chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose of Menveo- 2 vial was administered to a patient; 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 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA701A, expiry date APR-2023) and (batch number AMAA701A) for prophylaxis.   On 11-MAY-2023, the patient received Menveo. On 11-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo- 2 vial was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-MAY-2023 Nurse reported that an expired dose of Menveo- 2 vial was administered to a patient. The Vaccine Administration Facility was the same as Primary Reporter Patient received a dose of Menveo on 11th May 2023 which was expired on April 2023, which led to expired vaccine used. The reporter consented to follow up via email or phone.
About 10 minutes after receiving the vaccine, pt began complaining of a tickle in her throat and mild SOB. After 13 minutes she began complaining of her throat feeling tight.
Not long after the vaccine I began to develop sharp, electrical, stabbing pains all over my body in random places; arms, legs, back, feet. The foot pain is getting worse so I felt I should report it. It feels like someone is driving hot, electrified needles in to my skin. It is not chronic, but it happens sporadically throughout the week and is very painful.  I am also having memory issues. My concentration and focus is worse and I am not sleeping as well as I used to.
PREGNANT ESTAMATED DUE DATE  01/06/2022  PATIENT IS ALSO UNDER 18 YEARS OLD AT TIME OF VACCINATION
pt recvd vax 21APR93 & 5MAY93 pt devel a fever of 101 which went as high as 102.5; On 6MAY93 devel red blisters on chest & cont to have a temp of 100.2; presented to MD & dx as having chickenpox;
neurological issue; acute bursitis; unable to lift my left arm 45 degrees and suffered non-stop pain; lack of sleep; extreme pain in my left shoulder; patient had had a 101.5 temperature; Initial information received on 12-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 72 years old patient who experienced neurological issue (neurological symptom), acute bursitis (bursitis), temperature 101.5 (pyrexia), unable to lift left arm 45 degrees and suffered a non-stop pain (mobility decreased), lack of sleep (insomnia) and extreme pain in my left shoulder (musculoskeletal pain), while he/she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Nov-2019, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the left shoulder.  On an unknown date, the patient developed a non-serious neurological issue (neurological symptom), acute bursitis (bursitis), temperature 101.5 (pyrexia), unable to lift left arm 45 degrees and suffered a non-stop pain (mobility decreased), lack of sleep (insomnia) and extreme pain in my left shoulder (musculoskeletal pain) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Relevant laboratory test results included: On an unknown date the body temperature 101.5.  Laboratory details were not reported.  Final diagnosis was neurological symptom, bursitis, pyrexia, mobility decreased, insomnia and musculoskeletal pain.    It was not reported if the patient received a corrective treatment.  The event outcome for neurological symptom, bursitis, pyrexia, mobility decreased, insomnia and musculoskeletal pain was reported as unknown.  Information on batch number is requested.
Chills started about 8:30pm. Shaking started about 9:00. Fell asleep and woke up at 11 with sweats and fever of 101.9, terrible headache and muscle aches. Took 2 Tylenol and 2 ibuprofen which brought the fever down but the body aches and headache lasted until well into the afternoon of the 9th of March.
soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling hands and feet; legs are jerking; This is a spontaneous report from a contactable consumer   An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) via an unspecified route of administration, in Arm Right on 20Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation.  Medical history included parkinson's disease, cardiac pacemaker insertion and seafood allergy. Concomitant medications were not reported.  The patient received first dose of BNT162B2 (lot number EL1283) on 30Jan2021 at 10:30 on right arm. On 20Feb2021 the patient experienced soreness muscle and joint, stiffness, difficulty swallowing, trouble controlling hands and feet, legs are jerking. All the events were reported as non serious. No treatment was administered for the events. At the time of the reporting the patient had not yet recovered from the events.
exacerbated the hives; exacerbated the hives; This is a spontaneous report from a contactable consumer, the patient. A 70-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EM9809), via an unspecified route of administration in the right arm on 15Feb2021 at 08:00 (at the age of 70-years-old) as a single dose for COVID-19 immunization and ampicillin (AMPICILLIN), via an unspecified route of administration from an unspecified date at an unknown dose for an unspecified indication. Ampicillin was given within two weeks of BNT162b2. Medical history included penicillin allergy and sulfa drugs allergy; all from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks. The patient previously took nitrofurantoin (MACROBID) and prochlorperazine maleate (COMPAZINE); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient experienced exacerbated the hives on 15Feb2021 at 12:00. The patient had hives from ampicillin and believed that BNT162b2 exacerbated the hives. The patient went to the Emergency room/department or urgent care due to the event, exacerbated the hives. The patient received prednisone as the treatment for the event. The action taken in response to the event for ampicillin was unknown. The outcome of event, exacerbated the hives was recovering.
i woke up on 5/4 with extreme vertigo. i wasn?t able to go to class that day. symptoms lasted the entire day but got better as the day went on and were gone by 5/5
I did and still got it; Initial information received on 26-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and gender patient who did it and still got it after receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient did and still got it (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Metallic taste immediately, dizziness, nausea.  The. 2 days of fatigue, fever 101 and waves of nausea. Day 8, injection site reaction.  Large (about 1/2 dollar in size) red/brown, itchy welt.
PATIENT STATED HE HAD SEVERE FLU LIKE SYMPTOMS FOR 9 WEEKS FOLLOWING THE BOOSTER DOSE. HOT, BURNING  AND OVERALL BODY ACHES. CLOGGED SINUS, FATIGUE  OVERALL SYMPTOMS 15 TIMES THE 1ST AND 2ND DOSES OF SAME VACCINE.
Mild redness (urticarial wheal) at (R) thigh at site of immunization (PREVNAR) began within 24 hours - treated with oral BENADRYL - seen in clinic on 10/17/08
Patients sister called to let us know that her sister woke up at 1 am on 1/25/22 with a headache, vomitting and having trouble breathing. It was bad enough that they called an ambulance for her. The sister was not sure if it is related to her getting a booster shot on the 24th or if something else was going on but wanted to keep us in the loop.
Flu shot given on 11/4/05 went to ER on 11/5/05 had broke out in hives on trunk and legs over night; no distress- hives fading due to any intervention.
lost my sense of taste/smell.; lost my sense of taste/smell; This is a spontaneous report from a contactable other hcp, the patient. This 44-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EH9899), intramuscularly in the right arm on 16Dec2020 at 18:30 (at the age of 44-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took ceclor for an unknown indication and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 24Dec2020 at 12:00, the patient experienced losing her sense of taste and smell. It started changing over the course of the day. Things tasted and smelled different or oddly before the senses going away. No therapeutic measures were taken as a result of the events. The clinical outcome of the loss of sense of taste and smell was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt devel n,v,d following vax w/Hep B; No further details were provided;
Still feeling dizzy; Dizzy; Not able to concentrate on his work; Weakness; This is a spontaneous report from a contactable consumer (patient himself). A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), intramuscularly in right arm on 01Jun2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), intramuscularly in right arm on 12May2021 (at the age of 29-year-old) as a single dose for COVID-19 immunization and had fever. The patient did not receive any other vaccines 4 weeks prior to COVID-19 vaccination. It was reported that, patient stated, he had his second dose of COVID Vaccine like 12 days ago. So he was still feeling dizzy on an unspecified date in 2021, and he was not able to concentrate on his work on an unspecified date in 2021. So he just wanted to know how long it would last. Patient stated that he experienced side effects mostly after the second shot. Patient had ibuprofen after the vaccine. Patient was still experiencing dizzy and was not able to concentrate on his work. Patient experienced only dizzy, weakness on an unspecified date in 2021. No investigation assessment. The outcome of the events was unknown.
My blood pressure normally averages 115/65 to 120/70 on a daily basis. Following my injection my blood pressure was 135/77, 140/80, 132/76, 129/79, 126/80 and has been consistently in the mid 120's over 75 to this date. The day following the injection I experienced the normal pain at the injection site but three days later I also started experiencing  tingling that radiates from the injection site to my finger tips. This feeling can be described like the arm falling asleep. This continues to this date. (21 days later). I have at least two episodes an hour and It is worse at night with cramping and when trying to do chores around the house or work like vacuuming and washing floors.
Last dose of Gardasil was administered in January, 2009.  Adverse symptoms include:  Migraine headaches, dizziness, lightheadedness, chronic fatigue, seizures, intermittent paralysis, numbness in lower extremities, leg pain, temporary loss of vision, muscle weakness, fainting spells, memory loss, joint pain, muscle pain, hair loss, chest pain, appetite loss, loss of weight, insomnia, itching and rashes.
bi-lateral leg pain within 1 week of shot. then severe back pain after 2 weeks. difficulty breathing week 3. Admitted to hospital for multiple blood clots in legs & lungs.
I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; I have cold and numbness and a dull ache in the arm of the injection; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: Eh9899), via intramuscular route of administration, on 19Dec2020 (at the age of 43 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history was Hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020, the patient experienced cold, numbness and a dull ache in the arm of the injection. No treatment was received for the events cold, numbness and a dull ache in the arm of the injection. The outcome of the events cold, numbness and a dull ache in the arm of the injection was not recovered. Since the vaccination, the patient had not been tested for COVID-19.
Immediately after injection: pain and soreness around injection site.  Starting about 3-4 hours later: impaired coordination.  The next morning: severe dehydration, disorientation, loss of balance, very low energy, headache, body aches, inability to remain standing or sitting, difficulty walking, fever, feeling hot and cold, sweating and shivering intermittently and sometimes both at the same time, impaired mental focus, worsened pain and soreness around the injection site, nightmares. Slept the majority of the day, rising only to eat and drink lots of water.  Symptoms abated throughout the day. By about 7pm, I was able to sit up enough to play some video games.  The second morning: most symptoms gone or almost unnoticeable.  Hot/cold flashes, impaired coordination and low energy continue, but improving. Attempted to go out for my usual 2-mile jog after work, but only made it about one block walking before becoming both too cold and too tired to continue.  The third day, afternoon: completed my usual 2-mile route, at a walk, with frequent stops to rest.  No noticeable symptoms from the 4th day after injection, onwards.
This is a spontaneous report from a contactable consumer, the patient, from Pfizer Sponsored Program. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and ongoing. The patient's concomitant medications were not reported. On an unknown date, the patient experienced pneumonia, rapid heartbeat, short of breath, and headache. The clinical course was as follows: The patient received the vaccine and had a reaction which was clarified as a rapid heartbeat and short of breath. She had COPD and was not sure if the shortness of breath was related to receiving the vaccine or COPD. She also had a headache. She had pneumonia for a while. The clinical outcome of the pneumonia was recovered on an unknown date after about 2 weeks. The clinical outcomes of rapid heartbeat, short of breath, and headache were not recovered. The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.
Fever, sleepiness, crying lasting 48 hours after vaccinations. Then on April 24, 2017 child stopped breathing, arched back, went limp, and was rushed to the ER.
reports itching at the site of injection  5 minutes after vaccine was given    observed for 30 minutes itching continue  given fexofenadine 60 mg   by mouth given.  observed for additional  30 minutes. states itching resolved and felt good enough to drive safely.
Upper left arm is red and swollen 8 days after shot. Was ill with fever yesterday.
Pt reported having pain, soreness and tenderness at the injection site. Reported symptoms last for 4 days since day of injection. pt deny any shortness of breath, chest pain.  Pt reports the tenderness reminding the same but getting better on soreness. having pt to monitor symptoms and checking with MD for further evaluation.
very irritable, mom describes inconsolable crying for next 24-48 hrs @ intervals; mom also describes irritable for over 1 wk; leg also swollen & reddened; t100.9;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. In or around 18-AUG-2016, the patient was vaccinated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for its intended purpose the prevention of shingles, Shortly thereafter, the patient reported falling out of bed due to dizziness and ringing in her ears. In or around February 2017, the patient presented to her physician for these issues and was diagnosed with vertigo, bilateral tinnitus, and sensorineural hearing loss. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to ZOSTAVAX. The patient has also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, sensorineural hearing loss was determined to be medically significant. Falling out of bed due to dizziness, vertigo, bilateral tinnitus, and sensorineural hearing loss were considered disabling. Additional information has been requested.
3 inch diameter red rash at injection site.  Lasted 3-4 days.
MUSCLE SPASMS IN THE RIGHT SHOULDER; RIGHT ARM AND LEG TINGLING; RIGHT ARM  AND LEG NUMBNESS; RIGHT ARM AND LEG WEAKNESS; FEELING VERY UNCOMFORTABLE; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-JUL-2021, the subject experienced feeling very uncomfortable. On 28-JUL-2021, the subject experienced right arm and leg tingling. On 28-JUL-2021, the subject experienced right arm and leg numbness. On 28-JUL-2021, the subject experienced right arm and leg weakness. On 03-AUG-2021, the subject experienced muscle spasms in the right shoulder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle spasms in the right shoulder, feeling very uncomfortable, right arm and leg tingling, right arm and leg numbness, and right arm and leg weakness. This report was non-serious.
1 hour after injection, while at home patient developed fever, chills, body aches, temperature was 105 (as per mom). Patient was taken to the ER by parent as fever persisted.
Positive for COVID; Positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4129680.  A 73-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Shoulder issues", start date: 2017 (unspecified if ongoing), notes: On 2017, the patient experienced shoulder issues, On 01Jul2022 she had shoulder surgery. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Sep2021, outcome "recovered" and all described as "Positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2021) Positive; (01Jun2022) Positive. 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.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA291005. This case involves a  10 years old male patient who received a pediatric dose 0.25 ml of vaccine FLUZONE QUADRIVALENT (lot UT6259NA and expiration date 30-Jun-2019) via intramuscular route in the left deltoid on 13-Oct-2018. The patients past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to vaccine underdose. It was not reported if the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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. List of documents held by sender: none.
((L) arm) pt. reports pain immediately after vaccination which got worse and approx. 1 wk later, couldn't lift arm above head; was seen at urgent care and then regular physician approx. 1 week later and was given 3 day tx with prednisone which helped but as soon as d/c'd got worse again. He ortho consult and told it was nerve damage from shot. Has been in PT 3x/wk and not progressing. Pt. is to schedule MRI and appt. with neurologist.
pt recvd vax; w/in 12-24 hrs devel iflam at inj site & a knot below inj site;
PATIENT RECEIVED COVID VACCINE MIXED WITH BACTERIOSTATIC 0.9% NORMAL SALINE INSTEAD OF PLAIN NORMAL SALINE 0.9%. THIS WAS DISCOVERED ON 5.12.21