chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tachycardia; Fever; Migraine; Fatigue; not feeling well; shortness of breath; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Jan2021 (at the age of 40 years old, not pregnant at the time of vaccination) (Lot Number: EL3249) as single dose for covid-19 immunisation. Medical history included migraine, attention deficit hyperactivity disorder (ADHD), irritable bowel syndrome (IBS-C), Gluten intolerance, Gulten allergy. Concomitant medications received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ibuprofen; topiramate (TOPAMAX); linaclotide (LINZESS). The patient previously received the first dose of BNT162B2 (Pfizer, lot number: EJ686) in Left arm on 01Jan2021 (at the age of 40 years old) for Covid-19 immunization. No other vaccine in four weeks. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021, the patient experienced Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse events included Beta blocker, labs, holter monitor, ekg, echo, str. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Covid test Nasal Swab post vaccination with the result of Negative. The events were non-serious per the reporter. The outcome of the events was Recovered with lasting effects.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2  to the events of Fever, migraine, fatigue, not feeling well, shortness of breath, tachycardia cannot be excluded. The case will be reassessed once more information become 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On day following 6 month IZ's, patient had tarry stool and next day, emesis of coffee ground material. Total of 2 tarry stools over 3 days and 2 coffee ground emesis - Low grade fever 24 hrs after IZ's. Exam unremarkable. Hemoglobin stable. Hematest positive emesis. Treated with ZANTAC. Suspect may have been due to ingested maternal blood from nursing.
Information has been received from a nurse concerning a male who on 18-DEC-2009 was vaccinated with a dose of PNEUMOVAX 23 (LOT# 665402/1339Y). After vaccination, the patient experienced redness, swelling and itching around the elbow on the arm where the patient received the vaccine. The patient was treated with antibiotic (manufacturer unknown) and "DEPO". The patient was recovered on an unspecified date. Follow up information has been received from a registered nurse (RN) who reported that on 15-DEC-2009 at 2:15 PM the 75 year old retired male patient with no known allergy or illness at time of vaccination was vaccinated IM with a dose of PNEUMOVAX 23 (LOT# 665402/1339Y) in the right deltoid. Subsequently, the patient came in with complaint of soreness and stiffness of his right arm which developed on 18-DEC-2009 at 12:50 PM. It was reported that the patient's "bicep was very red". The physician diagnosed as an allergic reaction. The patient was given antibiotics (ABT) and allergy medication (unspecified). At the time of the report, the patient was recovered on an unspecified date. This is one of the two reports from the same source. Additional information is not expected.
pt recv vax & exp nausea lasting more than 2mo;further details have been requested;
Pt c/o 24 hour course of HA, fever, chills, joint pain and upset stomach--resolved overnight.
Arm pain that continued for weeks, eventually referred to ortho shoulder specialists. Diagnosed with SIRVA. Sending him to physical therapy now.
12 hours after severe chills, body aches, shakes. Fever 101.3-103 nausea lymph gland swollen under left arm. Fever now going on 2 days.
Injection site pain; SIRVA; This spontaneous case was reported by a consumer and describes the occurrence of SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (Injection site pain) in a 71-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) and INJECTION SITE PAIN (Injection site pain). At the time of the report, SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (SIRVA) had not resolved and INJECTION SITE PAIN (Injection site pain) outcome was unknown.            No concomitant medication were provided by the reporter. No treatment information were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received for the case: MOD-2021-028253 on 02-07-2021 new event and second dose information were added.
Post injection Day 1, merely lethargic & painful arm. Day 2, absolutely PERFECT. Day 3, low-grade fever, uncomfortable arm but never inspected Day 4 (today):  Noticed redness on arm, reaching 4-1/2 inches in length below site of injection, warm to the touch.  Low grade fever of   98.1  when normal is in the 97.1 area.
approx 1/2hr p/vax pt exp numbness to tongue;pt given DPH;tingling in legs/feet, arms/hands;
No additional adverse event details available; PROQUAD  that have been stored outside of recommended range have been administered to patients; This spontaneous report has been received from the office manager referring a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On an unknown date in 2022, reported as between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  lot number W006585, expiration date: 23-AUG-2023, as prophylaxis (vaccination scheme, dose, anatomical location and route of administration were not provided) following a temperature excursion of 6°F up to 14°F for 0 hours 50 minutes 0 seconds; 14°F up to 46°F (15F) for 0 hours 30 minutes 0 seconds (product storage error). There was stated that no previous temperature excursion occurred. No additional adverse event were reported.; Sender's Comments:  US-009507513-2207USA000775: US-009507513-2207USA000771: US-009507513-2207USA000470: US-009507513-2207USA000561: US-009507513-2207USA000544: US-009507513-2207USA000552: US-009507513-2207USA000563: US-009507513-2207USA000765: US-009507513-2207USA000553:
Episodes of Room spinning dizziness which started after a week of getting the 1st dose of vaccine.  It has been 11 days and still having dizziness.
Headache arm soreness, redness Narrative:  Rash noticed to injection site 12/31/2020.
Information has been received on 23-NOV-2016 from a pharmacist via an employee referring to an 83 year old male patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 15-NOV-2016 the patient was vaccinated with PNEUMOVAX 23, (lot number and expiration not reported) unknown route for prophylaxis. On 15-NOV-2016 the patient developed swelling and redness on his injection arm from his armpit to his wrist. The patient reported feeling like his injection arm was "flappy" or "asleep." The patient reported experiencing tingling in his injection arm and feeling very uncomfortable. The pharmacist states that there is a slight chance that he was bitten by a bug around the same time he received PNEUMOVAX 23. The pharmacist emphasized that the patient's swelling and redness was on the inside of his arm or the anterior aspect of the injection arm. The pharmacist didn't specify whether or not the patient was ever vaccinated with a pneumococcal vaccine before 15-NOV-2016. The patient did seek treatment by consulting with the pharmacist. No additional information was provided. The outcome of tingling in his injection arm, feeling very uncomfortable and swelling and redness on his injection arm was reported as recovering/resolving. The causality was not reported. Additional information has been requested.
Fever, chills, headache, nausea, muscle aches, fatigue, injection site swollen and hot and painful
No immediate adverse events to report after vaccine administration. Weeks later I noticed small heart issues of small fibrillation's a few times a week and also a couple larger events. In December, I experienced a major Crohn's flare-up that included blood loss.
has had pneumonia three times; This spontaneous report was received from a patient's caregiver (also reported as received from a consumer on behalf of his mother) via Pfizer and refers to an 83-year-old female. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2008, the patient was vaccinated with her first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown dates in 2016, 2018 and in October 2020, the patient was vaccinated with three doses of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On 10-FEB-2022 (reported on 11-FEB-2022 as "yesterday"), she was vaccinated with her second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On unknown dates, the patient experienced pneumonia three times. At the time of reporting, the outcome of the event was not known.  This case was also reported as medical inquiry. The reporter wanted to know a difference between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and pneumococcal vaccine conj 20v (PREVNAR 20). A pharmacist relayed that pneumococcal vaccine conj 20v (PREVNAR 20) would not allow his mother to get pneumonia and the consumer wanted to know how far apart should the vaccines be spaced if the patient was to receive pneumococcal vaccine conj 20v (PREVNAR 20) after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The causal relationship between the event and the suspect vaccines was not provided.  Upon internal review, the event of pneumonia three times was determined to be medically significant.
Per mother, child had been incredibly fussy since vaccines given on 1/23/18. When mother went to change child's diaper 2/1/18 AM, she noticed a half-dollar size lump/redness on child's R thigh, at the area where MMR had been administered.
Bad raised rash all up and down both arms. Extremely itchy. Itchy scalp as well. This reaction is happening right now so I'm not sure if I will need medical attention.
Thrombophlebitis of left leg- pain, redness, swelling.  Started 11 days after 1st COVID vaccine. Treatment with warm compresses, NSAIDS, rest, elevation.
Developed rash on legs, thighs and chest, very itchy, lasted about one week post second vax in series. Didn't report first reaction to first vax. Thought it was a heat rash. Prescribed cortisone.
Within two or three minutes minutes of receiving the injection, patient experienced lightheadedness and felt like fainting.  Shaking or pulsating sensation felt in the arms and hands, along with sweating and elevated heart rate, lasting for about 10 minutes.  Lightheadedness went away after about 30 minutes.
Patient given 0.25mL of Moderna booster 50mcg instead of the Moderna 25mcg.
On August 3rd, 2002, noon I was administered Varicella Vaccinne, MMR Vacinne, Td, and a PPD test. This was done in connection with documentation needed for immigration purpose.   For 2 days following the shots I had mild tenderness, and redness over the arm where I received the shot.  On August 15th, 2002 I got an itchy rash over my back shoulder region and fever. On August 16th evening, I had high fever about 102 F and the rash started becomming red, and two more rashes started appearing.   I consulted the Clinic where I received these shots, and they said "this rash was normal and it would subside in 2 days and this didn't warrant a doctor's attention at that point."  The next day August 17th, number of rashes started increasing exponentially, all over my back. Areas include: abdomen, back, then over face, thighs, upper arms in the above order. Number of rashes amounted to 15 almost. Accompanying all this was intermittant high fever to almost 102F.   Rashes were red, round, 1-2 cm in diameter, extermely ichty.   Seeing the rapidity with which the rashes compounded, we decided to set up an appmnt with our insurance doctor. The doctor saw us and felt it was "urticaria" and prescribed "Allegra" and "topical steriod - triamcinolone".   I applied them for 2 days. The existing rashes are the same, and new rashes started appearing on my fore arms, and on my knees, and leg. Some more on my back and trunk. The total number of rashes now exceed 30. Rashes now are also prevalent on my scalp and forehead.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 13:00 as dose 5 (booster), single (Lot number: GJ5665) at the age of 66 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Mar2022 at 02:00 as dose 4 (booster), single (Lot number: FK9896), in right 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: "Lymphoma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 09Jan2023 to 13Jan2023.
The Moderna 6mo-5Years was diluted with 2.2ml of 0.9% sodium chloride (normal saline, preservative -free diluent. Administered .2ml to left vastus lateralis. Parent notified 07/08/22 at 4:49pm of incident. No adverse reaction at that time. Educated parent to signs and symptoms of adverse reactions. A follow up call will ensue with the CDC recommendations for further vaccination information.
Received notification from pt's mother reporting the Wednesday night of pt receiving influenza vaccine, pt c/o arm hurting and developed a hard knot to the left arm injection site, with a little redness, then on Thursday redness extended to elbow, hard, warm, and tender to touch.  Mother gave pt Benadryl and applied cold compress.  Symptoms had decreased by Friday and Saturday per mother.
This case was reported by a healthcare professional and described the occurrence of lump (NOS) in a 47-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medical conditions included hypertension, reflux and coronary artery disease.  In 2005 the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced lump (NOS), erythema, swelling and pain.  At the time of reporting the outcome of the events was unspecified.  Follow-up received on 10 October 2007 indicated that the subject had experienced the same reaction with the influenza vaccine (unknown manufacturer) that she received in 2003 and 2004.  She had no problems with the influenza nasal spray.  She stated that following vaccination with Fluarix, she immediately experienced lump (NOS), erythema, swelling and pain.  The events resolved.  The reporter considered that the events were probably related to the use of Fluarix.
Die; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: DEATH (death, medically significant), outcome "fatal", described as "Die". The patient date of death was unknown. Reported cause of death: "Die". It was not reported if an autopsy was performed. Clinical course: it was reported patient died in the first day of trials. One died instantly. 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-202201082234 Same reporter, event, drug, different patient;US-PFIZER INC-202201082235 Same reporter, event, drug, different patient;US-PFIZER INC-202201082233 Same reporter, event, drug, different patient;US-PFIZER INC-202201082236 Same reporter, event, drug, different patient;; Reported Cause(s) of Death: Die
Redness and swelling starting at injection site about 24 hours after admin. Redness and swelling spread around arm - severe by eval 4 days after admin. ? Cellulitis vs. allergic rxn vs. other ADR.
HCP calling to report AE for patient who received improperly stored VARIVAX on 11OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; HCP calling to report AE for patient who received improperly stored VARIVAX on 11OCT2023. No side effects reported. No other medical information known. Operator of Device was a Healthcare Professional. HCP permission to contact obtained. See addition; This spontaneous report was received from Other Health Professional and refers to a patient (age,gender and race were not reported).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) (lot number X007372 has been confirmed to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), expiration date reported as 12-MAR-2025) subcutaneous injection (strength, route of administration, and indication were not provided).   On 11-OCT-2023, the HCP calling to report AE for patient who received improperly stored (Improper storage of product in use) varicella virus vaccine live (oka/merck) (VARIVAX).; Sender's Comments:  US-009507513-2310USA007934:
Slight tinnitus that comes and goes in both ears.  More concerning is intermittent hearing loss in right ear. Feels like hearing volume turns up and down, as though there is a blockage. There is also pressure that won?t go away (pop). I have not sought treatment and am waiting to see if issue resolves on its own. I don?t want to take steroids.
At approximately 1100, patient reported to Lead Nurse she received a 1st dose of Moderna. Patient received her first dose of Moderna (LOT# 042L20A) on 01/17/2021 in left arm. Patient reported a first dose reaction. One day after her vaccination, patient noted left arm redness and swelling at the injection site. Patient immediately went to urgent care. Urgent care doctor advised patient to go to the emergency room. Patient was hospitalized for one night in the emergency room and reported hives all over the body. Lead nurse elevated to supervisor. Supervisor elevated to medical consult team. Medical consult team advised patient to receive a single dose of Janssen Covid vaccine. At 1342, patient received a single dose of Janssen (LOT# 211A21A, exp. 12/14/2021) in right arm. Patient advised to wait in observation for 30 minutes. Lead Nurse educated patient on signs/symptoms of when to seek emergency care, to follow up with primary care provider, and to sign up on v-safe. At approximately 1412, patient left facility with unlabored respirations and steady gait.
Approximately at around 10:30 AM, following the administration of an MCV4 #2 and HPV #1 vaccines, the 16 year old client developed moderate swelling to his right inner eye lid that interfered with his vision and generalized itching. He also complained of feeling tired. He returned with his mother and sister to the health department where it was determined that he was having an allergic reaction and Epinephrine and Benadryl were administered intramuscularly and he was kept under observation for a period of 60 minutes. His vital signs were stable: Blood Pressure was 120/72, Pulse was 70 beats per minute, Respirations were 16 per minute. Upon assessment at about 15 minutes following the administration of Benadryl and Epinephrine, swelling and general itching was significantly subsiding. Mother was asked if her son had an attending physician and she replied that he did not; as a result, she was referred to the clinic's social worker who determined that he qualified for CHIP. Mother was advised to follow up with attending physician and establish a medical home. Mother was contacted at 2:30 PM and she advised me that her son had fully recovered. She was still advised to follow up with her son's physician. She verbalized understanding. It was also advised to defer any future HPV vaccines until it was established what caused the allergic reaction.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of LIQUID PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Heart palpitations - very strong and frequent, occurring every minute.  High blood pressure  I have never had either of these conditions ever in my life. I went to urgent care once, and ended up in the ER om 4/20/21. 1 month after my second shot, the palpitations are getting better and my blood pressure is going back to normal.
booster given and pt also received flu vaccine . During observation, pt complained to RN of nausea and  "throat was feeling tight.  Patient looked pale and anxious.  Pt was evaluated by provider.   Pr received EpiPen 0.3 mg x1.  911 was called for pt.  paramedics provide pt Benadryl 50mg IV.
Extreme swelling 2 weeks after vaccine. A lot of bruising. Left hard very sore size of quarter place on right arm. Blood a lot when injection was done.
Fever (101F), chills, general soreness and fatigue. Symptoms came on quickly, then gradually lessened with recovery by Saturday (3/13) morning.