chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4344715-00 (RA). A 79-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 80 years, all intramuscular for Covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore arm following Covid vaccine"; SMALL INTESTINAL HAEMORRHAGE (medically significant), outcome "unknown", described as "Hemorrhage duodenum"; ANAEMIA (non-serious), outcome "unknown", described as "Anemic". The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (adalimumab): The reporter's causality for the event (s) of hemorrhage in duodenum, sore arm following COVID VACCINE and anemic was not provided. Regulatory Authority opinion is that the events of hemorrhage in duodenum and anemic are not assessable. Regulatory Authority opinion is that there is no reasonable possibility that the event of sore arm following COVID VACCINE is related to HUMIRA (ADALIMUMAB). Causality for (BNT162b2): The reporter's assessment of the causal relationship of "hemorrhage duodenum", "sore arm following Covid vaccine" and "anemic" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the available information and the known product safety profile, a causal relationship between the reported events, Duodenal hemorrhage, vaccination site pain, anemia and BNT162B2 is considered possible. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
2 minutes post vaccination pt found on floor after thumping sound - unresponsive - revived with ammonia capsule - moving all extremities - responsive to all commands - no apparent injury except brushburn (L) elbow - denied pain - left with parent.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown gender and age. On 12-SEP-2014, the patient was vaccinated with an expired dose of ROTATEQ 2ml dose, oral, lot number J000988, expiration date: 11-SEP-2014 (dose number not reported). It was reported that the potency was supported. No adverse effect to patient. The patient did not seek medical attention. No product quality complaint (PQC) involved. Additional information has been requested.
Pt had fever 103.6; mom noted pts hands trembling; MD contacted, t101.4 in AM; p/drinking milk, vomited; Seen by MD 27AUG91 dx DTP rxn; DT recommended for future immun; @ MD office localized redness & tenderness @ inject site, rash;
Racing heart; Breathing difficulty; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 23Sep2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset 27Sep2021, outcome "unknown", described as "Racing heart"; DYSPNOEA (non-serious) with onset 27Sep2021, outcome "unknown", described as "Breathing difficulty".  Additional Information: Patient was a minor, the child of a friend. He experienced symptoms while at school and followed up with his physician. Vaccine was administered Thursday last week and symptoms occurred Monday, so there may be no correlation. Event took place after use of product.  Follow-up attempts completed. No further information is expected
Feels like rotator cuff injury. Weakness within the shoulder when raising shoulder to put shirt on. Discomfort wakes me up in the middle of the night. Has been a concern since vaccine was given a week ago. No skin RXN. The inflammation feels like it is under muscle in the bursa area. No fever or redness associated, only soreness and reduced range of motion.
lightheaded, tingling on the feet, seen & cleared by EMS. B/P 140/69, P-79
Patient received only the adjuvant; Patient received only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received only the adjuvant AS01B of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a Registered Nurse (R.N.) referring to a 12 month old male patient. Pertinent medical history, concurrent conditions, and concomitant therapies were not reported. On 30-MAY-2015, the patient was vaccinated with VARIVAX (lot # H019449, expiration date 25-OCT-2014, 0.5 ml; M-M-R II (lot # H015833, expiration date 24-AUG-2014, 0.5 ml; both subcutaneously and VAQTA (lot # H019104, expiration date: 19-JUL-2015, 0.5 ml, intramuscularly. Dose number and anatomical location were not reported. The Registered Nurse reported that the patient developed hives and sought Medical Attention (unspecified). An unspecified treatment was given for hives. At the time of reporting the outcome of urticarial was unknown. The Registered Nurse stated that the patient, now four years old, had been given his unspecified vaccines individually and had no side effects. The reporter did not provide the causality assessment between the event and the suspect therapies. There was not a product quality complaint involved. Additional information has been requested.
This case was reported by a consumer and described the occurrence of injection site warmth in a 37-year-old female patient who received BOOSTRIX (batch number 55MT7, expiry date 14th February 2017). Concomitant products included Tuberculosis vaccine. On 29th April 2015, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injection site warmth, injection site wheal and injection site itching. On an unknown date, the outcome of the injection site warmth, injection site wheal and injection site itching were unknown. It was unknown if the reporter considered the injection site warmth, injection site wheal and injection site itching to be related to BOOSTRIX. Additional information received: On 04 May 2015, a consumer reported that she experienced hot to touch, red welts, and itchy at injection site after BOOSTRIX vaccine administration on 29 April 2015. Now, patient is in stable condition. A nurse visit has been scheduled on 05 May 2015.
Within 15-20 minutes of receiving the flu shot I experienced a red patch around the injection site followed by patches of hives on my chest, neck, shoulder back, under my arms, wrist, and palms of my hands. The hives and itchy continued to my ears, eyebrows, scalp and eventually my throat and tongue became irritated. My voice turned hoarse.  Both of my legs became weak. I received the flu shot at work. The pharmacy came to my place of employment. I was given a benedryl and had to be picked up from a family member. The symptoms did not improve, so my doctor office is treating me with a 5 day dose of steroids twice a day for 5 days. Tomorrow morning will be 48 hours since the shot, and I am still experiencing the above symptoms. My skin is itchy and almost feels hot. I continue to take the benedryl and steroid.
Case previously recorded as MA2009-4547. Initial case received from a nurse, on 18 NOV 2009. A 3-year-old patient was accidentally vaccinated with 0.5 mL of FLUVIRIN 2009/2010 intramuscular (batch no. 102126P1A, expiration date 31 MAR 2010) on 17 NOV 2009. No adverse events was reported. Reference no: NA09-008426.
Intense erythema/edema of skin overlying inject site. Extended to involved entire lateral arm. No fever, no tenderness.
CHRONIC PALPITATIONS PRIOR TO CHEST PAIN/CARDIAC EVENT LEADING TO TAKOSUBO CARDIOMYPATHY DIAGNOSIS/ HOSPITALIZED FOR 4 DAYS/ CARDIAC CATHETERIZATION. MEDICATION AND FOLLOW UP SPECIALISTS APPOINTMENTS.
Patient woke up the day after his second Pfizer covid vaccine dose with an isolated right eye ptosis. No other signs of stroke or cranial nerve dysfunction.
Mild (worstening) vertigo, moderate (worstening) tinnitus. Mild chills
Patient's mother reports non-stop crying for approximately 3-4 hours the morning after receiving immunizations.
Rash on legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Oct2021 (Lot number: FH8020) at the age of 72 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing), notes: HBP - 20mg lisinopril. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, lot unknown reason=Unable to locate or read the details), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, lot unknown reason=Unable to locate or read the details, After 2nd dose: red spot rash over stomach, arms and legs.), administration date: Feb2021, when the patient was 72 years old, for Covid-19 immunization, reaction(s): "Red spot rash over stomach, arms and legs". The following information was reported: RASH (non-serious) with onset Oct2021, outcome "recovered with sequelae" (Oct2021), described as "Rash on legs". The event "rash on legs" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash.  Additional information: Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19 via Nasal Swab in May2021 and result was negative.  No follow-up attempts are possible. No further information is expected.
have a very bad allergic reaction to eggwhite; her lungs lock up and can't breathe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FOOD ALLERGY (non-serious), outcome "unknown", described as "have a very bad allergic reaction to eggwhite"; DYSPNOEA (non-serious), outcome "unknown", described as "her lungs lock up and can't breathe". Additional information: It was reported that the patient got all her COVID-19 shot because she have health issues and stuff.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax AUG97 & approx 5 days post vax pt devel a stiff neck & a rash on lower extremities;lately devel some lesions on arm & one in the groin area;
I received the 2nd vaccination on 2/ 26/2021.  I have had raised area on both arms since the vaccines. I kept thinking they would go away, like it says in the warnings, but it hasn?t. They don?t hurt, but it?s like a line of raised skin, on both arms. This couldn?t have been caused by anything else.
Fever, severe chills and fatigue, headache, body aches, pain in left arm,  full body hot rash. Began on the afternoon 3/14/21, became severe in the evening, into 3/15/21. Symptoms have improved, but are still present, I have been in bed for 24 hours.
Recovering well from URI with bronchitis.  Following IZZ c/o worsening cough & shortness of breath evening of IZZ until 3 d later visited clinic for same.  No sx improvement with Xopenex x2.  Have on prednisone taper & Zithromax.
Patient presented to the ED on 5/3/21 with sharp chest pain since 5/1/21.  He had received his second dose of Moderna COVID-19 vaccine on 4/15/21.  The patient was diagnosed with gout approximately 1 week prior and had been placed on prednisone.  The patient was found to have ST elevation MI with myocarditis along with cardiogenic shock.  He was managed in the CCU requiring IV dobutamine and IV furosemide.  Patient was transferred to secondary Medical Center on 5/4/21 for advanced heart failure therapy
Shots are painful; 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.   Previously administered products included Shingles vaccine with an associated reaction of pain (for tolerance of 1st dose refer linked case US2022AMR117903).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR117903   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that shots were painful but it was a few seconds.  After patient had no soreness. Follow up would not be possible as no contact details available; Sender's Comments:  US-GSK-US2022AMR117903:Same reporter.
Is exasperated my asthma, which had been basically dormant for 5 years, and suddenly I had a few asthma attacks. It also exasperated my dry cough from my asthma.
This spontaneous report was received from a register nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that from 21-NOV-2014 through 16-JAN-2015 the patients were vaccinated with doses of VAQTA 0.5 ml, intramuscular, (lot # and expiration date were not reported) that were improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rt arm is mildly erythemic, hot to touch has large amount of edema from shoulder to elbow has good bilateral strength & ROM of both hands; 2+ brachial & radial pulses bilaterally; c/o pain upon palpation, has inc basal body temp, itching;
Red swollen area measuring 4 1/4 " x 3" wide. warm to the touch.
there was a device malfunction and the patient only received half the dose with no reported adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient, there was a device malfunction and the patient only received half the dose with no reported adverse event with INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection via unknown route in unknown administration site for influenza (strength, formulation, batch number and expiry date: unknown), there was a device malfunction and the patient only received half the dose with no reported adverse event (incorrect dose administered) (latency same day). Information on the batch number was requested  Reportedly, The information provided was that there was a device malfunction and the patient only received half the dose.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event incorrect dose administered   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 the 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.
5/19/02 fever 101, Rash on legs, chest, back and face. Diagnosis chicken pox per personnel in office
This spontaneous report as received from a licensed Vocational nurse refers to a 77 years old male patient with tetracycline allergy. The patient was vaccinated with ZOSTAVAX (dose, route and frequency not provided) (lot number reported as 0071AE and expiry date reported as 03-APR-2013, also reported as 03-APR-2020) on 07-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date in September 2012 the patient experienced redness and swelling that became larger than size of a half dollar at the injection site. The patient sought medical attention by office visit. The patient was given BENADRYL. The outcome of redness at the injection site and swelling that became larger than size of a half dollar was reported as recovered on an unknown date in 2012. The relatedness for redness at the injection site and swelling that became larger than size of a half dollar was unknown for ZOSTAVAX. This is one of the several reports received from the same reporter. Additional information has been requested.
Niece confirmed Pt is a resident at Assisted Living and provided the address and phone # which updated into system and changed district. Niece stated her Aunt spiked a fever on 7/27 after being exposed to another Pt at the LTC facility. Because of her medical condition she was transported to Hosp. and was admitted. She fever and mild cough for 1 week and is being discharged today to return to Assisted Living. Pt has Kidney disease, cong heart failure, diabetes, dementia and HBP. Pt is fully vaccinated which she received at the LTC facility in March.
Case number PHEH2015US025773, is an initial spontaneous report received from a health care professional on 07 Dec 2015. This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with FLUVIRIN (batch number: not reported) that was left out at room temperature before administration. No adverse event was reported.
Experienced neuropathy (numbness) in left foot around 10:00 am. Progressively became more numb with & pain in entire left leg. Went to local ER around 3:30 pm. Ultrasound showed no blood clots. Given various pain medication, with no relief. Around 6:00 PM right foot began numbing with pain in right leg.  Left local ER And went to Specialty Clinic ER.  Was admitted immediately.
Chills, exhaustion, edema in ankles, tightness in right chest alleviated with Tums, severe headache.
Client given Tdap - recommended for ages 11-64 only. ADACEL- lot # C3027AA in right deltoid.
Unable to get hold of patient's  parents due to address being hotel and hotel confirmed that family did not check into hotel  and reservation was canceled. Phone number is not a valid number. Patient received pediatric pfizer correct dose and vaccine was given but was not mixed with diluent prior to administration.
DVT - Femoral vein from knee to groin Lovenox injections Xarelto bid  DVT resolved
Patient fainted at 15 min mark after receiving vaccine. She was out for about 2 minutes. Her oxygen level dropped and blood pressure increase. Patient was given one dose of Nitro 0.4 mg SL and one tablet of Diphenhydramine 25 mg .
red, splotchy rash on arms, legs, stomach last nite; today marked myalgias, arthralgias t98.9;
L arm with redness 3cm x 4cm, warmth, and local swelling (does not extend past site). Pt states noticed redness last pm at ~9pm. Swelling/redness increased since that time. Pt x/o tenderness also.
Menstruation  was over a week late, experienced severe cramping  and back pain as if I was menstruating during the entire week  3/15/21-3/20/21.  Menstruation finally occurred on 3/22/21 and lasted the normal 5 days but was very heavy and painful.
fainted; body pain; throwing up; fever; couldn't speak; This is a spontaneous report from a contactable consumer(patient). A 53-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: fc3181) via an unspecified route of administration in arm left on 18Aug2021 08:15 (age at vaccination 53 year) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were none. Patient was not pregnant at time of vaccination. No other vaccine in four weeks, no other medications in two weeks and no known allergies. The patient did not had covid prior vaccination and no covid tested post vaccination. On 18Aug2021 20:00, the patient experienced body pain, throwing up, fever, fainted and couldn't speak, that shot killed her. No treatment received for the events. On an unspecified date in 2021, events body pain, throwing up, fever, fainted and couldn't speak, that shot killed her were recovered with lasting effects.  Follow-up attempts are completed. No further information is expected.
Floating black dots in right eye, floating blurry spots in right eye starting about 1 month after vaccination