chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 72-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 15-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805479 was crossed linked to original cases 201804863 due to same reporter.
This spontaneous report was received from a registered nurse refers to a 4 year old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 28-OCT-2016, the patient was vaccinated with improperly stored doses of PROQUAD lot # M032497, 02-JAN-2018. No adverse effects were reported. Additional information has been requested.
Rash developed on face then spread to trunk and limbs pt took BENADRYL with no relief of sx-rash began about 24 hours after receiving influenza vaccine. RX- watch and wait.
A few hours after receiving the injection, I experienced a rapid onset of joint pain throughout my entire body. I was unable to move from the pain, and lost consciousness for several hours as a result of this pain. When I regained consciousness, the pain had decreased, but I was still sore and felt lethargic for several days.
BLACK AND BLUE MARK AT SITE OF INJECTION; SHE FELT PAIN DURING THE  INJECTION OF THE VACCINE; This spontaneous report received from a patient concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included deaf. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced black and blue mark at site of injection. On 19-MAR-2021, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from black and blue mark at site of injection, and the outcome of pain was not reported. This report was non-serious.
Extremely All over body pain  and exhaustion.  Arm In which vaccine received extremely painful and cannot lift al the way up.  When lifting pain radiates up the arm to the neck.
Initial report received from a health care professional on 18 November 2010. A 66-year-old female patient, with a history of brain surgery for a facial nerve which required wrapping in Teflon, hypertension and thyroid disorder, received on 28 September 2009 an injection (route and site not reported) of FLUZONE No Preservative 2009-2010, lot number UT3172BA. Within two weeks of receiving the vaccine, the patient developed Global Transient Amnesia. The patient had just lost her husband and went on a trip. When she woke up she knew people but did not know where she was. The patient was seen  by a neurologist. The outcome was reported as recovered. Documents held by sender: None.
Patient had no reaction at time of vaccination, got up out of chair and walked approx. 20 feet to sit down in a chair with arms in the vaccine observation area at 1715. At 1722 patient fell out of chair and onto floor. PharmD started emergency chain including 911 call and call to patient's emergency contact. PharmD ran to patient and observed him lying facedown with head facing left. Eyes open but unresponsive, his name was called with no response. Right as he was observed to be breathing normally with a steady pulse, patient had mild seizure with jerking movements. He was turned to his side during seizure event lasting no longer that 2 minutes. Patient then regained consciousness and was kept on his side. Was alert and oriented. He knew where he was, who he was, what day it was. He was able to answer all 911 dispatcher questions relayed to him. Dispatcher advised he could sit up on floor, which he did. PharmD stayed right behind him until paramedics arrived. He was kept talking to stay alert. It was unknown if he hit his head on the initial fall. Paramedics arrived and checked BP/Pulse/EKG. Pt then had a gasp/shake attack that paramedic notated as a panic induced episode. He calmed and was transferred to ER
approximated  4 minutes after first dose of  covid19 -moderna  vaccine Pt started feeling sweaty, shaky, lightheaded. during assessment BP: 174/100 HR: 101 02 sat 98%. Ten minutes after pt's progressively feeling better BP:  153/91, HR:91 02 sat 98%. Offered water and she drank 500 ml. Internal Medicine  Dr came to vaccination clinic basement  and did a physical evaluation to pt. As per MD Pt was anxious.  Pt remained for another 30 minutes and left feeling better stating still feeling mild lightheaded so her son was coming to pick her up.  Last  vital signs before she leaving BP 150/90,  HR 89, 02 sat 98%.  Anticipatory guidance for pt and any s/s concern to report to PCP or to go Urgent Care. Pt instructed to take her BP meds as prescribed and to come back to clinic for BP check follow up in one week.
Local erythematous reaction at the injection site. Asymptomatic for infection, no treatment given.
Received FLUZONE High-dose 2017-18 0.5ml SYR and began feeling throat soreness and urge to cough within a couple hours after injection. Throat discomfort increased over the next several hours, accompanied by upper respiratory congestion and watery eyes that became crust overnight. In short, it felt like having a case of flu.
01/11/2022: Event occurred after 2nd vaccine.     Patient presents to the emergency department with complaints of shortness of breath, cough is nonproductive and altered mental status.  Patient has a history of COPD, Patient denies: vomiting, diarrhea, fever, urinary symptoms, Past medical history: COPD, diabetes mellitus, hypertension, hyperlipidemia, CVA with right-sided deficit 01/13/2022: remains in hospital
On Monday morning I had a headache and by noon had a fever of 102.4 with chills. Fever broke on Tuesday but had headaches till Thursday. Tired but ok now! Really  glad to get it.  Feel lucky. This was my 2nd shot.  Only sore arm with first one.
I had multiple side effects, which I will list below, but the one that was most concerning and which I have not seen listed as a typical side effect is that I got very dizzy and fainted, losing consciousness briefly. I got my vaccine around 10am.  By 9pm I had severe chills and was achy.  Around midnight I got up to use the bathroom and felt dizzy, then I fainted.  Thankfully I had called for help beforehand, so my husband caught me and called my name until I regained consciousness.  Immediately after coming to I started sweating profusely.  My temperature at that time was 100.3.  Through the rest of the night and for the following day and night I experienced nausea, chest pains, achy, sore arm, weakness, and fatigue.  I felt relief from symptoms by about 48 hours after my vaccination.
swollen lymph node under his left arm; tenderness at the injection site/his arm was tender; felt like he got light-headed was going to pass out; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GR2613, expiration date: not reported), via an unspecified route of administration, administered in arm left (left upper arm, around his shoulder area) on 24Mar2021 19:00 as dose 1, single for COVID-19 immunisation (reason for vaccination: at his age, he had elder parents and grandkids and he wanted to protect himself and protect others). The patient's medical history was none and concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine, no additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. No family medical history relevant to adverse events. On 25Mar2021 (yesterday) he felt fine, but he felt a tenderness around the injection site. The patient stated that he had tenderness at the injection site on 25Mar2021 (yesterday). On 26Mar2021 (this morning) his arm was tender, and he noticed a swollen lymph node under his left arm, in which the node was the reported as the size of a baseball. He had received the vaccine in the left arm. On 26Mar2021 (this morning) whenever he got out of the shower, he noticed his lymph node underneath his arm was swollen and tender. He started rubbing it and then he felt like he got light-headed was going to pass out (start: unspecified date in 2021). Tenderness around the injection site felt a lot better on 26Mar2021 (today) than it did yesterday, and it was just a little tender today. His lymph node was very tender, and it was not that bad, until he started rubbing on it, then it went down-hill after that. No physician office, no emergency room visit. He was asking if this was normal and if this was something that should go back down in 2 or 3 days and if he should get this looked at by a doctor and will the swollen lymph node go down. The outcome of tenderness at the injection site was recovering, light-headed was unknown, swollen lymph node under his left arm was not recovered. No follow-up attempts are possible. No further information is expected.
2 x 3 area erythema with control 4 x 1cm area of vesicles at site of injection w/i 24 hrs of having the vaccination.
Presented with increased SOB x 4 days, normally on 2 LPM O2 at home; + Covid ED; Admit 9/20 medical Covid infection and COPD exacerbation; Tx: 9/20 maxipime, steroids, symbicort, singulair, zinc O2: 4 lpm with admission; down to 2 LPM (baseline) at dc
Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Jul-2022:  Reporter comment: This case was reported by a patient via interactive digital media. The patient experienced the rash. Follow-up would not possible as no contact details were available.
I26.99 ACUTE PULMONARY EMBOLISM 8/19/2022 SYSTOLIC HEART FAILURE, ACUTE I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/19/2022 SYSTOLIC HEART FAILURE, ACUTE R57.0 CARDIOGENIC SHOCK 8/18/2022 SYSTOLIC HEART FAILURE, ACUTE I26.99 ACUTE PULMONARY EMBOLISM 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 8/18/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 8/18/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 8/18/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R57.0 CARDIOGENIC SHOCK 8/18/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY I82.403 ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 8/19/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY R57.0 CARDIOGENIC SHOCK 8/18/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED    HEART FAILURE W REDUCED LVEF <=30%, UNSPECIFIED ACUITY
Initial report received on 14 October 2009 from the consumers parent. A 12-year-old male patient, who had no concurrent illnesses, had received an intramuscular right arm injection of FLUZONE (lot number unknown) on the morning of 09 September 2009. The patient received flu vaccine in the past; however it is unknown if he experienced any adverse events with prior vaccinations. The patient has a complicated medical history that includes febrile seizures, asthma, heart murmur with two repairs and a history of an unknown allergy that causes general rash. The afternoon after receiving the FLUZONE, the patient's right arm "doubled in size with swelling that was spongy", hot and itchy. The following day he developed a cough. The next day, the patient experienced a temperature of 103.0 degree Fahrenheit and was sent to the emergency room and hospitalized for pneumonia. Treatments received and diagnostic tests performed were not reported. At the time of this report, the patient had not recovered and was still hospitalized. Documents held by sender: None.
On 1/25/01 at 20:00, the site of injection was red and swollen and warm to the touch. The redness is 2 1/2" wide and 3" in length. On 1/26/01, doctor's office visit and leg was still swollen and red. Area was the same size as stated above.
about 10 hours after the second shot. I got really nauseous then I couldn't breath got dizzy and fainted. I was in and out of consciousness. ER doctor said I didn't show any signs of an allergic reaction.  The next few months I had an elevated heart rate and my blood pressure would drop randomly drop.
Noted onset of numbness/tingling to both feet on the weekend of Oct 11th. The altered sensation has been persistent since then and gradually progressing to now include the entirety of her body down from the mid-chest region. She also is reporting severe neck tightness and itching involving her upper chest area for the past two days. She was evaluated in Emergency Department yesterday and was given Valium 2 mg IV in addition to Ibuprofen 400 mg PO which provided some pain relief while she awaited MRI Cervical Spine and Brain. She was evaluated by pediatric neurology and the admitting team where it was determined that she also had increased reflexes on both sides involving her patellar tendon and Achilles in addition to subtle right sided weakness and diminished proprioception and dysmetria. The initial MRI read by neurology is consistent with transverse myelitis so she will be starting a course of Solumedrol 1 gm IV x3-5 days, IvIG 400 mg/kg/day x 5 days, Zantac and PT/OT evaluation.
itching; Rash; sharp pain on the arm; nausea; chills; Rash double its width and length; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), RASH (Rash double its width and length), RASH (Rash), VACCINATION SITE PAIN (sharp pain on the arm) and NAUSEA (nausea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included IRBESARTAN and TAFLUPROST (ZIOPTAN) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-1021, the patient experienced RASH (Rash double its width and length). On 02-Feb-2021, the patient experienced NAUSEA (nausea) and CHILLS (chills). On 08-Feb-2021, the patient experienced RASH (Rash) and VACCINATION SITE PAIN (sharp pain on the arm). On 10-Feb-2021, the patient experienced PRURITUS (itching). The patient was treated with CLOBETASOL (topical) on 11-Feb-2021 for Rash, at a dose of UNK, tid. On 05-Feb-2021, NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (itching), RASH (Rash double its width and length), RASH (Rash) and VACCINATION SITE PAIN (sharp pain on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient went to dermatologist and treatment for the events included steroid cream.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 67-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 30-JUN-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions by healthcare provider at a pharmacy. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider in a clinic for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Information has been received from a nurse concerning a 68 year old female patient with hypertension who on 08-FEB-2008 was vaccinated in her left arm with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (LOT # 658398/1087U). "Approximately 10 days ago" the patient developed shingles upon her return home from a vacation. The nurse reported that the patient started with back pain and was put on VALTREX to treat her symptoms. The patient went back to her physician's office due to "being in a lot of pain". She was treated with a combination therapy of VICODIN, LYRICA and ULTRACET. At the time of reporting it is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with a history of chickenpox and no known allergies. Concomitant therapy included hydrochlorothiazide (manufacturer unknown), aspirin (manufacturer unknown), and lisinopril (manufacturer unknown). The rash was on her right lateral chest wall. It was an erythematous macular rash with vesiculation. Number of lesions was unknown but there were 3 scattered areas. Other systemic symptoms included pain in the right side of her chest. Her maximum temperature was 97.5 F. No specimen was taken because the vesicles healed. At the time of reporting the patient had recovered. No further information is available.
gout; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included Gout.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GOUT (gout). At the time of the report, GOUT (gout) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Information has been received from a pharmacist technician concerning a patient (age and sex not specified) who on 06-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 650456/0974P).  On 06-OCT-2005 , within 24 hours, the patient developed an injection site reaction of swelling and redness.  The patient sought unspecified medical attention.  It was reported they have requested a check of lot 650456/0974p.  At the time of this report, the outcome of the events were unknown.  The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory.  The lot complies with the standards and was released.  Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2 NOS), on 28Oct2022 at 14:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart stents" (unspecified if ongoing), notes: Heart stents. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient was nervous upon arrival.  Stated did not eat breakfast or any foods.  After administration, waited, then walked around to get Tylenol.  Felt dizzy, "distant muffle" hearing, shortness of breath, chest tightness.  911 was called.  Emergency service responded.  Patient felt better and left store when Emergency service responders left the store.  Pharmacist called to follow up.  Patient reported feeling fine.
A few days after receiving my vaccine I developed a markedly swollen and tender lymph node above my collarbone on the same side as my vaccine administration (left). I also had some tenderness in my underarm which I blame on a lymph node but was  never able to feel a swollen one there. Both my underarm and collarbone area remained tender/sore for about two weeks. No systemic symptoms.
Low grade fever, malaise, chills, soreness at injection sight; resolved the next day with rest and fluids
rash, papular on the entire body sparing the palms and soles.  started 2 days after vaccine.  no other symptoms
Left Arm pain about 4 months after receiving vaccines arm becomes very week I?ve dropped things because it was so week . Went to  Emergency Room my own Dr was unavailable.Also I?m having left leg pain really bad my fingers hurt constantly
Urticaria developed day after vaccine on chest and face -> responding to BENADRYL.
pt recv vax; redness, swelling, pain rt arm extending from upper arm to elbow; warm & tender; dx in er as cellulitis; tx w/ diclox & heat;
Rash appeared below injection site less than a day after booster shot. Same rash appeared 7 days after initial Moderna vaccination on 05/20/21. Swollen lymph nodes under arms with all three vaccinations, but no rash on the second vaccination. Rash stayed for 5-6 days initially. Benadryl helped.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 12-DEC-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J002618 and expiry date: 01-MAR-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.