chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was my pt.  Presented with normal first trimester ultrasound giving EDC 9/27/21.  Returned with normal 15 week visit with positive fetal heart tones and no complications.  Pt states she received her covid vax towards the end of that week (facility unknown, I believe by Pfizer).  She presented 3 1/2 weeks later to my clinic with bleeding.  Dx intrauterine fetal death that occurred at 16 weeks 2 days by growth on ultrasound (shortly after covid vax).  Options below are not appropriate- Fetal death
Several episodes of facial burning and tingling. Bilateral eye burning. R sided weakness, headache and dizziness. Several episodes from 7/19-7/21. Was determined to have an acute ischemic stroke.  Given heparin, phenylephrine, aspirin, clopidogrel, and eventually underwent embolectomy today. Still hospitalized.
I had fatigue, fever, sore throat, lost of taste and smell.  This symptoms lasted about 3 days.  I went to get tested for Covid-19, which came back positive.
Large red welt, itchy, painful to touch, warm, worse as day goes on  Ibuprofen
14th: low grade fever and fatigue took tylenol and went to sleep around 7:30pm 15th: woke with a fever around 101, took tylenol, drank biolyte and water by 1pm I had a fever of 103.8 took a lukewarm shower, tylenol fever dropped to 102 and fell asleep 16th: woke at midnight my fever at 103 again, husband helped put me in the shower, took more tylenol and then played in bed with a cool rag on head, woke  around 7am with a fever of 102, started drinking water mixed with pedialyt, switched to Naproxen by 9pm fever had gone down to 100.4 17th: fever 100.0 at 8am took naproxen fever reduced to 99.1. A rash developed on left arm covering the whole of my bicep. Warm to the touch and extra tender, feels similar to fire ant bites, not fun applied benadryl cream, calmed burning sensation but rash still persist, temperature currently at 100.0 at 7:50pm
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report from contactable other healthcare professional via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date was not reported) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 04Jan2021 and was diagnosed with COVID on 07Jan2021. Outcome of the event was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Although, BNT162B2 vaccine immunogenicity is not in full effect after short time (3 days in this case) from the first dose administration, a causal relationship between event "diagnosed with COVID" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
A male reported that he received an injection of Tetanus Toxoid Fluid, Ultrafined on 05/03/2000. On 05/10/2000, the patient developed an injection site reaction characterized by swelling, redness. and firmness. On May 11, 2000, the size of the reaction was larger. The reporter declined to provide additional information and declined to grant permission for follow up investigation.
Patient received KINRIX for their Dtap and Polio at the age of 2.
Fever to 104.5 for 3 days.  Vomiting on day 2, seen in ER and found to have a bulging fontanelle.  Septic workup including LP was negative.
Under my left arm (where  got shot) swelled to big enough size. would say it was as big as golf ball and assuming it was a lymph node; Arm could not go straight down and it was very tender; Had a rash covered whole body for a full week. The sun seemed to aggravate the rash; It was a rash that itched; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FP 7533) via an unspecified route of administration in the left arm on 01Apr2021 at 16:15 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included latex allergy and COVID-19. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 06:00, after 24 hours of vaccine, the patient experienced under left arm (where got shot) swelled to big enough size that arm could not go straight down and it was very tender. It was as big as golf ball and patient assumed it was a lymph node. Patient also had a rash covering her whole body for a full week. The sun seemed to aggravate the rash and it was a rash that itched. Therapeutic measures were taken as a result of the event rash and itchy rash and included treatment with BENADRYL. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event under left arm (where got shot) swelled to big enough size that arm could not go straight down and it was very tender, had a rash covering her whole body for a full week and it was a rash that itched was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Pt called the next day, 10/04/2012 to report itching and swelling at the injection site. She took over the counter Benadryl which temporarily helped but symptoms returned not long after. Other symptoms denied.
INTERMITTENT NUMBNESS IN THE FINGER TIPS OF THE LEFT HAND; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included: sprained neck, and other pre-existing medical conditions included: The patient had no lifestyle changes. The patient had no other issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced chills. On 02-SEP-2021, the patient experienced headache. On 03-SEP-2021, the patient experienced intermittent numbness in the finger tips of the left hand. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills on 02-SEP-2021, and headache on 03-SEP-2021, and had not recovered from intermittent numbness in the finger tips of the left hand. This report was non-serious.
fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
nausea; vomiting; light-headed; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (also reported as: 83, unit unknown) received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on 09Jan2021 at single dose for COVID-19 vaccination. Medical history included tested positive for COVID on 13Apr2020. The patient's concomitant medications were not reported. Resident received 1st dose of vaccine 09Jan2021. On 10Jan2021, resident had nausea, vomiting and "light-headed". The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
A report has been received from a health professional concerning a 12 year old male subject, who had been receiving nasal FLUMIST started on 15-JAN-2014. The patient was administered expired FLUMIST on 15-JAN-2014. The outcome of the event of EXPIRED FLUMIST QUADRIVALENT ADMNISTERED is unknown. The report was considered to be non-serious by reporter.
Had my shot, Then got them.\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles shots and got Shingles but not very bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient presented on 05/13/2022 to receive Dose 1 Pfizer orange cap 5-11 vaccine. The vaccine administered on 05/13/22 had expired on 02/28/2022. The expiration was extended in error based on the updated State guidance received that was extended the expiration dates on frozen vaccines vs. refrigerated vaccines.
This spontaneous report was received from a medical assistant referring to a multiple unspecified patients. There was no information about the patients' concurrent conditions and medical history provided. The patients' concomitant medication included sterile diluent (MERCK) which was properly stored. On an unspecified date in December 2017, the patients' were vaccinated with an improperly stored dose of PROQUAD (dosage, frequency and route of administration were not reported), lot#: N013295 (expiration date: 28-APR-2019), lot#: N012489 (expiration date: 17-OCT-2018) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit (10.6 F) for 15 hours, as recorded by a data logger. The vaccines had not had any previous temperature excursions. There was no adverse effect reported. Lot number N013295 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. This is one of four reports received from the same source. Sender's Comments: US-009507513-1802USA008842: US-009507513-1802USA008838: US-009507513-1802USA008840: US-009507513-1802USA008841: US-009507513-1802USA008836: US-009507513-1801USA014257: US-009507513-1802USA008837: US-009507513-1802USA008835.
Small, dark red spots across chest and on backside/glutes after 1st Moderna dose, no itching. After second dose, headaches. Also caused an allergen skin prick test taken 1.5 weeks later to be more severe, with constant itching despite treatment with antihistamine right after for several days.  Three weeks after shot, the sites of allergen prick test reappeared on arms.  Five weeks after 2nd dose,  began developing hives for the first time ever, first localized to the wrists for the first few days. Hives progressively worsened over next few weeks. Diagnosed as chronic urticaria after that.
administered with Menactra that had expired with no adverse event; Initial information regarding this valid unsolicited non-serious case was received from other healthcare professional on 08-Oct-2020.  This case involved a 17 years old female patient who was administered with a dose of expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. (Expired product administered),   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications was not reported.   On 08-Oct-2020, the patient received a 0.5 ml once dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Lot number- U6365AA, expiration date-24-Sep-2020) via unknown route in the left deltoid for prophylactic vaccination.  This is a case of actual medication error due to an expired vaccine used. (latency: on the same time of vaccination)  At the time of report, no adverse event was reported.  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.
Boostrix - got injection on Tue afternoon.  Tues night, eyes started to feel itchy. Tried moisturizing eye drops w/out relief.  Eyes and lids started turning red, itchy, and burning. Next am, red hot itchy rash on appeared on area under eyes and on lids, right cheek and temple, forehead and along hair line, with a few spots down neck. Injection site was just a little sore as patient expected. No other symptoms manifested at all anywhere else. Symptoms today, 2 days later, are slowly resolving. Using hydrocortisone cream lightly on face, as well as moisturizing eye drops. Pt will be trying oral benadryl this evening, and will be discussing with primary care provider at next scheduled visit which is tomorrow, Fri 6/21/19.
Received Comvax on 9/17/02. Was seen on 11/4/02 with mom reporting very clumsy and URI symptoms x 2 wks. Dx cerebellar ataxia. Continues with mild ataxia.
Arm swollen, red and painful.  Swelling from shoulder to elbow.  Pain in arm and shoulder and elbow.  Treated with Benadryl, ice pack and time.
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 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6205), in right arm, on 24Mar2021 as dose 2, single (Lot number: ER8727), in right arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FD0809), in right arm and on 08Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 67 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: MTX [METHOTREXATE] taken for rheumatoid arthritis, stop date: 13May2022. Past drug history included: Known allergies: macrodantin, reaction(s): "Known allergies: macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19.
after second vaccination 3/4/2021 developed erythema at vaccination site that then spread down arm to trunk other arm hands and legs, then developed vesicles and bullae. the spread occurred over 13 day period then seen in clinic. vaccination given at second dose lot number was EN6203
Headache, nasal congestion Narrative: Received 2nd dose on 1/29/21 - 16 hours later a severe headache and nasal congestion which persisted until 2/4/21. Missed work x 1 day due to severity of headache. No known prior COVID infection.
My father went into get his Moderna booster and his flu shot.  The person administering the vaccine gave my father 2 doses of the Moderna vaccine (1 in each arm) and no flu shot.
Patient woke up to get ready for work and noticed blood coming out of right ear. Clots were in the blood that came out of the ear.
Pt tested positive for COVID on 7/5/21 after being fully vaccinated w/ 2 doses Pfizer.
Bells Palsy, facial paralysis on right side of face.  Has not resolved at time of this report.
03/11/2021 - I was not pregnant at the time of the vaccination. I started taking progesterone injection 2ml a day on 03/20/2021.  I did an embryo transfer on 03/25/2021. On 04/17/2021 in the evening,  I suddenly stated cramping, I was bent over, it was hurting really bad and shortly after that I started bleeding. I went to the Emergency Room. I'm RH negative blood type, to get a Rhogam shot. I had an ultrasound and I was told I was carrying twins. They also did blood work and my Eosinophil count was high. They both (babies) had heart beats, but one was lower than the other. I was put on bedrest. I saw my fertility doctor on 04/20/2021, the one (baby) where the bleed was coming from no longer had a heartbeat. The other one (baby) did have a good heartbeat. I was put back on bed rest, On the 04/27/2021, I returned to the fertility doctor, and neither one (baby) had a heartbeat anymore.
Chest pain, 3/10- onset 25 minutes after vaccine given. Elevated BP 140's/90's and elevated HR to 126 noted on initial eval CP persisted throughout eval GI cocktail given and pt took own clonidine 0.1 mg once BP and HR normalized about 2.5 hours after onset
Pfizer 1/5/21, 1/26/21, 10/18/21. Positive on 1/24/22
40 days after receiving the second dose of the COVID-19 vaccination the patient was riding her exercise bike and she began to feel very drowsy, nausea with vomiting and bilateral Lower extremity numbness/weakness. She was able to crawl to the couch and rested there until her father came home and found her. He took her to the local Emergency Department where she was transported to the local hospital for additional care.  She required emergency brain surgery and required extensive physical therapy. She was discharged home but required a walker and had to continue physical therapy to regain her ability to walk.
Scratchy Throat; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy Throat) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (different underlying health problems and allergies). Concomitant products included MONTELUKAST, ATENOLOL, ALLOPURINOL, ACETAMINOPHEN, CALCIUM CARBONATE (TUMS 500 CALCIUM), FISH OIL, TRAMADOL, METFORMIN, AMLODIPINE, ESTRADIOL (ESTRADIOL ANTIBIOTICOS), LOTEPREDNOL ETABONATE and CITICOLINE for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT IRRITATION (Scratchy Throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat irritation, at a dose of UNK dosage form. On 28-Feb-2021, THROAT IRRITATION (Scratchy Throat) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified eye drops.
I was hospitalized with visual disturbances which lasted about 30 minutes and transient aphasia that lasted about 1.5 hours and blood pressure of 190/85.
strong dizziness, weakness after 2 minutes of taking the shot , ambulance came took pressure oxygen level, sugar level and these were ok. no need to be hospitalized  4 hours after taking the shot I started having numbness in my fingers, numbness went away within few days
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient felt faint, blood pressure dropped and 911 was called. pt's spouse informed us after the vaccination that she has this reaction with all vaccinations due to a branch block. paramedics cleared patient to leave after observation period.
Immune complex mediated Purpuric dermatitis to bilateral lower legs Reaction to COVID Pfizer vaccine 3/4/2021  Resolved with steroids Patient was advised to NOT get the second dose of the vaccine.
Welt (swollen) warm 1/2 inch out by 1-2 inches long.
This spontaneous report was received from a registered nurse and refers to a 10 year old male patient. The patient's concurrent conditions and medical history were not reported. On 05-JAN-2017, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 93 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA014053.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VAQTA (dose, unit and route not reported, lot # L048460 with expiration date 14-JAN-2017 and lot # K012457 with expiration date 04-JUN-2017). The vaccines were exposed to 34 F for 30 minutes, previous temperature excursion included 55 F for 16 hours and 34 F for 2 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Entire left side of body from face to feet went numb and has been numb for 4 days now. Very scary feeling so reported to doctor. Vomiting for 24 hours.