chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bump on right thigh, pea-sized, tender when touched, but otherwise ambulating without difficulty. 2 cm area of bruising with a pea-sized papule just below the skin on the anterior medial part, movable and firm. Likely, walled-off cyst or scar tissue. No treatment required.
migraine, nausea, foggyness, body aches, neck pain, fatigue since date of booster.... symptoms getting worse not better
Soreness / tenderness of injection site on arm for each dose.  The soreness did not present until I was in bed for the first does in my left arm (not dominant) and progressively got worse.  It was not unbearable, but more intense than when I get the flu shot.  The soreness lasted for about two days.  The soreness for the 2nd does in my right arm (dominant arm) started almost immediately as I recall.  It was did not get as sore as the first dose and lasted about 1 1/2 days.  I was somewhat tired the evening of the second shot, but nothing dramatic and may be unrelated.
This spontaneous report as received from a nurse refers to a 8 months 29 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose, strength and route unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contaca6t details were provided.
That evening pain in right temple. After going to bed got extremely cold, shaking, shivering. Put on 5 blankets to get warm. Next day felt extremely tired and sick. Also noticed a vein on left side of forehead became quite enlarged. After a couple days the vein was not noticeable anymore.
My baby quit breathing, was not able to be revived through CPR and passed away. Irritability in the weeks prior.
patient arrived via ems from nursing facility with complaints of low oxygen saturation. Patient was recently diagnosed with pneumonia. Patient is currently taking a zpack and received a rocephin shot tonight at facility.
Chills, extreme fatigue, nausea, loss of appetite, headache lasting two days
Noticed on apple watch HR was going up to 120s/HR still elevated. Goes up to 120 when standing. Went to take a shower and HR was 150; diarrhea; Developed rhinorrhea; Developed a pruritic rash on right side of back; chest heaviness; allergic reaction; SOB; chills; This is a spontaneous report from a contactable nurse. A 12-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported), intramuscular, administered in left arm on 15May2021 as first dose, single dose for covid-19 immunisation. Medical history included allergic rhinitis/conjunctivitis from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications included medications the patient received within 2 weeks of vaccination as cetirizine 5mg, and clotrimazole 1% topical cream. The patient previously took amoxicillin and experienced allergies. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient been tested for COVID-19 which included Covid 19-PCR (nasal swab) on 16May2021 as negative. On 15May2021, the patient received vaccine (Pfizer) and got chills a couple hours later. On 16May2021, patient developed a pruritic rash on right side of back and mom gave an allergy medicine (cetirizine), developed chest heaviness, and SOB (shortness of breath), no tongue/lip or throat swelling. Patient came to ED and received albuterol and decadron due to concern for an allergic reaction. On 17May2021, patient developed rhinorrhea; and chest and SOB improved, but continued to use albuterol. On 18May2021, patient had rhinorrhea and diarrhea; continued to use albuterol. On 19May2021, patient had diarrhea and noticed on apple watch HR (heart rate) was going up to 120s; last use of albuterol. On 20May2021, patient's diarrhea resolved, HR still elevated, went up to 120 when standing; and went to take a shower and HR was 150. The events were reported as serious medically significant, resulting in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures in response to the events included diphenhydramine, decadron, and albuterol. The patient recovered from the event diarrhea on 20May2021. The outcome of the other events reported was not recovered.; Sender's Comments: Based on temporal association and profile of the product, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0168, expiry date not reported).
severe rash all over her body; itching; Sweating a lot; Shivers; Fever of 100.4- 100.6 degrees; very tired; left side of head hurting so bad she couldn't touch it; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PYREXIA (Fever of 100.4- 100.6 degrees), FATIGUE (very tired), HEADACHE (left side of head hurting so bad she couldn't touch it) and RASH (severe rash all over her body) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Apr-2021, the patient experienced CHILLS (Shivers). 30-Apr-2021, the patient experienced PYREXIA (Fever of 100.4- 100.6 degrees), FATIGUE (very tired), HEADACHE (left side of head hurting so bad she couldn't touch it) and HYPERHIDROSIS (Sweating a lot). On 01-May-2021, the patient experienced RASH (severe rash all over her body) and PRURITUS (itching). On 02-Apr-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 30-Apr-2021, CHILLS (Shivers), PYREXIA (Fever of 100.4- 100.6 degrees) and HYPERHIDROSIS (Sweating a lot) had resolved. On 01-May-2021, FATIGUE (very tired) and HEADACHE (left side of head hurting so bad she couldn't touch it) had resolved. At the time of the report, RASH (severe rash all over her body) and PRURITUS (itching) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, Body temperature increased: 100.4- 100.6 (High) 100.4- 100.6 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is not on any concomitant medications, but took Tylenol for symptoms. she contacted her doctor who told her to take Benadryl.   This case was linked to MOD-2021-103627.
DTaP - HiB combo given before 15 months of age.  No side effects reported.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with VARIVAX (Merck) (dose, units, route of administration, anatomical location were not reported) which was exposed to a supported temperature excursion on 15-AUG-2014. No adverse events had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
p/vax pt devel intussusception requiring reduction in OR; septic shock secondary to re-perfusion injury-PICU-intubated, dopamine; fungemia & pseudomonas pneumonia during hosp course; D.I.C.;ARDS;acute renal failure s/p peritoneal dialysis;
On the 9th day after vaccine (2/25) the injection site started getting a red rash, was itchy, hot and painful to touch. It has gotten progressively worse. Yesterday, 3/1, there was an obvious lump/knot under the skin but has receeded today. About the same time (9th day) started having gastro issues. Stomach pain and vomited on February 27th. Have had stomach pain and diarrhea every day since. I have also had a headache since the onset of the rash. I have not taking anything due to fear of causing more reactions. Only using a cold compress.
Intense uncontrollable shaking, uncontrollable contraction of all muscles, inability to control breathing, intense very shallow hyperventilation, Inability to speak or answer questions, severe muscle aches, soreness.
On the 19th to the 20th after the vaccination My mother had a lot of headache and on the 21st day after the second dose of the vaccine was administered she had a lot of pain in both legs for 4 days, she could hardly walk. We did not suspect it was the vaccine so she just rested and did not contact her doctor. But yesterday we saw in a news story that this symptom should be reported.
Information has been received from a "over 50" year old female consumer reporting on herself who on 30-MAR-2011, was vaccinated with a dose of PNEUMOVAX 23. On 30-MAR-2011, the patient experienced injection site swelling "below". The injection site that was on "the face of the arm and then rotated around the arm and was hot and painful". By Monday (04-APR-2011), it had subsided. Also, it was reported that then Wednesday through Saturday she had a fever of "100 degrees". At the time of the report, the patient outcome was unknown. Additional information is not expected.
The pt's mom called on 10/24/01 at 11:00 am with a temp of 100.2, was fussy. Given Tylenol and advised to call if there are changes.
Within 5 minutes of receiving both the Meningococcal B and Meningococcal Conjugate, Patient was able to get down off table and sit in near by chair of her Mother. Mother noticed she was slumped over and upon further observation of daughter she was having tremor/seizure like symptoms. Mother called her name to get attention of daughter and within seconds the daughter responded and came to. Daughter did not know what took place and felt clamy, light headed, with color removed from face and eyes dilated. Daughter laid down on table and within a 5-10 minutes took some sips of water and regained strength and stability to walk out on her own.
Metallic taste; Migraines; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: ER8733) via an unspecified route of administration in the right arm on 26Mar2021 at 09:00 (at the age of 62-years-old), as a single dose for COVID-19 immunisation. Medical history included gluten and amoxicillin allergy. Concomitant medications included meloxicam (MANUFACTURER UNKNOWN) and levothyroxine (MANUFACTURER UNKNOWN). The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced metallic taste within first minute on 26Mar2021. The patient had several (three) days of migraines during the five days since vaccination. The patient had not receive treatment for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of metallic taste and migraines was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
PT HAD SWELLING AT INJECTION SITE, HIVES ON SHOULDER FACE AND TORSO.
p/vax pt devel vomiting/bloody stools/abd pain; adm to hosp; A nurse reported that a 2-month-old male received Rota Shield, DTAP (manufacturer unknown), Hib (manufacturer unknown) and IPV (PMC France) vaccines on 26-Apr-1999 and subsequently developed loose stools with gas and pain and crying. He was seen by the physician on 06-May-1999. A diagnosis of formula intolerance, umbilical hernia and "constipation" was made. The mother was instructed to decrease administration of mineral oil and change the formula to Nutramigen. A copy of this report has been forwarded to PMC, manufacturer of IPV. Additional information received 09-Feb-2000 provided patient, vaccine, and administrator information. Follow-up information received 17-Jul-2000 indicated that the infant recovered. The Hib-Titer lot number was corrected.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns an 81-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 15-Oct-2018, the patient was administered FLUAD (TIV), [route of administration: Intramuscular, anatomical location: right deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805474 was crossed linked to original case 201804863 due to same reporter.
COVID-19 vaccine (Pfizer BioNTech for 12 years old and above; Lot # FK9729) administered at 3:36pm. Patient walked out of the nurse's room after vaccination and sat down in the hallway to be observed for 15 minutes. At 3:38 pm, this nurse was alerted by a noise outside her room and found the client being assisted by other staff. This nurse immediately came to the location and observed the client to be pale, but alert, client stated  "he looked down on his phone and then felt lightheaded, weak and didn't know what happened". Client was assisted to a wheelchair and brought back inside the exam room, assisted the client to transfer to the exam table and laid him down for further observation. Vital signs checked at 3:40 pm - Blood Pressure 108/49 mmHg; Pulse 64 bpm; Oxygen Saturation via pulse oximeter 97%. Patient is alert and oriented to name, time and place, in no respiratory distress, no visible injury noted. Nurse assessed patient's head, arms, and legs for any injury or swelling, none noted at this time. Client denies any pain on his extremities, denies any headache, ice pack placed on the client's back side of the head to provide comfort. Supervising Clinic Nurse and Nurse Manager notified of the event. Client reported that he "hasn't eaten anything today, got out of bed and came to his appointment." Adult client's mother is an employee at this facility and actively present during this time. Mother stated that her "son usually faints when having blood drawn or receiving vaccines." Client was provided with a soda and granola bar to eat. Vital signs re-checked at 3:45 pm - Blood pressure 133/71 mmHg; Pulse 82 bpm; Respirations 18; Oxygen Saturation via pulse oximeter 98%. After 30 minutes, client is observed to regain his normal color, and in no respiratory distress, sitting upright, and talking. He is alert and oriented to name, time, and place, denies any headache, nausea, blurred vision, or dizziness. At 3:52 pm, vital signs checked: Blood pressure 123/71 mmHg; Pulse 83 bpm; Oxygen Saturation via pulse oximeter 99%. Client ambulating with a steady gait, stated he "feels better". He was discharged to mother (PHN) who was advised by Supervising Clinic Nurse to continue monitoring for additional 30 minutes to make sure he is stable before he is driven home by her or himself. Mother reported that the client was feeling better and left the clinic via his own vehicle at 4:55 pm.
Uncontrollable, high pitched cry times 5 hours within 24 hours of vaccine in association with fever 102.2 (ax).
On June 10, 2021 around 1:20am, child woke me up and stated that he has a headache.  After feeling his head, he felt very warm with a temperature of 102.3 using both a digital and under the tongue thermometers.   I had child to take a Tylenol pill with something to drink.   At approximately 4:45am took the child's temperature again and it was 99.6 degrees and I had the child to take another Tylenol pill at that time, so that the temperature wouldn't spike up.  Around 9:30am, after allowing him to sleep, he woke up and stated that he felt better.  Then, I was able to go to work.
PATIENT FELT VERY TIRED ON SAME DAY HE GOT THE VACCINE. ALSO ON THE SECOND DAY HE DEVELOPED SPOTTED RED AREA AROUND INJECTION SITE WITH RASH HOWEVER AS PER PATIENT IT IS GETTING BETTER.
Vaccinator: Was told by screener pt is getting Moderna. I grabbed 1 Moderna vaccine and put syringe label on screener sheet. Next car was getting Pfizer. I grabbed Pfizer vaccine and took of sticker and gave to screener. I went to paitients car and gave Pfizer vaccine by mistake. Staff was notified.
Dizziness and vertigo with movement. Worsened the next morning and developed nausea and headache.
Developed hard lump at injection site,about the size of 2/3 of a dollar bill. It was very painful and protruded from the arm about a half inch. Next day felt tired, feverish and gradually whole upper arm swelled up and turned red. November 8/9 the swelling began to go down but I noticed 2 little "bags" of skin on either side of the elbow that looked like they contained fluid. Dead white cells, I suspect. As of 11/11, arm back to normal size, redness almost completely gone, and skin "bags" almost gone.
Patient developed blistery red rash 2 days ago.  Seen by physician: diagnosed Varicella
Client received a Pfizer Booster at Event lot#FK9894. Client was vaccinated with Pfizer Booster at 910 by RN. At approximately 945 client stated he had mild eye burning, Client denied itchiness or difficulty swallowing. No eye swelling was observed, and client denied swelling in eyes. Client stated, he had never experienced this symptom before. Client also stated he?s been having symptoms of numbness in arm, headache and weakness. RN recommended client to seek emergency care for the symptoms he?s been experiencing. RN asked client at 954 if his eyes were still burning.  Client stated the burning had subsided. Client denied any other symptoms.  RN educated client in seeking emergency care for worsening symptoms. Client verbalized understanding. Client left vaccination site in a steady gait.
injection site swelling; injection site warmth; Very sore arm; Flu like symptoms; Rough, terrible headache; Low grade fever; Body aches; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of injection site warmth (1st dose received on an unknown date and had injection site swelling, refer case US2021AMR178354), MODERNA COVID-19 VACCINE (1st dose received on an unknown date) and MODERNA COVID-19 VACCINE (2nd dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced injection site swelling, injection site warmth, pain in arm, influenza-like symptoms, headache, low grade fever and general body pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the injection site swelling, injection site warmth, pain in arm, influenza-like symptoms, headache, low grade fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site warmth, pain in arm, influenza-like symptoms, headache, low grade fever and general body pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the 2-shot last year.  After the 2nd dose of Shingles vaccine, the patient experienced very sore arm, flu like symptoms, terrible headache, low grade fever and body aches. No contact details were reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178354:Same reporter.
Patient reports itching under the skin of arms and face that has been unrelieved by OTC and prescription antihistamines that has been ongoing since receiving the vaccine.
09/21/22 presents to ED for "fall" "leg injury". PMHx of "dementia, HLD, HTN, DMT2"
Injection site swollen, raised, itchy, red, hot.  Ice pack, benedryl, advil.  Slowly went away and then came back again on 01/04/21 woke up 6:00 am injection site raised, itchy, red, hot, swollen.  Used hydrocortisone cream and benedryl.
I don't normally have headache but after the Pfizer vaccine, I realized my head is constantly hurt. Even I sit and drive in my car. I relax on couch or working. It is not a heavy like migraine headache but more like a lightly headache that is distracting me. I keep feeling a little pain up behind my back head.
The pt experienced a severe local reaction at the injection that was painful and with an 8 x 4 cm area of erythema and induration.
He was lifting weights 4 days ago, states he did chest press of 135lbs, 4 sets of 15 reps.  He stated this was lighter than his usual work out, but noted he noted no chest wall pain during or after work out. Of note, pt did receive anthrax vaccination 2-3 weeks prior in left arm on March 21, 2011
Rapid heart rate for about 1.5-2 hours starting about 4 hours after booster vaccination and several episodes of palpitations the following day - resolved without seeking medical care. Very tender and swollen lymph node left underarm from 12/29/21 till 1/2/22 - some ongoing aching but mostly resolved. Heavy vaginal bleeding began 12/29/21 around 10-11am, about 2 weeks after last menstrual bleeding - has gradually reduced from 12/29/21 to present 1/7/22 with light bleeding ongoing. Notably had Mirena IUD placed 9/22/21 but cycle had seemed like it was starting to normalize before this.
pt recv vax & devel an inj site rxn (red, warm @ site) in OCT96;
Pt woke up with diffuse pruritic rash afebrile. Several scattered papules/pustules/vesicles with erythematous base. Increased over the next 2 days.
Warm, white center red around, painful and itchy around injection site. Seen by clinic, diagnosed as cellulitis. Treated with cephalexin.
This is a spontaneous report from a contactable physician via a Pfizer employee. A currently 24-month old female infant received PREVNAR 13 at an unknown anatomical site in Feb2011. Relevant medical history was unknown. Relevant past drug history included three doses of PREVNAR. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. On unknown date at an unknown time after the patient received the PREVNAR 13, the patient was diagnosed with otitis media and non-effectiveness of PREVNAR 13 was suspected. Relevant lab data included culture of otitis media carried on an unknown date which revealed 19A serotype. As of 13Apr2012, the clinical outcome of the otitis media was unknown.