chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itching all over body - no rash. Had a welt on L thigh (but injection was given on arm). Encouraged to see physician to girl friend.
This spontaneous report as received from an immunization official referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition, drug and allergy history were not reported. The reporter stated that from 25-APR-2017 to 09-MAY-2017, improperly stored doses of VARIVAX lot # M039318, expiration date 20-SEP-2018 (dose, route, frequency was not reported) for prophylaxis, were administered to unspecified patients .The patients' concomitant therapies were not reported. No adverse effects were reported. On an unspecified date, the digital data logger registered a temperature ranges between -9° Celsius (°C) to 8°C during a time frame of 666 hours with no previous temperature excursion.This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA008457:
a Nurse cut her on finger on the broken finger flange of a syringe while preparing to administer 1 dose of PNEUMOVAX 23; a Nurse cut her on finger on the broken finger flange of a syringe while preparing to administer 1 dose of PNEUMOVAX 23; a Nurse cut her on finger on the broken finger flange of a syringe while preparing to administer 1 dose of PNEUMOVAX 23; This spontaneous report was received from a business support coordinator and refers to a female nurse of unknown age. No information regarding her pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 09-SEP-2019, the nurse was preparing a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 0.5 ml (lot # S002582, expiration date 10-AUG-2020) to administer it to the patient. While preparing the dose, she cut her finger on the broken finger flange of a syringe. It was "tiny cut". She had it bandaged. It was reported that the syringe broke before it came in contact with the patient. It was reported that on 16-SEP-2019, the hospital pharmacy received 2 other syringes that were broken at the finger flange (lot # S012244, expiration date 09-FEB-2021). One had a broken piece with a sharp edge and the other two syringe finger flange were broken into several pieces (product quality complaint only). The outcome of product quality issue was unknown. The outcome of product package associated injury was reported as recovered on an unknown date in 2019. The causality assessment was not provided.
Excruciating pain in my right shoulder that is worsening each day and sending pain down my arm into my wrist and hand as well.
Customer's wife called on 10/11/23 to question if a small rash that developed on patient's leg on 10/03/23 and then developed to a full body rash on 10/07/23 could have been related to Abrysvo vaccination given on 9/27/23.   Customer did report to hospital due to symptoms.  Tests were run during that visit.  Hospital called customer and requested he return to hospital due to a suspected blood infection.  Customer is still currently hospitalized.  No further information is known at this point.  Pharmacy only had one call from family member with no follow up at this point.
Symptoms.  Extreme leg and leg pain.  Unable to stand for any length of time. Unable to feel my feet.  My left knee froze up .  Weak wobbly legs.  Bleeding gums.  Back pain radiating up to my neck.  My Neuropathy was pretty much in control until I took the vaccine.  I am back in a wheelchair .
No adverse event; The caller said the patient received a dose of MMRII on 6/27/2023, after the product was involved in a temperature excursion that reached 48.8 F and the product was out of range for 7 hours and 45 minutes.; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX). Additionally, the patient's pertinent medical history, drug reactions or allergies were not provided.  On 27-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, one dose, lot number was reported as W035041, which upon internal review was determined to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), expiration date was reported and determined to be valid as 24-MAY-2024, albumin status rHA, administered as prophylaxis (strength, dose, frequency, route of administration, albumin status, and anatomical location was not provided) after a temperature excursion (product storage error) with a temperature of 48.8 degree Fahrenheits for 7 hours and 45 minutes. No adverse event reported..  This is one of the several reports from the same reporter.
INJECTION SITE INDURATION OVER 70MM DIAMETER WITH BLISTERS THAT GREW TO DIME SIZE AND POPPED/DRAINED OVER THE NEXT 3 DAYS. 10/22/16 4AM AWOKE WITH SEVERELY SWOLLEN TONGUE AND TONSILS, HAD TO TAKE ANTIHISTIMINE WHICH HELP DECREASE SYMPTOMS AFTER 2 HOURS.
This is a spontaneous report from a contactable physician. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient was young and healthy. On an unspecified date, after the vaccination, the patient developed COVID-19. The patient tested positive via SARS-CoV-2 test on an unspecified date. The reporter was concerned that certain retail outlets where vaccines were kept were not adhering to proper storage mechanisms. The reporter did not know of any specific locations and did not know that product incorrect storage was being performed, but wanted Pfizer to be aware of the potential issue. The clinical outcome of "developed COVID" was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.  There is limited information provided in this report.  This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Approximately 12 hours after the injections; fever developed (100), extreme swelling and tenderness developed underneath the left arm / arm pit area. Swelling lasted for approximately 3 weeks, and slowly resided. Tenderness in area lasts for approximately 3 months.
Information has been received from a Medical Assistant concerning a 17 year old female who 12 weeks ago was vaccinated with the first dose of GARDASIL.  On 17-FEB-2009 the patient learned she was pregnant.  The patient came to the clinic.  Type of pregnancy test that was conducted to patient was unknown.  At the time of reporting, the patient was fine.  Additional information has been requested.
Vaccine Error, Administered after available date to be used. Notification of Pfizer Bivalent to end received 9.12.23 late afternoon.
Body aches; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 01Apr2021 at 02:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient underwent lab test and procedures, which included COVID-19 virus test on 10Feb2021 and tested negative. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the arm left on 08Mar2021 at 02:15 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 02Apr2021 at 06:30, the patient experienced body aches, chills and headache. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported event included Tylenol. The clinical outcome of the events body aches, chills and headache was recovered on an unknown date in April 2021.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from contactable consumer. The reporter is the patient. A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 08Feb2021 12:00 (Lot number: EM9809) at the age of 70 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (Feb2021), described as "entire arm was aching"; MOBILITY DECREASED (non-serious) with onset 08Feb2021 23:00, outcome "unknown", described as "arm/ trouble lifting it"; HEADACHE (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (13Feb2021 23:00), described as "dull headache"; FLUSHING (non-serious) with onset 08Feb2021 23:00, outcome "unknown", described as "flushing"; FEELING HOT (non-serious) with onset 08Feb2021 23:00, outcome "recovered" (09Feb2021 23:00), described as "getting really hot/ warmth"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "unsteadiness"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". Additional information: Arm aching lasted four to five days. The patient didn't normally get any shots, even the flu shot. The warmth she felt was gone within a day. She didn't take her temperature but didn't think she had a fever. The dull headache lasted for five days. No follow-up attempts are possible. No further information is expected.
Initial unsolicited report received from a healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2016552021) on 13-Dec-2016. This case involves a female patient (onset age not reported) who was vaccinated with a dose of Influenza high dose seasonal (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on 31-Oct-2011. Patient's medical history included back surgery in 2010, joint replacement of left rotator cuff in 2005, hysterectomy complete/total in 1980 and concomitant medications were not reported. On an unspecified date, unspecified timeframe following vaccination the patient experienced atrial fibrillation, Malignant hypertensive chronic kidney disease renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled, neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg, excluding foot, osteoarthritis of knee, gastroesophageal reflux disease, chest pain, dyspnea, allergic rhinitis due to pollen, nausea, bacterial infection disease, chronic bronchitis, diarrhea, dyslipidemia, shoulder joint pain, low back pain and headache. Patient received influenza, seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 09 November 2015, influenza seasonal injectable vaccine (manufacturer: Novartis pharmaceutical corporation) intramuscularly in right arm on 05 October 2012. Laboratory investigations and corrective treatment were not reported. The outcome of the events was not reported. The reporter had considered the case serious for the important medical event for: atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, benign essential hypertension, Type 2 diabetes mellitus without complication and Type 2 diabetes mellitus uncontrolled with symptoms of neuropathy, organic sleep apnea, asthma with status asthmaticus, IgE-mediated allergic asthma- reactive airways, urinary tract infectious disease, cellulitis of leg. List of documents held by sender: none. Sender's Comments: Patient with history of multiple surgeries and was on multiple medication received INFLUENZA HIGH DOSE SEASONAL (manufacturer unknown) and experienced atrial fibrillation, Malignant hypertensive chronic kidney disease- renal insufficiency, Type 2 diabetes mellitus uncontrolled, Organic sleep apnea, Status asthmaticus, Urinary tract infection, Cellulitis of leg, excluding foot and multiple events. Time of onset was unknown. This is poorly documented case. More details regarding concurrent condition, concomitant medication, exact time to onset, investigation reports to rule out the alternative cause are needed for complete assessment of the case. Based on the available information, no conclusion can be drawn.
Since I relieved my first Modern a Vaccine, I have lost control of my bladder at times, my legs are very weak and at times unable to move properly, and my asthma has become worse and uncontrollable. I am having trouble sleeping and have no appetite.
Information has been received from two healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 11-MAR-2015 the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt recvd vax & exp generalized joint pain/swelling which lasted 5 months; treated w/azulfidine & Feldene; pt now believes that adverse exp is not due to Engerix-B;
Pain, swelling & redness of upper arm around injection site, starting 3 days after injection and increasing each day until about 14 days after injection when swelling and redness began to decrease. At its largest, swelling was about an oval about 2-1/2  wide x 3-1/2 long. Pain was significant enough that I couldn?t sleep on my right side. Swelling and redness are gone, but area is still tender to the touch.
GNA approached this nurse and reported resident had bloody nose. Upon entering room, resident noted sitting in W/C holding bloody kleenex to nose. This nurse spoke with resident and she asked me to pinch her nose for her. While pinching nose, resident coughed up bloody clots and spit them into kleenex. This continued for several minutes as resident blew her nose and spit up clots. Cold pack held to bridge of nose slowed the nose bleed however resident continued to cough up bloody clots.  Resident's body stiffened, her head went back and jerked for a few seconds as this nurse held her head upright. Resident did not appear to be breathing, she was placed into bed and staff were unable to obtain BP or HR or respirations, eyes fixed and dilated. Paramedic arrived and called TOD @ 1545.
Day1:  swelling in axillary and clavicle lymph nodes Day 2: lymph nodes near breast tender and swollen Day 3: brain fog, feeling jittery, chills, fever 100.2
Patient complained of having numb whole arm one hour after first pfizer covid vaccine lasting 3 days then disappearing. Arm fine after that.
14 years old at time of both vaccinations. EAU is for 16 years and greater.
8 days after receiving the 1st dose of the Moderna Vaccine my right arm swelled up near the injection site the swelling was immediate covering an area about 3" in diameter and felt like a bee sting. The swelling and itching went down after ~24hrs, but the area is still red as of today.
As soon as I had the symptoms start, I called, and she gave me Paxlovid. I started taking it on Sunday. On Sunday when my symptoms started, they were headache, sore throat, fever of 100 degrees, fatigue, and some sniffles. I also had mild coughing. The symptoms came on pretty quickly and the amazing really is when I started the Paxlovid I started feeling significantly better. By Tuesday night the only thing I had left was a mild sore throat. As of today, I would say that I am almost symptoms free.
Debilitating headache; nausea; vomiting; ringing in the ears; L eye drooping; numbness and tingling of lips; numbness and tingling of lips; trembling of R side of body; abnormal/change in gait; change in vision; hypertension; This is a spontaneous report from a contactable nurse (patient herself). A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date was unknown), first dose via an unspecified route of administration on an unspecified date, second dose via intramuscularly in right arm on 16Jan2021 15:30; both at single dose for COVID-19 immunisation in workplace clinic. The patient's medical history included depression, MTHFR (methylenetetrahydrofolate reductase), latex allergy. Concomitant medications included venlafaxine, L-methylfolate; the patient received both the drugs within 2 weeks of vaccination. The patient previously took fluoxetine, citalopram and experienced known allergies for both the drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. The patient experienced debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension on 25Jan2021 06:00. On 01Feb2021, the patient underwent lab test and procedure included nasal swab/ COVID-19 by PCR: Negative. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV Dexamethazone, Diphenhydramine, ketorolac, promethazine for all the events. The outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.; Sender's Comments: On the basis of the available information, the reported events debilitating headache, nausea, vomiting, ringing in the ears, L eye drooping, numbness and tingling of lips, trembling of R side of body, abnormal/change in gait, change in vision, hypertension would seem most likely related to intercurrent and/or underlying medical condition and concomitant medication, which is not related to bnt162b2. This case will be reassessed when additional information becomes available. This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
After 2nd dose, large rash on chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (COMIRNATY), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Cominarty (prev dose product: COVID 19, prev dose brand: Cominarty, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose number: 1), for Covid-19 immunization, reaction(s): "severe flu like symptoms". The following information was reported: RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "After 2nd dose, large rash on chest". It was unknown if therapeutic measures were taken as a result of rash.  Additional information: It was unknown if other vaccine within four weeks. It was unknown if covid was prior vaccination and If covid tested post vaccination.  Follow-up attempts completed. No further information is expected.
No adverse effect reported.; schedule: "8/18/2011, 1/11/2012, and 2/13,2012".; This spontaneous report was received from a consumer referring to her 15 years old female patient daughter. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.  The patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not provided) for prophylaxis on the following schedule: "18-AUG-2011, 11-JAN-2012 and 13-FEB-2012" (inappropriate schedule of product administration). No adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008183:
Fever, Chills, Nausea, Muscle soreness, Tired over 24 hr period
Vaccinated with ZOSTAVAX on August 27, 2014. Sept. 11th, around 10pm I got queasy stomach and went to bed. I woke up with headache and body pain, stiff neck on the 12th. Went to Clinic on 13 & 14 Sept. Ended up in hospital on the 14th, from the clinic. Then I do not remember much of anything until the 25th Sept, 2014.
My 8 year old daughter has never received the MMR vaccine. Within about a week after I received the vaccine, she started showing symptoms of mumps. Flu like symptoms, mild rash, swollen lymph nodes. I took her in to urgent care and the doctor suspected the same diagnosis. My daughter never had any of these symptoms before with the exception of the flu. There is no chance that this was just a coincidence. It can only be spread supposedly through feces except our hygiene practices are pretty up to par and we don't play in each other's poop.
Covid vaccine-Pfizer. Administered on 2/20/21. Swollen arm, fever, aches, chills, sweats, rash, wheezing, lasting 5 days
Erythema, pain, swelling of entire upper arm.Fever 101-102.
Guillain-Barre syndrome;Pt developed GBS p/receiving vax;Pt required hospitalization & is currently receiving PT.Pt ex vague epigastric discomfort & weakness in legs 6 wks /p vax.DX @ D/C from hosp neuropathy, hypothyroidism,poss B12 defic.
RECEIVED VACCINE TWICE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 02-JUN-2021, and dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 22-JUN-2021, the subject experienced received vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received vaccine twice was not reported. This report was non-serious.
Parent called after hours and reported 102 temp & screaming to on call provider Dr who recommended TYLENOL.
Nausea/Vomiting; Soreness; Lethargy; Fever.