chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/26/21-He presents with 2-day history of nasal congestion, sinus headache, chills, cough, and sweats.  Denies any fever or shortness of breath.  Denies any leg pain or leg swelling.  Has some fatigue.  He has been vaccinated against COVID-19 with Pfizer vaccine.  No known COVID-19 contact  10/26/21-Patient was given Regeneron infusion
On day 5 after my first shot I experienced extreme brain fog.  I was struggling to find words and my mind will completely blank out in the middle of speaking a sentence.  I have a difficult recalling and retaining new information.  My symptoms worsened as the week went on and continues to be an issue 3 weeks after my first shot although the severity is lessening daily.
Information has been received from a pharmacist referring to unspecified number of patients with unknown age and gender. There was no information about the patient's medical history and concurrent condition. On unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
My daughter received her flu shot at the pediatrician's office. She has had a prior injection site reaction with her 4 year old vaccinations. At that time, she received two shots in each thigh. She developed severe swelling, erythema, pain, and induration. I took her in for evaluation with her pediatrician and conservative management was recommended. She had no systemic allergy symptoms. The swelling, erythema, pain, and induration subsided within 5 days. THIS time, on 10/15, she is currently 6 years old and received the flu shot. The same symptoms occurred in her left deltoid area, the location of her injection. Within 24 hours after her shot, she had a 3 inch area of swelling, warmth, erythema, pain, and induration. She does not have any severe allergy reactions such as airway issues, swelling of the throat, etc.
Initial information received on 14-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a five-months old male patient who received only the liquid portion of the PENTACEL, while he received vaccine PENTACEL. Concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 09-Nov-2018, the patient received a once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5518AA in the right thigh (It was reported that the vaccine was administered in right vastus). It was actual medication error due to Inappropriate reconstitution technique. (It was reported that patient who received only the liquid portion of the PENTACEL). It was not reported that the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Patient stopped by the pharmacy to advise us that she broke out in rash down  arm. Patient appears not to be in distress and the rash is not itchy.  She was advised to follow up with her doctor so they knew she had a reaction.
Around 7:30 p.m. my face and especially cheeks, started getting very hot and even appeared to be very red.  This continued through the night and forced me to blow a fan on my face in order to sleep.  The hot feeling in my face had dissipated by the time I woke up at 6:30 a.m., however, my cheeks remain rosy in color.
Began itching the morning following the vaccine around 5am.  Itching increased throughout the day becoming unbearable by early afternoon.  Hives were presenting.   At 3:30 that day I went to urgent care and was prescribed Prednisone, 2 tablets per day, 20 MG and Benadryl.  On the way home from urgent care my throat became extremely itchy and began to swell.  I returned to urgent care immediately and received a dose of epinephrine.
Approximately 3 cm erythema papular eruption at site, with localized tenderness. Observation only.
Moderna booster was administered to patient although patient was not 18 years of age (off-label use). Patient reported no reaction to the vaccine.
HEAVY SWEATING, NAUSEA, SKIN COOL TO THE TOUCH AND NUMBNESS OF THE KNEES. SHE'S 6 MONTH PREGNANT.
Could not move; Extreme nausea almost to the point of vomiting; Chills; Headache; Extreme fatigue/Fatigued/just tired/Tired; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Could not move), NAUSEA (Extreme nausea almost to the point of vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extreme fatigue/Fatigued/just tired/Tired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 023C21A and 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arm fracture (Broken arm). Concomitant products included MELOXICAM (MOBIC) for Arm fracture.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced MOBILITY DECREASED (Could not move), NAUSEA (Extreme nausea almost to the point of vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extreme fatigue/Fatigued/just tired/Tired). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date for Adverse event, at a dose of UNK mg. At the time of the report, MOBILITY DECREASED (Could not move), NAUSEA (Extreme nausea almost to the point of vomiting), CHILLS (Chills), HEADACHE (Headache) and FATIGUE (Extreme fatigue/Fatigued/just tired/Tired) outcome was unknown.            Patient stated that after getting her shot (booster dose) yesterday, she woke up with extreme nausea almost to the point of vomiting, chills, headache, extreme fatigue, and chills. She was just immobile yesterday when it happened, just tired and fatigued, she could not move her due to headache just pounding. She took Extra Strength Tylenol 1000 mg; she could not take Ibuprofen because is taking Mobic 15 mg for broken arm.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: EP7533), on 15Apr2021 as dose 2, single (Lot number: ER8731), on 02Dec2021 as dose 3 (booster), single (Lot number: Fj8762) and on 12May2022 as dose 4 (booster), single (Lot number: FN9222) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Parkinson" (unspecified if ongoing), notes: other medical history: Parkinson. Concomitant medication(s) included: SINEMET, start date: 29Sep2019; EFFEXOR, start date: 31May2021; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; MELATONIN, start date: 31May2021. Past drug history included: Sensitive to codeine, reaction(s): "Allergy", notes: known allergies: Sensitive to codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Report about covid treatment reported as Yes. if vaccine received reported Yes. other medication in 2weeks reported as Yes. Anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 14Jun2022, treatment stop date: 18Jun2022, indication: Treatment of COVID-19. Adverse event reported as Rebound case of Covid 6 days after completion of course of Paxlovid.
Pt vaccinated w/1st dose of Recombivax HB noted chest tightness, fogginess in her head & sneezing;
Less than a week after my shot I started bleeding heavily with clots. I had already been on my period 2 weeks prior. I bled heavy for 8 days which is unusual. I have only had one period since then in this time span. I have hot flashes now and no period. I am like clock work. I also was just checked last year to make sure I was not in peri menapause as we may have to adjust my thyroid medication or treatment plan.. but I was not. My levels were WNL. I also have substantial bruising as well. Randomly on my body. I?m a RN and I actually didn?t know who to report these things too as there  was no information given to me at the time of my vaccine.
Immediate injection site became feverish and swollen. Arm doubled in diameter and was very red and hot. Feverish, stomach cramping, fatigue accompanied with severe headaches for seven days. The knot in my arm is still blue after over 2 months. Fatigue was severe and I needed 9 hours sleep to overcome.
This case was reported by a consumer via call center representative and described the occurrence of injection site burning in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site burning, injection site lump, numbness, tingling and injection site bruising. On an unknown date, the outcome of the injection site burning, injection site lump and injection site bruising were recovered/resoled and the outcome of the numbness and tingling were not recovered/not resolved. The reporter considered the injection site  burning, injection site lump, numbness, tingling and injection site bruising to be possibly related to SHINGRIX. Additional details were provided as follows: The patient picked up the prescription for the vaccine at her pharmacy and took it over to her doctor's office where it was administered. The person administering the vaccine told her it was being given intramuscularly into her left upper arm muscle. While the vaccine was being administered, the patient felt a feeling of burning in her left upper arm which resolved soon after the vaccine was administered. The patient was not sure what was administered. The patient commented aloud about the burning feeling during the vaccine administration and was told that she was the first patient who had complained of that symptom ever before. The patient arm then hurt at the site of injection for about three or four days. Within about one week after she received the vaccination, from her shoulder to her elbow she started feeling numbness and tingling which comes and goes and had not changed or not yet resolved. The patient described that the numbness and tingling felt like the feeling of her arm's falling asleep. The patient wondered if the vaccine was perhaps administered incorrectly or if possibly a nerve was hit while the vaccine was being administered. The patient did not know if she wants to have the second dose in the series. The vaccine was administered a couple of months ago. The day after the vaccine was administered a small bruise started around the injection site of her left upper arm muscle, and it grew in size within the next couple of days to the size of a 50 cent piece. The bruise lasted about one and one half weeks. The next day after the vaccine was administered she had a lump described also as a knot at the injection site which within one week resolved. The patient had denied permission to contact their physician. The patient declined to provide concomitant medications, reporting that she never had the reported symptoms while using her regular medicines prior to the vaccine administration.
Post menopause bleeding on 3/14/2021. Was heavier than normal with severe stomach cramps.
fever 104, joint pain neck, spine, arms, legs, chills-redness, swelling @ inj sites; rx w/Pred 17NOV95; adm to hosp 18NOV, dx cellulitis lt arm rx IV ATB (Vancomycin discharged 19NOV;
Injection area very tender 3hrs after injection , joints experiencing pain especially when exiting a vehicle . or that type movement . i have swelling under my arm pit area about 4 inches in diameter and is about three times normal size compared to my right side.  The arm is still tender maybe a 3 out 10 scale , This is Sunday morning and the under arm is till swelled.
Fever 103.7, then thrombocytosis (> 10^6), then pulmonary embolus, then acute liver failure
Pt went into shock like condition became ashy pale & clammy; Femoral pulses & heart rate remained normal; Heart tones were strong; Color returned in 5-10min; Started sucking on bottle; Pt was alert; no tx required;
This case was reported by a physician and described the occurrence of sore arm in a 17 yr old female subject who was inadvertently vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). At the time of administration of Infanrix, the subject was taking Azithromycin for bronchitis. On 25OCt05 the subject inadvertently received a dose of Infanrix in the left arm (dose number and lot number not provided). Infanrix is not recommended for immunizing individuals 7 years of age or older. On 25Oct05, the subject was also vaccinated with influenza virus vaccine (Fluzone). The site of the injection of the Fluzone was not provided. On 25Oct05, less than one day after vaccination with Infanrix and Fluzone the subject experienced a sore arm. At the time of initial reporting, 27Oct05, the sore arm was ongoing.
Vaccination given 5/24; redness started 5/25; evaluated 5/26 and treated for cellulitis. (tx: KEFLEX and BENADRYL).
After approx. 4 days, wherein the pt was very sleepy with high fevers. Pt began making high-pitched screams, especially at night. Soon afterwards, his eye contact diminished. At the time, we thought these were temporary symptoms or perhaps a developmental phase. "PDD" dx'd by developmental pediatrician at 2 1/2 year old (5/30/00); heavy metal urine analysis reports indicate severe mercury poisoning, first confirmation on 3/23/01.
Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. The patient's concurrent and historical conditions were not reported. The nurse reported that doses of GARDASIL (dose, route and site of administration were not reported, lot # K006960, expiration date 19-FEB-2017 and lot # K016966, expiration date 10-MAY-2017) which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 18-JUN-2015. Concomitant therapies were not reported. No adverse effects had been reported. This is one of several reports from the same reporter. Additional information has been requested.
It was reported that a 29 year old male received Fluzone SV 98-99 USP on 10/12/1998. Reportedly 12-13 hours after receiving the vaccine the pt developed shaking chills, myalgia, and a fever of 103 F. No hives, wheezing, or dysplasia. Reportedly the pt recovered from this experience. From additional information received on 11/13/98, it was reported "reviewed, no additional information at this time, MD 11/10/1998"
Patient received vaccine on  1/3.  On 1/5 developed worsening neck pain and HA.  Went to ED where lumbar puncture showed mild pleocytosis to 14 with 80% lymphocytes, 0 RBC, and normal glucose and protein.  Patient was admitted and treated for viral meningitis. Next day HSV PCR came back negative and after treatment with  APAP, compazine, and morphine patient's HA resolved.   CMV, EBV, VZV, enterovirus, and parechovirus, test of CSF all were negative.  Determined to be aseptic meningitis and patient was discharged home.
Client complaining of rash on upper chest and feeling flush . evaluated by EMS. BP 140/94, P 90, O2 97% Lungs clear.Client called family to pick her up and take to her PCP.
This case was reported by a physician via call center representative and described  the occurrence of feeling bad in a 19-year-old female patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018). Concomitant products included ADDERALL and fluoxetine. On 10th January 2018, the patient received the 3rd dose of BEXSERO .5 ml. On 10th January 2018, less than a day after receiving BEXSERO, the patient experienced feeling bad and extra dose administered. On an unknown date, the outcome of the feeling bad and extra dose administered were unknown. The reporter considered the feeling bad to be probably related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in right arm. The patient received 3rd dose of BEXSERO, which led to extra dose administered. After receiving BEXSERO, the patient physically felt bad. No further details were known.
Dizziness - weakness - numbness 5th digit at home for about 10 - 15 mins. Patient treated with Epinephrine SQ.
Flu symptoms improving; reports this response every time he gets the flu, will enter as adverse response. Flu like symptoms. Loratadine 10 mg every day.
Within 3 minutes after the shot , I got dizzy, felt warm, sick to my stomach, and it felt like someone was squeezing down my spine in  4 places in succession and I let out some gas.  This reaction lasted maybe 2 minutes and it disappeared. It was like a wave of reactions that happened quickly, 1 after the other.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: PATIENT RECOVERED AFTER LYING HER ON HER BACK WITH FEET ELEVATED.
(Immediately after - soreness of the injection site arm and that was it. The next day, it didn't even feel like I had had a shot.) Health Event in August - I felt fatigue for two days or so. I felt like I was out of breath then two days after that. Both of these symptoms continued. And also I had a lack of appetite and a lack of taste right off the bat. I had a cough. My chest  - I felt like I couldn't take a full breath but my oxygen level was between 92-96 most of the time. My wife checked my temperature - and it was 99.8. Then my fever started going up- 99.8 and then 101.2 - I took acetaminophen - my fever was going down a little bit with that. A week into it, I got a fever of 104. I had diarrhea, too. My liver transport coordinator told me to go immediately to go to ER and get an infusion of monoclonal antibodies. ER was hot and packed with people. It took almost 40 minutes to get checked in and an hour later and they came out saying that it would a long time before we could be seen. My wife was feeling sick too and she was worried that she wouldn't be able to drive me home if we waited into the night. The next day we went very early in the morning and then I was able to get the infusion (Regeneron). They kept me a little while - an hour or so to make sure the infusion they gave me didn't give me any side effects. I went home and it took a couple of days for me to feel better. Quarantined until about August 28th - until I didn't have a fever for several days.
Child received FluMist per protocol and after review of signed consent form on 9/26/06 an AM at school clinic conducted by health dept. Mom reported child played football that evening. After school on 9/27/06 mom noticed redness around nose, inside of nose and under eyes. On 9/28/06 child went to school with same amount of redness on his face. On 9/28/06 at 10:00am, the school called the parent due to an increase in the redness. Mom took the child to Dr who evaluated the rash. Mom was asked if it was poison ivy. Mom stated no that she thought it was a reaction to receiving the FluMist vaccination two days earlier. Dr gave child oral Benadryl and cortisone cream with instructions to return if condition worsened. Mom gave the child cortisone cream but there was no positive effect. Child was a little itchy but Benadryl controlled the itch. Mom returned to Dr on 9/29/06 because reddened area had spread to trunk and extremities. Area around face (nose, nostrils, and under eyes) was slightly raised and contiguous (as reported by mom). Area on body (trunk and all extremities front and back) was speckled (as reported by mom). Mom reported that reddened areas became slightly raised but did not weep. Dr gave child Oraped and Benadryl orally Q 6 hours PRN. Mom took pictures of child on 9/29/06 to document affected areas. Mom said that she would send copies of the photos for reference. On 10/2/06 in the afternoon, nurse manager notified director of nursing of childs reaction and clinic management of the condition. Director of Nursing was able to contact mom the morning of 10/3/06 to discuss events and gather information for VAERS. They informed mom that they were submitting VAERS and reporting the incident to the vaccine manufacturer. In addition they recommended that mom talk with their pediatrician before receiving another influenza vaccination. Mom reported that child was recovering fine but still has some redness.
Information has been received from a physician concerning a male pt in his sixties with no allergies or pertinent medical history who on 16-FEB-2005 was vaccinated in the left deltoid with a 0.5 ml dose of Pneumovax 23 (lot # 649912/0529P). On approximately 17-FEB-2005, the pt developed an 18 centimeter erythematous, macular-papular diameter. Unspecified medical attention was sought and the pt was treated with oral Benadryl and topical hydrocortisone. At the time of the report, the pt had not recovered. The physician requested a lot number check. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards of CBER and was released. Additional information has been requested.
pt recv vax; very fussy; large red area to thigh & knee; hot to touch;
patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-369020 (Patient Link).
After vaccination received small blisters 1 and 1/2 to 2 inches in diameter, resolved in 3 to 4 days, no treatment.