chrisvoncsefalvay/vaers-outcomes huggingface dataset:
died from clots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: THROMBOSIS (death, medically significant), outcome "fatal", described as "died from clots". The patient date of death was unknown. Reported cause of death: "died from clots". It was not reported if an autopsy was performed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300112856 same reporter, drug and event, different patient;US-PFIZER INC-202300112855 same reporter, drug and event, different patient;; Reported Cause(s) of Death: died from clots
This spontaneous report was received form a physician concerning to a 16 years old female patient. Information regarding the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications was not reported. On 23-JAN-2019, the patient was vaccinated with the second dose of GARDASIL 9, (strength, dosage schedule, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On unspecified date in 2019, the patient experienced rash on their abdomen and arm (rash). It was also reporter that the patient had been seen by a dermatologist numerous times. It was unknown if laboratory test were performed.  At the time of this report, the outcome of rash was unknown. The reporter did not provide the causal relationship between GARDASIL 9 and rash.
This is a spontaneous report from a contactable consumer.  A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL1283, subcutaneous on 20Jan2021 15:00 at SINGLE DOSE for COVID-19 immunization. Medical history included diabetes, anaemia, blood pressure, cholesterol. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EU9899, in the left arm on 30Dec2020 15:00 at SINGLE DOSE for COVID-19 immunization and experienced swelling and redness at the site. Concomitant medications included liraglutide (VICTOZA), labetalol (LABETALOL), diltiazem (DILTIAZEM), valsartan (DIOVAN), rosuvastatin, metformin, aspirin and iron. The patient thinks that it wasn't given to her intramuscularly. This is a potential inadvertent subcutaneous administration of the BNT162B2. This patient received her second dose on 20Jan2021 on the side of her arm and reported that it was swollen, red, and hot, but has gotten 100 times better' over the last 6 days since administration. She was asking for efficacy of the incorrectly administered dose. It was further stated that in the middle of the night, her arm was red almost like a little bullseye and she said that she was getting burning, and pins and needles down her arm, and a fullness in her hand like her hand was swollen. She said that she still kind of feels it. As the days progressed on day 2, 3, and 4, the swelling got more intense, the circular red swollen area got worse to the size of like a small baseball. She was feeling okay other than that. Today was day 6 and it was not as red and was more black and blue, swelling went down 80 percent, she still feels a little bit of the pins and needles and the fullness in her hand. She said that there was like a big knot that was very hot. It was a hard like knot at the injection site. The injection site was really big, round, hot, red, and had a knot that lasted; adds it is still there but 99% better; and she had tingling down her arm with pins and needles in her hand. She noticed it was little red a couple of hours, like 8 hours later; but by the next day it was circular, more red, swollen, itchy, and burning down her arm. By the third day, the site had a big, red, hard knot; still burning down her arm and with pins and needles down her arm. She added that her hand felt like a fullness in her hand filled with fluid. By Friday the swelling at the site was gigantic. The site swelling is improved but the redness was more of a black and blue now. Her arm has been very dark red, discolored, swollen, painful and has nerve pain described as "hot tingling down the arm like pins and needles" to her hand. She states that she has a very large knot at the injection site. This was in her non-dominant arm. She spoke with two of the pharmacists that she works with and they looked at her arm and both felt like she may have received the injection subcutaneously instead of intramuscularly. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.
Information has been received from a physician concerning a 13-year-old male patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The physician reported that the patient subsequently developed chickenpox (also reported as possible breakthrough varicella) characterized by approximately 80 lesions. Unspecified medical attention was sought. at the time of this report, the outcome was unknown. Additional information has been requested.
This spontaneous report as received from a other health professional (reported as medical assistant and healthcare worker) refers to unspecified number of patients of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. It was reported that from an unknown date the VARIVAX (Merck) was improperly stored for a full year and on an unknown date unspecified number of patients were vaccinated with VARIVAX (Merck) (dose strength, indication route was not reported). It was unspecified as how many doses were administered to how many patients with this improperly stored VARIVAX (Merck). It was also reported that no adverse effect was reported. The outcome of improperly stored and no adverse effect is unknown. No product quality complaint was involved. This case is linked to the case 1404USA005734. Additional information has been requested.
pt recv vax & as late as 7 days p/vax pt devel localized rash @ the inj site & erythema;
My arm starting hurting badly at the injection site. I had the pain for 5 days. I contacted my doctor and they told me to go to urgent care. At urgent care, they said it was not anything serious. And told me to get it the other arm for the next shot. She just examined the injection site.
On 05/13/2021, approximately 48 days after receiving the second Pfizer COVID-19 vaccine dose, a rash appeared on the left arm at the injection site. Rash was circular, pink/red in color, and approximately 2 inches in diameter. Rash did not disappear after using topical medications including lotions and creams. After a few days rash became itchy. After a week, the rash became less pink in color and the skin began to peel, similar to a sunburn. Pink rash is no longer present 20 days later, however the area continues to be itchy and the skin continues to be dry, even with the use of lotion and hydrocortisone cream.
Patient developed rashes all over body more than 24 hours after the second dose and also indicated numbness in the arm. Patient also reported tightness in the chest
Nausea; Chills; Fevers beginning two days after second dose; This is a spontaneous report from a contactable healthcare professional. A 64-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 arm left on 05May2021 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. The patient preciously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on unknown date in 2021 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medications included metformin (MANUFACTURER UNKNOWN) from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07May2021, the patient experienced nausea, chills and fevers beginning two days after second dose. The patient still experiencing symptoms 7 days later (as reported). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events nausea, chills and fevers beginning two days after second dose was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous reported by a consumer, describes the occurrence of pain in extremity (arm was sore) and feeling hot (arm was sore and hot) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm was sore) and feeling hot (arm was sore and hot). At the time of the report, pain in extremity (arm was sore) and feeling hot (arm was sore and hot) outcome: unknown. No concomitant medication or treatment information reported.
Case number PHEH2014US025267, is an initial spontaneous report received from a nurse on 12 DEC 2014, with a follow up report received from the nurse 10 FEB 2015. This report refers to a 22 years old female patient. Medical history and concomitant medication were not reported. She received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M14025) intramuscularly in left deltoid without being reconstituted with Men A lyophilized conjugate vaccine component on 21 NOV 2014 at 11:45 AM. No adverse event was reported following this administration error (inappropriate preparation of medication). Follow up report received from the nurse on 10 FEB 2015: Updated patient demographics and vaccination details.
Tuesday evening I thought it was a couple of pimples By Wednesday evening it had quadrupled in size & was weeping. Went to Dr Friday & received shingles diagnosis
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Within one day patient complaining of oral irritation, metallic taste in mouth and hoarse voice.  Has persisted for 3-4 weeks
This case was reported by a consumer and described the occurrence of stopped breathing in a 2-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. In 1988 the subject received unspecified dose of INFANRIX (unknown). In 1988, 76 hours after vaccination with INFANRIX, the subject stopped breathing. At an unspecified time after vaccination, over the next year, the subject experienced seizure. The subject was hospitalised. At the time of reporting the events were resolved. The vaccination course with INFANRIX was discontinued. The reporter stated that in 1988 when her daughter was 2 months old she received INFANRIX. Within 76 hours of the vaccine her daughter stopped breathing. Over the next couple of weeks her daughter experienced several more episodes where she stopped breathing. Over the next year the subject experienced seizures. Subject received follow up vaccines, however, the pertussis portion was removed. Reporter is calling now 20 years later to find out if the vaccine was yeast based.
Had vaccine and flu shot administered on Friday, had flu like symptoms over the weekend which resolved but gastrointestinal and high hr issues began on Monday and continued. Was placed on omeprazole for on 12/22/21 for four weeks, during this time symptoms did not resolve but were exacerbated by anxiety (not a previous condition).  Stopped meds and anxiety resolved but gastro symptoms continued. In April, tried alternate medication which again left symptoms unresolved and added anxiety. Medication was stopped again but continue to suffer with chronic loss of appetite and nausea with daily periods of intensification that include agitation and elevated HR - significantly interfering with QOL.
The nurse "misread" the vaccine being requested and gave my 7 month daughter DTaP/Hep B/IPV instead of DTaP. We explicitly stated to only give her the Rotavirus and DTaP vaccine on multiple occasions. I was called to be advised that the nurse gave her the incorrect vaccine but no harm should come to her. My daughters medical rights and her parents wishes were not adhered to.
Swelling in muscle near injection site followed by red rash with mild discomfort . Rash still present
This spontaneous report as received from a health care worker refers to a unspecified number of patients of unknown age. The patients medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose: 0.5 milliliter (ml), intramuscularly). Concomitant medications were not reported. On an unknown date the unspecified number of patients received GARDASIL doses that were stored at 34 Fahrenheit (F) for 7 hours. No adverse effects were reported. The outcome of received GARDASIL vaccine doses that were stored at 34F for 7 hours and no adverse effects reported was unknown. The healthcare worker stated that no patient or lot information was available. This case is linked to 1406USA003839, 1406USA003840, 1406USA003841 and 1406USA003842 (same reporter link). Additional information has been requested.
Pt was fully vaccinated with both doses of the Pfizer COVID-19 vaccine (4/28/2021 and 5/19/2021).  Pt tested positive for COVID-19 via PCR on 8/4/2021 via routine admission testing.  Primary diagnosis was seizures, however pt did still develop enough COVID symptoms to warrant treatment with dexamethasone and remdesivir.  He has been admitted since 8/4/2021 and remains admitted.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 03-JAN-2018, the patient was vaccinated with an expired dose of VARIVAX lot # L050560 and expiration date of 14-DEC-2017, subcutaneously for prophylaxis (dose not reported). The vaccine was reconstituted with sterile diluent (MERCK) (lot number and expiration date were not reported). No adverse effects were reported.
A week after I received the vaccine I started having painful lymph node swelling on the injection side of body Clavicle, armpit, left knee and  arm. I contacted my Doctor but I cannot get into see them for a week
extremely sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: Unknown) as dose 1, single and administration date 31Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure; "Severe Joint Damage" (ongoing), notes: Verbatim: Severe Joint Damage. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "extremely sore arm".  Additional information: Covid Vaccine: extremely sore arm, Related, Reporter states she was driving and some details were unable to be obtained. There was a lot of road noise and/or muffled sound that made some things difficult to hear. Call handler did ask caller to repeat or clarify if it was thought to not have been heard.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Very sore arm, swollen armpit (glands) into the side of the breast, cannot lift arm over head,  flu like symptoms (chills, achy, fatigue)  Currently on Day 3 and symptoms slightly improving
Hives and itching on face, neck, chest, back, and arms.  Was at school - 3 tsp. Benadryl liquid given. Parents took home.
8 DAYS AFTER VACCINATION MY RIGHT ARM STARTED ITCHING AT THE INJECTION SITE AROUND 4PM ON 01/02/2021; LATER THAT NIGHT MY RIGHT ARM BECAME VERY HOT, ITCHY, RED AND SWOLLEN.  ON 01/13/2021 I WAS AT WORK AND SPK TO A CO-WORKER WHO SUGGEST SOME ICE.  I PUT AN ICE COMPRESS ON AREA, WENT TO THE URGENT CARE @ 8AM WAS THAN DX'D WITH "CELLULITIS". THE DR. PRESCRIBED 500 MG CEPHALEXIN; 1 CAPSULE, 3X'S A DAY.
I was diagnosed with COVID; I was diagnosed with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I was diagnosed with COVID". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid for 5 days. Consumer stated he/she have had 5 Pfizer shots for COVID. Consumer added that he/she just came back into the country, a week ago and was diagnosed with COVID for which he/she got medication from local pharmacy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222823 same patient, different drug/event;
This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 02-NOV-2011, the patient was vaccinated with a dose of VARIVAX (strength, dose number, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. It was reported that VARIVAX dose was administered in less than 28 days after patient received live influenza nasal spray (name and manufacturer unspecified). No product quality complaint was involved. Additional information has been requested.