecified route of administration on 27Mar2021 (at an unspecified age) at dose 2, single in the left arm for COVID-19 immunization. Medical history included borderline blood pressure. The patient had no other vaccines received on the day of vaccination of the Pfizer vaccine. Concomitant medications included amlodipine for borderline blood pressure and omeprazole; both ongoing. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6202, expiration date: unknown) received in the morning of 06Mar2021 at around 10:30 am in the left arm for COVID-19 immunization. On 10Apr2021, exactly 2 weeks after the second shot, the patient had a stroke. The patient had no previous issues. Since then, the patient has had no cholesterol issues, no heart issues, and no blood pressure issues (as reported). The patient had nothing before and since then, all tests including an echocardiogram, and stress tests show that there did not appear to be any heart issues (negative). The reporter further stated that they called it a mini stroke and the symptoms disappeared very quickly.  There were no residual effects of the stroke. The patient wore a heart monitor for 2 weeks and there doesn't seem to be anything that would have caused this. The reporter finds it strange that it happened so quickly after the patient took the shot. The reporter heard of several stories of people who knew people who had strokes similar to this situation, aged around 50 years old and so forth with no previous heart issues. The reporter wanted to know if this was something Pfizer has seen a lot. It was reported that the patient's stroke initially caused some effects which was why he was brought to the emergency room where it was diagnosed as stroke and was admitted to the hospital for 4 days from an unspecified date in 2021 to an unspecified date in 2021. Outcome of the event was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Onset some fatigue 1-2 days after vaccine, onset headache 7 days post vaccination, moderate in severity, helped by ibuprofen, headache has recurred over 48 hour period.
nauseous; started vomiting still vomiting today, twice a day.; "potabolism" to go down.; tingling started off in hands in feet; my fact mouth gums tongue tingling.; my fact mouth gums tongue tingling.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for covid-19 immunisation, reaction(s): "headache". The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "nauseous"; VOMITING (non-serious), outcome "not recovered", described as "started vomiting still vomiting today, twice a day."; METABOLIC DISORDER (non-serious), outcome "unknown", described as ""potabolism" to go down."; PARAESTHESIA (non-serious), outcome "not recovered", described as "tingling started off in hands in feet"; PARAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious), outcome "not recovered" and all described as "my fact mouth gums tongue tingling.". Relevant laboratory tests and procedures are available in the appropriate section.  Course of events: When she got the other shot couple of days after she was nauseous and started vomiting still vomiting today (16Jan2023), twice a day. Caller states this has caused her "potabolism" to go down. And after this last shot, now tingling started off in hands in feet, now its her fact mouth gums tongue tingling. Caller states she went to hospital, she has had an MRI and they cant figure out why this is happening.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a Registered nurse concerning a 21 year old female patient with no known drug allergies, no pertinent medical history who on 18-AUG-2008 was vaccinated with a first dose of RECOMBIVAX HB lot # 0762U. There was no concomitant medication and no other vaccination given to the patient. The nurse reported that twenty minutes after vaccination the patient developed malaise, fever and slurred speech after getting the dose of RECOMBIVAX HB. She was sent to the emergency room (ER) and was treated with intravenous (IV) corticosteroids (unspecified) and BENADRYL to prevent neurological disorder. Unspecified laboratory tests were done at the E.R. The patient left ER on course of oral prednisone which was completed on 25-AUG-2008. The patient recovered and went back to work. The reporter considered patient getting I.V. steroids and BENADRYL in the emergency room (ER) was an intervention to prevent a serious criteria and it was reported as an other medical event (OME). The nurse reported that the events were related to RECOMBIVAX HB. This is one of two reports from the same source. Additional information has been requested.
Headache and fatigue. Tylenol taken. Headache is resolved. Continues to complain of fatigue.
Arm soreness has never fully gone away and about 1 month ago, patient developed muscle cramps in conjoining shoulder & neck.  The muscle tightness & cramps are continuing to get worse.  Patient is receiving physical therapy including dry needling but there has not been any significate changes.
Received the Pfizer vaccine at 3:18pm, 20 minutes later reported itchy throat and nose. Reported 3/10 severity of symptoms. Patient reported mild swelling of throat 5 minutes later.  When reassessed her symptoms were the same, no signs of angioedema, no coughing. Patient able to talk with no difficulty, denies shortness of breath and chest tightness, patient was able to drink and swallow without much difficulty. Patient continued to complain of symptoms and requested IM Benadryl. Reported her partner would be picking her up and take her home.  Vital signs were taken prior to Benadryl administration and were: BP 108/71, HR 69, O2 99% RA at 4:15pm. Benadryl 25mg IM administered to right deltoid at 4:21pm. Vital signs taken after administration were: BP 105/69, HR 72, O2 99% RA at 4:31pm. Declined ED, states she is feeling better. Patient was escorted by RN to partner's car; she was ambulating and declined the wheelchair.
Severe arm pain radiating outward from injection site.  Runny nose Fatigue Irritability Emotional instability (depression)
This case was reported by a physician via sales rep and described the occurrence of presyncope in a 16-year-old male patient who received BEXSERO (batch number U5752AB, expiry date 16th November 2018) for prophylaxis. Concomitant products included MENACTRA. On 22nd June 2018, the patient received BEXSERO. In June 2018, less than a day after receiving BEXSERO, the patient experienced presyncope, lightheadedness, pallor, visual disturbance and nausea. On an unknown date, the outcome of the presyncope, lightheadedness, visual disturbance and nausea were recovered/resolved and the outcome of the pallor was unknown. The reporter considered the presyncope to be related to BEXSERO It was unknown if the reporter considered the lightheadedness, pallor, visual disturbance and nausea to be related to BEXSERO. Additional details were reported as follows: The patient experienced pre-syncope episode. The physician reported the patient became very lightheaded, pale and had brief vision changes and some nausea. The patient recovered fully from the episode after sitting down and drinking some water. The physician reported that the patient received MENACTRA in the other arm at the same time as BEXSERO dose.
On 10/21/21 the employee reported that after the vaccine he has been having a stinging pain in his arm when he raises his arm above shoulder height. The employee stated that his arm was sore for the first 24 hours after the vaccine, then he stated the pain went away for the next 24 hours, and then the stinging started when he raises his arm out in front of him, above shoulder height. It was recommended that the employee see his primary care provider. The employee stated that he has tried to stretch his arm, but has not tried any other treatments for the pain.
Several hours after flu vaccine was given, developed multiple pruritic urticarial lesions - generalized - face - extremities trunk.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Medium
Noticed a red rash on her left arm the day after vaccine. Did not look again until 8 days later and noticed the reddened area  got bigger. Has tried putting ice on it, as my daughter recommended her to do 2 days ago in 15 minutes intervals 3 times a day. Slowly fading now since been placing ice on it.   Spoke to my doctor yesterday who recommended her to call VAERS and make a report and then call back and make an appointment to get checked out once I spoke with you (VAERS).
Fever 101, aches and pains, chills, headache, tired, lack of focus starting 8 hours after vaccine.  Fever mostly gone the next day.  Aches and pains and lack of focus/mental acuity continuing and slowly getting better.
Flushed face w/in 10 minutes - After 20 minutes, began with chills & severe shaking. Temp 99.3 - Took Aleve 4:30 went to Urgent care per Doctor's advice. Given injections of Prednisone & Antihistamine at 5:15pm. Told to take OTC Benadryl. Went home & to bed. Shaking ceased shortly after injections. 6pm temp at 101.2 ceased shortly after injections. 6pm temp at 101.2 8pm 100.6 - 10am 98.6 - tired, achy, but better by end of day.
5/8/11 swelling & redness of entire arm, a knot at site of vaccine, all over body aches. Urgent care treated with 5 days of Antibiotics, Prednisone.
A 4 year old female patient had a DTAP 0.5 cc vaccine on 5/24/04 with no redness or swelling on 5/24/04. On 05/26/04 she developed redness and swelling on left anterior thigh
Nausea 2nd vaccine. Reported same with first vaccine lasted 2 HR. Feels OK to go home.
After my 2nd dose vaccination I experienced the following symptoms: Headaches, fever, chills, upset stomach, fatigue and this went off and on for 6 weeks. I took Advil for treatment and a lot of bed rest. After 6 weeks the symptoms subsided and I was feeling much better.
shingles; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer(patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Consumer stated he was scheduled to receive the second dose on 21 MAR 2021. Consumer states he was diagnosed with shingles a couple days before his scheduled appointment for the second dose. Outcome of event was unknown.Therapeutic measures were taken as a result of shingles.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Noticed within 24 hours of injection itchy rash - joints - armpit - elbows - knees - ankles - stomach.
Two days post vax, the pt complained of fever, rash on face, vomiting in the PM. Treated wit Motrin and Atarax by attending physician.
HPI: patient presented to the ED with 2 day history of chest and back pain, in Ventricular Tachycardia and cardioverted,  73yr old male with a history of CAD status post stent who presented to the ED with 2 days of chest pain, shortness of breath and weakness.  Symptoms worsened today.  He arrived to the emergency department in ventricular tachycardia.  His blood pressure was 103/69.  He was given succinylcholine 50 mg IV as an attempt at cardioversion.  This apparently worked.  A repeat EKG demonstrated a left bundle branch block which is new.  And there was concern for ischemic change specifically in leads V2 and II.   Chest x-ray shows hypervascularity concerning for fluid overload.  Mediastinum appears normal.  CBC shows leukocytosis.  Creatinine minimally elevated at 1.51.  It was 1.35 two weeks ago.  DIAGNOSIS: #1.  Acute coronary syndrome #2.  Ventricular tachycardia #3.  Chest pain #4.  Congestive heart failure new onset
chills; Case reference number MOD-2021-009276 is a spontaneous case report sent by a Non-Health Professional on 19-JAN-2021 00:00:00 , which refers to a Male aged 72 Years .  The patients past medical history included: No adverse event   . .  On  the patient started taking Moderna COVID-19 Vaccine for . Some  later, the patient developed Chills. Over a period of the next <ENTER DURATION OF EVENT> days, the patient also developed . Relevant laboratory results included   and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:. The eventual diagnosis made on was Chills . .  The patient was treated for the event with  . <ENTER ANY PROCEDURES> The action taken for Moderna COVID-19 Vaccine was  Unknown on . An autopsy was performed on .The Non-Health Professional did not declare any relatedness between chills and Moderna COVID-19 Vaccine In their opinion, other possible etiological factors included  <STATE OTHER FACTORS> and the patients age/ history or other factors <LIST OTHER RELEVANT  FACTORS> .  The company believes the following facts are also relevant in this case: <LIST OTHER RELEVANT FACTORS HERE> OR  <THERE IS NO KNOWN PLAUSIBLE MECHANISM BY WHICH THE DRUG WOULD CAUSE THE PRIMARY EVENT>.  The medical reviewer may provide a case evaluation statement, including other possible etiological and confounding factors, e.g. (only limited information has been obtained so far, it is difficult to assess the cause and effect relationship; the co-medications y and x should also be considered causative as the reported event is labeled for both drugs; the company's view is the event is not due to the drug for the following reasons  (probably due to pre existing disease); there is no plausible mechanism to implicate the drug.  .   Terse Narrative (for PSUR narratives and signal review) Brief 3 line summary of above for CIOMS listing: Report Source- Non-Health Professional,  Age- 72 Years,  Sex- Male,  Suspect Drug- Moderna COVID-19 Vaccine,  Treatment-    Diagnosis\Outcome-  .