chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a 16 month old twin female with bat exposure on 08/10/02 received RIG and Rabies vaccine on 08/14/2002. Patient's mother reported that 54 hours after vaccination, patient awoke during the night with the following symptoms: dazed, sweaty, cold, not focused, possible focal seizure, and low grade temperature. Patient was fully resolved. Patient was vaccinated at the hospital. From FOLLOW-UP information received on 08/20/2002, "EM received RIG 180 units left thigh, Rabies vaccine 1 cc right thigh on 08/14/02, no lot # recorded. On 07/17/02, twins returned to ER for second injections of rabies injection. At 13:26 PM, EM received 1 cc rabies vaccine in right upper leg (lot # U0595, expiration date 08/28/04. No adverse reaction reported  on either twin. Mom is not sure if bat bit children. JM received RIG 180 units in the right thigh on 08/14/02 and 1cc rabies vaccine in left thigh on 08/14/2002 and on 08/17/02, 1cc rabies vaccine in right upper leg, same lot as sister UO595. Twins are to return on 08/21/02 to receive next doses. Hospital staff to inquire about the reported adverse event after the first dose and notify us with the information. Twins were to returned on 08/21/02 for next series of injection, but as 08/22/02, 16:00 had not returned. No hospital record for adverse event that mother has reported. Hospital was unable to confirm AE report. Linked with U2002-00645
Fainted approximately 10 minutes after receiving injections.  Sustained bump on head and left bruised shoulder.  Patient called next day for follow-up.  No abnormal signs or symptoms related to head trauma - patient at work.  Patient stated "he was fine".
After vaccination pt became dizzy and diaphoretic, assisted to recumbent position with BLEs elevated, cold compress applied to forehead. No LOC, no head trauma. VS as follows: BP laying down 146/84, HR 88, sats 98% on RA. Pt given water and snacks. VS 5 mins later as follows: BP sitting up 142/81 HR 80, sats 98% on RA. Pt recovered within 10 mins and ambulated out of clinic in NAD.
Using V Safe I reported mild symptoms of soreness & swelling at the injection site which abated by day 5. V Safe stopped communicating by Friday, 3/19. I'm trying to make the CDC aware that they are missing reportable adverse react because of limited follow-up. I developed itching at the injection site on 3/20 in the a.m. I note approximately a 15 cm area of erythema around the injection site. On 3/20, after a 5 mile walk I felt similar symptoms that I had in the first couple of days after the injection of lightheadedness and felt poorly enough to have to rest the remainder of the day. I am better today and was able to function, but not ready to resume exercise. How many others have had a delayed reaction that is being missed because V Safe stops the follow-up when initial signs & symptoms disappear?
Stroke; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4486513-00.  A 61-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovered", described as "Stroke". The action taken for adalimumab was dosage permanently withdrawn. The event abated after stopping the drug Humira (Adalimumab). The patient experienced an event of stroke like symptoms with Humira (Adalimumab). On an unknown date, the patient experienced stroke like symptoms. On an unknown date, stroke like symptoms resolved. Pfizer Biontech COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient was on Humira but had to be removed because it caused him stroke like symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter considered "stroke" related to BNT162b2.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of stroke like symptoms with Humira (Adalimumab) was a reasonable possibility.  Causality for Humira (Adalimumab)  1) Stroke (Cerebrovascular accident) Action(s) taken with drug: Drug discontinued Causality as per reporter (Drug/Vaccine): Probable Dechallenge: Yes  Causality for Pfizer Biontech COVID-19 Vaccine (Tozinameran)  1) Stroke (Cerebrovascular accident) Causality as per reporter (Drug/Vaccine): Possible  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event stroke and the use of suspect product BNT162b2 cannot be fully excluded. The case will be reassessed once further information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Temperature induced urticaria (angioedema?), involving the entire body (heat, as when sweating during a run, and cold, as when in ocean water for several minutes).  Symptoms last 1-2 hours, no response to benadryl.  Cannot be prevented with premedication with antihistamines.  Symptoms are recurrent and have increased in severity with each additional administration of HPV and Hep A vaccines.
Stared with a temp 102.5 the day after vaccine, headache, chills and body aches. Was seen at urgent care 8/5/18, dx cellulitis of arm  given Keflex 500mg 1 po tid x10.
low grade fever; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (patent).  This case involves a 52 years old female patient who experienced low grade fever after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. is unknown if the patient had any  concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed low grade fever (pyrexia) (unknown latency). It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Patient was feeling warm and light-headed at 15 minute mark, so we kept for further observation and gave water to hydrate. At about the 17 minute mark patiently suddenly fainted in his chair for 15-30 seconds. He then began to vomit and woke up in the process. Once he fully came back to, he said he felt remarkedly better and no longer felt light-headed or clammy. Following this episode he reported feeling back to normal and that he had just ate a large breakfast before coming in for the shot, but did not feel bad in any way anymore. We observed for another 30 minutes and patient showed no further sign of issues. He was released with his wife.
Pt woke up with cold sore and took 2 tablets of acyclovir 200mg. Called pharmacy, told pt not recommended to take antivirus & to follow up with MD office. Called Merck to verify they recommended filling out report.
Patient presented to pharmacy for booster vaccine.  Pharmacy student took the patient's information and conducted interview.  Vaccine was administered and when student was updating vaccine card, she realized that 6 months had not lapsed from patient's second dose.
(I took Benadryl and ibuprofen prior to vaccine administration because of previous sensitivity to flu shot), but still had palpitations and heart racing and chest tightness/pain--extreme for first 14-16 hrs, intense for another 24 hrs. Resolved completely after 5 days. Pulse irregularity,  shortness of breath, face & arms were flushed but cold, extremities were cold/tingling sensation (& other Raynaud's syndrome symptoms) fatigue and muscle ache, light headedness, nausea, unable to void for almost 36 hrs. Everything resolved about 5 1/2 days later.
A spontaneous report has been received from a Health Professional concerning a patient, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT INTRANASAL started on an unknown date. The patient reported expired FLUMIST QUADRIVALENT administered. The outcome of the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
PUI admitted to hospital on 4/18/21 and diagnosed with Pneumonia. PUI is experiencing dizziness, loss of appetite, and fever
This spontaneous report was received from a healthcare worker concerning an unspecified number of patients (demographics unknown). The patients' pertinent medical history and concurrent conditions were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route, lot # and expiration date were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Very severe headache very severe body aches and appendecitis I am not sure if the appendicitis is related to the shot but I thought I should report that
Injection site reaction, sore arm, large red bump at injection site, scaly skin at swollen area
Day after vaccination a a slightly painful lump appeared inside my scrotum near one of my testicles.  Day two after the vaccination another slightly painful lump appeared inside my scrotum near my other testicle.  Both are slightly painful to the touch.
Hives on face within 1 hours of receiving vaccines. Went to Emergency Room where she was given BENADRYL and prednisone. Disch with the same next morning hives much worse - entire body - ret. to ER. Given more prednisone. Hives remained till 3/21/10.
First dose in the series was given on 6/21/2021. Second dose given early on 7/2/21. Patient experienced more fatigue, muscle soreness and chills than on the first dose.
pt recvd vax & on 19oct94 had t 102;taken to hosp; very irritable; febrile sz; all 4 extremities shaking;  eyes deviated upward for 30 sec;
This spontaneous report was received via company representative from a physician, and refers to a 65 year old female patient. No patient's medical history, concurrent conditions or concomitant therapies were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, frequency, route of administration, lot # and expiration date not specified). On an unknown date the physician noticed that the patient had cellulitis, which started to expand and continued to expand at the time of the report. The patient sought medical attention. The outcome of cellulitis was unknown. The relatedness between PNEUMOVAX23 was not reported. Additional information has been requested.
1 week after 2nd moderna vaccination patient started to get a rash spreading from injection site, down chest and arm
A non-serious spontaneous report of six-month-old got H1N1 was received from a mother/consumer concerning her six-month-old daughter, subsequent to H1N1, Intranasal. The patient had no past medical history or concomitant medications. The patient received the vaccine on 23-Oct-2009 for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 12-Nov-2009 and incorporated into the narrative: patient's medical history, concomitant medications and patient's demographics.
Immediately after the COVID shot, I felt my heart slightly race, felt a rapid heart beat and shortness of breath.   Several hours later in the evening around 10:00 pm. I got a fever, muscle aches and shortness of breath.  I was off for 4 days before I felt like to serum had run its course.
This case was reported by a pharmacist and described the occurrence of swelling of tongue in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in October 2006, on or before 26 October 2006, the subject received unspecified dose of Fluarix. On an unspecified date in October 2006, less than one month after vaccination with Fluarix, the subject experienced swelling of tongue and injection site irritation. The subject was seen at a physician's office. The subject was treated with oral diphenhydramine hydrochloride (Benadryl0. At the time of initial reporting, 26 October 2006, the tongue swelling had resolved. The outcome of the injection site irritation was not reported.
8 hours after receiving shot, I had migraine, sensor out to light, body aches and chills and could not sleep due to uncomfortableness.  These symptoms continued for another 32 hours. By Friday morning I no longer had the chills. By Saturday, I no longer had major body aches and  my right arm at injection site  is swollen, puffy and hot. Still have a slight headache
complained of nausea and feeling light headed sat down and then stated that she thought she was going to pass out, she said she could hear everything going on around her but could not respond this lasted for about 20 seconds then family was called because she was not able to move she said she felt heavy, she was taken to the hospital where they said she had a vasovagal reponse and after she was able to move went home on 12/13/2009 she was at school and had another episode similar to the previous one described she was taken by ambulance to ER where they thought she had possibly had a seizure
This spontaneous report as received from a licensed practical nurse refers to a unspecified patients of unknown age and gender. The nurse reported improperly stored vaccines, GARDASIL (dose and lot number were not reported) which were exposed to 18.3 Celsius degrees for 86 hours and 16 minutes. Nurse did not know if any of these improperly stored vaccines were administered. Improperly stored GARDASIL may have been administered to unspecified patients on unspecified dates. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of shoulder pain in a female patient who received BEXSERO (batch number PP-148901A, expiry date 30th September 2016). Concomitant products included MENACTRA. On 10th March 2016, the patient received BEXSERO .5 ml. On 10th March 2016, less than a day after receiving BEXSERO, the patient experienced shoulder pain and injection site pain. In March 2016, the patient experienced tingling of extremity. On an unknown date, the outcome of the shoulder pain and injection site pain were not recovered/not resolved and the outcome of the tingling of extremity was unknown. It was unknown if the reporter considered the shoulder pain, injection site pain and tingling of extremity to be related to BEXSERO. Additional details were as follows: The patient experienced deep left shoulder pain, painful to touch at injection site and tingling down left arm (less than a week after vaccination). The reporter was unable to provide patient's date of birth.
Extreme pain upon injection, slight numbness in hand. The next morning the deltoid area very sore, lasts another 2-3 days and then pain migrated under left scapula. Very very sore, feels inflamed,  it?s just at the deltoid attachment point. No oral over the counters help, icing helps a little. 3 weeks later it is still VERY sore, I?m thinking SIRVA.
Arachnoid cyst/Brain cysts have now developed; migraines; "ice pick" headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 as dose 4 (booster), single (Lot number: 6J3275) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EM9810, Anatomical location: Left arm), administration date: 26May2021, for Covid-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/lot number: EM9810, Anatomical location: Left arm), administration date: 16Jun2021, for Covid-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/lot number: FD7218, Anatomical location: Left arm), administration date: 06Jan2022, for Covid-19 immunisation. The following information was reported: ARACHNOID CYST (disability, medically significant), outcome "not recovered", described as "Arachnoid cyst/Brain cysts have now developed"; MIGRAINE (disability, medically significant), outcome "not recovered", described as "migraines"; PRIMARY STABBING HEADACHE (disability, medically significant), outcome "not recovered", described as ""ice pick" headaches". The events "arachnoid cyst/brain cysts have now developed", "migraines" and ""ice pick" headaches" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Negative; Magnetic resonance imaging: Cleared; SARS-CoV-2 test: Negative. It was unknown if therapeutic measures were taken as a result of arachnoid cyst, migraine, primary stabbing headache. Clinical course: Brain cysts had now developed to the patient. She had migraines and had have clear MRI scans prior to vaxxing. She kept a journal "after vaxxing" and She complained of headaches. lasting a week or two after vaxxing. Now she had been diagnosed with "ice pick" headaches in addition to migraines after vaxxing also brain cysts. Patient had no covid prior to vaccination.
rotator cuff tendonitis is reported in a pt receiving 1 dos of fluogen given on 13OCT93; pt noticed initial tenderness which did not resolve w/in 3-4 days; 2NOV93 pt seen for persistent pain & was dx w/tendonitis; pt recovered;
Information has been received from a nurse practitioner concerning her daughter who in October 2008, was vaccinated the first dose of GARDASIL. Concomitant therapy included meningococcal vaccine. In October 2008 after she received the dose , the patient experienced fainted. Subsequently  the patient recovered. It is unknown if the patient sought medical attention. Additional information has been requested.
Pt had onset of red macular rash with pruritis within 24 hours of receiving HAVRIX and FLUMIST. Rash associated with significant pruritis but not associated with any symptoms of respiratory distress or mouth/tongue swelling. Rash treated with BENADRYL and resolved by 72-96 hrs.
Low grade fever, chills, fatigue, muscle aches lasting 24 hours following vaccination; resolved shortly thereafter. Seven days after receiving the vaccine and having no other symptoms, developed a large, swollen, red welt (raised approximately 1.5 inches) over the vaccine site, along with pain and itchiness. The swelling dissipated after 24 hours, but redness expanded and continued with a diameter of approximately two inches.
HCP stating patient inability to walk after receiving VAXNEUVANCE administration. Caller stated patient then had blood work and x-rays performed. Caller confirmed adverse event did not relate to PQC case. Additional AE case 02472371 and PQC case 0247; This spontaneous report was received from a Consumer and refers to a 5-year-old male patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X005583, expiration date: 10-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 28-AUG-2023, the patient experienced inability to walk after receiving pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) administration. Caller stated patient then had blood work and x-rays performed (results not provided). On an unknown date in 2023, the patient recovered from inability to walk.   The causal relationship inability to walk after and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was unknown.
This spontaneous report as received from a pharmacy intern (healthcare student) refers to an adult consumer of unknown age and gender. On an unspecified date the adult patient received the series of RECOMBIVAX HB (Lot#unspecified) dose, frequency and location unspecified for vaccination in a shorter than recommended time frame- the time period between dose two and three was only 30 days. No adverse effects reported. Additional information has been requested.
red rash on lower legs; This is a spontaneous report from a contactable consumer, the parent. A 16-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8732) via unspecified route of administration in the right arm on 27Mar2021 at 11:30 (at the age of 16-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergy to pet dander. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for unknown indication taken within two weeks of vaccination. On 28Mar2021 at 15:00, the patient experienced red rash on his lower legs. The patient did not receive any treatment for the reported event. 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 red rash was unknown. No follow-up attempts are needed.   No further information expected.
Two days after injection sight swollen and red. Four days after injection rash started to develop on my back and continued to cover my whole body except face. Very itchy. Day 5 rash continues but seems to have peaked.  Treating with Benadryl.
Information has been received concerning a pt who was vaccinated on 06/10/00 with her first dose of varicella vaccine. On the 06/16/00 she was seen in the physician's office and diagnosed with a chickenpox rash. The pt was seen again on 06/26/00 and it was noted that the rash had dried up.