chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart attack; clogged her arteries; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program.   A 63-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EW0171), dose 2 via an unspecified route of administration on 28Apr2021 as dose 2, single and dose 1 via an unspecified route of administration on 29Mar2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. No PQC was present. Medical history included heart disease (mother's side). The patient concomitant medication was not reported. On 10Oct2021, the patient experienced heart attack, and on an unspecified date in 2021 the patient had clogged her arteries. The patient underwent lab tests and procedures which included electrocardiogram resulted normal. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine; Sore arm/Had typical sore arm at injection site; Light body aches and sniffles started about 10-12 hours after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine), PAIN IN EXTREMITY (Sore arm/Had typical sore arm at injection site) and PAIN (Light body aches and sniffles started about 10-12 hours after second vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included GERD. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOLOC) for GERD.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced DYSGEUSIA (Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine), PAIN IN EXTREMITY (Sore arm/Had typical sore arm at injection site) and PAIN (Light body aches and sniffles started about 10-12 hours after second vaccine). On 16-Jun-2021, DYSGEUSIA (Ability to taste seems to have been affected/Metalic taste in mouth appeared about 18 hours after second vaccine) and PAIN (Light body aches and sniffles started about 10-12 hours after second vaccine) had resolved. On 21-Jun-2021, PAIN IN EXTREMITY (Sore arm/Had typical sore arm at injection site) had resolved.            No treatment information was reported Had similar reaction with previous flu Vaccination   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Event details, Concomitant medication, Other medical history and patient demographics updated.
A report has been received from a Health Professional concerning a patients of unknown gender, who had been receiving Nasal FLUMIST (intranasal), Once/Single administration for PREVENT THE FLU. FLUMIST (intranasal) started on an unknown date for PREVENT THE FLU. The patient experienced SINUS SYMPTOMS and SEVERE HEADACHE. The outcome of the event of SINUS SYMPTOMS and SEVERE HEADACHE is unknown. The reporter's description of the event (s) was as follows: unknown. The report was considered to be non-serious.
I experienced chills, body aches, back pain, dizziness, nausea, dry heaves and passed out. When I passed out, I bit my lower lip and it bled quite a bit. I had brain fog, and couldn't come up with the correct words. Also, I could not sleep that night, at all without taking a few sleeping pills. It has been a week since this happened and I still can't sleep on my own.  I used to be able to go right to sleep without any sleeping pills within about 5 min after laying down at night.
Brain fog, severe fatigue, very strange dreams.  This lasted until 01/27/2023.  I could not work for 6 days.  I visited my doctor, they took blood tests which showed nothing wrong. They did not know what to tell me.
Pt presented with abd pain with cholelithiasis. No interention needed, asymptomatic covid pt discharged home.
Fever, cough, stuffy/runny nose, nausea and vomiting, body aches, headache
Given a vaccine that expired yesterday; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given a vaccine that expired yesterday) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given a vaccine that expired yesterday). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Given a vaccine that expired yesterday) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided.  No treatment information was provided.
Felt like a electric shock at the moment of vaccination. On the next day, extreme weakness, severe body pain, and dizziness. Felt like she was going to pass out in the bathroom so she called her husband to assist her. Stayed 1 day in bed. Didn't received treatment.
C/O dizziness, throat swelling sensation, throat soreness, throat tightening, itching near the eyes, light-headedness. Client can swallow water without difficulty. No SOB noted. RR-20, O2 sat 97%; HR 105; BP 110/76. Per auscultation, no stridor noted. EMT at vaccine facility present and requested EMT support. 2:15 PM Ambulance arrived. EMT evaluated and recommended transport. Pt. declined transport. 2:25 HR 104; BP 110/80; 97% Patient stood without lightheadedness and ambulated on own with sister accompanying to personal vehicle. Gait steady.
This spontaneous report was received from a Medical Assistant concerning an unspecified number of patients of unknown ages and gender. Pertinent Medical History and Drug Reactions/Allergies were not reported. On an unknown dates, the patients were vaccinated with unspecified doses of improperly stored GARDASIL (Batch, lot # K0090202, expiration date: 17-DEC-2016) (route not reported). Concomitant therapies were not reported. No adverse effect were reported. No further information was provided. This is one of four reports from the same source. Additional information has been requested (correspondence containing a request for additional information is scheduled).
Cramps in calf and upper thigh caused me to go to ER. Pain when at rest or during bathing. After using  a lotion there was a pain like a scratch, burn, or abrasion localized.  Received leg cramp info.
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 24th September 2020 20:43, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and on 24-SEP-2020 20:43:01 experienced fever. The age group was not reported but was captured as adult as per vaccine indication.
Patient stated that she developed a red, hot, and hard lump on her arm a week after her vaccine.
Round knot at the injection site; Injection site is warm to touch; Round knot at injection site that is itchy; Round knot at the injection site that is red; Round knot at injection site that is tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Round knot at the injection site), VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Round knot at injection site that is itchy), VACCINATION SITE ERYTHEMA (Round knot at the injection site that is red) and VACCINATION SITE PAIN (Round knot at injection site that is tender) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS (autoimmune disease).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE MASS (Round knot at the injection site), VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Round knot at injection site that is itchy), VACCINATION SITE ERYTHEMA (Round knot at the injection site that is red) and VACCINATION SITE PAIN (Round knot at injection site that is tender). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Round knot at the injection site), VACCINATION SITE WARMTH (Injection site is warm to touch), VACCINATION SITE PRURITUS (Round knot at injection site that is itchy), VACCINATION SITE ERYTHEMA (Round knot at the injection site that is red) and VACCINATION SITE PAIN (Round knot at injection site that is tender) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a certified medical assistant refers to a pediatric patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with VAQTA, 0.5 ml, intramuscular; third dose (lot number not reported). Concomitant medication was not reported. No adverse effect reported. This is one of several reports from the same source (1407USA011285, 1407USA011905, 1407USA011907, 1407USA011908, 1407USA011909, 1407USA011910, 1407USA011911). Additional information has been requested.
Needele and syringe detached while in guestes arm. estimated more than 50% of vax given
excursion vaccine was administered with no reported adverse event; vaccine Act-HIB for which cold chain break is reported with no reported adverse event.; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  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 guidelines. 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.; Sender's Comments:  US-SA-2023SA124713:master case
Chest tightness,  shortness of breath,  throat tickle then tightening,  coughing,  rash.... monitor ( bp high,  o2ok ekg looked like a fib then was ok) then epi, used inhaler, benadryl,  epi and then taken to hospital where I received steroid injection and prilosec with continue monitoring.  Next 5 days medrol pack,  benadryl and prilosec
SPONTANIOUS BLEED IN RIGHT THIGH MUSCLE COMPARTMENT SYNDROME EMERGENCY FACIOTOMY BLOOD CLOTS
Breakthrough case admission after three vaccines Moderna 3/20/21 Lot# 038A21A;  Moderna 4/17/21 Lot# 037B21A;  Moderan 12/22/21 Lot# 067H21A
Pain in the arm and migraines. When I was trying to walk up the steps I had shortness of breath. I tripped up the steps because I got lightheaded. I went to my doctor. I took Excedrin. I wanted to be sure the SOB was checked. Doctor checked my medication, and took my vitals. BP was high, then I had to wait 45 minutes for the doctor to take my BP again. The second time my BP was taken it was a bit lower.
Patient was supposed too receive Hep A vaccine and instead received IPV (dose 2)  on July 24th 2019, 12:15 pm  No further treatment necessary, patient will come back to the clinic to receive Hep A vaccine.
Mass palpated in right thigh, noted 2 weeks after IZ given in right thigh. No treatment. Will have pt follow-up to document resolution.
Pt comes for evaluation of red swollen right thigh. Warm to touch. Sore. Treatment advised: supportive measures. Cool compresses and Tylenol.
Woke up with a lot of fatigue (found it hard to move my body at my usual speed), a lot of chills, and body aches in my arms and legs.
No other adverse events were reported. No additional AE/PQC.; HCP reported inadvertently administering MMR-II to a patient that was 3 months and 28 days old on 28JULY2023. No other adverse events were reported. No additional AE/PQC.; This spontaneous report was received from a medical assistant and refers to a 3 months and 28 days old patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 28-JUL-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, once, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). No other adverse events were reported (No adverse event). No additional AE/PQC.
Generalized itchy/painful rash over whole body since last covid vaccine 3/5 (2nd dose in Moderna series). Adminsitered by the Center.
Employee received 0.5ml Td vaccine on 10/13/03. C/o headache, fever (99.8 to 100), weakness and vomiting x1 starting 10/13/03 night. Referred to ER on 10/15/03. Diagnosed "viral syndrome" prescribed Tylenol 650 mg prn. Recovered on 10/16/03.
p/vax pt w/lump & pain @ inj site;returned to clinic on 10/27/99;quarter size lump noted to lt deltoid w/erythema & blanche in center & hot to touch;eval by MD instructed to take APAP PRN & use heat compresses;
On 7/2/2022 I noticed red dots on my feet and legs.  On 7/3/2022 I had two nosebleeds.  On 7/4/2022 I had numerous random bruises all over my body and the red dots had spread up my body and into my mouth.  On 7/5/2022 I went to the ER where I was treated and admitted.
I received my booster at 5:00pm Friday. I started experiencing abdominal pain that evening. The pain progressed thru Saturday and was not able to keep food down. I went to the ER on Sunday and was Dx with appendicitis and had an appendectomy at 11:30PM  on Sunday.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old female patient who received vaccine FLUZONE HIGH DOSE inadvertently. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TENIVAC for Immunization. On 02-Oct-2018, the patient received a Dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI994AA expiry date: 04-Sep-2019 via unknown route in the right deltoid. It was case of actual medication error due to Inappropriate age at vaccine administration and overdose. No side effects were 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. List of documents held by sender: none.
Patient reported having loss of control of arms, legs, and bladder, vomiting, sweats and generalized pain that began about 2 hours after having the vaccine and lasted about 14 hours after.  Did not contact our office until 10/12/22 and did not seek treatment at ER.
really bad headache; temperature 103; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (really bad headache) and PYREXIA (temperature 103) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (really bad headache) and PYREXIA (temperature 103). At the time of the report, HEADACHE (really bad headache) and PYREXIA (temperature 103) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pain at the injection site / worst shot that he ever got; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe (batch number Unknown, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at vaccination was not reported. The nurse practitioner states that his other son, age unknown, received a dose of Bexsero on an unknown date. At an unknown time, after the dose of Bexsero was administered, he experienced pain at the injection site. On an unknown date, approximately 2 weeks after the start of the pain at injection site, the pain at injection site resolved. The patient stated that the Bexsero was the worst shot that he ever got. No other information stated by the reporter due to limited time. All other information is unknown. The reporter consented to follow up. This case was linked with US2021AMR061883 and US2021AMR061889; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061883:Same reporter. Patient #1. US-GLAXOSMITHKLINE-US2021AMR061889:Same reporter. Patient #3.
Chills, fever (101.1-102), fatigue, malaise, joint pain. Headache
Severe side effects compared to Moderna 2nd Shot including high fever, teeth rattling chills, joint and muscle pain,  sob, severe fatigue and malaise. These sxs were for the Moderna Booster Shot(3rd Shot) Sx resolved after 36 hrs.
Mother reported per phone that client is having cramps on the right leg, worse above the knee, thigh area. Advised to call the doctor immediately or go to the Emergency room. She promised she will call the doctor after she hangs up.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 69 years old male patient who experienced possible skin reaction at same area of his flu vaccine along with raised, scaly and discolored area on his left deltoid, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history included mole of skin which was scaly, and is darker brown in color. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018, the patient received 0.5 ml dose of suspect FLUZONE HIGH DOSE lot UJ000AA, expiry date: 28 Mar 2019 via intramuscular route in the left deltoid. On 22 Oct 2018, the patient developed a non-serious possible skin reaction at same area of his flu vaccine/raised/scaly/discolored area on his left deltoid (vaccination site reaction) 17 days following the administration of FLUZONE HIGH DOSE. Patient was encouraged to follow-up at the ER there or his regular HCP. Other relevant tests included no lab test. Final diagnosis was possible skin reaction at same area of his flu vaccine/raised/scaly/discolored area on his left deltoid. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for possible skin reaction at same area of his flu vaccine/raised/scaly/discolored area on his left deltoid. Documents held by sender: none.
Initial unsolicited report received from a healthcare professional (PharmD) on 04 May 2015. A 62-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number C4774AA) into left deltoid on 30 April 2015. The patient did not have any known allergy. On 30 April 2015, same day after vaccination, the patient experienced approximately 4 inch diameter at injection site of redness, bruising and erythema. The patient did not experience pain at site or other symptoms. Laboratory investigations and corrective treatments were not reported. At the time of this report outcome of events were unknown. Documents held by sender: none.
Received vaccine on 01/26/2021 and unknowingly experienced event.  Early morning of 01/28/2021 had fainting spell and thought it was caused by low blood pressure.  Felt fine for remainder of  day.  On evening  of  01/29/2021 I started having strange symptoms.  Could not concentrate,  vision  impaired and couldn?t figure out what evening meds I needed to take.  Decided to go? to hospital on 01/30/2021.  Getting ready, I passed out and husband called emergency services.  Husband learned later in the day that I had a stroke.  Doctors  i;nfo?rmed that had blood clots in heart and lungs.  Doctors advi;se not to get second vaccine shot.