chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 3/5/2021, 3/26/2021, and 10/12/2021. Presented to ED 9/17/22 w/generalized weakness, fatigue, and SOB. Recent CTAP w/PCP concerning for pancreatic cancer w/mets confirmed by IR liver bx on 9/15/22. Course c/b COVID, concern for GI bleed, acute bilateral PEs, hyponatremia, and anemia requiring transfusions,and acute respiratory distress. Transitioned to comfort care and expired on 10/05/22.  Tx'd w/cefepime, rocephin, metronidazole, vancomycin, meropenem and refused other COVID-19 therapies.
Rash similar to Sulfa rash, started about 24-30 hours after first shot (taken in my left arm). I noticed an eczema style patch on my right hand then shortly after my arms started resending and looking splotchy. I had a sulfa rash reaction to a steroid in 2009 that also showed up after a day or two so I recognized it and started taking Benadryl.  It seems to be helping but not completely clearing the rash. My blood pressure was also high this morning, which is abnormal for me.
temp to 102, nausea & vomiting; no hx of viral exposure no prev reaction to immun;
Started having chills and tiredness that night.  The next day it was much worst and it didn't get better until FOUR days after.
This spontaneous report was received from a nurse practitioner (also reported as nurse prescriber), concerning a patient of an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 09-APR-2017, the patient was vaccinated with an expired GARDASIL with lot # L039066 and expiration date on 19-MAR-2017 (strength, dose, frequency, route of administration and anatomical location were not provided), for prophylaxis. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
20 minutes after injection I began to rash on both arms. Both upper and lower parts of arms including my hands and chest.  I continue to have the rash 5 days later
This spontaneous report as received from a nurse refers to a 17 year old patient of unknown gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-SEP-2015, the patient was inadvertently vaccinated with doses of both (Oka/Merck) VARIVAX injection (dose, route of administration, lot# and expiry date were not reported) and (Oka-Merck) PROQUAD injection (lot# L002213, expiry date 21-JUL-2016; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021; A 16 year old patient got her both doses; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses). On 18-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A 16 year old patient got her both doses, 1 st dose of the Moderna COVID-19 Vaccine on 31Jul2021 and second dose of the Moderna Covid-19 vaccine on 18Sep2021) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient got her both doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-325327 (Patient Link).
his wbc T and B cells are elevated/Elevated T cells and B Cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "his wbc T and B cells are elevated/Elevated T cells and B Cells". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that patient received vaccine 6 months ago, and went into the doctor to have some blood work done checking on his T-level thing just general just general guide stuff and he came back and told me that T-cells and my B-cells both in his immune system are elevated, patient asked did the vaccine caused that. One of his HCPs says no and one of his HCPs says yes. Declined transfer to (Redacted) Medical Information as he stated previous agent did not have any information for him at that time. Declined to complete a report at that time. What happened to him just let him know the vaccine was working on the immune system. His HCP has him going to a person to do bloodwork on the 31st to see if he has lymphoma because his T cells and B cells are elevated. It was confirmed that patient's WBC are elevated after getting the Pfizer COVID 19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My grandmother died a few hours after receiving the moderna covid vaccine booster 1. While I don?t expect that the events are related, the treating hospital did not acknowledge this and I wanted to be sure a report was made.
A day after I could feel all the way up to 2 weeks (current) I could feel my heart. Heart had pain every now and then but mostly I can just feel it in my chest and I never could before the shot.  A numb, type of feeling.  It hurts sometimes when I turn a different way.
Felt faint, anxious, BP 93/59 (pulse 77), O2 sat 100%. Water given. F/u BP 98/56.
Increasing redness, itching + swelling at shot site L upper arm starting approximately 24 hours after shot has  8x5cm are erythema + swelling + tenderness P OTC antihistamine hydrocortisone cream
Administered to an infant over 8 months of age. Was confused about the timing restrictions of ROTATEQ.
very sick after her second shot; aches and pain in body; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick after her second shot) and PAIN (aches and pain in body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced ILLNESS (very sick after her second shot) and PAIN (aches and pain in body). At the time of the report, ILLNESS (very sick after her second shot) and PAIN (aches and pain in body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were reported.  No Treatment information was reported.   This case was linked to MOD-2021-048221 (Patient Link).   Reporter did not allow further contact
Dizzy spells. Irregular heartbeat. Fluttering and racing heart. Shortness of breath.  Tightness of chest.  wheezing - even when resting.  fatigue.  in ability to complete regular exercizes.  warm tingling sensation throughout body - across skin and hair folicules.  short aches in joints such as knees and elbows -- and especially in the neck.   Ears warm, tingling, ringing, with intermittent sharp pain of inner ear.   This continued for almost exactly two weeks.    mostly better now though sometimes feel that I am experiencing some residual effects.
Patient with single J+J COVID vaccination who admitted to hospital with COVID detected test, cough, weakness.  Provider d/c summary below:  "87 year old female with a history of MI, coronary artery stenosis with stent placement, bronchial cancer, hypertension, atrial fibrillation, and T2DM who presents with 2 day history of generalized body aches. She has also had a non-productive cough, chills and malaise. She denies any shortness of breath, chest pain, headaches, or N/V/D, leg swelling, pain with inspiration, abdominal pain, problems with urination or stooling.  She says that her daughter had similar symptoms about a week ago and that the patient was around her frequently. She says that she was recently hospitalized for a heart attack and dual stent placement. She has been taking all of her medications but has not tried anything over the counter to help with her symptoms. She denies any smoking, alcohol consumption or drug use.    In the ED, patient hemodynamically stable.  Labs notable for elevated troponin at 384 and BNP 26140. With concern for NSTEMI, patient given full dose aspirin and started on heparin gtt. Patient is fully vaccinated and subsequently tested positive for COVID-19.  Patient admitted to the general medicine service for evaluation and further management. Cardiology was consulted for further management and assess possible catheterization versus medical therapy. Since she is fully vaccinated for COVID and she did not experience respiratory symptoms, will hold on antivirals on discharge. Her heparin drip was discontinued and patient does not need further anticoagulation at this time. Therapies recommend home physical therapy so she will have home care services. Patient improved and discharged in stable condition. She is to hold on losartan given softer blood pressures, defer to cardiology when to resume medication. Her home amlodipine and lopressor were discontinued. She is to start Metoprolol succinate. Rx sent to patient's pharmacy. She is to continue her other home medications as prescribed. Follow up with PCP and cardiology as able."
toothache; Bad flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms and toothache. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the toothache was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and toothache to be related to Shingrix.  Additional information received were as follows: This reporter was the patient's friend. The age at vaccination was not reported. Around 18th to 19th July 2019, the patient received Shingrix. The patient experienced bad flu-like symptoms for a week after the injection. As far as the reporter knows, the patient was still experiencing the toothache at the reporting date.
He reported that he had puffiness around his lips and he was itching like crazy; itchiness; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EN4809) as SINGLE DOSE for covid-19 immunisation. Medical history included surgery (three or four years ago) and gastrooesophageal reflux disease. Concomitant medication(s) included metformin; metoprolol; acetylsalicylic acid (BABY ASPIRIN); amlodipine; rosuvastatin; ezetimibe; famotidine (PEPCID [FAMOTIDINE]) for gastrooesophageal reflux disease; irbesartan and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient reported, he received his first shot of the Pfizer BioNTech COVID-19 vaccine on 04Feb2021 and is scheduled to receive his second on 22Feb2021. States that after his first dose, he experienced puffiness around his lip and itching like crazy with scratching his forehead, scalp, and shoulder. He hasn't experienced these symptoms for the last 4-5 days and reports it wasn't nasty. It doesn't last long. It has been tolerable. He remembers when he got the Shingles shot he had some itchiness. At the end of this week, he has to get the second shot. The outcome of event Lip swelling was recovered and for itchiness it was unknown on 06Feb2021.
Patient received 3 Moderna COVID vaccinations per records 5/9/21, 6/6/21 and 8/18/21 - patient admitted 9/21/21 to hospital with anemia and hypotension - found to be COVID + in ER.
Fever 104F, back ache, vomiting, diarrhea and pain when walking.
Headache; Chills; nausea; This is a spontaneous report from a contactable consumer. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Apr2021 at 12:45 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient did not have allergies to any medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included sertraline hydrochloride (ZOLOFT) from an unknown date, for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 30Mar2021 (at the age of 22-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 04:00, the patient experienced headache, nausea and chills. Therapeutic measures were taken as a result of the events headache, nausea, chills and included treatment with Tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea and chills were resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fever:  38.5 C, responsive to Acetaminophen 1g IVPB, and 1g ceftriaxone IV  down to 37.1 C, 90 minutes after administration Patient reported altered mental status, unable to remember how she arrived to ER
One to two weeks post vax the pt developed four to five pruritic skin lesions around the injection site. The lesions resolved after two to three days.
Tachycardic, Tingling of lips, Shivers but felt hot, nausea, flushing
COVID-19; Appetite absent; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DECREASED APPETITE (Appetite absent) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19) and DECREASED APPETITE (Appetite absent). At the time of the report, COVID-19 (COVID-19) had resolved and DECREASED APPETITE (Appetite absent) outcome was unknown.            No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality of Humira as per reporter for event COVID-19 was No reasonable possibility and for event Appetite absent was Not reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
hives; itchiness; scratch marks; rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), PRURITUS (itchiness), SCRATCH (scratch marks) and RASH (rash all over the body) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced URTICARIA (hives), PRURITUS (itchiness), SCRATCH (scratch marks) and RASH (rash all over the body). At the time of the report, URTICARIA (hives), PRURITUS (itchiness), SCRATCH (scratch marks) and RASH (rash all over the body) had not resolved.            No concomitant medication information provided. The reporter reported that the patient has been taking allergy medicines as a treatment to calm down the events occurred for the past month and a half. The patient took her booster dose and experienced events after 4-5 days after taking vaccination.
shoulder tender; shoulder swollen; shaking arms and legs; shoulder red; aches and pains; fever 102ºF; chills; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen), TREMOR (shaking arms and legs), ERYTHEMA (shoulder red) and PAIN (aches and pains) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (They had COVID back in March (in late March), and they were very sick with it: fever, chills, aches and pains.) in March 2020. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Dec-2020, the patient experienced TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen), TREMOR (shaking arms and legs), ERYTHEMA (shoulder red), PAIN (aches and pains), PYREXIA (fever 102ºF) and CHILLS (chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 03-Jan-2021, TENDERNESS (shoulder tender), JOINT SWELLING (shoulder swollen) and ERYTHEMA (shoulder red) had resolved. At the time of the report, TREMOR (shaking arms and legs) and CHILLS (chills) had resolved and PAIN (aches and pains) and PYREXIA (fever 102ºF) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, Body temperature: 102 (High) Degree F.     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.   Patient who is also a physician reported , he tested for COVID in their office both with the swabs and the quick read and 15 minutes test,  and also tested for antibodies several times since then. Obviously had the IgG but still has the IgM does not know whether it's from past infection or for being exposed pretty much on a daily basis from patients populations.
Covid positive - cough, fever up to 101.5, body aches, fatigue   7/9/2022 - 7/16/2022   Still have metallic taste in mouth ad no sense of smell
This spontaneous report was received from a physician referring to a 5 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 07-JUN-2011, the patient was vaccinated with a dose of M-M-R II lot number reported as: 1618Z, expiration date on 18-NOV-2012 (strength, dose number, route and anatomical location were not provided) for prophylaxis. On 22-AUG-2015, the patient was vaccinated with a dose of PROQUAD lot number: L009210, expiration date on 17-SEP-2016 (strength, dose number, route and anatomical location were not provided) for prophylaxis. On 27-FEB-2017 the patient was diagnosed with the Influenza. On 03-MAR-2017, the patient went to the physician office with swollen salivary glands and fever, then, on an unspecified date in 2017, the patient went to the emergency room for worsening symptoms of salivary gland enlargement and pyrexia. It was reported that the patient was treated with unspecified antibiotic. On 10-MAR-2017, the patient was in an office visit and was recovering. The reporter did not assess the relatedness between all adverse events and suspect therapies. This is one of several reports received from the same reporter. Lot number 1618Z has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live with HSA as albumin status. Additional information is not expected, since no consent to contact the reporter was provided. This is an amended report, as corrected. The reference type for the number US-009507513-1703USA006841 was changed from Company Number to Linked Report. Sender's Comments: US-009507513-1703USA008042: US-009507513-1703USA006841: US-009507513-1704USA008484: US-009507513-1703USA006841: US-009507513-1704USA008486.
Patient presents today for evaluation of rash after receiving COVID vaccine. On 8/25/21 received Pfizer COVID vaccine at in left arm. Within 40min had a red, hot to touch rash around injection site and down most of left arm. The rash was not itchy or painful. No paresthesia. No swelling. Then last week, the rash has went to stomach, legs, right arm and face. Most spots have improved yet new areas develop. Again no itching or pain. Unsure if Zyrtec or Benadryl help which she already routinely takes for allergies. Has a history of multiple allergies but never to a vaccine. Prior to vaccine was feeling well and feels well besides rash. No fever. No lip, tongue, facial swelling, wheezing or SOB.