chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Dec2020 at 16:00 as dose 1, single (Lot number: EH9899), in left arm, on 19Jan2021 at 15:00 as dose 2, single (Lot number: EL1283), in left arm and on 06Sep2021 at 17:30 as dose 3 (booster), single (Lot number: FC1180), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "GAD" (unspecified if ongoing), notes: GAD; "CRPS" (unspecified if ongoing), notes: CRPS. Concomitant medication(s) included: SERTRALINE oral, start date: 05Oct2021; PROPRANOLOL oral, start date: 09Feb2016; CLONAZEPAM oral, start date: 16Jun2022; ELIQUIS oral, start date: 11Nov2020; LOSARTAN oral, start date: 15Jul2016; TRAMADOL oral, start date: 20Jul2022; METHOCARBAMOL oral, start date: 20Jul2022; VITAMIN C + ZINC oral, start date: 03Sep2022; ELDERBERRY [SAMBUCUS NIGRA] oral, start date: 01Jan2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on available information, a possible contributory role of  subject product BNT162B2 vaccine cannot be excluded for the reported event, based on temporal relationship.. There is  limited information provided in this report.  This case will be reassessed upon receipt of follow-up information.
Local 3" redness, swelling X 3 days. Treated with Benadryl.
Out of the blue with no prior noticeable effects, I was alerted to blood stains on the back of my pants.  Upon inspection, I found a significant amount of blood, approximate size of stain was 6 inches by 12 inches, as well as visible blood clots.  I contacted an advise nurse and subsequently had a video appointment with an internal medicine physician and was then referred to a gastrointerologist. Several blood tests and tests for thyroid function and to determine whether or not there were vitamin deficiencies were ordered and finalized.  With the exception of the size of red blood cells all were WNL.  The red blood cells were found to be larger than normal.  To date there has been no further follow up regarding this outcome.  A colonoscopy has been scheduled for 11/5/21.
Large blister-like lesion appeared on lower lip and lasted for several days-started out white in color, then became smaller and yellow in color then cracked, eventually was gone (no treatment).
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ, lot number M041768 with an expiration date of 25-JUN-2018 and lot number N004946 with an expiration date of 05-OCT-2018 orally for prophylaxis (dose was not provided). The vaccine was exposed to a temperature excursion of 47.1°F with a time frame of 30 minutes. There was no previous temperature excursion. A "data logger" was involved. No adverse effects were reported. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA006357: US-009507513-1710USA006358: US-009507513-1710USA006359: US-009507513-1710USA006360: US-009507513-1710USA006361: US-009507513-1710USA006362: US-009507513-1710USA006373: US-009507513-1710USA006364: US-009507513-1710USA006365: US-009507513-1709USA011980: US-009507513-1710USA006367: US-009507513-1710USA006368: US-009507513-1710USA006369: US-009507513-1710USA006370: US-009507513-1710USA006371: US-009507513-1710USA006372: US-009507513-1710USA006356: US-009507513-1710USA006355: US-009507513-1710USA006363:
held breath between sobbing; happened p/waking up-APAP worse off-had shot @ 3PM this happened between approx 7-8PM; hospitalized for observaation;
2 wks after vaccination, child developed upper body weakness and pain. He was diagnosed with Transverse myelitis. He has received rehabilitation therapy but has not fully recovered.
Atrial Fibrillation (AFib) episode that lasted about 3 hours; A spontaneous report was received from a consumer who was also a 73-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation (Atrial Fibrillation).  The patient's medical history included acid reflux, atrial fibrillation and high cholesterol. Products known to have been used by patient with in last two weeks included omeprazole, simvastatin, amlodipine, apixaban, famotidine, multivitamin, and probiotics.  On 04 Feb 2021, patient received his first of the two planned vaccine doses of mRNA-1273 (Lot number: 10N20A) intramuscularly.   On 08 Mar 2021, approximately one day prior to the event, the patient received his second of two planned doses of mRNA-1273 (Lot number: 032N20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient experienced the event atrial fibrillation episode that lasted about 3 hours and heart rate reached 160 BPM at rest, and continued to fluctuate up and down. It was reported that the patient had cardiac conditions that periodically caused him to experience Afibs, but those usually only last for about 2 minutes.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, atrial fibrillation, was considered resolved on 10 Mar 2021.; Reporter's Comments: Based on the current available information and the subject's underlying history of recurrent Afib, the event was assessed as Unlikely Related to study drug. The case is confounded by the subject's underlying history of Afib, which was reported to occur periodically and subsiding on its own.
Tdap- Tender to touch, red, lump x2 days - lump size of quarter. Hives on face, chest 11/03/2008. Member also had FluMist-- sneezing, drainage, conjestion, persitant cough, body aches. Vaccines administered on 29 Oct 2008
Severe weakness, chills, loose stool, cough. Symptoms started shortly after the vaccine was given. Mild cough  at first. As the day progressed the cough continued and fatigue started to be present. The next day cough stayed the same with more fatigue and some nasal drainage. The third day weakness, lightheadedness to the point of almost passing out, uncontrolled bowels with watery stool, chills and sweats. Cough continued, although no sore throat. The third day and fourth there was pain in the area that had been previously fractured. My left foot and left wrist. Also my hips were achy, more on the top of the pelvis instead of the joint.
4 YO. male inadvertently administered Pfizer 5-11 y.o. covid vaccine when he was to young to receive it.
Moderna COVID-19 Vaccine EUA I woke up with the typical body aches, fuzzy head, headache and fatigue on 04/20/2021. On 04/21/2021, I had the same symptoms, less severe and developed a new one....my face and forearms were pink and the skin on my arms burned all day long. It felt similar to that of a light sunburn. Today is 04/22/2021 and all symptoms are gone except the pink on my face and arms and burning of my arms, which is getting better.
Both my lips are swollen and I had to get rushed to the ER and I?m having chest pain
swelling & redness in inj site; T103 devel 2-3 hrs p/vax; temp lasted x 4 days ranging from 101-103.5, rash occurred;16AUG95 taken to MD evaluated as having viral systemic response
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned an 80 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1), (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 in total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced suspected clinical vaccination failure, and suspected covid-19 infection (dose number in series 1). The reporter stated that the patient currently has COVID-19. It was reported that, the patient received an antibody infusion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. The patient received Pfizer vaccine (dose number in series 2), (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported for prophylactic vaccination, for 12 years and older formulation (purple cap) one week before she got COVID-19. It was unknown whether patient had adverse event following Pfizer vaccine (dose number in series 2). This report was serious (Other Medically Important Condition). This case was associated with product quality complaint: 90000214016.; Sender's Comments: V0: 20220147651-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS 20220147651-COVID-19 VACCINE AD26.COV2.S-Suspected Covid 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 7-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Pt experienced vasovagal syncope a couple minutes post-vaccination. Pt only lost consciousness for a few brief seconds. Vitals were immediately taken. Pt was monitored for approximately 45 minutes until he felt well again. Vitals stayed stable throughout monitoring. BP: 122/76 HR: 52 (pt's baseline heartrate is low, this is normal for him) RR: 14 O2: 97% Temp: 97.6. Pt reports he has experienced syncope in the past with blood draws-- last occurrence approximately 2 years ago.
clots in her lungs and on a ventilator; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (clots in her lungs and on a ventilator) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (clots in her lungs and on a ventilator) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, PULMONARY EMBOLISM (clots in her lungs and on a ventilator) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported.  Company comment: This case concerns a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious unexpected event (AESI) of pulmonary embolism on unknown date after receiving a dose of the vaccine on unknown date. Limited information. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report; Sender's Comments: This case concerns a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious unexpected event (AESI) of pulmonary embolism on unknown date after receiving a dose of the vaccine on unknown date. Limited information. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report
i have developed a very itch rash that is ongoing and has not resolved 12 days after as of today.   I went to the emeregncy room  on the 27th of January.  and made a follow up appointment with my doctor who is referring me to an allergy specialist.
fever reaching up to 101F; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever reaching up to 101F) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Lupus erythematosus.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever reaching up to 101F). At the time of the report, PYREXIA (fever reaching up to 101F) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and no treatment were provided .   This case was linked to US-MODERNATX, INC.-MOD-2021-025550 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-025550:Dose 2
Shortness of breath.      Anxiety.   Both to the point I went to the ER
A small hematoma; A small drop of blood was noted when the needle was withdrawn; This spontaneous case was received on 05-Sep-2020 from pharmacist via agency (reference number: SEQW20-01289) and concerned a male patient of an unspecified age.  The patient's medical history was not reported. The patient's concomitant medication included unspecified anticoagulant for unreported indication.  On 05-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: left deltoid, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 276531 and expiry date was 02-Jun-2021.  On the same day, when the needle was withdrawn after receiving Flucelvax Quadrivalent, a small drop of blood was noted, and a band aid was placed on the site. The patient left.  On the same day, about 10 minutes later, the patient returned with a small hematoma and in questioning if the vaccine was administered subcutaneously. The pharmacist used a 25-gauge (G) 1-inch needle and felt the vaccine was injected intramuscularly. The patient did not receive any treatment measures associated with event.   At the time of initial reporting on 05-Sep-2020, the patient had not recovered from the event of hematoma.   The outcome of 'vaccination site bleeding' was not reported.   The reporter did not provide a causality assessment.  The reporter assessed events as non-serious.  Company comment: The patient developed hematoma and vaccination site hemorrhage on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to ''relate'' in the safety database for reporting purposes).; Sender's Comments: The patient developed hematoma and vaccination site hemorrhage on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Pt received vaccines, Saturday 3/24/12, received call from mom stating that child woke up Sunday morning with right arm swollen from shoulder to elbow & warm. No fever. Evaluated in clinic on Mon 3/26/12. Positive warmth, erythema to mid-arm. Recommend ibuprofen & monitoring.
Dad called pharmacy 8/21/2022 and stated son had a seizure (~15 seconds in duration) in church this morning.
p/vax pt devel a pruritic maculopapular rash;it was reported that pt then devel croup which is ongoing;pt sought unspecified medical attention;
02/09/2021-right side of face was numb that I keep close my eye and my cheek was twitching. 02/15/2021 Virtual health visit- Bell's palsy was diagnosed. Prednisone and Valtrex was prescribed.
complained of pain to injection site followed by itching to arm and then a cough and tightness to throat
This spontaneous report as received from a consumer refers to a 5 month old male reporter's grandson. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-APR-2015, the patient was vaccinated with a dose of ROTATEQ (oral, dose, frequency, lot # and expiration date unspecified by the reporter). On 19-APR-2015, the patient developed a diarrhea and vomiting and was hospitalized. On the same day, the patient also received a surgery (reported as "open surgery") for life-threatening intussusception. The patient had not been discharged at the time of this report. The patient was treated with TYLENOL. Lab diagnostics studies included nuclear magnetic resonance imaging (MRI) and an x-ray on an unknown date. Results not provided. The patient sought medical attention and the event intussusception required intervention to prevent serious criteria (medically significant). The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and the vaccination with ROTATEQ was not reported. Additional information has been requested.
Small flat red spots, no itching, beginning on right side of abdomen and axillary area, extending to left side by 9:00 AM and on infant's back. No fever ntoed.
Information has been received from a registered nurse concerning a 33 year old male patient with no known allergies and no medical history who on 28 MAR 2001 was vaccinated with his first dose of varicella virus vaccine live, (Lot # 532044/0947K) in the PM subcutaneously in the left arm. There was no concomitant medication or illness at the time of vaccination. On 18 APR 2001 (also reported as 16 APR 2001) the patient developed a rash throughout the body with vesicles. The patient also had flu-like symptoms plys aches, especially in the back. The patient sought medical intervention. It was reported that the patient recovered on 20 May 2001.
bloody mucous loose stools; diarrhea; bloody mucous loose stools; This case was reported by a nurse via sales rep and described the occurrence of blood in stool in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 3CR3S, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd March 2021, the patient received the 1st dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. In March 2021, less than a week after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced blood in stool (serious criteria GSK medically significant), diarrhea and mucus stools. On an unknown date, the outcome of the blood in stool, diarrhea and mucus stools were not recovered/not resolved.   It was unknown if the reporter considered the blood in stool, diarrhea and mucus stools to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 7th March 2021, the patient mother called complaining of bloody mucous loose stools, diarrhea 2 to 3 days after receiving the Rotarix vaccine. They are awaiting on a stool culture from the patient. The reporter reported that there are no new events. The reporter consented to follow up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058813:same reporter US-GLAXOSMITHKLINE-US2021AMR058850:same reporter
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # reported as M010440 with expiry date: 09-DEC-2018 (dose and route of administration were not reported). Administered doses of vaccines experienced the temperature excursion of 32.97 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.