chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt fine at first for the 15 minutes they held me for observation. But as I walked out to my car I quickly got heavy and tired and started to ache and have a headache. I had to rest in my car for a while before driving home. Once home I crashed immediately for around 4 hours in the middle of the day which is not like me. I had an important dinner meeting i had to attend for my livelihood. I thought I was feeling better but half way through Dinner  I started feeling bad again. Got to the point that I stopped eating and excused myself to get home and rest. Symptoms progressed rapidly. Unfortunately I was pulled over for a minor traffic stop and  tried to explain that I was having a bad reaction to the vaccine and needed to get home. They wouldn?t believe me  and torturously treated me like an OVI. I?m hoping that I can get some kind of documentation and or assistance. I have court on the 1st and it will be devastating if I am convicted. I was not intoxicated  and was not warned about the dangers of driving after the vaccine. Please call me. I need help
Body Aches; Diarrhea; Nausea; Chills; Injection Site soreness; General arm soreness; Fatigue; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in left arm, administration date 15Jan2022 at 15:00 (Lot number: F31614) at the age of 35 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing), notes: Migraines; "Shellfish allergy" (unspecified if ongoing), notes: Known allergies: Shellfish and "Allergy to nuts" (unspecified if ongoing), notes: known allergies: Tree Nuts. Concomitant medications included: ADVIL and SUMATRIPTAN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3246, Anatomical location: Left arm, Administration time: 12:00, Route of administration: Intramuscular), administration date: 14Jan2021, when the patient was 34 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN5318, Anatomical location: Left arm, Administration time: 12:00, Route of administration: Intramuscular), administration date: 03Feb2021, when the patient was 34 years old, for COVID-19 immunisation.   The following information was reported: IMMUNISATION (non-serious) with onset 15Jan2022 at 15:00, outcome "unknown", described as "Dose received: 3"; PAIN (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Body Aches"; DIARRHOEA (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Diarrhea"; NAUSEA (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Nausea"; CHILLS (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Chills"; VACCINATION SITE PAIN (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Injection Site soreness"; PAIN IN EXTREMITY (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "General arm soreness"; FATIGUE (non-serious) with onset 16Jan2022 at 08:30, outcome "unknown", described as "Fatigue". Therapeutic measures were not taken as a result of pain, diarrhoea, nausea, chills, vaccination site pain, pain in extremity and fatigue.  Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
9/13/16 at bath time mom noted (L) leg swelling and redness at immunization site. 9/14/16 customer evaluated in clinic. Tx: BENADRYL OTC PRN, cold pack to area, follow up if no improvement in 2 days.
Pfizer on 10/12/2022 sent for a removal of Lot# FL2757 due to expiration date of 9/30/2022. Dose was given before email for removal came through. Pfizer indicated that the stability data supports the use of the product through 10/19/2022. No revaccination or patient notification required.
Patient described the reaction as a "big red reaction, the size of a baseball/red/hot; took about a week to go away."
Patient vaccinated x2 (Moderna): 3/19/21, 4/16/21  Patient admitted to hospital after testing positive for COVID19 on 1/31/21
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M044395, expiration date 31-MAY-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours and 53 minutes and then for 1 hour and 19 minutes. Data logger was not involved. No additional information was reported.
received only the dtap/ipv portion of the pentacel vaccine with no adverse event; Initial information received on 08-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 2 patients of an unknown age and gender who  received only the dtap/ipv portion of the Pentacel vaccine with no adverse event for the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE (ROTAVIRUS VACCINE); and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  On 06-Jun-2022 or 07-Jun-2022, the patient received 0.5 ml  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE, once ( lot: U7054AA ; expiry date: 18-Dec-2022)  via intramuscular route in left thigh for immunization.  It was reported that 2 patients received only the Dtap/Ipv portion of the Pentacel vaccine with no adverse event (single component of a two-component product administered) (onset: unknown) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE. The ACT-HIB vial was not given to 2 patients  Action taken : not applicable.  Outcome: unknown   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.
Developed Bell's Palsy 4/25/2021 - after 2nd COVID vaccine given 3-2-2021  This is the 2nd time to get Bell's Palsy, Right side of face this time  Previously Developed Bell's Palsy 1/7/2015 after Zostavax (Shingles Vaccine) given 12/5/2014 . That was on left side of face.  Both instances of Bell's Palsy occurred within weeks of getting vaccines
The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022; dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Patient had no allergies, no acute/ chronic illnesses.     On 08-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 25Feb2022 and date administered on 8 Apr 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Patient had no Covid-19 infection within last month..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Dose administered after 30 day use by date or after manufacturer date of expiry. Number of doses or vials administered 36 doses. Date and time the vial was initially stored in the refrigerator 25-Feb-2022. The vial had not undergone any temperature excursion.  No treatment medications were reported
On March 1st started with a stiff neck, which followed by a massive headache.  Approximately two hours later started to vomit and went to the ER.  CT scan completed and shown an subarachnoid hemorrhage.  Transferred to Neuroscience ICU and hospitalized until March 13th  before release.  No aneurysm detected in scans and angios.
Her arm has been hurting; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; pregabalin (LYRICA), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced her arm has been hurting. Stated, "she had a few questions because her arm has been hurting recently and so she was having a few questions about all that from Lyrica. Just that she did also take the Pfizer COVID Shot (further clarification unknown if consumer's arm has been hurting because of Lyrica or COVID Vaccine hence captured both as suspect) as well if that helps." The clinical outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Issues with my stool for 8 months.  After finally having a colonoscopy done, I was diagnosed with Lymphocytic Colitis
pt recvd vax 21MAR94 & devel a macular papular rash primarily on trunk & extremities; pt did not exp itching, & did not devel a fever or adenopathy; seen by MD;
8/7/99 pt leg swollen & red day p/vax given;mom spoke w/MD & MD ordered DPH & child to be seen in office on 8/9/99;
pt recvd vax; severe inject site rxn p/ vax; erythema, swelling & pain;
A report has been received from a Health Professional concerning a 28 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 07-Oct-2013. The patient experienced swollen left hand which started on 11-Oct-2013 and sneezing which started on 08-Oct-2013. At the time of reporting, the event of swollen left hand and sneezing was improving. The report was considered to be non-serious.
This spontaneous report has been received from a registered nurse referring to a 18 year old female patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. In 2000 (reported as "sometime in the 2000's"), the patient was vaccinated with RECOMBIVAX HB (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. Then, after vaccination, a Hepatitis B titer test was performed, which showed a low hepatitis B titer (hepatitis b surface antibody negative). The outcome of hepatitis b surface antibody negative was unknown. The causality assessment was not reported.
Information has been received from a nurse concerning a patient over the age of 60 years who on 25-JAN-2007 was vaccinated intramuscularly with Pneumovax 23 (lot # 655591/0886F).  Subsequently, on an unspecified date, the patient developed injection site redness, warmth, and swelling.  Unspecified medical attention was sought.  The patient subsequently recovered from the injection site redness, warmth, and swelling.  Additional information has been requested.
Threw up 4 times; Shaking---Freezing; Very Bad Headache; Fever--101; Body aches  No appetite.
The night she received vaccinations, she experienced fever and sweats (102°F). The area is swollen and hot to the touch. Very red. She states entire arm hurts. She has also experienced bleeding of the gums and blood in urine (today) 8/26.
Information has been received from an 85 year old female with penicillin allergy and aspirin and inhibitors drug hypersensitivity who on 13-JUN-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (route and administrating site not reported). Concomitant therapy included LIPITOR. One hour after getting the vaccine the patient experienced a bad headache. The patient took some TYLENOL and the headache stopped a couple hours later. The patient did not seek medical attention. No further information is available.
pt recv vax;unconsolable cont crying from 12:30 - 4:30pm;had macular rash to abd for about 3 hrs;to MD;pt fine at time of rpt
Itching all over the body; Hives all over the body (Looked Like Shingles); Skin Burning (Hives Area); Warm to the touch injection site; Stiff Neck; Difficult to keep head up; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site) and MUSCULOSKELETAL STIFFNESS (Stiff Neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthrodesis.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and HEAD DISCOMFORT (Difficult to keep head up). At the time of the report, PRURITUS (Itching all over the body), URTICARIA (Hives all over the body (Looked Like Shingles)), SKIN BURNING SENSATION (Skin Burning (Hives Area)), VACCINATION SITE WARMTH (Warm to the touch injection site), MUSCULOSKELETAL STIFFNESS (Stiff Neck) and HEAD DISCOMFORT (Difficult to keep head up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported. The patient had itching 1 hour after vaccination. The hives were mostly in the lower back and shoulders. It was painful and itchy on her back while taking hot shower. After shower, the patient was relieved for a couple of hours and had less itching.   This case was linked to MOD-2021-034571 (E2B Linked Report).
Stiffening body, crying inconsolably for 45 min, refusing to nurse, fever 102 that lasted and hour and a half. Crying when we picked her up or touched her.
Information has been received from a physician assistant concerning a 70 year old female patient with hypertension, hyperlipidaemia, depression and no drug reactions/allergies who "5 years ago" approximately in November 2004, was vaccinated with the first dose of PNEUMOVAX 23. Patient did not have any reactions after first dose. On 17-Nov-2009 the patient was vaccinated intramuscularly with the second dose of 0.5 ml PNEUMOVAX 23 (lot # 664000/0621Y). Concomitant therapy included simvastatin (MS, DYAZIDE, ZOLOFT. on 17-Nov-2009 the patient experienced injection site reaction as hot to touch, not as bright red as the reaction from the other patients, swelling, painful that went from the top of the shoulder area almost to the top of the elbow all the way around the arm. The patient is applying hot packs and BENADRYL to the area as intervention to prevent serious criteria. The patient had sought medical attention via office visit. No laboratory diagnostic study was performed. at the time of reporting, the outcome of the event was unknown. Injection site reaction as hot to touch, swelling and painful that went from the top of the shoulder area almost to the top of the elbow all the way around the arm were considered as other important medical events by the reporter. This is one of several reports received from the same source. Additional information has been requested.
On Day 7, a small and mildly itchy rash developed at the site of my injection and is painful (slightly) if pressed or scratched. Otherwise, my arm has been fine and I have had no other adverse symptoms.  website article described what I am experiencing exactly as a condition known as "Covid-arm" which has been infrequently experienced post-Moderna vaccine.
Pain in Rt Shoulder getting worse. Has Ortho appointment. 5/10 at its worst. Feeling it in shoulder joint; muscle hurts. At one point was waking in the middle of the night. Pretty unhappy. Waiting for it to go away. Has history of arthritis---spinal stenosis---has had MRI. Motrin helps her vaccine related shoulder pain but it comes back. Not interfering with quality of life. It's like she's suddenly developed arthritis there.
Patient's mother called stating she had a reaction to vaccination several hours after administration. Symptoms included post reaction redness and pain and lack of appetite. She also experienced weakness and syncope following a bath, which apparently led to a fall and possible head injury. She also stated a general lack of feeling and numbness affecting the arm, which was largely the reason for submitting the VAERS. I have been unable to follow up at this time, but the mother was considering taking her to the ED at the time of the report.
BRIEF OVERVIEW: Admission Date: 9/1/2023 Discharge Date: 9/4/23 Discharge Disposition:  skilled nursing facility      Active Issues Requiring Follow-up:  Deconditioning: SAR on discharge  ?  No future appointments.   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Pt is a 84 yr old F with PMHx of recent GI bleed at Facility in July 2023, HTN, HLD, GERD, spinal stenosis, chronic back pain, OAB, urinary retention, Parkinson's disease, depression and insomnia presented to ED on 9/1 with weakness from Independent living. She was ambulating and felt her legs were weak so she lowered herself to the ground without any injuries, fall or trauma.    In the ER- pt was hypertensive but otherwise stable. Labs without acute pathology. COVID positive, EKG NSR without acute ischemic changes. CXR with patchy airspace disease.  No medications given in the ER.    Pt admitted for Remdesivir and PT/OT eval. As patient was not hypoxic, steroid were not started.   PT/OT recommended SAR on discharge to help with deconditioning and to improve overall strength. She was discharged to SAR in stable conditions on RA with covid precautions and plans to follow up with PCP after SAR.
No adverse event. Patient received correct dose. An earlier patient with same first name received the vaccine under this patients name.. but both needed shingrix vaccines.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
Shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 28Jan2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On 16Feb2021, patient experienced shoulder pain and went to the doctor. Patient was scheduled for her second dose on 18Feb2021. She never mentioned that she was supposed to get second dose tomorrow. Her doctor gave her a cortisone injection (anti-inflammatory shot) yesterday, 16Feb2021. Patient asked if it would be okay to proceed with the second vaccine dose tomorrow or she will need to postpone it and have it rescheduled. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Patient just reported via Law Office on Aug 8/2012. She claims upon leaving the pharmacy she had pain from left hand up to her neck and could not move her arm. The pharmacist later told her to put ice on it. Her symptoms remained so she has undergone trigger point therapy and 3 stellate ganglion nerve blocks. She states she is on pain management therapy.
ocalized reaction to the first COVID vaccine.  She recieved it 11 days ago.  States that it did not hurt or flare at first, she had no symptoms.  Within in the first 5 days post vaccine she noted redness and heat at the injection site.  it began itching and growing in size until today.  Area is clearly demartcated, raised in center, reports heat to area, measuring i16cmx10cm as reported by patient.  She does state that today it is less itchy and appears to have gone down in size a little.  Has tried taking benadryl for past 3 nights, takes a daily zyrtec, tried hydrocortisone cream and arnica OTC but reports none of these medications reduced size, itching or swelling.  Denies any systemic symptoms including SOB, cough, itchy nose, facial swelling, anxiety.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: FJ1620) 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: "Multiple sclerosis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown result. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Antiviral details: COVID 19 Treatment: Paxlovid, Treatment start date: 12May2022 to 16May2022, Indication: Treatment of COVID-19. No known allergies reported.  No follow-up attempts are possible. No further information is expected.