chrisvoncsefalvay/vaers-outcomes huggingface dataset:
WARM RUSH FEELING IN HEAD; SWEATING; BLOOD PRESSURE HIGH; HEART RATE INCREASED; CANNOT SLEEP; TENDERNESS TO ARM ELBOW TO WRIST; CHILLS; SWOLLEN ARM ELBOW TO WRIST; ANXIOUS; MUSCLE STRAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle strain. Laboratory data included: Blood test (NR: not provided) did not find anything, and Diagnostic ultrasound (NR: not provided) did not find anything. On 11-APR-2021, the subject experienced swollen arm elbow to wrist. On 11-APR-2021, the subject experienced anxious. On 11-APR-2021, the subject experienced sweating. On 11-APR-2021, the subject experienced blood pressure high. On 11-APR-2021, the subject experienced heart rate increased. On 11-APR-2021, the subject experienced cannot sleep. On 11-APR-2021, the subject experienced tenderness to arm elbow to wrist. On 11-APR-2021, the subject experienced chills. Laboratory data included: Blood pressure (NR: not provided) High, and Heart rate (NR: not provided) Increased. On 13-APR-2021, the subject experienced warm rush feeling in head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm elbow to wrist, tenderness to arm elbow to wrist, anxious, chills, sweating, blood pressure high, heart rate increased, cannot sleep, warm rush feeling in head, and muscle strain. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Patient's wife called and reported side effects such as itchy eyes, scratchy throat, lethargy, fever and vomiting which all lasted a day.
Treated with BENADRYL (Pharmacist). Regarding injection and reaction received at same time from pneumonia PPSV23 and Recombinant Zoster Vaccine on 3/12/18 at 10 AM. Received both in left upper arm. 3/12/18 - Noticed swelling and redness that evening at injection sites. 3/13/18 - In morning swelling was 2" x 2" and bright red. Called drugstore and reported the reaction to the pharmacist. 3/14/18 - 9 PM, swelling was 3" x 4 1/2" x 3/8" thick and hard. Area was bright red, with rash, from injection site to elbow. 3/15/18 - 8 AM, Swelling was receding area becoming paler. Using BENADRYL as recommended by pharmacist. 3/16/18 - until. 3/23/18 - Swelling 1" in diameter and softer. Redness almost gone and rash area smaller. At the worst, pain was from top of shoulder to below elbow. 3/25/18 - The left arm and shoulder, which has always been the least painful for years, has become the worst since the vaccinations. Pain has increased and the limitation of motion has increased. Arm still itches, especially at night. 3/26/18 - Pain in left arm and shoulder has decreased some and motion has increased some. Although still itching the swelling has gone down to about 3/4". 3/27/18 - Pain has decreased and motion has increased. Swelling is down to about 5/8", there is still some itching.
Patient experienced al large red rash measuring four inches by 2 inches at its largest. Rash  was very warm and had some swelling.
Fluarix, Boostrix, 23.4 Celsius for 1 month; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season and Boostrix. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Fluarix, Boostrix, 23.4 Celsius for 1 month).  The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Sept-2023 Clinic Manager called to check stability of vaccines, Fluarix and Boostrix at 23.4 Celsius for 1 month. No prior. The reporter inquired that what if vaccines were administered. The reporter reported that he or she thought that the vaccines were administered.  The reporter unable to provide any vaccine or patient details due to still investigating. Did not consent to follow-up. The patient received Fluarix and Boostrix after temperature excursion, led to incorrect storage of drug.
Rash under breast line, then welts started all over head, feet, face, legs, back. Rash started 2/17/06.
Alcohol intoxication with delirium. Health facility admit and treatment. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
PATIENT'S LEFT ARM HAD SIGNIFICANT BRUISING AND SWELLING FOR 3 DAYS THAT HAS NOT YET RESOVLED. PATIENT DID NOT SPEAK ENGLISH AND I WAS SPEAKING WITH HER THROUGH A TRANSLATOR. I TOLD HER TO PUT ICE ON IT AND GO TO AN URGENT CARE TO SEE A DOCTOR TONIGHT. I ALSO RECOMMENDED A BENADRYL FOR ANY ALLERGIC REACTION AND TYLENOL FOR PAIN AND SWELLING. OUTCOME UNKNOWN.
he tested positive after receiving the first covid vaccine.; he tested positive after receiving the first covid vaccine.; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient wanted to know if he should receive his second COVID vaccine since he tested positive after receiving the first COVID vaccine on unspecified date. The patient also experienced unspecified side effects on unspecified dates. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
difficult raising left arm; fever; headache; body aches; flu like symptoms; inappropriate schedule of vaccine; pain at injection site; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th March 2019).   On 16th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 16th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site swelling, movement disorder, fever, headache, general body pain, influenza-like symptoms and inappropriate schedule of vaccine administered. On 17th October 2019, the outcome of the fever, headache, general body pain and influenza-like symptoms were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site swelling and movement disorder were not recovered/not resolved and the outcome of the inappropriate schedule of vaccine administered was unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, movement disorder, fever, headache, general body pain and influenza-like symptoms to be related to Shingrix.  Additional details were received as follows: The patient was suppose to get her second injection on or before 8th September 2019, but was late, which led to lengthening of vaccination schedule. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up. This case was linked to case US2019044314, reported by the same reporter.
This non-serious spontaneous case, initially recoved from other non-health professional (consumer) on 11-Feb-2018, concerning 59-year-old an adult, female patient. The patient's current conditions included hypertension and cardiac arrhythmia (since an unspecified date). The patient concomitant medications included Metoprolol and LEVOXYL. The patient's surgical procedure included thyroidectomy (unspecified date in 2003) due to lesions. On unspecified date in 2013, the patient was administered with INN flu vaccine (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number and expiry date: not reported). On the same day, within an hour of vaccination, the patient had tingling in the feet and legs and got resolved in a period of 2 hours. On next day, patient had head ache and sore neck on the left side. The back of the neck was swollen and pain radiated towards the cervical vertebrae. The patient took ibuprofen, within 4 days, the swollen and neck pain got resolved and headache got faded. The patient stated that headache reappeared again, between the doses of ibuprofen. The patient felt heaviness in her head and stated that it was not like normal headache. The outcome of the events (mecl pain, swelling, spinal pain and paraesthesia) not recovered. The outcome of the event headache was not recovered.
Client received a Tdap and MCV4 vaccine After sitting in biosafety area, client reported feeling faint, pale and diaphoretic. Client was assessed and noted responsive at all times, awake and alert.  Immediately feeling better. Client was responsive, awake and alert left with family at 1910.
Left thigh red, swollen, itchy and painful at both immunization site. Fever of 104 documented.
My daughter began to have facial(flat) warts on her face and chest after the 2nd dose of Gardasil.  There are many warts on her face and chest at least 20 or more.  She has never had this problem before receiving the vaccine.  She was treated for warts by her Doctor and now has been referred to Dermatology.  She has not recovered yet.  She will not receive the 3rd dose.
J18.9 - Pneumonia N17.9 - Acute kidney failure, unspecified
inadvertently given 0.25mL dose of FLUZONE QUADRIVALENT instead of the intended 0.5mL dose with no reported adverse event.; Initial information received on 29-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA360543.  This case involves a 3 years old male patient who was inadvertently given 0.25ml dose of Influenza quadrival A-B vaccine [Fluzone Quadrivalent] instead of the intended 0.5ml dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (COVID-19 VACCINE) for Prophylactic vaccination.  On 26-Aug-2022, the patient was inadvertently given 0.25ml dose of suspect Influenza quadrival A-B vaccine, suspension for injection, (strength: unknown) (lot UJ879AB; expiration date: 30-Jun-2023) via intramuscular route in the left vastus lateralis for immunization instead of the intended 0.5ml dose with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken : not applicable.  Outcome: Unknown.  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 guidelines. 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.
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other: Moderna/ Vaccine brand: Pfizer / BioNTech; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 12:00 as dose 4 (booster), single (Lot number: 069f21a) at the age of 34 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 at 12:00 as dose 1, single (Lot number: EN6206), in right arm and on 31Mar2021 at 12:00 as dose 2, single (Lot number: ER8732), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Dec2021 at 12:00 as dose 3 (booster), single (Lot number: GJ6665), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Vaccine brand other: Moderna/ Vaccine brand: Pfizer / BioNTech". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Mom alleges that childs breast asymmetry (Rt breast larger) was caused by HPV vaccine?
Rash and bruising growing larger over 3 days about 2 weeks post vaccination.  Hot to touch and oddly itchy.
This spontaneous report as received from the patient's father concerning his 16 year old son with allergy to red dye 40 and no pertinent medical history. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose and lot # not reported) intramuscularly. There was no concomitant medication.       On an unknown date, the patient experienced hives. The patient spent an unspecified amount of time at urgent care and received an unspecified treatment. There were no Lab/diagnosis or studies performed. The patient would see his physician on 10-FEB-2017 for a follow up. At the time of the report, the patient had not recovered.  Additional information is not expected as the reporter does not want to be contacted.
reports antero-retrograde memory loss for week after vaccine, emotional detachment, loss of sense of smell
Information has been received from a physician concerning a 1 year old healthy male with  no know allergies and no past medical history who on 08/20/2001 was vaccinated SC with the first dose of MMR vaccine. Concomitant therapy on 08/20/2001 included the first dose SC of varicella vaccine. There were no other concomitant therapies or illnesses at the time of vaccination. On 08/29/2001, the child developed red bumps with moist surfaces scattered from head to toe. On 08/30/2001, the child presented to the physician's office with scattered red bumps about 0.5 to 1 centimeter in size all over the body. There were no lesions on his hands or feet. It was noted that the lesions were not vesicular and that they blanched on pressure. The child also had a low grade fever. Over the follwoing 24 hrs, the rash became progressive, the lesions became larger and more confluent, and it was reported that they "ran together." The lesions were reddish on the outside an dpurplish on the inside suggesting an erythema multiforme pattern. It was noted that the child had no lesions in his mouth or on his hands or feet. The following day, the child developed several spots on his hands, scalp and in the diaper area. It was noted that the child" looked relatively well and was not ill-appearing" throughout his experience. He was administered Atarax through 09/04/2001. It was reported that the child recovered from his experiences on 09/02/2001. No further info is available.
The customer called to say that he had seen his md for a swelling under this arm and it was deteremined that he had a staph infection.  His MD told him that he thought it was related to the vaccine and that he should call the pharmacy to let us know of the reaction.  He was prescribed antibiotics and the infection was getting better
Although fully vaccinated and I also received the booster shot, I still tested positive for covid. Had sore throat, couch, shortness of breath, fatigue.
-Redness, itching near neck area. -Started about 4 weeks after administer date. -"Pimple like" bumps/blister. -Instructed to use BENADRYL.
Blurry vision, dizziness, loss of balance and falling to my left.  Seen to hospital directly from urgent care.
This spontaneous report as received from a registered nurse via company representative refers to a 13 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date in  June 2015 (reported as "two months ago"), the patient was vaccinated with the second dose of GARDASIL injection (dose, lot # and expiry date were not provided) intramuscularly. While receiving the second dose of GARDASIL, the patient broke out in hives on his face and arm. Therapy with GARDASIL was discontinued. The patient sought medical attention, by coming to the office for a scheduled office visit. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Additional information has been requested.
Approximately 17 hours after vaccine, suddenly got very tired, brain fog, and had some type of sleep attacks, yet couldnt sleep, head just nodded up and down.  felt very hot suddenly from the sides of the throat down straight and under both breast, felt as if I was being squeezed to death.  chest felt very heavy. yet not gasping , or breathing fast. Im a respiratory therapist disabled now. I took bp was 120/80, o2 sat was 97, heart rate was 16, pulse 83. I  could not lie down as felt as if being smothered.  had to lie down but elevated very high.  felt as if throat and chest were hot, but i did not get up to see if red, as i was having severe brain fog and oh so sleepy, yet felt so wired  on friday evening March 5,2021 when I had the shot.  I was awake, this tiredness and  heaviness didnt happen until 1pm the next day.  Saturday evening, I took o.1 ativan , thinking it was maybe anxiety as the brain for cleared after 3 hours, the chest heaviness got better, but still persisted over to sunday, march 7, but throat feeling closed in dissipated after 3 hours on saturday. 3/6. Sunday still unable to lie down as chest still felt heavy, bp 140/80 which was elevated. pulse elevated, respirations were 20.  however all side effects seemed to be subsiding
Varicella-like rash with unroofed vesicles at different stages of healing, spreading over trunk and upper extremities (total of 10 - 15 vesicles).
Headache within approximately 2 hours after the shot and has been continual for 6 days Soreness at the shot site 2 days Aching joints (day 5) after the shot
Extreme period cramps. Never had any symptoms (including period cramps)  in 11 years of having my menstrual cycle. Excruciating pain in 1st and 2nd day of period starting
Patient hospitalized due to COVID. Patient is fully vaccinated.  Symptoms: fever, fatigue
got a very strong reaction; had fever of 101ºF; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got a very strong reaction), PYREXIA (had fever of 101ºF), CHILLS (chills) and MYALGIA (body aches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got a very strong reaction), PYREXIA (had fever of 101ºF), CHILLS (chills) and MYALGIA (body aches). At the time of the report, VACCINATION COMPLICATION (got a very strong reaction), PYREXIA (had fever of 101ºF), CHILLS (chills) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101ºF.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated events outcome.
This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a male patient who received a second dose on 2/21/01. On an unspecified date, the patient developed autism. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 2/21/01. Dose regimen was 1 dose. Additional suspect vaccines included Hib-Titer vaccine and Acel-Imune vaccine. Concomitant medications were not reported. On 2/21/01, the patient received a second dose of Prevnar. On an unspecified date, the patient developed autism. The patient's outcome is unknown. No additional information was available at the time of this report.
5/12 1 am fever, chills, nausea, belly ache 8 am add headache, body aches, congestion, lethargy, lack of appetite, body temperature feverish or low Took Tylenol through the day. Unable to get out of bed. Heart racing, extreme fatigue.  5/13 4 am fever began to break, sweat through the night 8 am, chills, fever, nausea, body aches, and lethargy, extreme headache. No appetite. Fought dehydration 8 pm fever finally subsided, body aches and head ache began to lessen,, nausea letting up. 5/14 headache and belly pain persist, bowel incontinence Took peptobismal 5/15 functioned through headache and belly pain, tried eating a little, fighting dehydration but felt more energetic  5/16 headache and belly pain lessened, tried eating, easily tired, able to drink more 5/17 belly pain present, diarrhea but not incontinent, notified Goforth of lingering symptoms
SOB, DOE, pleuritic chest pain x2 weeks progressively worsened, the patient presented to hopsital and was later transferred to secondary hospital.
Had shingles vaccine injected on 7-8-09 at 1:30 P.M, had a couple of spots on my stomach that night (thought that were bites) - Thurs A. M. (7-9-09) they looked worse and by Thurs Eve. I had many rashes and blisters in left side of stomach. Went to doctor at 8:00 A.M. Friday, 7-10-09, and she wanted me to send this report to you. She prescribed prednisone 10 mg and famciclovir 500 mg. I have a case of shingles that fortunately does not hurt or itch.
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 24 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "booster dose"; FEELING COLD (non-serious) with onset 28Dec2021, outcome "unknown", described as "feet and legs as well as hands and arms feel cool"; PARAESTHESIA (non-serious) with onset 28Dec2021, outcome "unknown", described as "she got pins and needles sensation". Additional information: Patient received Comirnaty booster dose on Monday and day before reporting got pins and needles sensation and her feet and legs as well as he hands, and arms feel cool. Patient did not know whether these were normal and already called the doctor and was told to Pfizer. The lot number for bnt162b2 was not provided and will be requested during follow up.