chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Palpitaions; Tachycardia/ Episodes of tachycardia during sleep; Chest pain; Body weakness; Left eye twitch; Feet burning; Cold sensation; SOB; Heat and exercise intolerance; Heat and exercise intolerance; Electric feeling throughout body; Numbness in left ring finger and pinky; This is a spontaneous report from a contactable other healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30130BA) via an unspecified route of administration in the arm left on 16Sep2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included citalopram hydrobromide (CELEXA) and multivitamins (unspecified); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 26Aug2021 at 16:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 16:00, the patient experienced palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB),episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling through out body, numbness in left ring finger and pinky. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events palpitations, tachycardia, chest pain, body weakness, left eye twitch, feet burning and cold sensation, shortness of breath (SOB), episodes of tachycardia during sleep, heat and exercise intolerance, electric feeling throughout body, numbness in left ring finger and pinky were not resolved at the time of this report.
Injection site reaction. Two by two inch square that is red, swollen, itchy, and warm.
started feeling unwell the night of Dec 12th. woke up with a croupy cough.  no fever.  That lasted a few days.  Turned into intermittent cough and post nasal drip. no fever
Tingling feeling, severe headache, was found unconscious and taken to the hospital, exhausted, became paralyzed, having trouble breathing, blood found in urine, unnormal bowel movements, and seizures.
Initial information received on 04-Jan-2019 regarding an unsolicited valid non-serious case received from other health professional. This case involves twins of 12 months old patient who received vaccines MENACTRA lot number not reported via unknown route in unknown administration site instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration. It was reported that a 12 month old getting a MENACTRA instead of an MMR. The injection was given to twins when theycame into the practice to get an MMR. It was unknown if any adverse event was occurred. 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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Patient was given a 4th dose of 0.25 ml.  Patient had previously received a 0.25 ml dose in Nov 2021
102 Degree fever.  General lethargy.  Lack of appetite.  Symptoms presented themselves within hours of the vaccine and have continued for 2 days so far.
Pfizer Vaccine--Generalized rash over entire body 5 days post 2nd vaccination.  Treatment was Benadryl and topical cream.  Rash continues to improve 4 days later, but remains itchy and red.
Pt reports he has had symptoms of nausea, fatigue, headache, weakness, fuzziness , sinus burn and metallic teste for about 6-7 days after he had 1st Moderna shot (021C21A). Other than that, everything is fine.
Temp 105 deg 3/20/03 PT seen at MD's office and then sent to ER. Mom phoned on 3/21/03 9 a.m. Child Dx'd with ear infection and recovering.
The day after his flu shot he started to get a headache and diarrhea. Left arm red and swollen around injection site and improvement with BENADRYL. Tx with KEFLEX for cellulitis.
Test: Home Ag/Result: Positive; Test: Home Ag/Result: Positive; fever; fatigue; rhinorrhea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from product quality group.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 48 years as dose 3 (booster), single, administration date 23Mar2021 (Lot number: EL3247) as dose 2, single and administration date 02Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant) with onset 23Feb2022, outcome "unknown" and all described as "Test: Home Ag/Result: Positive"; PYREXIA (non-serious) with onset 21Feb2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 21Feb2022, outcome "unknown", described as "fatigue"; RHINORRHOEA (non-serious) with onset 21Feb2022, outcome "unknown", described as "rhinorrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Feb2022) positive, notes: Unknown. It was unknown if therapeutic measures were taken as a result of covid-19, pyrexia, fatigue, rhinorrhoea. Clinical course includes that, SX 21Feb2022 after ice hockey event with known exposure then family members in household got covid and so did he mild SX fever fatigue and rhinorrhea. Covid prior vaccination was unknown. Other vaccination in four weeks was unknown. Post vaccination covid was tested positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Information has been received from a 26 year old female consumer with no pertinent medical history and no drug allergies, for GARDASIL, a Pregnancy Registry product, concerning that on 13-JUL-2009 she was vaccinated with her third dose of GARDASIL (lot # not provided). There was no concomitant medication. She became pregnant after receiving her full dosing schedule of GARDASIL. The patient's last menstrual period was approximately 26-JUN-2009; estimated delivery date was 02-APR-2010. There were no labs and diagnostic tests performed. Follow up information received from a pregnancy questionnaire indicating that on an unknown date in April 2010 the patient had delivered a normal infant without congenital anomaly. Follow up information received from a pregnancy questionnaire indicating that on 13-JUL-2009 the female patient was vaccinated with her third dose of GARDASIL (lot # 662229/1497X). On 24-MAR-2010 the patient had delivered a female infant without congenital anomaly at 41 week and one day from LMP. The patient's current medication included prenatal vitamins. No infections or illnesses were specified during pregnancy. There were no medications used during pregnancy. The patient experienced fourth degree laceration. Lab test included ultrasound on 03-MAR-2010 which showed normal 36 weeks fetal age, amniocentesis and MSAFP (results unknown). The patient had 5 previous pregnancies and 5 elective terminations. The patient's estimated conception date was reported as 01-APR-2010. No further information is available.
h/a, general malaise, rx ASA;large muscle groups began to ache;joint pain, sore throat-progressed to chills-hot/cold sx persist for over a week;
Substernal chest burning, chest tightness on full inspiration under sternum. Throat clearing, persistent cough laying down, wheezing at night, slight SOB. On 1/12/22 through present.
Approximately 5 minutes after receiving the injection, I became dizzy and lightheaded. My  eyesight became blurry and my hearing very "tinny". I felt nausea and  thought I was going to throw up. I sat down in a chair and was given a granola bar and some water. After about 3 or 4 minutes the majority of these  seemed to fade, but I still felt slightly "off". Approximately 9pm that evening I felt very fatigued, so I went to bed. At approximately midnight, I woke up shivering, extremely cold, and sweating. Around 2am I had a fever of 102.3. I took some Tylenol to try to bring my fever down, which seemed to help. Around 9am the next morning my fever was gone, though I still felt extremely fatigued.  Later that evening, after several naps, I started to feel a little better. Most of these adverse events were resolved by 28 hours after injection. I had arm soreness at the injection sight that felt like having been punched in the arm for about a week after the injection.
The patient states night sweats, fever (100.6 degrees F), and visual disturbance ("red spots"). The "red spots" are still present and can be seen when her eyes are open or closed. Due to a previous UTI the patient was screened for infection, however this was negative.
Symptoms: Pain, redness, swelling on the arm vaccinated; Tiredness, headache, muscle pain, chills, fever Treatment: Tylenol
6/14/89-severe stomach cramps X 3 wks in the liver area with nausea (compazine); 6/15/89-stomach pains in upper abdomen X 3 wks, pain is constant and meds not working; 9/5/89-pain in right abdomen, (indomethacin) given for pain causing an allergic reaction (anaphylactic); 10/22/89-stomach ache with bloody diarrhea X 3 days, vomiting, dizzy and headaches; 4/30/90-stomach ache and diarrhea; 6/19/90-sharp pain under anterior ribs, diaphragm area (Tylenol) before seeing doctor; 9/17/90-fell and sprained ankle; 7/25/91-visual defect.
ear ringing Tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 11:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing); "border High BP" (unspecified if ongoing); "Spinal condition" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]; HYDROCHLOROTHIAZIDE; METFOR; JANUVIA. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FK9894, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 15Apr2022, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: FG3527, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 10Nov2021, when the patient was 65-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 20Oct2021, when the patient was 65-year-old, for Covid-19 immunization. The following information was reported: TINNITUS (disability) with onset 08Dec2022 at 12:00, outcome "not recovered", described as "ear ringing Tinnitus". The event "ear ringing tinnitus" required physician office visit. Therapeutic measures were taken as a result of tinnitus. Clinical course:Initiation of ear ringing Tinnitus after patient's most recent Pfizer covid vaccine that has not stopped to date. Patient was currently seeing an ENT Dr. with authorizations for allergy tests and an upcoming auditory hearing test. The FDA just granted in Apr2023 the Tinnitus Treatment Medical Device that reduces the symptoms of Tinnitus significantly. Because this is a new treatment, only the hearing doctor in patient's area had availability of this new coveted device. It costs patient a minimum of (dollar) 5,000.00 to obtain this device. Other insurance combo does not provide authorization for this new device. Finally in this world there is Tinnitus relief. Patient was requesting Pfizer to fund this product for him despite Pfizer's denial of tinnitus symptoms after vaccine receipt by many. If other vaccine in four weeks: Unknown. Ae treatment: Referral to ENT, Audiologist. If covid prior vaccination: No If covid tested post vaccination: No. Known allergies: Not Known.
My husband and I both were diagnosed with SARS-cov-2 in the past two weeks despite being fully vaccinated with the Pfizer COVID Vaccine; My husband and I both were diagnosed with SARS-cov-2 in the past two weeks despite being fully vaccinated with the Pfizer COVID Vaccine; This is a spontaneous report from a contactable Pfizer colleague reported similar event for herself and her husband, this is for the husband (patient). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single and via an unspecified route of administration on an unspecified date as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that her husband and she both were diagnosed with sars-cov-2 in the past two weeks despite being fully vaccinated with the pfizer covid vaccine on an unspecified date. Both her husband and she were symptomatic but did not require hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of the events was unknown.  Information about lot/batch number has been requested.
10 days after the Moderna booster, I started feeling unbearably itchy and my skin became inflamed whenever coming into contact with anything (i.e. scalp inflamed after brushing hair, nose inflamed after wiping with a tissue). Big white welts developed within minutes after contact
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL lot # K006960 exp. 19-FEB-2017, (route and dose were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Received vaccine left deltoid has soft tender area 8 inches from injection site pain with palpation 4/10. No brusing or rash noted . Ice pack applied. Moderna information number given to client.
Information has been received from a nurse, concerning a 12 year old male with a history of cardiac murmur as an infant, who was vaccinated with a first 0.5ml, SC, dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed a mild breakthrough case of chicken pox. Unspecified medical attention was sought. The patients status is unknown. No product quality complaint was involved. Additional information has been requested.
tested positive for COVID 19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID 19). At the time of the report, COVID-19 (tested positive for COVID 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment for the events was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for COVID 19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was Reported.     On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (tested positive for COVID 19). At the time of the report, COVID-19 (tested positive for COVID 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment for the events was not reported.
Heart fluttering; Chest pain; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant) and CHEST PAIN (Chest pain). At the time of the report, CARDIAC FLUTTER (Heart fluttering) and CHEST PAIN (Chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was provided.  No treatment medication details was provided.   Patient did not confirm whether or not she had a history of myocarditis or pericarditis.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 25-JUN-2017, the pt was vaccinated by a healthcare provider with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles and she was treated by a physician. The outcome of shingles was not specified, and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Having arm pain, redness at injection site, knot at injection site, fatigue, achiness, no fever, some itching around the redness.
awoke the morning after with stiff neck, jaw pain shoulder and pain the back of her head on the right side( opposite side  of the injection ) shaky and weak , muscle cramps, fatigue and nausea, anxious nervous feeling
pt recvd vax & devel fever 103.9; marked irritability; diffic in consoling;
Tired, slight chest pains, low fever. Red rash on my left cheek; I also remembered that I had those red rashes after my second does COVID vaccine shot.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 14-DEC-2012 at 7:45, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 13.25 hours. On 18-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 12.75 hours. On 22-DEC-2012 at 18:30, ZOSTAVAX lot # H016765 was exposed to -14C for an estimated total time out of range of 5 hours. On 07-JAN-2013, the patient was vaccinated with an out of range dose of ZOSTIVAX (dose and route administration were not provided) (Lot number H016765). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
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 medication. On an unknown date in 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Intense headache that began the morning after the vaccine injection and has been continual, still persisting as of today, day 16 after the vaccine injection.