chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received one dose of Flulaval which is indicated for adult use only.  Pt received injection in left deltoid.  Per father, patient did not have any reactions.
Sore arm on day of shot.  Next day, sore arm, fatigue, chills, muscle soreness
pt recv vax 23AUG95 & on 17OCT95 pt exp 1st outbreak of 30-40 chickenpox vesicles,predominantly on torso;exp lasted a couple of days & resolved;a few days later a cluster of more vesicles appeared then resolved;
This case was reported by a physician via call center representative and described the occurrence of injection site discomfort in a 62-year-old male patient who received Hepatitis B vaccine. On 1st October 2015, the patient received the 1st dose of Hepatitis B vaccine .5 ml. On 1st October 2015, less than a day after receiving Hepatitis B vaccine, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown. It was unknown if the reporter considered the injection site discomfort to be related to Hepatitis B vaccine. Additional details provided were as follows: This case was previously reported to a doctor.
Mild rash 6in long injection site 3rd day after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot). At the time of the report, VACCINATION SITE RASH (Mild rash 6in long injection site 3rd day after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment medications was provided.
Right sided transient facial weakness of lower half of the face. First noted in the morning, asymmetric smile, difficulty moving lower half right side of face, improved throughout the day, fully resolved within 3 days.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
vaccinated on 3/20/21 & 4/10/21 and diagnosed with Covid on 8/12/21 U07.1 - COVID-19
she got her first dose of covid vaccine but got covid a month ago; she got her first dose of covid vaccine but got covid a month ago; This is a spontaneous report from a contactable other health care professional and non-contactable other health care professional. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reports no side effects to xeljanz. The patient experienced she got her first dose of covid vaccine but got covid a month ago on an unspecified date (medically significant) and was waiting 90 days until she can get second covid dose of vaccine. She reports missing a few doses. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event s drug ineffective and covid19 cannot be totally excluded.
2 days after ZOSTAVAX -swollen pustules in mouth. Rx for viscous  lidocaine 4 days later.
Limp, lethargy, T 103 degrees, decreased appetite -called aid car - referred to PCP. Lasted 45 min. Occurred 6-7 hr after shots. Exam normal in office.
Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023; No adverse event; 9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date), PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (9 Patients received doses of the Moderna COVID19 vaccine bivalent after its beyond use date) and PRODUCT STORAGE ERROR (Date vial was initially stored in the fridge 14Dec2022 and administered on the 14Jan2023).    No concomitant medication was reported.  It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine was received.  9 patients received doses of the Moderna COVID-19 vaccine bivalent after its beyond use date lot AS7168B.  On 14-Dec-2022, the vial was initially stored in the fridge.  Pharmacist would like to be advised about the stability information, validity of the doses and if the patients should be revaccinated.  Vials was of size 2.5ml which did not undergo any temperature excursions.  This case contains information for the 5th of 9 patients described by the reporter.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704964 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704964:Master case - 1st adult patient (vaccine start date: 13-Jan-2023)
Hive-like rash on forehead neck dorsal arms and hands. Pt was treated with calamine lotion and put on quarters to prevent potential spread of vaccinia.
At approx. 10:00, child (very small child-reported to be the size of an average 4 year old) was given immunizations and Mantoux test and had no problem here but at 11:00, mom called to say child was "swelling up" around his eyes and his throat was bothering him. Mom was advised to call 911 and take child to hospital. He was taken to ER by ambulance and given epinephrine and Benadryl.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with SODIUM CHLORIDE (SALINE NASAL SPRAY) at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) for Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 degrees F.. On an unknown date, SARS-CoV-2 test: Negative and Positive.         Patient reported that she caught Covid around the 5th of June. She said that the symptoms were fairly mild. She had nasal congestion which lasted 3 1/2 weeks. She kept testing negative and then finally tested positive for COVID-19. Caller used a neti pot a couple of times and the saline nasal spray and the constant draining made her cough so she took a cough drop and a Alka seltzer cold.   This case was linked to MOD-2022-662837 (Patient Link).
The day following Adacel, the patient developed myalgias, fever and a tender erythematous area at injection site. No sore throat, cough, or other flu symptoms Pt. seen today.  Temp 100.7  4 cm tender erythematous swollen area at injection site.  ++ tender swollen  axillary nodes.  physical exam otherwise unremarkable.   Last dT was in 1996.
painful rash to the back of the left ear with pain that radiated into the left ear/diagnosed with shingles/herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 24-JUL-2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (exact dose, dose number, route and site of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, reported as shortly after zoster vaccine live (ZOSTAVAX) vaccination, the patient suffered a painful rash to the left ear with pain that radiated into the left ear. The patient was diagnosed with shingles/herpes zoster. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, the patient's symptoms have resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of zoster vaccine live (ZOSTAVAX) use, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) use the patient 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 zoster vaccine live (ZOSTAVAX) use, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was reported as not recovered. The relatedness between the event and zoster vaccine live (ZOSTAVAX) was reported as related.  The event of shingles/ herpes zoster was considered to be disabling.
Patient reports a bruise on left wrist appeared the day after vaccine administration (5/19).  Followed by new, transient bruises to right abdomen and both ankles. Patient also reports headaches and frequent heartrate drops. Patient went to see Dr.  with  Health Systems and he reviewed lab work with patient indicating all blood levels are safe. Patient was prescribed pain medication for persisting pain at injection site that began today, 5/26, and encouraged to come back for a check-up in a few weeks.
Restless legs , severe pain in legs - had to keep moving which was hard because was already tired. Fatigue.
No additional adverse effect reported; patient received improperly stored PROQUAD; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported.       On 08-MAY-2020, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # reported as "S006019" with expiration date reported as "27-FEB-2021"  and included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # and expiration date not reported); both for prophylaxis (strength, dose route of administration and anatomical location were not reported for the suspect vaccines). No additional adverse effect was reported. Concomitant therapies included sterile diluent(STERILE DILUENT) which was properly stored. It was stated that the vaccines were exposed to a temperature between 6 to 14 °F (10.4 °F) for 15 minutes. A previous temperature excursion was reported with a temperature between 6 to 14 °F (11.1 °F) for 15 minutes. A digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number S006019 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD).; Sender's Comments:  US-009507513-2007USA001308: US-009507513-2007USA001612: US-009507513-2007USA001668: US-009507513-2007USA001240:
COVID-19 symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 symptoms) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included IBUPROFEN for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (COVID-19 symptoms). At the time of the report, COVID-19 (COVID-19 symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Inhaler and cough medication. Concomitant medications reported also included diabetic medication, cholesterol medication, blood pressure medication.  The patient recovered from COVID-19 after a period of 3 weeks to a months and had symptoms for 7 to 10 days.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The second dose of vaccine was added. The event outcome updated to recovered.
I started to fill itching and tingling In the feet and hands and face. Then developed fever and nausea vomiting. Then started to have itching more and more and as my symptoms of flu like symptoms went away the itching and skin hyperdilation continued. I get welts after itching and burning sensations that cause like a histamine reaction that causes my skin  to keep itching. Almost like a bad mosquito bite. I have to keep using Claritin to keep the itching down but the redness and skin redness does not go away. I did not have any of this prior to the vaccine. Also feel that sometimes a get this generalized fatigue that seems to be unexplained.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) sometime in the past from an unspecified healthcare provider and she developed a shingles-like rash. The patient's husband then developed shingles himself because he was exposed to the patient's rash. The patient's husband and the patient have both recovered. The relatedness of the event with ZOSTAVAX was not provided. Additional information is not expected.
Arm started swelling and became very swollen; Arm hot to touch; Extremely itchy and looks sort of like tracks; Underneath the armpit was really sore; Red; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started swelling and became very swollen), FEELING HOT (Arm hot to touch), PRURITUS (Extremely itchy and looks sort of like tracks), AXILLARY PAIN (Underneath the armpit was really sore) and ERYTHEMA (Red) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history information reported .  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm started swelling and became very swollen), FEELING HOT (Arm hot to touch), PRURITUS (Extremely itchy and looks sort of like tracks), AXILLARY PAIN (Underneath the armpit was really sore) and ERYTHEMA (Red). At the time of the report, PERIPHERAL SWELLING (Arm started swelling and became very swollen), FEELING HOT (Arm hot to touch), PRURITUS (Extremely itchy and looks sort of like tracks), AXILLARY PAIN (Underneath the armpit was really sore) and ERYTHEMA (Red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient followed up with PCP and placed her on antibiotics.  No other treatment information was provided.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 29-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6204), at the age of 29, in left arm, on Mar 5, 2021, at 15:30, single dose, for COVID-19 immunisation. Medical history included chocolate and Kiwi allergy (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced euphoric mood/slight euphoric feeling, onset Mar 5, 2021, at 16:10, with outcome of recovered (Mar 5, 2021, at 18:10). Therapeutic measures were not taken as a result of euphoric mood. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination, and has not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts needed. No further information expected.
Swollen lymph nodes/worsened; Cannot really walk, hard to get up/ worsened; Rash; Hard to breathe; Internal fever; Joint pain/worsened; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: WM5429) dose 1 via an unspecified route of administration on 31Mar2021 07:20 (at the age of 45 years old) as dose 1, single for COVID-19 immunisation. Medical history included surgery from 1997 and ongoing for had metal rods in her left femur and left cheek, Chicken pox. The patient concomitant medication was not reported. On 31Mar2021 the patient experienced internal fever, hard to breathe. On 01Apr2021 the patient experienced rash. On 06Apr2021 the patient experienced swollen lymph nodes/worsened, cannot really walk hard to get up/ worsened. On an unspecified date patient experienced joint pain/worsened. She mentioned in the beginning she had an internal fever. She was not sure if she had an actual fever but had an internal fever. She also had a rash. Her body got hot. In the very beginning the Pharmacist increased the amount of time she had to wait and was watched for 30 minutes instead. Her head got hot, and it was hard to breathe. She also got rashes, they were on her face, leg, and arm. She just scheduled an appointment with the doctor because she had bad swollen lymph nodes and will see the doctor if they do not get better. She also had joint pain. She was not able to walk because it hurts so bad. She confirmed she does not have an email address to provide for the doctor. The internal fever happened while waiting in the pharmacy. It lurked around for about two days. She confirmed she had recovered completely and feels fine now. The swollen lymph nodes are bad. She officially noticed it last night. The joint pain started last week; she does not remember the exact day it started. It had been around her knees. Her knees have been hurting and her legs are hurting. Now she had swollen lymph nodes. She commented she wonders if her lymph nodes were swollen at the time of joint pain last week but was not noticeable then. She did not notice the swollen lymph nodes until last night. Caller not being able to really walk and hard to get up like out of bed started last night. History of all previous immunizations with the Pfizer vaccine considered as suspect: None, this was the First dose. While capturing details for Vaccine Supplemental Form caller commented she needed to disconnect as she must get back to work. The adverse events not resulted in an emergency room visit and physician office visit. The clinical outcome of the event hard to breathe was recovered on 31Mar2021, internal fever was recovered on an unspecified date of 2021. The clinical outcome of the events rash, swollen lymph nodes/worsened, joint pain/worsened, cannot really walk, hard to get up/ worsened was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 27 year old male patient. On 20-AUG-2014 the patient was vaccinated with RECOMBIVAX HB lot # K003533 and expiration date 07-FEB-2016, intramuscular, (dose not reported). On 20-AUG-2014, the patient experienced tachycardia, unspecified bumps under his tongue, shortness of breath, sweating and tiredness after receipt of the vaccine. The patient's symptoms began the day of vaccination and lasted 9 days. The patient did not seek medical attention. The outcome of the events was reported as recovered on 30-AUG-2014. Additional information has been requested.
Myalgia, Arthralgia, Fever, NauseaVomiting, CHILLS, LOSS OF APETITE Narrative: