chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt returned home post visit w/o issue. Bandaids removed later that evening and localized redness and swelling were visualized on R thigh at injection sites. Some hardness. This afternoon redness has enlarged, mild swelling is still present, hardness is gone. Afebrile. Patient in no obvious discomfort and behaviors are unchanged. Pt came in for nurse visit. Area was visualized by employees and another CMA. Agreement that no signs of infection. Advised monitoring and applying icepacks. Mom given after hours contact number, if sx worsen she will call.
Initial information received on 03-Jan-2019 regarding an unsolicited valid non-serious case received from non health professional. This case involves 12 year old male patient who received an 0.5 ml expired dose of vaccine FLUZONE QUADRIVALENT. (Batch number UI714AA, expiry date: 30-Jun-2017) via intramuscular route in the right deltoid 31 Dec 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient did not received no other vaccines. It was a case of actual medication error due to expired vaccine used. It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
7-16-17-Went to PM pediatrics due to neck pain. Was jumping on trampoline day before. 7-19-17 seen here due to neck pain, nausea, loose stool, sore throat, dizziness. 7-21-17 seen by orthopedics due to neck pain. 8-7-17 seen due to sore throat, nausea, anxiety. 8-8-17 seen by gastroenterology due to poor appetite, nausea, heartburn-endoscopy done subsequently. 8-25-17 seen due to rash. 12-2-17 seen for headaches and nausea and referred to neurology.
Injection site soreness; headache; nausea; lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp via medical information team.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 23Feb2021 at 11:13 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced injection site soreness, headache, nausea and lymphadenopathy. The patient took (paracetamol) TYLENOL for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Patient had a syncopal episode within 15 minutes of vaccination.  He drank some water and felt better. He was released to home.
neurological symptoms, cold and then hot feeling throughout body, dizziness, vertigo, metal taste, nausea,  teeth chattering, tremors, muscle spasms, flashing lights when eyes are closed, headache; burning, tingling, pins and needles feeling throughout body, including but not limited to: head and neck; numbness throughout body including: neck, throat and tongue, ringing and motor sound in both ears; eye crossing with trouble focusing, unable to sleep, brain fog, hyper salvation
itching; received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps; she has joint pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA426189.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "lost 50 pounds" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers; "skin ulcers" (unspecified if ongoing), notes: The patient's past medical history included lost 50 pounds intentionally and had skin ulcers. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "she has joint pain", "Itching", "received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps". The following information was reported: PRURITUS (non-serious), outcome "not recovered", described as "itching"; VACCINATION SITE SWELLING (non-serious), outcome "not recovered", described as "received her Pfizer booster in her left arm and the second booster on her right arm and both of those left her with bumps"; ARTHRALGIA (non-serious), outcome "not recovered", described as "she has joint pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: She received her Pfizer booster (second) on her right arm and both of those left her with bumps. Itching still has itching on her arms, she has joint pain Treatment included was she was adding over the counter cream (unspecified) for she stated that she still has itching on her arms and not reported for other events. Reporter causality: Not reported for all events. Company causality; Not reportable for all events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On days 11,12,13 & 14 - have experienced 6 sever nose bleed events, lasting 10 minutes each or longer.; This is a spontaneous report from a contactable consumer (patient) reported for himself that: A 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN0169) via an unspecified route of administration, administered in Arm Left on 19Apr2021 10:30 (Age at Vaccination 61-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Food allergy to lemon from an unknown date and unknown if ongoing, coronary artery disease from an unknown date and unknown if ongoing Verbatim: I am a heart patient with coronary artery disease, stent placement from 29Dec2016 to an unknown date Verbatim: 2 stents placed in the LAD & L Circ. on 29Dec2016. Concomitant medication(s) included immunoglobulin varicella-zoster (ZOSTER IMMUNOGLOBULIN) taken for an unspecified indication from 17Feb2021 to 17Feb2021; ticagrelor (BRILINTA) taken for cardiac disorder, start and stop date were not reported; carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:30 AM (Age at Vaccination 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Past drug included Amlodopine, Patient took zoster immunoglobulin in left arm dose 1, statins and experienced drug hypersensitivity, amlodipine and experienced drug hypersensitivity. Prior to vaccination, patient did not diagnose with COVID-19. Since the vaccination, patient did not test for COVID-19. The patient experienced on days 11,12,13 & 14 have experienced 6 sever nosebleed events, lasting 10 minutes each or longer on 30Apr2021 10:00. It was reported that on days 11,12,13 & 14 - have experienced 6 sever nosebleed events, lasting 10 minutes each or longer. No prior similar instances in the last 5 years. I am a heart patient with coronary artery disease, 2 stents placed in the LAD & L Circ. on 29Dec2016.Therapeutic measures were taken as a result of on days 11,12,13 & 14 - have experienced 6 sever nosebleed events, lasting 10 minutes each or longer. Doctor or other healthcare professional office/clinic visit, treatment received for the adverse event First aid to stop the bleeding. The outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.
Severe leg pain resulting in going to the emergency room. The pain was so intense that I thought I had a blood clot.
Possibility that the vaccine was over-diluted with 1.8mL instead of 1.3mL prior to administration.
17 year old received Flublok vaccine with no adverse event; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received 0.5 ml once INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2028, expiry date: 30-Jun-2021) via un unknown route on left arm on 24-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided. No other vaccines were administered.  It was an actual medication error case due to Inappropriate age at vaccine administration. (latency: same day)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient staying in nursing home; positive test for COVID-19 on 9/30/21; O2 supplementation and antibiotics; DNR; comfort measures; patient died in the facility.
Anaphylaxis type reaction with chest tightness and throat fullness. Pt had reaction first dose with Benadryl IM used with a lot of anxiety . Second dose very anxious gave Epi x 2  and Benadryl with pt going out via 911. Pt was awake and talking BP 175/106, P81 O2sat 98%
6-7" circle of swollen, red, sensitive flesh w/1"x2" very hot, red, swollen center area at injection site. Almost looks like hives, but is larger and limited to injection site.
Patient was over vaccinated.  He was already given a dose of Prevnar 13 in March and again on 9/28/2016.
flu; Initial information was received on 08-Dec-2021 regarding an unsolicited valid non-serious case from Social Media via a consumer/non-healthcare professional.  This case involves a patient (demographics unknown) who had flu (influenza) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   In October 2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via unknown route in unknown administration site for prophylactic vaccination.  In Nov and Dec-2021, the patient developed non serious flu (influenza) approximately after a month following the administration of INFLUENZA VACCINE.  It was reported "Got the flu shot in October and then had the the flu for 3 weeks in November and December"  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the event.  On an unknown date, the patient was recovered from the event.  There will be no information available on the batch number for this case.
Information has been received from a consumer concerning her 65 year old mother with cervical cancer and high blood pressure who on approximately 15-OCT-2010 "mid October 2010", was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant medications included high blood pressure medication (unspecified). It was reported that on approximately 16-OCT-2010 "a day after receiving the vaccine" the consumer's mother experienced headaches and at the time of the report she was hospitalized. The patient had a blood work and a magnetic resonance imaging (MRI) performed (results not provided). At the time of the report the patient's outcome was unknown. No further information is available.
The first 24 hours were very difficult for me. I have never been so sick in my life. I got the typical muscle aches, chills, etc. In fact I got every side effect listed plus more. I want to discuss the other side effects. On day 3 I started to develop extreme chest pain and pressure. It is a dull pain as if someone if sitting on my chest that will not go away. I also started to experience sudden bouts of dizziness and vertigo. It will not go away. Today is Day 7 and I spent the night in the emergency room because my chest pains got so strong. However, all the work up came back okay. I also have this strange feeling of electrical shocks running thru my head, those last about .5 seconds and go away, but it is a very weird feeling I have never experienced. I also have a strange desire to constantly burp, when I do my chest pain feels better. If I don't burp my ears start to feel full and sometimes they ring. Its Day 7 and I still feel SO miserable. Why id no one speaking about these chest pains? I know 5 people who have experienced the same.
Patient given flu shot 12/1/11. Patient called to complain of itch & swell at site, 12/3. 12/4 Patient called to say was seen by urgent care and told was cellulitis. Put on KEFLEX, cleared op.
Pt presented to ED on 11/09/2021 as a referral for altered mental status and fall from bed. Patient was vaccinated for COVID-19. When the patient had EMS called the patient blood sugar level of 29 and the patient was given 250 cc of D10 which improved the patient's blood sugars over 100. When the patient was brought to ED she was hemodynamically stable.  She was noted to have a right hip wound with significant drainage. Her COVID-19 test found to be positive but the patient was not hypoxic. Labs showed HB 7.1 with MCV 83 with hypoalbuminemia 1.7 with hypokalemia 3.1 within normal troponin/lactate/procalcitonin. Chest x-ray showed bilateral opacity consistent with the patient's known coronavirus. Patient was admitted for further evaluation and management of altered mental status with severe anemia with hypoglycemia with hypokalemia with right hip wound with COVID-19 positive status.  During the hospital course patient was noted to be hypoxic requiring 2-3 L NC O2. Patient was started with IV Decadron. The rest of her hospital stay was not related to COVID 19.
Moderate localized reaction about 6 in diameter erythematous and painful no pruritis.
Shingles, diagnosed by dermatologist who prescribed Valacyclovir. Shingles appeared on Sept 8 or Sept 9 of 2021. I thought it was just a mild rash, until it started getting bigger and I decided to go to a doctor.
pt recv vax on 31may95 & 31jul95; lab evaluation revealed the pt had failed to seroconvert;
Pt recvd 3 doses of Engerix-B & 6 wks following the inject had no HBSAB when titer was checked;
I had the senior flu shot on Thursday and that night I had cold chills, fever and body aches. This lasted until Saturday.
3 hrs p/administration of .5cc each DTP/HIB pt had fever 104; Fever lasted 24 hrs;
Itching at injection site, 4 inch red ring around injection site, armpit pain on left arm
This spontaneous report as received from a pharmacist via field employee refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, dose (unknown), route of administration (unknown). Concomitant therapies included many therapy unspecified. On an unknown date, the patient became dizzy and developed redness of her arm at the injection site, shortly after receiving with ZOSTAVAX. Patient sought medical attention because adverse event occurred in pharmacy. BENADRYL was given as treatment for adverse events. Action taken with respect to ZOSTAVAX was not applicable. No product quality complaint was involved. The outcome of events was reported as resolved. Causality was not provided. No other information was available. Additional information has been requested.
Temp of 104 and febrile seizure about 12 hrs after vaccine was administered. 3 more seizure-like episodes within the next 24-hour period.
PATIENT CURRENTLY HOSPITALIZED (6) DAYS  He is a 67 y.o. male with past medical history of poorly controlled DM II, CKD 4, obesity, OSA on BiPAP who presented to the ED with generalized weakness and recurrent falls at home.   Patient was recently hospitalized 12/15-12/24 for DKA and AKI from medical non-compliance. He was evaluated by PT/OT during that time who recommended SAR however patient refused and was discharged home. Unfortunately, the patient had a fall this morning when getting up to use the commode. He reports his legs gave out from underneath him and he fell hitting his head. He denies associated LOC or pre-syncopal prodrome. Reports this is his first fall since being home from the hospital. States his appetite has been poor and has continued to feel weak and tired. He hasn't been getting out of his bed much but does report being complaint with his medications. Denies fever, chills, URI symptoms, SOB, chest pain, unilateral weakness or joint paint.   Upon arrival to the ED, patient was afebrile and hemodynamically stable. Labs were notable for BUN 25, Cr 2.59, mg 1.4, hgb 12.4. CTH and CT cervical spine were negative for acute pathology. Patient received magnesium supplementation while in the ED.   Patient will be admitted to Facility for further treatment and evaluation.
Developed lump at injection site with a redness at site the size of a silver dollar - lasted two weeks. Developed hives on the bottom of the right food on the instep. (injection was in left arm)Hives still present. Formed a blister which broke open.
severe pain in entire arm, Severe fatigue, GI discomfort, Headache, This lasted 3 full weeks
flu vaccine may be ineffective due to temperature excursion; Initial information was received on 09-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 71 years old male patient who stated flu vaccine may be ineffective due to temperature excursion after receiving influenza quadrivalent recombinant vaccine [Flublok qiv].  The patient had no medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 17-Oct-2022, the patient received an unknown dose of suspect influenza quadrivalent recombinant vaccine (unknown formulation) (lot: QFAA2248) (expiry date, strength, frequency was unknown) via intramuscular route in unknown administration site for prophylactic vaccination.  On 17-Oct-2022 the patient had a non-serious event flu vaccine may be ineffective due to temperature excursion (product storage error) (latency: same day) following the administration of influenza quadrivalent recombinant vaccine.  There were no lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hours after vaccination I began to have a fever.  Woke up with body aches and a fever of 104.00  Fahrenheit. Fever lasted 24 hours, body aches lasted a full week including severe headache. I started experiencing severe pain on my left eye by day three post vaccination. I had to seek medical attention and was diagnosed with scleritis. Doctor encouraged me to file a report on my symptoms. I also got mouth sores and pain in my throat. Tonsils were inflamed and red.
Experiencing heightened psychosis with bouts of uncharacteristic anger with no other probable cause. Started calming down 5 days after onset. Peak psychosis at 4 days after vaccine. Still some residual effect today (6 days in), but psychotic symptoms are manageable, as before vaccine.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chills-Medium, Systemic: Tachycardia-Medium
headache on my left side where I got my shot; painful chest pressure/burning and pressure in chest; painful chest pressure/burning and pressure in chest; tested Covid positive; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263 and expiration date: unknown), via an unspecified route of administration on the left arm on 27Jan2021 at a single dose for COVID-19 immunization. Medical history included reflux diagnosed about 6 years ago, cholesterol and osteoporosis. Concomitant medications included alendronate sodium (ALENDRONATE) for Osteoporosis-the doctor told her to stop this one because it may contribute to heart problems, atorvastatin (ATORVASTATIN) for Cholesterol-taking probably 2-3 years, and omeprazole (OMEPRAZOLE) for reflux, which the patient has been taking about 6 years. The patient received her first Pfizer vaccine dose and had some symptoms right after- burning and pressure in chest, states they kept longer than 15 minutes about 30 minutes, then she went home. She developed painful chest pressure and a headache on the left side where she got her shot. The patient went to the ER and was admitted for 2 days. She then tested positive for Covid and was upset because she was reportedly careful. The doctors wanted to do a heart catheterization to check for blockage and she refused. States they gave her high blood pressure medication, metoprolol, in the hospital but her primary care told her to stop taking it because she doesn't have high blood pressure. States she also takes vitamins including vitamin d3, Caltrate 600+D3, and CoQ10 200mg, and just started taking a baby aspirin in the morning. She also had a headache the whole time in Jan2021, that resolved a couple of days ago. She was released (discharged) on 29Jan2021, and is to follow up with a cardiologist, but they will not see her until she is negative for Covid 19. She spoke to her PCP and she will be out of quarantine on 08Feb2021. She was supposed to get a phone call or text from the vaccination location about scheduling her second vaccine dose. She was also asking if she can delay the second immunization shot until she gets her cardiology issues resolved. The event "headache on my left side where I got my shot" resolved in Feb2021, and the event "painful chest pressure/burning and pressure in chest" had not resolved, while the outcome of the rest of the events was unknown.