chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling and numbness in my left hand and arm began 4 days after the vaccine and has lasted in varying degrees until today, 11/1/01. I went to see my doctor on October 14, and she prescribed muscle relaxers and said to give it time. Tingling spread up the left side of my face and over my scalp and into my right arm over the course of the next week (10/14-10/25). I went to urgent care on 10/25 and they took an EKG, a catscan of the head and neck, and some blood tests. All were negative. My symptoms worsened on 10/26 so I went to the ER. They refused to treat me. On 10/27, I saw a spine specialist who ordered a lyme blood test and a B12 deficiency blood test; both were negative. on 10/28, I went back to my GP, who ran   additional blood tests to check for thyroid problems and vitamin D deficiency. Both were negative. on 10/30 headache developed and stiffness on the whole left side.  headache and stiffness continued on 10/31. 11/1 numbness in left arm and hand continues and tingling on top of scalp is constant. The tingling and numbness have also spread to my legs and feet sporadically over the last two weeks.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On 6th August 2018, the patient received the 1st dose of SHINGRIX. On 7th August 2018, 1 days after receiving SHINGRIX, the patient experienced muscle pain, tiredness, feeling hot and nausea. On an unknown date, the outcome of the muscle pain, tiredness, feeling hot and nausea were unknown. It was unknown if the reporter considered the muscle pain, tiredness, feeling hot and nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting, the patient experienced muscle aches, nausea, tiredness and she felt like she had a fever, but she had no fever (felt feverish). The patient did not want to provide her address and she did not wanted to answer any questions. She said that the company could contact her directly by phone if needed.
Pt developed tiny vesicles or papular erythematous base - mild yet - few on face, ear, chest, mild abdomen.
Initial misuse report received from a pharmacist on 14 October 2013.  The patient had received FLUZONE. Pharmacist claims dose was administered more subcutaneously than intramuscularly on a large patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient is a 20 year old male who was vaccinated on 28 Dec 04 with the vaccinia virus.  He reports having severe body aches and fevers to 101.5 and headaches.   Nine days after vaccination he began to have headaches with subsequent vomiting.  He reports 5-6 episodes of emesis over the next 12-24 hours.  No blood.  He also complains of feeling weak and tired for the next 48 hours.  He reports the headaches lasted for four days and have since resolved in the last 12 hours.  The vaccination site was also the worst at that time with redness, tenderness, swelling, and oozing of the site.  Approximately 2 days prior to the headaches and peak of symptoms, he noticed small bumps scattered on arms, legs, back and chest.  One of the bumps on same upper arm as the vaccine developed into a blister.  The others continued with papules only.  In the last 12 hours his headaches have improved, the vaccination site has improved, no further vomiting, strength is slowly returning but the rash not improved.  Currently no fevers or chills, no vomiting, no diarrhea, headache is gone.  No sick close contacts MEDICATIONS: 1. Motrin  Supplements: None  No over-the-counter medications   PMH: 1. None  MED ALLERGIES: 1. NKDA   Social History Never smoked  No pets  No allergies  No history of problems with vaccines
Within a month I started to have joint pain. Knuckles started to get arthritis bumps. Hard to grip with both hands. Elbow is also painful. No signs of Arthritis before March 2021.
Slightly after injection I began to feel light headed, flushed, dry throat, and increase in heart rate. I was monitored after for about 15 minutes which the symptoms seem to have resolved on their own. No treatment was needed. I didn?t think much of it until I realized some people were getting same side effects.
evening of vaccine patient developed, reportedly, temperature to 103°,body aches, shortness of breath and elevated blood pressure. Patient took NSAIDs and acetaminophen and was normal the next morning.
LONG HEAVY PERIOD WITH CLOTS; LOWER BACK PAIN; SLEEPINESS; WEAK; HEADACHE; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included asthma, and concurrent conditions included seasonal allergy, no alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced long heavy period with clots. On 12-APR-2021, the subject experienced lower back pain. On 12-APR-2021, the subject experienced sleepiness. On 12-APR-2021, the subject experienced weak. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from long heavy period with clots, headache, lower back pain, weak, and sleepiness. This report was non-serious.
Severe itching and breaking out in hives. Hives and itching move around body. This has lasted over a month.
Patient admitted as observation on 1/17/22 due to acute respiratory failure with hypoxia. Patient was tested for COVID-19 and was positive on 1/15/22.
15 minutes after vaccine, patient complains of feeling 'Hot". Stated "I feel like my throat is closing and it feels like bugs are crawling on me".  Patient also developed itching 30 minutes after vaccine. Patient was assessed by an MD, Benadryl 50 mg IM given in clinic and patient was reassessed again after 30 minutes. Patient reported that symptoms had resolved and patient was discharged home.
Immediately had metallic taste in mouth. When I stood up my head felt like it was going to explode. My heartrate was fluctuating between 208 bpm and going down to 40 bpm. I waited the 15 minutes and was released. The headache continued as did my fluctuating heartrate for two days. On day 3, I woke up with my muscles hurting and my joints swollen and red, especially on my hands, elbows, knees, and ankles. I have head a headache everyday since January 21, 2021. At times, I have vision trouble in my right eye and do not have complete vision in my right eye. My heartrate sometimes fluctuates to the very high level and then very low. My joint swelling continues and at times I cannot walk.  I have lots numbness in my legs and feet.
This study case was received from the investigator on 10 June 2011. A 23-year-old male subject, with no significant medical history, received an injection of ACAM2000, sanofi pasteur Inc. lot not reported, an injection of TYPHIM Vi, sanofi pasteur SA lot number not reported, and an injection of ANTHRAX, manufacturer and lot number not reported, on 01 February 2011. On 07 February 2011, the subject had an abnormal electrocardiogram (ECG). The results of the subject's Troponin I and echocardiogram were not available. On the 24 February 2011, the subject was diagnosed with unspecified disease of the pericardium. The outcome was not reported. Additional information will be requested from the investigator. Document held by sender: None.
burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration on 11Feb2021 09:00 at single dose in left arm for COVID-19 immunisation. She received the first dose BNT162B2 (lot number: EL8982) in Left arm on 22Jan2021 06:00 PM for COVID-19 immunisation. Medical history included depression, high blood pressure, thyroid disorder, obesity. The patient was allergic to codeine and pennicilian. The patient was not pregnant at the time of vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC), lisinopril, levothyroxine, bupropion hydrochloride (WELLBUTRIN), omeprazole (OMEP). The patient previously took the first dose of Shingrix (lot number: 5816001912) 50 mcg on Dec2020 in left arm for immunisation. On 12Feb2021 09:00, 24 hrs post 2nd vaccine BNT162B2, the patient experienced extreme fatigue, muscle pain, dizziness and 36 hrs after the second vaccine (12Feb2021 21:00) she also started having burning pain in her left armpit, and the next morning also burning pain in both armpits. No treatment received for the adverse event. Events outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.
arm is a little sore from the flu vaccine; Initial information received on 15-Sep-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case is linked to case 2023SA226846(CLUSTER).  This case involves a 78 years old female patient who experienced arm is a little sore from the flu vaccine after receiving 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, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown expiry date, lot number and strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date, the patient developed an event of arm is a little sore from the flu vaccine (pain in extremity) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were 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 arm is a little sore from the flu vaccine.
Patient was administered the Pfizer bivalent as the second dose in the primary series.  No adverse reaction noted.
Vaccine administered in am. Symptoms started at approximately 4-5 pm. Sore arm - fever, chills, nausea, heavy breathing.
ADACEL given 10/30/12 to (L) arm per MD orders. <24 hours - below elbow to upper shoulder red/hot/inflamed, tender. MD ordered SEPTRA DS BID x10 days prior to knowledge of Rx. Then Dc'd and change to ROCEPHIN IV QD x10 days. Fever 100.8 10/31/12.
Chest pains, almost passing out. profuse sweating,throwing up, EMT ride to Hospital, full series of heart and arty tests. Cat scan EKG,ultra sound, blood tests, All came back negative no known cause for episode. Only thing different in life style was the vaccine
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:30 as dose 5 (booster), single (Lot number: GH9696) at the age of 37 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: 1 day after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound COVID 3 days after finishing paxlovid and 1 day after testing negative. Starting feeling sick with sore throat and sneezing.
cough remain ongoing; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves Child male patient who experienced cough remain ongoing after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation. Information on the batch number was requested.  On an unknown date the patient developed cough remain ongoing (cough) (unknown latency) following the administration of influenza vaccine.  Patient's mom reports new symptoms of cough remain ongoing. cough started over the weekend. around that same time (over the weekend) patient received a flu shot.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event (cough remain ongoing).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event.
A report has been received from a physician concerning a 49 year old female patient, enrolled in a study. The patient's concurrent disease(s) included thyroid cancer. Concomitant medications of the patient was not reported. The patient had been received FLUMIST (intranasal) started on 23-Oct-2014. The patient experienced headache which started on 24-Oct-2014. Patient went and came back from ER (emergency room) in hospital on 29-Oct-2014. The outcome of the event of headache was unknown. The reporter considered the event headache to be serious due to important medical event. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the events of headache be related with the suspect drug of FLUMIST.
Abdomen cramps, acid reflux, blood pressure varies, blood high cholesterol, gastritis, heart rapid pulse rate, heart palpitations, pain lower back, pain right hip, reflux, urinary frequency.
Patient was hospitalized on 6/7/2021 for severe protein-calorie malnutrition and received the first dose of covid vaccine while hospitalized. Patient received second dose on 6/30/2021. Patient presented to the ED and was subsequently hospitalized on 7/4/2021 for squamous cell carcinoma of right lung. She died on 7/20/2021.
After breakfast on March 14, she started to have a low grade fever.  She took a two Tylenol (extra strength gel capsules) and decided to lie down in bed. Around noon, she tried to get out of bed to go to the bathroom but was unable to stand and fell out of bed and onto the ground.  While trying to get up she started to feel dizzy and was too weak to get herself up.  Also while still on the ground she started to feel nauseous and eventually vomited.  After vomiting , she was able to get up and the dizziness and nausea went away.  For 2-3 days (Sun-Tues) after the incident, she experienced muscle aches and pain around her waist/stomach area.  Also during this time she continued to take the 2 Tylenol every 6 hours and is currently still taking it.
Menactra vaccine was used as a diluent for MMR vaccine, administered Menactra in the same syringe/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who received vaccines MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] as a diluent for MMR.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing HIV infection.   On 02-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site.  On 02-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL VACCINE (MMR) not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Wrong technique in product usage process.  There is no more AE information available for this report.  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.  Information on the batch number was requested.  Documents held by sender: none.
07/30/2001 approximately 3 hours after immunization, pt had  persistent crying, low-grade fever, green mucous stools. On  08/02/2001, went to MD with red rash on trunk of body with previous symptoms continuing. Given Tylenol with codeine, resolved on 08/05/2001.
Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (086396). The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; palbociclib (IBRANCE), since 2018 at 75 mg for breast cancer female. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunisation; Bnt162b2 (Dose number unknown booster (2nd booster)), for COVID-19 immunisation, reaction(s): "arm a little sore". The following information was reported: FATIGUE (non-serious), outcome "recovering". The action taken for palbociclib was unknown.  Additional information: Patient stated the last few weeks she has been experiencing fatigue. She stated this could be due to getting her third COVID booster shot. She stated the second booster shot made her arm a little sore but after this one the fatigue has lasted a couple weeks and it is very clearly fatigue, not just being tired. She was starting to feel better now. She has been on Ibrance since 2018. Also reported she was diabetic and was four years into this and it wasn't getting any easier.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200128174 same patient/different suspect drug and AE;
dose number:3; dizziness; nausea; muscle aches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Nov2021 (Lot number: FH8030) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3248), administration date: 09Mar2021, when the patient was 39 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: 3248, Route of Administration: Intramuscular, Location of injection: Arm Right), administration date: 30Mar2021, when the patient was 40 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "dose number:3"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue".  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine No Prior to vaccination, was the patient was not diagnosed with COVID,  Since the vaccination, has patient has not been tested for COVID  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.  Follow-up (02Dec2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent via follow-up letter which included that:  Updated information: This follow-up contains no new safety information. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 17-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K009894, expiry date: 11-JAN-2016 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested
Patient up to date on COVID vaccinations who admitted with complications related to COVID.  Provider d/c note:  "79 yo F with a PMH of HFpEF, ESRD on HD (MWF), CAD, CAS, AAA who presented to the ED with complaints of chest discomfort noted at dialysis. She was able to "run" for 3 hours. On arrival she was found to be tachycardic in setting atrial fibrillation with rapid ventricular response. She was initiated on IV diltiazem and converted to NSR. She was also found to be COVID + and was initially hypoxic and placed on 2L NC. She was not started on treatment as she had previously had COVID and was weaned off of supplemental oxygen without intervention. She was seen by Cardiology and Nephrology. Nephrology recommended continuing her MWF HD schedule and no needs for urgent HD. She was transitioned to PO Cardizem and her home Procardia was discontinued. HR and BP remained stable during admission. She was discharged home in stable condition with strict return precautions. "
PC from mom. Pt received KINRIX and PROQUAD on 8/29/18. Mom reports that 2 days ago she noticed a raised red spot at the site of injection on left leg (site where Proquad was administered) about the size of a silver dollar. Pt said it "kind of" itches when mom asked him about it. No visible bruising or insect bite mark. Site is still red today, but less so. No other symptoms.
Headache, Myalgia,  Erythema, swelling at vaccination site Redness swelling at injection site 10 days out. Headache, body aches 10 days later.