chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extreme pain in her back and arms; the area she got the vaccine was still red; The area where the injection site is red is still a bit hard and swollen; The area where the injection site is red is still a bit hard and swollen; muscle spasms; extreme pain in her back and arms; muscle pain; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer. A 62-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in Dec2019 at a single dose for immunization. The patient's medical history includes ongoing ankylosing spondylitis and neurologic issues. The patient was not in any medication for ankylosing spondylitis, the reason why the doctor gave her the vaccine. Concomitant medications were not reported. On an unspecified date, since her vaccination in Dec2019, the patient has been experiencing extreme muscle pain going into her back and the area she got the vaccine was still red and it's been a week. The patient added that area of the injection site was red and was still a bit hard and swollen. The patient thought that the injection caused muscle spasms that got into her trapezius muscle in the back. The patient was taking periodic muscle relaxants to try and relieve the muscle pains in addition to having Ankylosing spondylitis which causes extreme pain in her back and arms. The patient added that she has neurologic issues as a result of what's going on with her spine. The patient reported that the physician was looking to put her on Consentyx. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Fever, Sore Throat, Joint Pain, Abdominal Pain, Earache x 4 days, Tylenol as indicated by age for fever and pain.  Went to ER on 10/08/13, had fever of 101, influenza and strep test were both negative.
Patient came in and showed us her arm. She had a huge bruise going 4 inches below the injection site saying that she had more pain than usual after the injection. She also stated it was hard for her to sleep on that side for a day or two after.
Pt c/o feeling warm and flushed after receiving vaccine. Also reported "tingling" sensation in Lt fingers. Pt was reclined in seat and given pretzels and poweraide to drink. Medical director notified and pt Observed for additional 30 minutes. Initial bp 98/55 p- 44. Aftere reclining in seat BP 117/67  P-68, after eating/drinking and waiting 30 minutes  BP 120/71 P-61. before being released pt denied any symptoms and was driven home by wife.
Patient was inadvertently given an expired dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 11-MAY-2023, the patient received Kinrix. On 11-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Patient was inadvertently given an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 16-May-2023 The reporter was a nurse. The reporter reported that the patient inadvertently received an expired dose of Kinrix. The vaccine administration facility was the same as primary reporter. No further details were provided.  The reporter did consent to follow up. The patient received a Kinrix which was already expired, which led to expired vaccine used
2 hrs after injection, felt itching, soreness. Later felt hard lump at injection site with surrounding redness, swelling. No fevers, myalgias. Was improving by 24 hrs after injection.
Felt extremely fatigue, discomfort, fever, nauseous, unable to sleep but no energy to stay awake and sit up for first twenty-four hours.  It felt like my whole body had been turned inside out.  The second day was similar but half strength.  By the third day I was doing ok except for the lack of sleep from the previous two days.  Interestingly, my left arm tingled from the injection site down through my hand immediately after receiving the vaccine and that continued throughout the first day.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, route of administration, lot number and expiration date were not provided) for prevention of Shingles. On an unknown date in 2016 (also reported as about a year ago, after receiving ZOSTAVAX), the patient developed renal failure. It was further reported, that on an unknown date, the patient sought medical attention and the patient was admitted to an unspecified hospital for 4 days. The company representative stated, that she believed that the event of renal failure was life threatening. The outcome of renal failure was reported as recovered on an unknown date. The relatedness between the event of renal failure and vaccination with ZOSTAVAX was not provided. Upon internal review the event of renal failure was considered to be medically significant. Additional information is not expected since there was no consent to contact reporter.
Had a lot of gas; Developed a rash on the back of her neck and shoulders, as well as both arms; Dizzy; was terrible sick; fever; joint pain; muscle pain; fatigue; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Feb-2021 and was forwarded to Moderna on 02-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ILLNESS (was terrible sick), FLATULENCE (Had a lot of gas), PYREXIA (fever) and ARTHRALGIA (joint pain) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) for an unknown indication, IBUPROFEN (ADVIL 12 HOUR).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIZZINESS (Dizzy), ILLNESS (was terrible sick), PYREXIA (fever), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue) and HEADACHE (headache). On an unknown date, the patient experienced FLATULENCE (Had a lot of gas) and RASH (Developed a rash on the back of her neck and shoulders, as well as both arms). At the time of the report, DIZZINESS (Dizzy), ILLNESS (was terrible sick), FLATULENCE (Had a lot of gas), PYREXIA (fever), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigue), HEADACHE (headache) and RASH (Developed a rash on the back of her neck and shoulders, as well as both arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes antihistamine and Advil.
CC: DIZZY, INTERMITTENT SOB AND BURNING IN CHEST; BURNING IN CHEST RESOLVED AFTER 10 MIN; DIZZY AND SOB RESOLVED AFTER 30 MIN; EMT ON SCENE VSS; REFUSED HOSPITAL SENT HOME
Pt recv vax on 4/1/98; 20 min post vax pt exp nausea, passing out w/ rolled back eyes & jerking x 2 min, pale & weak
Skin lesion; The patient developed two pencil eraser sized lesions on her back; The patient was also experiencing swelling around the injection site although was not severe.; This spontaneous report was received from a patient's mother, referring to a 3-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.   On 21-JUN-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 injection subcutaneous (lot# R002051, expiration date 22-JAN-2020) and. The sterile diluent (MERCK STERILE DILUENT) used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# and expiration date were not reported).   On 23-JUN-2019, the patient developed two pencil eraser sized lesions on her back (skin lesion).  On 24-JUN-2019, the patient experienced two more lesions, one on the upper thigh and one on the sternum. It was reported that the patient was not experiencing any itching or discomfort. The patient was also experiencing swelling around the injection site although was not severe. There were no laboratories or studies performed.   At the time of this report, the patient was not recovered from the events. The causality assessment between the vaccination with varicella virus vaccine live (Oka/Merck) (VARIVAX) and the events, was not reported.
shingles; allergic reaction; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 50-year-old (also reported as 61-year-old, conflicting information) female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 13-OCT-2015, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) at a pharmacy for prophylaxis. As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 19-OCT-2015, the patient was caused to suffer an allergic reaction, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the patient requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. She is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct , and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered allergic reaction and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter.
arm was a little sore the night the patient got the shot; This is a spontaneous report from a non-contactable Nurse reporting for a patient. An elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration, administered in Left arm on 02Feb2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 02Feb2021, the patient experienced arm was a little sore the night the patient got the shot. No treatment was received for adverse event. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
Headache 12 hours after shot: Tylenol. Muscle and joint pain: Tylenol. Fever for 12 hours. Chills for 12 hours. Swollen arm glands. Since shot, still swollen: Tylenol, ibuprofen and heating pad. Felt tired since shot (including today).
contracted covid19; contracted covid19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Sep2021 (Lot number: 301858A, Batch number: EN5318) at the age of 61 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 27Jan2021 (Lot number: EN5318) as dose 2, single and intramuscular, administered in arm left, administration date 06Jan2021 (Lot number: EL0742) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing); "never smoked" (unspecified if ongoing); "blood pressure" (ongoing), notes: diagnosed over 20 years ago. Concomitant medication(s) included: RAMIPRIL taken for blood pressure abnormal (ongoing); FLU VACCINE VII, administration date Nov2021. The following information was reported: VACCINATION FAILURE (medically significant) with onset 18Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 18Jan2022, outcome "not recovered" and all described as "contracted covid19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive. Clinical course: It was stated that, dry cough and chills began yesterday 17Jan2022 and are ongoing and the same as when they began. Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient did not receive any additional therapies for COVID-19. Did not require the initiation of new medication or other treatment or procedure. Patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination; Sender's Comments: Based on the information in the case report, a causal association between reported events vaccination failure, Covid-19 and suspect BNT162B2 is possible.
bad headache causing blood pressure to go really high, chills, nausea, fast heat beat, legs felt like they weight 100 pounds each, got dizzy when trying to stand.
4/5/2022 Body ache started early in the day. 4/6 started to get a fever peaking at 102. Body aches continued. 4/7 get to urgent care. Tested with a rapid COVID-19 test, positive. Treated with ibuprofen and TYLENOL. Fever broke about 4/9 as well as body aches stopped. 4/10 tested positive on a rapid COVID-19 test. 4/15 returned to normal life.
I felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement (have an artificial heart valve).    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (I felt tired). At the time of the report, FATIGUE (I felt tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-379333 (Patient Link).
9/24/18 9:45pm complained didn't feel well. 10:20 Shaking no temperature. 10:39pm 99.5 still shaking. Eyes looked weird. (Medicated with Children's Acetaminophen). 9/25/18 Fought fever throughout night. 6:49am Vomited, temperature 102.2 7:30am 103.6 7:40am (Medicated with Children's Ibuprofen). Fought fever throughout day. Vomited five more times throughout day.  4pm temperature 100.9 shivering Continuing alternating medication,  wiping him down, and hydration. He has been very inactive all day. He is usually a very active person. Complains of headache and sore throat and being cold. He was not having any symptoms of illness prior to flu shot. Assessing condition, as to whether to seek additional medical advice.
Right arm became swollen; Red rash; Itchy in the area where he got injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected). At the time of the report, VACCINATION SITE SWELLING (Right arm became swollen), VACCINATION SITE RASH (Red rash) and VACCINATION SITE PRURITUS (Itchy in the area where he got injected) outcome was unknown.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Acute kidney failure diagnosed after second PFIZER injection.  Kidneys were not in acute stage before PFIZER injections.
I began to feel fatigue about 8 hours after the vaccination. At 10 hours after vaccination I was having chills and 101 degree fever. I took Tylenol and went to sleep. After an hour I was drenched with sweat, and feeling hot instead of chills. Next morning, I was tired, but no fever. Later in the day I had a stabbing headache over my left ear.
Fever 103.1 - likely febrile seizure witnessed by grandmother. Child brought to primary care PNP and was sent to ER - Dx: Fever of unknown cause.
Case number PHEH2014US024337, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to a 71-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 03 Nov 2014. The nurse reported that FLUVIRIN prefilled syringe at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error. Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Bivalent Pfizer given to 4 year old patient not approved for emergency use at this age group. Only approved for 12 and over.
Received Pfizer vaccines on 1/6/21 and 1/27/21. Tested positive for COVID by PCR on 3/25/21. Symptoms of H/A, rhinorrhea/congestion beginning 3/23/21.
This spontaneous report was received from a certified medical assistant and refers to a 34-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions/allergies was reported. On 23-MAR-2016, the patient was inadvertently vaccinated with a dose of PROQUAD (Merck) (dose, lot #, expiry date, route of administration and anatomical location were not specified). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
03/31/23 presents to ED for "chills" "NVD". PMHx of "DM" "morbid obesity"
Trouble breathing, throat felt constricted with needing to swallow every few seconds. This occurred for a period of about 30 minutes at 11:30am. Gave 5mg of Benadryl. After 15 minutes, breathing improved. Difficulty breathing returned later that day (same day) with same symptoms. Gave another 5mg Benadryl and took 3 puffs of Albuterol inhaler. Symptoms resolved after 30 minutes. Symptoms have not recurred so far (3 days now after adverse event and 5 days now since the vaccine).
Tightness in chest; Shortness of breath; Egg size rash on arm; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 75-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced tightness in chest, shortness of breath, and egg size rash on arm. Therapeutic measures were not taken as result of the events. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right after the vaccine I just had a slight head ache. I had pretty typical symptoms. Around 8pm my arm got to 8/10 pain. I have waves of Tachycardia and nausea. I had pretty bad diarrhea the first day and second day, this was also a side effect from the Celexa. The Tachycardia was going up to 130-140 .  Very much flu like symptoms, heart pounding, head pounding and very light headed. I was having trouble controlling BP when I stood up.  I felt feverish, I kept checking my temp but it was normal.  This went on for two day, I wasn't able to eat or drink liquids. I ended up going and getting a Covid test on Tuesday morning, I was feeling somewhat ok. Then in the evening all my same symptoms came back.  I spoke with a Dr. who informed me I was probably dehydrated. I almost went into the Emergency Room because my high heart rate and thought I was having a heart attack. I didn't due to high volume of Covid in the ER. I have a follow up meeting with my PA before my second dose to come up with a strategy.  The left side of my face started to get numb and the left side of neck. My neck started to get still and went to my jaw.