chrisvoncsefalvay/vaers-outcomes huggingface dataset:
passing out; fainting; This case was reported by a nurse via sales rep and described the occurrence of passed out in an unspecified number of 16-year-old patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis and HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patients received Bexsero at an unknown dose, Menveo at an unknown dose and HPV vaccine at an unknown dose. On an unknown date, unknown after receiving Bexsero, Menveo and HPV vaccine, the patients experienced passed out (serious criteria GSK medically significant) and fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out and fainting were unknown.   It was unknown if the reporter considered the passed out and fainting to be related to Bexsero, Menveo and HPV vaccine.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that there were some patients,(most were 16 years of age) experienced passing out or fainting after receiving either Bexsero and Menveo or Bexsero, Menveo, and HPV vaccine at the same visit. It was unknown whether which group of patients received only Bexsero and Menveo or which group had received Bexsero, Menveo, and HPV vaccine. The reporter noticed that in 2 to 5 patients, but this had not occurred in the majority of patients.  It was reported that they had implemented a protocol to let the parents decide if multiple vaccines could be received and if parents chooses not to have multiple vaccines administered to child then the nurses visit was scheduled for additional vaccines, specifically the Bexsero which was usually rescheduled. If multiple vaccines were administered to the patients then the patient should wait for 20 minutes. The reporter had not agreed to follow up from GSK.
Headache, Myalgia, CHILLS, SWOLLEN AND ITCHING ARM AT  INJECTION SITE Narrative:  Other Relevant History:
Erythematous induration on the left deltoid area with tenderness distinct margins no axillary lymph node involvement no fever - no vomiting no respiratory distress. Treated with 10 day course of AUGMENTIN orally.
Went to bed with the chills, never checked temperature. Woke up in the middle of the night with chest feeling heavy , was hard  to breath, Sat up on edge of bed and then passed out and fell backwards in bed. Came to and passed out again.  Came to again and took temperature and had 101.3 temp. Ran a fever and had chills for most of the day. Fever was gone by the following day and felt back to normal, just a little fatigued.
Mother states rash appeared 5 days after vaccination - 7-10 red, raised, blister-like areas on trunk, arms (upper), thighs. C/o itching. By 7/13 lesions less red, drying.
This case was reported by a pharmacist via sales rep and described the occurrence of fatigue in a 89-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 1st October 2018). On 21st January 2019, the patient received the 2nd dose of SHINGRIX .5 ml. In January 2019, less than a day after receiving SHINGRIX, the patient experienced fatigue (serious criteria hospitalization). On an unknown date, the outcome of the fatigue was unknown. It was unknown if the reporter considered the fatigue to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported, but it could be 88 or 89 year. Within 24 hours after vaccination with SHINGRIX, patient was hospitalized for extreme fatigue. The reporter agreed to follow up from GSK.
10 hours after vaccine started to have pretty sore arm and felt fatigue. Went to bed. Had Severe chills. Body was shaking so hard. Could not warm up. Had difficulty getting up but eventually did to get a sleeping bag to put on top of my covers. Teeth chattering so hard my jaw hurt. Some pain going up into neck on left side, increased resting heart rate was average 80 when my normal is 62. Next day, chills were gone but had a headache and slight fever and fatigue. Swollen node and pain under arm pit on left side. Started taking Tylenol which helped. Day 3, still swollen node, joint pain in wrists and fingers. Fatigue.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. Initial information was processed with the additional information received on 12-JUL-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: not reported) dose was not reported,1 total, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-JUL-2021, the patient was tested positive for COVID-19 (suspected COVID-19 infection and suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected COVID-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000185610.; Sender's Comments: V0:20210723506-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
I am so damaged I haven't been able to report this until now. I got the 1st covid 19 shot in my upper arm and thought I was going to be fine. Then my energy & cognition overall state of health began to decline continuously and severely This decline had had me laying in bed or a couch most of the day Still to this day (11/11/2023).
Dizziness, lightheadness, mild decrease in blood pressure (from 115 systolic to 102 systolic).
viral rebound; viral rebound; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "viral rebound".  Clinical course information: Description of Event: The office reported at least 3 cases of viral rebound. Event took place after use of product.  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 known the information available the Causal relation between the events and suspect drug cannot be excluded completely,Linked Report(s) : US-PFIZER INC-202200981970 Same reporter/ drug/ AE, different patient;US-PFIZER INC-202200981971 same drug /event, different patient.;
Istated having a pain in the neck later that evening and I started getting headaches, so I went to the doctor 2 weeks later. I normally don't get headaches and I still have them a lot. I was very scared so I went to the doctor.
4/2/2021: I got my second shot Pfizer at 12:30pm , then at the midnight I began to got chills+fever+sweating+crazy body pain/back bone pain+fatigue.  4/3/2021:The symptoms  lasted till morning at 8am, I started to eat a painkiller which helped me reduce some pain and fever for couple hours, but still felt crazy body pain and fatigue. Then in the late afternoon around 5:00pm, my fever (101.2 f)+chills+sweating came back again. The fever went away at midnight.  4/4/2021: In the morning , I was still getting body pain and fatigue and sore arm with redness and swollen., my legs could not support my body weight.I did not have any urine for 13 hours.  4/5/2021: My legs could not support my body weight+body fatigue.
Patient received the vaccine @ 0830am in her Left deltoid, @ 10pm that night she developed chills, temp of 101.2, felt awful, mild/moderate headache. took motrin alternated with Tylenol, called out of work for one day, now present s with no temp. States she feels completely exhausted.
Site pain in left shoulder; Deep muscle pain; loss of rotator cuff movement without discomfort/pain; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: Pfizer ek:6/2L:EM:9810), via an unspecified route of administration administered in left arm on 05Feb2021 15:00 (at the age of 73-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high cholesterol, some back injuries, and known allergies with sulfur drugs and Flagyl. Concomitant medications included rosuvastatin calcium (CRESTOR) and diazepam (VALIUM). On 05Feb2021, the patient experienced site pain in left shoulder which has increased over three weeks, deep muscle pain, and loss of rotator cuff movement without discomfort/pain. There was no treatment received for all events. The patient had not yet recovered from all events.  No follow-up attempts are possible. No further information is expected.
Lower back pain started 2 days (1/12) after booster shot. 8/10 on pain scale. Limited mobility, agonizing pain when sneezing. Sharp pain when laughing. Not being able to bend down due to excruciating pain.  Pain persisted and now today (1/19) it has radiated down to my tailbone and I feel tingles down my  thighs and feet. Pain level is 5/10. I went to urgent care and they said I have back spasms and sciatic pain.  I have no pre-existing spinal issues or injuries. I am a healthy /fit young person.
Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IRON for Iron supplementation, APIXABAN (ELIQUIS), MIDODRINE, CLOPIDOGREL BISULFATE (PLAVIX), HYDROXYCHLOROQUINE, METHYLPREDNISOLONE, MIRABEGRON (MYRBETRIQ), MONTELUKAST, TAMSULOSIN, VITAMIN D3 and CYANOCOBALAMIN (VIT B12) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Ultrasound scan: clear (normal) Clear.         On 08-Mar-2021, the reporter noticed that the patient's left arm was swollen. The patient was taken to the emergency room  and was diagnosed with deep vein thrombosis. The patient was discharged on the same day. The patient was put on apixaban 10mg and later switched to apixaban 5mg. The patient would be monitored until ??-Sep-2021.   Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
A day after my second moderna vaccine I had flu like symptoms. In addition to body aches, slight fever and headache - I also had soreness on my neck. Next evening I noticed that my left shoulder blade area appeared swollen. I went to urgent care this morning and doctor did notice that I have swollen lymph nodes near my shoulder area on side I had my second shot. He told me to report this.
Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone; Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone; Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone), PARAESTHESIA (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone) and SWELLING (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced HYPOAESTHESIA (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone), PARAESTHESIA (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone) and SWELLING (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone). At the time of the report, HYPOAESTHESIA (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone), PARAESTHESIA (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone) and SWELLING (Surface numbness, tingling, and swelling in neck and left side of face all the way up to cheek bone) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
small local rxn-redness & itch area about 2-3cm in diameter;recovered p/48hr;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The batch number, expiration date, injection site or other details were not reported at the time of initial report. Till the time of reporting, the patient was experiencing injection site pain. At the time of reporting, the patient told the pharmacist that he just started to feel better.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with MMR II (dosing details were not reported) either 1 or 2 doses. On an unknown date the patient had titers drawn which showed negative for mumps (antibody test negative). The outcome of the event was unknown. There was no product quality complaint involved. Additional information has been requested.
experiencing  tingling; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "experiencing tingling".  Additional information:Caller: Concern is a pharmacist and she had a patient, after receiving her third dose of the vaccine, she's experiencing tingling specially with her foot. No color cap provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started breaking out various areas, and low fever of 100 on Wed, 2/9/00. By 2/10/00, was broke out with rash much worse. Sought treatment the eve of 2/10/00.
Initial report received on 14 July 2009 from a consumer. A 19 year old female patient with an allergy to fish and beans received MENACTRA (lot number U2915AA) intramuscularly on 07 July 2009. On 09 July 2009 the patient developed a moderate headache, which was somewhat relieved with Ibuprofen. The patient also began having mid to low abdominal pain which would come and go. The patient complained of feeling tired and having swollen lips. The patient did not have lab work or diagnostics completed. The patient did not recover. List of Documents held by Sender: none.
STROKE; This spontaneous report received from a consumer via a company representative through social media (J & J corporate) concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, one week after vaccination, the patient experienced stroke and it was reported as "same with my Mom. Her legs went out from under her to a stroke the week after shot. so sorry for your injuries". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221244027.; Sender's Comments: V0: 20221244092- Stroke.  The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Patient experienced vasovagal/syncope response, very briefly lost consciousness (<30 seconds) and fell to the floor (minor impact to forehead/bridge of nose).
Within 15 minutes of receiving vaccine I felt hot flushes lasting over 20 minutes. Arrived home from work at about 4PM and went to bed due to severe tiredness and muscle weakness. I woke up at 1am teeth clenching shivering, sweating, severe back and extremities pain especially flank pain, 104 fever, and a severe headache, I fell while trying to go to bathroom due to severe muscle weakness.  symptoms resolved the next day by 9PM but severe muscle weakness persist as of today.
pt recvd vax on 2nov94 in am; that noc had red raised rash on both arms & on waist; rash, pruritic, warm to touch, sxs lasted 1 wk; lesion scabbed over, had h/a; no n; sinus infect w/ body aches;
10 days after vaccine administration patient went to ER not feeling well. Patient was diagnosed with pneumonia. Admitted on 2-2-10 and released on 2-11-10.
Covid arm, first day hot to the touch and itchy. Second day, bumpy and a little swollen. Noticed it first think Friday morning.
Patient has presented with headache, fever and tiredness. Patient's mother contacted daughter physician who recommended to give child acetaminophen and continue to observe.  Child has an appointment on February 14, 2022 with pediatrician.
Patient received vaccine on Thursday evening.  He began to feel very tired Monday and Tuesday.  Wednesday he woke up in alot of abdominal pain.  We went to healthcare facility at 4:30pm.  He was diagnosed with Acute Pancreatitis.  He was sent home at 10:30pm    We went back to ED at 1:30 am Thursday.  He was admitted during the day.  In the early morning of Friday May 28th his blood pressure tanked and he became unresponsive.  His heart stopped and they did compressions for 8-9 minutes.  He was put into ICU.  By 3am we were told he may not survive.  By 5 am we were told his organs were shutting down.  He passed around 7:45am.  In researching the vaccine we discovered the SARS virus used in vaccine can attack the pancreas.  We believe he died as a result of the reaction to the vaccine and his body and organs could not fight.
52 year-old male patient, with a PMH of severe aortic stenosis 2nd to native bicuspid aortic valve; S/P Bioprosthetic AVR in 2014, complicated with Dressler syndrome 2 months later, and Infective endocarditis in 2017 ( Strep Mutans) treated with CTX for 6 weeks, presented with fever and chest pain for 2 weeks duration.  Patient history goes back to September 27th, when he took COVID-19 booster shot, the day after, he started feeling unwell and developed fever, highest reaching 101F, associated with fatigue. Patient also reports feeling dull aching chest pain, radiating to his left shoulder, graded 3/10, improved on Ibuprofen PRN. Patient contacted Cardiology office on 10/06/2021, and given the persistant chest pain, He was concerned of COVID-19 vaccine myocarditis, but that was ruled out at the ED. After that, the patient was started on colchicine and Ibuprofen. Patients states having 3 episodes of night sweats the past week, and is uncertain whether he might have had another episodes of low grade fever the past week as he was taking NSAIDs regularly as ordered.  Blood culture was drawn the day before admission, and showed gram positive cocci (strep) in 2 bottles.   Patient denies significant chest pain, SOB, palpitations, Loss of consciousness. but states that colchicine has caused him diarrhea.
Extremely high blood pressure levels, extreme fatigue, shortness of breath, and dizzy spells
This spontaneous report as received on 24-APR-2017 from a female pharmacy technician, referring to one unspecified patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies were not reported. The pharmacy technician reported that on an unspecified date, one unspecified patient was vaccinated with improperly stored ZOSTAVAX (Lot number M036296, expiration date 14-NOV-2017) reconstituted with properly stored DILUENT MRK (Lot number reported as L037795 (as reported), expiration date 04-MAY-2018) for prophylaxis. The Dose, strength, site of administration and route of administration of ZOSTAVAX was not reported. The ZOSTAVAX excursion information was reported as: exposed to temperature: "8.2 F" (8.2 degrees Fahrenheit) for a time frame of 1 hours 15 minutes. There was a previous temperature excursion reported (date not specified): "6F to 14" (6 degrees Fahrenheit to 14 degrees Fahrenheit) for 2 hours. The call was because of a "data logger." No adverse effect reported. There was no product quality complaint involved. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015287.