chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 day post vaccine-patient experienced fever, chills, body aches, fatigue, headache, swollen lymph nodes, and injection pain.   2 days post vaccine-patient's supervisor called with concerns that patient was faint and husband was picking her up.  Husband called back later to report patient was disoriented and unstable gait.  Patient was taken to ER.
EMS called to nursing home, pt. in resp. failure, immediately intubated in ER, admit to ICU. As of 9/15/2021 pt is extubated, improved, remains in hospital.
Shoulder pain; Body hurting; Headache; Area around my neck hurts really "bad"; My eye hurts; This is a spontaneous report from a contactable consumer (a Certified Nurse Assistant) reporting for herself.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 07:30 at single dose for covid-19 immunisation. Medical history and concomitant medication were none. Patient received the vaccine on 07Jan2021 at around 7:30 in the morning. On an unspecified date in Jan2021, she started developing like really bad shoulder pain and like her body was hurting, and she had like a severe headache and area around her neck hurt really 'bad' (not clarified). She had been taking Tylenol but did not work, nothing seemed improving and what else she could can take for it. Patient stated it was really bad. It didn't even help that much but she was taking. Patient further added she was taking '550 mg' (not clarified) per tablet and it was not working. When probed if still having the problems the patient stated they was just getting worst, and her eye hurt too (Jan2021). Final outcome of the events was reported as not recovered. Second dose of the vaccine was scheduled on 28Jan2021. Information on the Lot/Batch number has been requested.
0933: few minutes after receiving vaccine, c/o dizziness, chest tightness, feeling hot, starting to black out. patient then experienced syncopal episode, feeling clammy, while being placed on stretcher, thready pulse noted. regained counsciousness once laying flat on stretcher.  arriving to obs 0936: bp 111/71 hr 68 rr 18 sats 96%. patient arousable and reports feeling better. 0941: bp 110/69 hr 74 rr 18 sats 98%. patient able to sit up with ease, reports feeling back to baseline 0945: bp 120/86 hr 78 rr 18 sats 98% on ra. no further s/s of complications. departed to personal vehicle 0956.
Wednesday: swelling of injection site Thursday: red, raised welt measuring 3" x 6" from top of shoulder Injection site to mid-upper arm, warm and tender to the touch. Undable to raise arm above shoulder height. Drew watercolor black line at bottom of histamine reaction to indicate size for picture. Thursday nite before bed: drew red watercolor line under swollen raised, red welt  Friday morning: swollen below red line by 1/2" inch, almost down to elbow juncture, still red and warm to touch, for picture
This is in follow-up to report (s) previously submitted on 5/16/2008. Information has been received from a health professional concerning a 15 month old female who on 25-JAN-2008 was vaccinated with a 0.5 ml subcutaneous dose in the upper right leg of varicella virus vaccine live (Oka/Merck) (lot#"1580U"). Concomitant therapy included M-M-R II in the left leg, PedvaxHIB in the left leg, and Pediarix in the right leg. On 13-FEB-2008, the patient developed two varicella like eruptions, on her upper right thigh. Current patient was not reported. A product quality complaint was not reported. Follow-up information has been received from a registered nurse concerning this 16 month old female child with no known allergies who on 25-JAN-2008 was vaccinated SQ in the right thigh with a first dose of VARIVAX (Oka/Merck) (lot # 659420/1580U). There was no illness at the time of vaccination. Additional suspect vaccination included a first dose of MMR (lot # 653892/0538P) SQ in the left thigh. Concomitant vaccinations included a third dose of PEDIARIX (lot # AC21B127AA) IM in the right thigh and a third dose of ACTHIB (SPUF169A7) IM in the left thigh. Subsequently, on 02-FEB-2008 the patient developed two papules on her right anterior leg. There were no fluctuant masses underneath it. There were no lab studies performed. The patient was treated with KEFLEX "125" 1/2 teaspoons three times a day x 10 days and with ZOVIRAX ointment three times a day x 10 days. It was noted that the patient recovered on 17-FEB-2008. Additional information is not expected.
got the shot, still got shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got shingles. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. No follow up would be possible as no contact details were provided.
This case was reported by a physician and described the occurrence of abdominal infection in a male subject of unspecified age who was vaccinated with hepatitis b vaccine (Engerix B) for prophylaxis. The subjects history included abdominal abscess, appendicitis, enterocutaneous fistula, ischemic colitis, lymphadenitis, post surgical wound infection and wound evisceration. Previous or concurrent vaccination included Engerix B vaccine intramuscular given on Feb 8 2005, march 10 2005 and August 16 2005. On June 2 2005 the subject received 3rd dose of Engerix B 40 mcg, intramuscular. On Aug 5 2005, 2 months after vaccination, the subject developed hyperpotassemia and was hospitalized and and was discharged on Aug 13-14 2005. On Aug 6 2005, the subject developed abdominal pain. On the same day, he was admitted in the hospital for a study. On Aug 6 2005. leucocytosis was objectified. An abdominal CT scan was performed and showed mesenteric fat infiltration in the region of the ileocolic anastomosis, with unspecified thickness of the wall of the colic side of the anastomosis. The subject was treated with ciprofloxacin IV every 8 hours from Aug 6 to 10 2005 an till Aug 17 continued with ciprofloxacin PO. On Aug 8 2005, the abdominal pain abated, the subject recovered and was discharges from hospital. The investigator updated the patient status and Engerix dosing schedule. On June 20 2005, the subject attended a scheduled protocol visit and did not receive Engerix B. The fourth and last dose of Engerix B was administered on Aug 16 2005. The patient did not attend the protocol visit schedule for mid Sept 2005. On Sept 21 2005 the subject died of abdominal infection and septic shock. The investigator considered the event not related to study drug. Further information has been requested.
Bell's Palsy (facial nerve paralysis) started 3/10, 3 days after vaccination . Patient had history of same so had video visit. started on prednisone
This spontaneous report was received from a nurse referring to an unspecified number of patients of unknown age or gender. There was no information about the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, the patients were vaccinated with GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. The reporter stated that the patients could receive the second or the third doses of the vaccine on an unspecified date at intervals not in accordance with the dosing schedule detailed in the prescribed information. No adverse effects were reported in any patients. Additional information is not expected because there was no consent to contact the reporter.
vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (vaccination adverse reaction) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Treatment and concomitant medications were not provided.
AFTER PT RECEIVED THE PFIZER COVID VACCINE THE PT SAT DOWN AND SHORTLY AFTER FAINTED. THE PT WOKE UP AND WE GAVE HIM COLD WATER AND AN ICE PACK. PER PARENTS, PT HAS NO PREVIOUS HISTORY OF FAINTING OR ANY OTHER HEALTH CONDITIONS. PT LOOKED DEHYDRATED. SPOKE WITH PTS PARENTS AND TOLD THEM THEY NEED TO GO TO THE EMERGENCY ROOM AND THAT WE CAN CALL AN AMBULANCE. PARENTS REFUSED AMBULANCE AND INSTEAD TOOK THE CHILD TO THE EMERGENCY ROOM ACROSS THE STREET. SPOKE TO THE MOTHER AFTERWARDS. SHE STATES THAT HER SON WAS SENT HOME. THE DRS BELIEVE HE FAINTED DUE TO A LACK OF FOOD AND WATER (DEHYDRATION). THEY SENT HIM HOME AND TOLD THE PARENTS IT WAS OK FOR HIM TO RECEIVE A 2ND COVID VACCINE 21 DAYS LATER.
Treatment of COVID-19; Treatment of COVID-19; vaccine brand=Pfizer / BioNTech; vaccine dose number=5/ vaccine brand other=Moderna; vaccine dose number=4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19May2022 as dose 4 (booster), siingle (Lot number: 049CZ1A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine dose number=5/ vaccine brand other=Moderna; vaccine dose number=4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Information: No other medication in 2 weeks, for COVID 19 Treatment received Paxlovid from 07Feb2023 to 11Feb2023.
MA coordinator doing COVID waste count in AM on Wednesday 3/22 found Shingrix (antigen component) by itself, un-banded from adjuvant in fridge.  Found 1 patient that was given Shingrix. Adjuvant component was what was scanned into record.   After speaking with MA, it was determined that the patient recieved only the Adjuvant component of the vaccine, and not t o antigen.   The patient was contacted and will return for re-vaccination. The employee was educated on appropriate administration of Shingrix vaccine. Learning from Defects to be completed with all team members.
He had a rash on the cheek and then a week later he was tired, coughing. He goes to the day care and on Dec 29, a day care center called that he was too tired, with mild fever we took him to the doctor, and he was diagnosed with bronchitis, On Dec 29 he vomited and Dec 30. Doctor prescribed medication. For information: Pneumonia is a condition that he has suffered before and was hospitalized in August 2022.
a baseball size lump that had developed at injection site; is very red and painful; is very red and painful; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 20-JAN-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). The reporter stated that the patient received the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) around noon at the doctors office and within 30 minutes noticed a penny size lump at the injection site. The patient drove from a medical center to the reporter's pharmacy to pick up a prescription and showed the reporter a baseball size lump that had developed at the injection site (injection site mass). The reporter stated that it appeared to be growing in size, it was very red (injection site erythema) and painful (injection site pain), and almost resembled a "tick bite". The outcome of injection site mass, injection site pain and injection site erythema was unknown.      The causal relationship between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and injection site mass, injection site pain and injection site erythema was unknown.
Pt recvd 3 doses of Engerix-B, 3rd adm 1DEC90 & it was determined that pt was not immune to Hep B;
This spontaneous report was received from a pharmacist refers to a 79 year old male patient. On 23-OCT-2014 the patient was vaccinated with ZOSTAVAX, lot # J013134, expiration date: 17-JAN-2015 (dose, and route of administration were not reported). There were no concomitant medications. In October 2014 the patient experienced an injection site reaction that was slightly larger than the patient's wife vaccination (case # 1411USA001111). Pharmacist advised patient to contact physician. The patient did not receive any treatment for the adverse event. The outcome of the events was unknown. This is one of several received from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 11:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 11:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 77.94.  On 07-Jan-2021, Excursion time was 09 AM and 10 AM, temperature was 34, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Dad came to pharmacy and asked us to call 911.  Patient fainted as they were heading down to look at the squish mellows.   She had just gotten her flu shot.  Dad brought her back to pharmacy area and she was sitting in the chair and was alert and able to communicate.    EMT arrived and check her vitals.  O2 and HR within normal limits, bp on the lower side (~70).  Dad received shot first, and patient said it did make her nervous getting the shot after seeing that.  Dad and patient did not feel need to go to the hospital and went home after EMT left.
3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". The patient date of death was unknown. Reported cause of death: "3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine". It was not reported if an autopsy was performed. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200624880 same reporter/ drug/ event, different patient;US-PFIZER INC-202200625895 same reporter/ drug/ event, different patient; Reported Cause(s) of Death: 3 people who died from heart attack within 2 weeks after getting the Pfizer bionTech covid-19 Vaccine
Muscle pain and weakness right arm, right chest pain, starting day 2 after vaccination, and peaking at day 5 after vaccination
Headache, body aches and pains, dizziness, lightheadedness, tingling all over body. Temp 99-101 degrees from Friday PM to Saturday PM. Urgent care visit recommended alternating TYLENOL/ibuprofen. Ran 5K 3-4 h before shot. Better on Sunday.
SOME REDNESS/INFLAMMATION ON LEFT ARM AROUND INJECTION SITE, FEELS LIKE A LUMP TO TOUCH
Injection site soreness for ~24 hours (nothing more than the usual I've experienced with other types of vaccinations), then developed acute urticaria over 35% of my body on evening of Jan 4th. Distribution is very symmetrical involving upper arms, back of arms, pits, belly, small area of chest, front of thighs and center of back. No known exposure to possible allergens, bite, etc. Pruritis and hives have persisted. Pruritis decreases with histamine and topical medication such as diphenhydramine, fexofenadine and hydrocortisone cream 1%. No decrease in number, minimal change in appearance. Urticaria are an ongoing issue in this week however have never had a reaction to anything like this.  Otherwise I am normothermic, normal SpO2 on room air, no dyspnea, normal GI, just itchy! And ugly blotchy... Sigh.
Within minutes of vaccination, patient complained of itching to face, arms, chest and tops of thighs.  Complained of headache.  Initial BP - 138/108.  Administered Benadryl 100mg po per standing orders.  Within 30 min no further complaints of itching, and no rash noted on back and arms.  BP recheck, 120/88.  Patient instructed to follow-up with MD.  Reported no MD and no insurance.  Given name of 2 clinics in area as a resource. Telephone call to patient on 1/28/21.  Reports continued headache, fatigue and all over body aches.  States BP elevated in am, unknown value, but watch reporting BP at 102/58.  Instruct to have partner recheck this evening and to schedule appointment with MD for check-up
Injection site is red; Injection site swelling; Injection site itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE ERYTHEMA (Injection site is red), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included Benadryl.
The nurse administered the shot too high on my left arm. I had immediate pain that did not lessen, but grew worse, affecting my whole joint. I was not able to lift my arm without pain. Dec. 28, 07 I went to an orthopedic dr. who gave me an oral Medrol dose pack. On Jan. 10, 08 the same dr. injected Depo Medrol with 25% Marcaine.
Chills, pain throughout body, fainting (30 hours after injection, general weakness for 40 hours
His blood pressure dropped to 100/58 the first time I took it and 15 minutes later it went up to 108/58. He began to have really bad chest pain. He turned gray. All of this happened about 3 hours after he received the vaccine. I made him lay down and elevate his legs and I called the doctor's office and they advised me someone would follow up. It took him 2 1/2 hours to recover. I was advised by the doctor's office to monitor him and if he got worse to take him to the ER. He was back to normal after a few hours.
HOSPITAL COURSE:  Patient is a 78-year-old gentleman with a history of COPD, chronic nicotine abuse who had presented on September 27 with acute kidney injury complicating his COVID-19 illness.  He was initially admitted for COPD exacerbation and hydration but subsequently became hypoxic and thus qualified for treatment with remdesivir.     The following problems were addressed during his hospitalization:   1. Acute kidney injury With aggressive hydration the patient's renal function improved and at discharge his creatinine is 1.16, not quite back to his baseline of a year ago of 0.9-1.0.  During his hospitalization is lisinopril was held due to his acute kidney injury.  Despite that his blood pressure remaine
Systemic: Abdominal Pain-Mild, Systemic: Exhaustion/Lethargy-Severe.
Red area of approximately 3" X 3" for 7-10 days; fluish symptoms for 3-days; painful to touch for 4-5 days; warm to the touch for 4-5 days.