chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report is regarding the Pfizer COVID-19 vaccination you received on the above date, which was lot number FD0809. The Local Public Health District, Centers for Disease Control and Prevention (CDC), and Pfizer have determined that the dose of vaccine that you received is valid.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "PCN" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), 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. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
First, my throat was very itchy  Then, throat started getting very tight Then my hands starting getting large welts in them
Patient's daughter called the HD around 10 A.M. on 11/9/2020 and states that her dad is headed to the ER to be tested for COVID-19 she states on the morning on 10/8/2020, patient started having a headache, with fever and congestion, she stated he has had a cough for 5 days and its has progressively gotten worse.  She states her dad did no show any new symptoms after the vaccine that he was given around 1:30 in the office.  Patient did not have any signs or symptoms such as cough or shortness of breath while in the clinic.  Patient was asked current age and stated he was 65 years old.  Patient filled out form and stated on the Flu vaccination form that he was 65 years old.  Patient was then given the Fluzone HD.  Patient was in fact 64 years 11 months.
Pain in shoulder and knee joints, could not stand up from seated position without help. Had to sit up and twist my body so I could turn over when in a prone position. Had slight muscle soreness in biceps, calfs, and swollen hands.
ER visit for stroke like symptoms, aphasia, weakness. Transferred to long term inpatient acute rehabilitation
Fever, chills, sweats, headache, body aches, nausea, horrible pain at injection site  Lasted for 40 hours, then stopped completely
Red hard lump, warm to touch, & hurt if pressure on it. Was at another pharmacy to look for Benadryl, but pharmacist recommended Claritin. Marked boundaries & got bigger by the next day. Day 3 not as red but still a large area. Day 5 swelling down, but see circle where was swollen (bruise?)
Five minutes after dose my daughter began to feel dizzy, felt like fainting and blurry sight.  We were still at the pharmacy, I asked the pharmacist about her symptoms, about 15 minutes later, she told me she was feeling better, so we left.
Intense pain in right knee and right hip. Caused difficulty moving right leg or walking. Only slightly abated after 2 months
pt recv vax & w/in 20min pt lt upper arm turned bright red, became swollen & was warm to touch (from elbow to shoulder involving the entire circumference of the arm);no evidence of resp diff, nor any sx suggesting anaphylaxis;pt hosp
Pt noted symptoms approx 24 hours after injection-localized-redness, tenderness. Swelling to right deltoid. No systemic reaction. Symptoms resolved w/ice. BENADRYL after 2 days.
runny NOSE, HEADACHE, FATIGUE, COUGH, NAUSEA
INJECTION SITE SWOLLEN; INJECTION SITE REDNESS; This spontaneous report received from a patient via other manufacturer concerned a 6 decade old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received non-company suspect drugs included: adalimumab (form of admin was not reported, subcutaneous, batch number: unknown and expiry: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, first dose was administered on 01-DEC-2020 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 57 years old. On an unspecified date, the patient experienced injection site swollen, and injection site redness (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown and expiry: unknown) dose was not reported, 1 total, second dose was administered on 01-FEB-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.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with adalimumab was withdrawn. The outcome of the injection site swollen and injection site redness was not reported. This report was non-serious.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in an 81-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant  medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated  that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients. No adverse reactions were reported by patient. No treatment information reported.
changing colors from red, to greed, to dark and it is now purplish; Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (changing colors from red, to greed, to dark and it is now purplish) and VACCINATION SITE RASH (Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORAZEPAM, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and POTASSIUM for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (changing colors from red, to greed, to dark and it is now purplish) and VACCINATION SITE RASH (Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored). At the time of the report, VACCINATION SITE DISCOLOURATION (changing colors from red, to greed, to dark and it is now purplish) and VACCINATION SITE RASH (Rash on injection site 3 days after vaccination 4inches by 3 inches multicolored) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included fluid pill triamterene.  No treatment information was provided.
pt recv vax & devel redness @ the inj site & warmth @ the inj site that resembled cellulitis; 1 wk or more p/inj pt was sent to an allergist who found her pos for allergy to candida; No further details were provided;
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/17/21 (EN6200) Pfizer Dose 2 3/11/21 (EN6208) COVID Positive 10/4/21  10/4/21: Patient is a direct admit from ER.  A past medical history is significant with diabetes, CKD , CAD with stents, and deficiency anemia sleep apnea, hypertension.  She presented to the ER with complaints of losing balance, generalized weakness and frequent falls at home.  She is from home with her husband who called EMS services.  Upon arrival to the ER she was noted with a black left eye and has been reporting she fell out of the bed.   Blood work was completed at ER was significant with sodium 129, creatinine 2.3, D-dimer 1.21. She also has a positive urine and a positive COVID 19 test positive.  Due to her elevated creatinine a CTA was not done.  The patient was noted hypoxia requiring 2 L nasal cannula.   Upon arrival to medical unit the patient was noted with SpO2 86% on 12 L oxygen.  Respiratory eval and treat was ordered.  She was then transferred to ICU for close monitoring. Pulmonology consultation initiated. For transferring to ICU I addressed patient's goals of care and she was to continue with full treatment.  She refused to to be intubated if needed.  I discussed the plan of care with the patient and she is agreeable to stay in hospital for further management  10/9/21: Patient is a 74-year-old female who was admitted on 10/4/2021 with acute hypoxic respiratory failure, secondary to bilateral COVID pneumonia, elevated LFTs, secondary to COVID, AKI on CKD, and E coli UTI.  She was noted to be very weak and has been suffering frequent falls.  This is thought to be complicated by excessive amounts of lorazepam at home (3mg @hs).  She was admitted to the ICU.  Critical care intensivist was consulted.  She was started on IV Levaquin, IV corticosteroids, and supplemental oxygen.  Blood cultures and sputum culture were ordered.  Lorazepam was discontinued.  Her urine culture showed positive for E coli, resistant to Levaquin. Levaquin was discontinued and Rocephin and Azithromycin were started.  The patient has slowly improved.  She is currently only requiring 4 L of supplemental oxygen by nasal cannula.  Physical therapy evaluated her and recommended SNF placement.  Her vitals have been stable otherwise.  Blood pressures were mildly elevated, so the patient's amlodipine was increased to 10 mg p.o. daily. Labs have been unremarkable.  Patient is being discharged to swing bed.
Since receiving the vaccine, I have had severe tinnitus and also developed vertigo. Two bouts of vertigo since the vaccine was given. Severe dizziness, nausea, vomiting.
first dose / administered on 01Dec2018 and second on 30Sep2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old male patient who received Herpes zoster (Shingrix) (batch number K9R97, expiry date 15th November 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st December 2018).   On 30th September 2020, the patient received the 2nd dose of Shingrix. On 30th September 2020, not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received a late second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case has been linked to US2020243326, reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020243326:same reporter
fever (101 F), fatigue, chills, body aches, headache, pain in left arm
Headache; Chills; Fever; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 28Mar2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included escitalopram 15mg (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 07Mar2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021 at 08:00, the patient experienced headache, chills, fever and fatigue. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of reported events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) from an unknown date and unknown if ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, chills, fever and fatigue recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
From the ER report/note: About 2 hrs after vaccination, patient "developed the tingling and numbness in the right side of her face and neck and shoulder area". No weakness, swelling of the mouth or throat, or breathing problems.
Date of Admission  09/03/2021   Date of Discharge  09/06/2021   Reason for Hospitalization   Covid+ 10 days, increased shortness of breath  Hospital Course   Please see admission H&P for complete details.  Briefly, the patient is a 77-year-old gentleman with very few medical problems who presented acutely with a worsening 3 to 4-day history of diarrhea nausea and vomiting.  He was brought in by his son who was concerned had recently been diagnosed with COVID-19.  According to him and the son he had symptoms for several weeks but only began to get worse that 3 to 4 days prior to presentation.  He is unable to eat or drink prior to this.  He had been prescribed hydroxychloroquine by her primary care provider as well as prednisone.  He was noted to be hypoxemic while in the emergency room.  He was started on dexamethasone and admitted to our inpatient unit.  He was vaccinated  Discharge Diagnoses      1.  Hypoxemia secondary to COVID-19  As above the patient was noted to be hypoxemic secondary to COVID-19.  He had a CT scan to evaluate for pulmonary emboli which was negative.  However, it did show findings consistent with groundglass opacities as we typically see with COVID-19.  He did peak at a total of 6 L required on 2 days post admission.  Was able to wean down to 3 L with activity.  He will be discharged with home oxygen and likely will require this from 1 to 2 months.  He should follow-up with his primary care provider as needed to determine any ongoing need for this.  He should avoid any activity involving fire or flames.  He is experience welder and is actually very familiar with these precautions  2.  COVID-19 pneumonia  As above patient was admitted with COVID-19 pneumonia.  He did also have GI symptoms with this.  I do suspect that he he was more acute than the family had thought.  Interestingly he had also had these skin lesions on his chest back thighs and legs that could be the cause of much of his prior discomfort.  However, I cannot quantify this.  He did respond to dexamethasone.  We started him on on remdesivir but stopped after noting bradycardia which is a known side effect of this medication.  3.  Dehydration likely secondary to diarrhea and vomiting secondary to COVID-19  Upon admission patient had mild AKI with creatinine of 1.3.  This responded well to fluid administration.  4.  Cutaneous skin lesions  The patient has extensive patches and plaques of his chest lower legs and around his waistband area he is says he has had these lesions for several years.  They tend to get better with steroid cream.  He has never had a biopsy of these.  Photos of these lesions were shared with her dermatology team who is on-call.  My personal concern is for cutaneous lymphoma.
Within 12 hours of vaccine, patient had 102 degree fever.  First day symptoms were also headache, dizzy, sore throat. Morning fever last multiple days. Today, 6 days later, fever is gone, throat is raw with cough, strep test is negative, patient is ill.  Dr. believes it is a viral infection, but cannot determine if related to vaccine or independent cause.
This spontaneous report as received from a registered nurse via company representative refers to an unspecified number of patients of unknown age and gender. Patients' medical history, concurrent conditions and concomitant therapy were not reported. On an unknown dates, unspecified number of patients were vaccinated with a doses of GARDASIL (lot number, dose and route were not reported). The reporter stated that in her clinic, all patients who stated HPV vaccination series with GARDASIL were switched to GARDASIL 9 (lot numbers, dose, and route were not reported). No adverse effects were reported. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-JUN-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # L040458, expiration date 04-FEB-2018; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 24, 47 and R. The storage criteria was refrigerator (R). This is one of two reports received from the same reporter. Additional information has been requested.
Pt is 15 years of age and received one dose of Pfizer BioNTech.  She is not a candidate for this vaccine until she is 16 years old. This error was not brought to our attention until 3/17/21 when she returned for her 2nd dose.  Her legal guardian consented to her receiving both doses of Pfizer BioNTech.  Upon discovery of her being underage for this vaccine, we did not complete her 2nd Pfizer vaccine at this time.
28 yo F here at 30mdg for covid vaccine. pt with h/o "anaphylaxis with other shots."  Pt notes had facial/nose/lip tingling with prior vaccines, requiring steroids and oral Benadryl.   Patient received the covid vaccine at approx 1715 on 21 Jan 2021. At approx 15 minutes, pt developed numbness and tingling to her nose and lips. pt notified Rapid Response Team, who notified Physician.  monitored patient for 5-7 min, pt noted that her symptoms were worsening, to include numbness and tingling affecting most of her face, cheeks, lips and nose. No trouble breathing. no lip swelling or tongue swelling. HR 78.  Gave oral benadryl - gave her 4 ml of po benadryl (12.5 mg/5ml) at approx 1735, and another 4 ml po benadryl (12.5 mg/5ml) at approx 1740.  pt prefers to be treated with steroids because a similar previous episode resolved with benadryl and steroids.   pt symptoms persisted with facial numbness and tingling ... and subjectively were worsening.  no coughing, no tongue swelling. no lip swelling. no shortness of breath.   FM physician arrived - prepped for 60 mg im solumedrol.  at approx 1750, FM physician gave IM Solu-Medrol in R shoulder.   pt waited for approx 15 min - felt better. numbness and tingling of face and nose were lessening, almost gone - only tip of nose was affected.  no facial swelling. no lip or tongue swelling. no trouble breathing. no shortness of breath.  physician gave return parameters - benadryl prn overnight  called patient the following monday - stated she slept that night (from benadryl), felt better the next day. no further concerns
Patient fainted and exhibited seizure-like activity within 15 minutes of vaccination.  Patient was transported to ER by EMS.
Arm is really sore; It hurt; Chills so severe; I was shaking; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included COVID-19 VACCINE.   On 1st December 2021, the patient received the 2nd dose of Shingles vaccine. On 1st December 2021, less than a day after receiving Shingles vaccine, the patient experienced pain, chills and tremor. On 2nd December 2021, the patient experienced pain in arm. On an unknown date, the outcome of the pain, chills and tremor were recovered/resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain, chills, tremor and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Covid-19 booster vaccine exactly 2 weeks before second dose of Shingles vaccine. The patient received Shingles vaccine and it hurt and the pharmacist wanted the patient to stick around to see if he/she had after affects. About 40 minutes later the patient experienced severe chills and was shaking. The patient reported that arm was really sore next morning. The patient felt better. The follow-up would not possible as no contact details were available.
2" x 2" darker, red spot at injection site swollen, hard and itching.