chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was the 6/7 i started feeling bad nut I'm not sure if it was jet lag or COVID-19 I knew my kids had it the days before. But i was having night sweats. My husband test positive. I didn't worry about my self because he was sleeping. I was sweating and a headache and sore throat. I pretty much didn't really pay attention to it, Mid June i started itch's and had eye ache and burns and they got worse when i got home on 06/28 and my eyes were so bad i didn't want to open then. The doctor treated it like it was an infection and that did help. And i never did feel that bad i just had night sweats. But i didn't i was hot during the day.
Patient received Tdap (Adacel) vaccine in consultation in the pharmacy with mother in the room. Patient began what appeared to be convulsing with a duration of less than one minute. Patient did not exhibit any additional symptoms after initial presentation. Emergency services were contacted per her mother's request, and patient and mother left the store with them.
Patient received a second dose COVID-19 Vaccine that was Pfizer product. He received Moderna as his first dose. No symptoms following injection reported when speaking with Patient today. States he continues to feel well.
w/in a few mins became pale, bradycardic to lethargic improved p/few mins of laying down; sx recurred @ home about 1-2 mins later & took a few hr a/pt was completely back to nl; fever noted next AM;
This spontaneous report as received from a physician refers to an unknown number of patients of unknown age. The patients might have received improperly stored RECOMBIVAX HB, GARDASIL, PEDVAXHIB, Live, oral, ROTATEQ, and VAQTA since May of 2012 to the reporting time. Lot numbers of all therapies were not provided. No concomitant medications were reported. No adverse event reported. It was unspecified if the patients had sought medical attention. Additional information is not expected.
Fever 102 day after vaccine administered, lasted 2 days. 4 cm X 7 cm red, firm, indurated area at injection site. Several urticaria patches inferior to injection site, largest one 3.5 cm X 5 cm.
CoughWheeze CHILLS, FATIGUE,NASAL CONGESTION Narrative:  DID NOT MISS WORK, HOWEVER HAS NEW SYMPTOMS TODAY
No additional AE information provided; via the intramuscular route rather than the subcutaneous route; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 04-MAR-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml via the intramuscular route rather than the subcutaneous route (lot #U027947, expiration date 08-SEP-2023; anatomical location not reported) for prophylaxis (incorrect route of product administration). No additional adverse event (AE) information provided.
Information has been received from a physician concerning a 9 week old male who on 16-JUL-2008 was seen at clinic for cough and while there was vaccinated with ROTATEQ, HIBTITER, PREVNAR and PEDIARIX. After the vaccines administered, baby became very ill with coughing spasms, which has been seen almost everyday in hospital or clinic period. The patient was hospitalized on 20-JUL-2008 to rule out pertussis. The reporter considered the event to be life-threatening. Additional information has been requested.
I got very itchy and developed hives and a rash over my chest, arms, and back. This lasted for about 5 hours.
from NH in cardiac arrest, cpr started by EMS. EPI x2 given by EMS, ROSC after second dose of EPI. Pt intubated.  Acute encephalopath, acute hypoxic resp failuCOVID +. on multiple pressors, neo, bicarb. no urine output, bolus given. decadron for COVID. transition to comfort care
Pt was administered the vaccine approximately 10:30 am. She reported feeling fine immediately after receiving the vaccine. She said she was walking around the store when she suddenly felt hot. She began searching for a place to sit down, but was unable to locate a seat. She stood by the refrigerated items in order to cool down when she semi fainted. She was caught by a front store employee. She reported no physical injuries at the time. She was carried to a chair and was able to sit upright on her own. She was able to speak in full complete sentences. She was alert and somewhat oriented. She said she felt very hot and dizzy. Her blood pressure @10:50 am was 108/81, pulse: 62, respiratory rate: 20. Vitals determined within safe limits. Pharmacy provided the patient with some water and Gatorade. We had the patient remain in sitting position. Patient reported slowly feeling better over time. Repeated vitals check @11:10 am with no significant change in blood pressure, pulse, and respiration.  Patient remained seated and when she was feeling better, attempted to call friends and family to come pick her up from the store. After approximately 1 hour after the event, patient was back to baseline. She was able to leave on her own without assistance.
Hep A vaccine administered 6/23/08. On 6/24/08 erythema of bilateral lower extremities, (right worse) developed. Pt's mother advised to give BENADRYL as needed for symptoms.
feels like she has a fever; Her arms and legs really hurt; pain at the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 17Mar2021 as single dose for COVID-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Historical vaccine included influenza vaccine. After first dose of the vaccine she stated that she felt horrible it had been 24 hours since she got the shot it was around 2:30 when she got it. She stated she did work today and all the sudden her body was killing her and feels like she has a fever. Her arms and legs really hurt. She is taking aspirin and drinking fluids and resting and cannot even think about eating. When caller was speaking about pain at the injection site she said that definitely hurts.  the patient experienced feels like she has a fever, her arms and legs really hurt, pain at the injection site on an unspecified date. Therapeutic measures were taken as a result of feels like she has a fever, her arms and legs really hurt, pain at the injection site. The outcome of events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Nausea, sweating, pallor. BPs 185/121 (pulse 110), 167/113 (pulse 80). Patient advised to take blood pressure medications.
started breathing really hard; got dizzy; body was tingling; side of face was itchy; almost passed out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out). At the time of the report, DYSPNOEA (started breathing really hard), DIZZINESS (got dizzy), PARAESTHESIA (body was tingling), URTICARIA (side of face was itchy) and PRESYNCOPE (almost passed out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. The patient received antihistamines as face was getting itchy.
Initial pregnancy report received on 10 June 2013 and follow-up information received on 12 June 2013 and 13 June 2013 from a healthcare professional. An adult female patient, whose medical history was not reported, had received an intramuscular dose 1 of ADACEL (Lot number U4612AN, anatomical site of vaccination was not reported) on an unspecified date. The last menstrual period date was 22 November 2012 and the expected date of delivery is 25 August 2013. As per reporter the patient had no adverse event. List of documents held by the sender: None.
Patient was not administered an improperly stored dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/ reaction and concomitant medications were not reported. On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, formulation, dose/frequency, route were not reported) lot # R028528, expiry date: 04-JUN-2021 (product storage error) for prophylaxis. The vaccine was stored at a temperature of 31.6 Fahrenheit for 13 hours 35 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Chills, Fever, Headache, Body Ache, left arm was really sore, Fatigue
THROMBOEMBOLIC COMPLICATION; This spontaneous report received from a patient concerned a 56 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included cardiovascular comorbidities. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry Date: UNKNOWN) with unknown dose, 1 total, on unspecified date for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced thromboembolic complication, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thromboembolic complication was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  This 56-year-old male patient, with unspecified cardiovascular co-morbidities, was reported in the news to have a "thromboembolic complication" and was hospitalized after an unspecified duration of receiving Janssen COVID-19 vaccine for the prevention of symptomatic SARS-CoV-2 virus infection.  No ther details was reported.  Based on the information that is available, the event is assessed as indeterminate with the causal association to immunization, per organization causality classification of adverse events following immunization based on a lack of a definitive plausible biological mechanism.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information will be requested once contact information is obtained
Myocarditis - developed chest pain, shortness of breath quite suddenly the morning of 10/5/2021.
Sore throat, runny nose, fatigue, muscle aches.  Patient was in superb health until onset of symptoms resulting from the vaccine.
Pt stated that the day after receiving the vaccine she had a 103.5 degree fever that did not break for 16 hours, pt self treated with otc medication.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced varicella with less than 50 vesicular typical varicella lesions in a zoster like distribution in cluster of 4-5. The main distribution was across the left axilla, and left flank and chest. There was one cluster at the left iliac crest and some single lesions. The pt was afebrile but itchy. Four days post onset the pt was seen by a physician and the majority of lesions were crusted with 1-2 of the lesions with a dew drop on rose petal appearance. There was significant pruritus with the appearance of varicella. Upon recovery there was hyperpigmented scarring.
No adverse side effects were reported with the administration of the vaccine.; HCP called to report a TE for VAXNEUVANCE (Lot #W039033; Expiration 10/01/2024; current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes) and ROTATEQ (Lot #1968385; Expiration; This spontaneous report was received from an other health professional and referred to a 6-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 08-JUN-2023, the patient was vaccinated with improperly storage pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection through right thigh, strength: 0.5 milliliter, dose: 0.5 milliliter, lot #W039033, expiration date: 01-OCT-2024, administered once for prophylaxis (route of administration was not provided); and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1968385, expiration date: 22-MAY-2024, administered once orally for prophylaxis (strength was not provided). It was reported that a temperature excursion (TE) for pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) with current excursion (49.1F) for 34 minutes, with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes; and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (same excursion details) (Product storage error). No adverse side effects were reported with the administration of both vaccines. User of the device was an HCP and product was not available to obtain. ; Sender's Comments:  US-009507513-2307USA004472:
I woke up and many of my joints were hurting.  Knees, Hips, shoulders, groin and feet.  It became excruciating  by the time of my daughters wedding which was 11 days later.  My lower back and hips hurt so bad as well as my knees.  I was no longer able to stand more than a few minutes or walk for more than a few minutes.  I can not take pain pills due to liver disease called nash . I had xrays of knees and it showed severe arthritis . had hip xrays that showed arthritis.  Am now awaiting spine mri.  My whole life has come to a halt and I have children.  I now use a walker.  There are no more activities. No walking, no shopping unless I can hold on to a cart. I'm done.
Approx 4 hours after vaccine administration. Pt. developed throat tightness, soreness (throat), cough, hoarseness, chest tightness.
20 year old patient received the 0.5 mL Hep A dose and not the 1mL Hep A dose.
past the 42 day window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (past the 42 day window) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011620A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past the 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past the 42 day window) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
pt recv vax 26MAR99 & devel 3day hx of tactile temp then devel erythematous rash on forehead that progressed all over body over next 2 days;had macular papular rash;poor light reflex;
consent form states patient's dob 5/15/2009, per insurance dob is 7/15/2009, tried to confirm with parents, left message no response
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm next day), FATIGUE (very tired the next day) and PYREXIA (low grade fever 99.4) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm next day) and FATIGUE (very tired the next day). On an unknown date, the patient experienced PYREXIA (low grade fever 99.4). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm next day), FATIGUE (very tired the next day) and PYREXIA (low grade fever 99.4) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Low grade fever and red spots forming on upper part of body. 3 on her right ear, 2 between her eyes, 1 on her cheek, and 1 on her upper shoulder. Child is fussy and also vomited. Doctor diagnosed the spots as petechiae. She also has a different rash on her left cheek.
Resident began having chills and weakness at 1700.  Was offered trip to ED but resident declined transport to local emergency department.  Resident was assisted to bed at 1730 and upon recheck at 1800 and 1900 resident was resting and not shivering.  Resident was monitored throughout the night.  At 0500 on 1/13/2022 resident was found to be unresponsive and death was confirmed.
I started having severe pain like needle being pushed into my hand on the left arm. It continued to get worse and on the Friday I went to the doctor and they diagnosed me with shingles.
Hoarseness, sore red & itchy eyes, cough for short time, ache, chills, lasted til after 10 PM, took two Tylenol and BED.
Headache, Myalgia, chills,fatigue Narrative:  Other Relevant History:
Given MMR S/C child active, playing 15 minutes.  Complained of itching on face, neck, complained of excessive nasal secretions, apprehensive. Given 1.5 tsp Benadryl. Child vomited, complained of hives on face. Remedicated with Benadryl. Complained of wheezing, (given) Xoponex via neb machine.
10 hours after receiving shot patient temperature spiked and at the ER the patient said it read 110
Pain in the injection area; Swollen lymph nodes; dose number=3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Dec2021 at 14:30 (Lot number: FH8027) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE Lot Number: EP6955 Anatomical site: Left Arm Administration time: 10:15 Route of administration: Intramuscular), administration date: 30Mar2021, for COVID-19 immunisation and Bnt162b2 (DOSE 1, SINGLE Lot Number: EL3247 Anatomical site: Left Arm Administration time: 10:00 Route of administration: Intramuscular), administration date: 09Mar2021, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 at 14:30, outcome "unknown", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "unknown", described as "Pain in the injection area"; LYMPHADENOPATHY (non-serious) with onset 16Dec2021, outcome "unknown", described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of vaccination site pain and lymphadenopathy.  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Had vaccines about 1.5 weeks ago. Developed a lesion on her left thigh about 3 days after the vaccine - resolved after a couple of days. Then, in the same place, developed a pimple like lesion. That lesion has gotten larger, harder, now looking purplish. Not painful. Swollen nodes in armpits and groin. Just noticed these today. Has rash on her back as well. About 5 days ago, after getting back from grandparents' started to have random bouts of crying. Has had lower energy than normal. Sleeping more than normal. Has a occasional mild cough. + rhinorhea/congestion also starting this week. Was having fevers, but last was night before last (nearly 48 hours ago). Fevers around 102.
profound sensorineural hearing loss in left ear; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 18-JAN-2012, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) in her left arm for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Less than 1 (one) month after receiving the vaccine, pt suffered profound sudden hearing loss and was later diagnosed with profound sensorineural hearing loss in left ear. As a direct and proximate result of the defective vaccine, pt's symptoms had resulted in physical limitations not present prior to using Merck's product. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of Merck's wrongful conduct, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of pt's conduct, pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was not recovered. The causality assessment was considered as related by the lawyer.  The lawyer considered the event profound sensorineural hearing loss to be disability. Upon internal review, profound sensorineural hearing loss was determined to be medically significant.