chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. An unspecified number of doses of improperly stored PROQQUAD (Merck) lot # L019997 exp. 02-DEC-2016, lot # L016394 exp. 08-NOV-2016, lot # L017140 exp. 13-NOV-2016, (route of administration and dose were not reported) were administered to an unspecified number of unspecified patients by an unspecified physician on unspecified dates. There was no adverse events reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
11/09/2021 patient felt muscle aches, tingling on hands and feet, 11/16/2021 rush her to hospital because of severe pain on both upper and lower extremities, admitted at hospital until 11/17/2021, readmitted on 11/20/2021 because patient cannot walk anymore, due to weakeness/paralysis. Diagnosed for Guillane barre syndrome from Moderna booster shot she got on 11/02/2021
At approx 9PM client noticed hives on her thighs.  They were not itchy, only red.  Upon further investigation she noted that the hives were on the back of her arms, her back and her scalp.  The scalp lesions were very itchy.  Client took two doses of Benedryl and a dose of Clarinex.  On 10/25 she noted that the lesions are gone from her arms.  The thigh lesions are diminishing to only red spots.  He scalp is still itchy.
Red raised rash covering 20-25% BSA appeared 2 days post vaccine. Trunk, back, arms.  Not itchy or painful. No relief with Benadryl.  No other symptoms
Instant left sided neck ache after shofr. Almost 24 hours later,, Extremely tender and swollen lymphnode in neck,  collar bone and armpit/breast. Entire arm was so swollen down to hand that could not put on wedding ring.  Nodes still swollen on collar bone and neck ares, making tuning neck to left uncomfortable.
Received immuns 9/29/08 (VZV right thigh).  On 10/7 developed 9 pruritis papules right lateral thigh, no fever.
Breakthrough case admission after two vaccines Pfizer 12/22/20 Lot# EL0140;  Pfizer 01/08/21 Lot3 EK9321
Post vaccine pt developed a fine erythematous,military type rash over both arms and legs. The rash was pruritic.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-237427 (Patient Link).
Breakthrough case admission after 3 vaccines Pfizer 1/28/21 Lot# EL9265;  Pfizer 2/18/21 Lot# EL9267;  Pfizer 9/28/21 Lot# FC3183
Flu shot given in left deltoid. Pain began on 10/21/09, the day after the injection and pain progressively worse to left deltoid with mild swelling. Rates pain 8-10.5 out of 10 weakness to left shoulder began around 11/11/09, worsen unable to lift arm. No prior injury.
runny nose; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A 78-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 29Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient experienced runny nose. Reporter stated that this week her husband was plowing the snow and his nose was running (stated that runny nose started at the beginning of the week probably Tuesday) and wanted to know could he go and get the second dose of the vaccine on Friday (19Feb2021). Reporter stated that she had been giving him Tylenol, that he did not have a fever. The event was assessed as non-serious. Therapeutic measures were taken as a result of runny nose. The clinical outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Headache, fever, muscle ache, fatigue. Took acetaminophen and symptoms mostly resolved within a few hours.
pt had a rash 9AM 15MAY93 which lasted until about 20th; pt was given DPH; t102; MD recommends no further pertussis;
Patient received the 1st dose 2 years ago before the pandemic.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on unknown date, 2 years before date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-May-2022 Reporter's Comments: Pharmacist unable to provide first dose details and declined to provide any patient details. Pharmacist called in to inquire for Shingrix second dose and asked whether they could restart or finish last dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
pt recvd vax 23sep94;on 2oct94 sl limp in late day;3oct would not walk or put weight on rt leg;sl swolling in rt thigh;to er;was swollen & hard & sl warm;3oct leg warm;no bend leg;t 101 5oct;walk better;consistent viral infect; has sl cold;
Discovered small welt 11/3/02; 11/4/02 small welt spread to reddened area 6x6cm went to med. Rx Benadryl, Tylenol; return to clinic AM 11/5/02 reddened area now 12x12cm, sent to ER. Low grade temp.
Pt then developed redness again about 1 week after getting the vaccine and it has continued to come and go. It is large area of redness, it is raised at times and warm to touch.
This spontaneous report as received from a health care worker via company representative. Information regarding patient's medical history and concomitant medication were not reported. On an unknown date the multiple unspecified patients were vaccinated intramuscularly with improperly stored RECOMBIVAX HB (lot # L040458, expiration date 04-FEB-2018) 10/1.0 mcrg/ml. No adverse effects reported. No further information was provided. Additional information has been requested.
About a week after vaccine (unsure of what time it started) I started experiencing palpitations and shortness of breath which persisted and I was at work one day (10 days after vaccine) and the palpitations and shortness of breath was strong and my blood pressure was about 180/100 something and they sent me to the hospital because my blood pressure was elevated. That persisted for many months and I was having palpitations and trouble breathing and so I seen a Cardiologist and started on blood pressure medication and wore a heart monitor for 2 weeks but nothing came up and the sensation persisted for three months. I also had several other tests like an EKG and stress test and a sonogram. I seen my Endocrinologist and my TSH spiked up with no change in my medication dosage so I think my body went into overdrive and spiked my thyroid hormones up. After 3 months I did feel better and I do still get shortness of breath and my blood pressure is still a bit high so I've continued my blood pressure medication, but all of this came up after the vaccine.
On 28APR2021, the patient's mother noticed a lump on her son's breast; This spontaneous repot was received from a licensed practical nurse via a company representative and refers to a 11-year-old male patient. No information regarding the patent's medical history, concurrent conditions or concomitant medications was provided.  On 15-MAR-2021, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, lot #, expiration date, route and site of administration were not reported).  On 28-APR-2021, the patient's mother noticed a lump on her son's breast. On an unspecified date in 2021, an ultrasound was completed, and the results were unremarkable. Action taken with the suspect vaccine was withdrawn, reported as the patient will not be receiving the second dose. The outcome of the event was unknown.  The causality assessment between the aforementioned event and the suspect vaccine was not provided.
This spontaneous report was received from a medical assistant and refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On unknown date in 2009, also reported as sometime in 2009 at the age of 2, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved. The reporter had no details to provide, as the vaccine was not administered in their facility but it was listed on the medical history. Additional information has been requested.
body aches; chills; fever; This spontaneous report was received from a pharmacist referring to a 79 years old male patient. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On 19-AUG-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, route, lot number and expiration date were not reported) in an unknown arm for prophylaxis.      On the morning of 21-AUG-2020, the patient experienced chills, body aches and a fever. The fever had been as high as 101 degrees Fahrenheit. The pharmacist reported that the patient took acetaminophen (TYLENOL) a few hours ago but the fever had only gone down to 99 degrees Fahrenheit. The pharmacist was trying to rule out coronavirus disease (COVID) symptoms. The outcome of all events was unknown. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Called by pharmacy staff to patient who was feverish and non responsive in a chair in the aisle. Patient was lied on the floor, ice pack applied. She came to and wanted to sit in the chair.  Was offered apple juice. After a few sips, she slumped and became unresponsive.  Her breathing was shallow. Mother said she had not eaten or drunk anything today.  She was lied on the floor again and remained non responsive and then said she was extremely tired. 911 was called, ice was continually applied. Patient did become responsive and drank 6 ounces of apple juice before EMS arrived.  She was taken by stretcher by EMS for evaluation.
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 17 year old male patient who received vaccine 0.5 ml MENACTRA (Batch no: U5917AA, expiry date 30 June 2019) in right thigh on 02-Aug-2018 and again received on 17 Oct 2018 (batch number U5986AA, expiry date 24-AUG-2019) in right arm. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to Extra dose administered. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
I got the injection at 3:35pm on 1/20 in my left arm. Within the first 30 minutes, my shoulder around the injection site was incredibly sore, my left elbow had a lot of joint pain, and my left thumb and index fingers went numb within the first 30 minutes, I woke up at 8:00am on 1/21 and noticed that I had a light headache, felt extremely groggy, and was experiencing an uncomfortable amount of muscular and joint pain. I went to work at 9:00 and on the drive there, I began to feel dizzy and I felt as if when I turned my head, my vision would lag behind and take a second to process my surroundings. By 10:00, my muscular and joint pains were significantly amplified, my headaches were increasing in frequency and amplitude. I also began to have the chills, followed by periods of radiating heat from my body. Coworkers told me I looked very flushed, however, I never developed a fever. By 11:00, the muscular and joint pains, coupled with the headaches forced me to sit down and I almost broke down into tears. There were three sperate times where I began to get very lightheaded and thought I was going to pass out ( I did not). I went home at noon and noticed that my muscles felt like they were on fire. I took Tylenol and Advil whenever I could, which helped to reduce the symptoms.  we had dinner at 7:00, however, I had no appetite, without eating since noon. On 1/22, I woke up at 8:30 with a pounding headache, muscular and joint pains still there, however reduced, and the same groggy feeling. This morning, I also noticed that I had a very sharp stomach pain in my abdomen. I also woke up with a severe nosebleed, which is extremely uncommon for me.
02/21/23 presents to EC ED for "chest pain". PMHx of "hypertrophic cardiomyopathy" "depression"
Patient stated to vomit in the bathroom. Patient was stable. Father of patient was with the patient. Father decided to take his daughter home and agreed to monitor her while home. Patient was given Gatorade as tolerated.
Case number PHHY2011US85595 is an initial literature report received on 04 Sep 2011. The authors present a case of adverse event in a neonate after immunizations. This report refers to a one month old neonate of unknown gender. This healthy neonate was vaccinated with Hib vaccine (manufacturer and batch number: unknown, therefore conservatively taken as VAXEMHIB), IPV vaccine (manufacturer and batch number: unknown, therefore conservatively taken as IPV VIRELON), HepB vaccine (manufacture and batch number: unknown), DTaP vaccine (other manufacturer) and PCV-7 vaccine (manufacture and batch number: unknown). Less than one day after vaccination, this neonate presented with inconsolable crying. The causality was assessed as possible by the reporter. No further information about the outcome of the event was available.
This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product (administered second dose 15 weeks after first one) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A) for COVID-19 immunization. No medical history reported. On Jan 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On May 5, 2021, patient experienced inappropriate schedule of product (administered second dose 15 weeks after first one). The reporter did not provide any causality assessments, treatment information or concomitant medication.
Pain in shoulder, radiating down her side, extreme pain, needed to take muscle relaxers, pain medication, and acupuncture with little to no relief.
Shortly after (2-5 days) immunization of with flu, TDP and typhoid I experienced hives on chest & under arm and blotches of hair falling out on right side of head continues to date (30 days). Client unsure of date of symptoms. Thinks they began on completion of oral typhoid.
It felt burning; It felt tingling; Still hurting; It is still sore/somewhat painful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (It felt burning), PARAESTHESIA (It felt tingling), DISCOMFORT (Still hurting) and VACCINATION SITE PAIN (It is still sore/somewhat painful) in a 69-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BURNING SENSATION (It felt burning), PARAESTHESIA (It felt tingling), DISCOMFORT (Still hurting) and VACCINATION SITE PAIN (It is still sore/somewhat painful). On 13-Feb-2021, BURNING SENSATION (It felt burning) and PARAESTHESIA (It felt tingling) had resolved. At the time of the report, DISCOMFORT (Still hurting) and VACCINATION SITE PAIN (It is still sore/somewhat painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
On the morning following Td vaccine, client states that she had (L) arm and (L) breast pain as well as a headache on the (L) side and that later on this day she had redness (baseball size) and hardness at inj. site and 101.2 fever.  On 10-16-08, she states that she had nausea and vomiting, that the fever is gone and that the injection site is still red.
Pt had a rash extending down the back of his upper arm, measuring approximately 5 by 2 inches. The rash was very red in various clusters and the pt complained of itching in addition to warmth and swelling. The reaction also involved a one-inch lump near the injection site.
Extreme chills 3 hours. Used weighted blankets; achieved slow warm up and chills stopped  Elevated temperature 101.8 - 100.8  -- Days 2- 4 in evenings after normal temp all days.- Took    acetaminophen.  Brain fog , physical clumsiness of movements.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # M018810, expiration date 28-MAY-2018; dose and route were unknown). The vaccines were exposed to temperature excursion of 1 degree centigrade for 12 hours and 1 degree centigrade for 10 hours. There were no previous temperature excursions. Data logger was involved. 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.
Had a severe headache by 4:00 pm and then began having chills and body aches and a very sore arm. Went to bed and the following day was just feeling very fatigued. Then around 6 o?clock I started getting horrible chills bodyaches and a low-grade fever. A large red rash appeared and my arm was incredibly sore and the skin was burning. I have experienced body chills off and on since the vaccine.
Short stabbing pain on the upper left of the back, close to the shoulder; This is a spontaneous report received from a Pfizer sponsored program. A non-contactable consumer (patients mother) reported that a 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 27May2021, as a single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, a little over a week ago the patient experienced short stabbing pain on the upper left of the back, close to the shoulder. It was reported that the consumer wanted to know if this was a symptom of the vaccine or if it was unrelated to the vaccine. It was stated that in a clinical study, adverse reactions in adolescents 12 through 15 years of age included muscle pain was 42.2 percent. The event was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
SMALL AMOUNT OF DISCOMFORT AT INJECTION SITE; This spontaneous report received from a patient concerned a male of unspecified age. 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced small amount of discomfort at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from small amount of discomfort at injection site. This report was non-serious.
Patient was given Immunization at 1100 and was stable at time of leaving clinic with mother. Was being walked out per staff due to hx of syncope post injections. When reaching bottom of steps, patient became pale and diaphorectic, and place in a nearby chair. Patient then lost consciousness for approx 30 seconds. Resuscitation efforts effective and heartrate improved and patient stablized.
Eight patients were dispensed Hepatitis A vaccine for adult use. The patient ranged in age from 8yrs old to 15 years old. I had ordered a box with 10 doses of Hepatitis A adult from the state immunization program and only used 2 doses. I had received orders for patient under 18 years of age and when I checked the dose of Hepatitis A for children and for adults and found that the dose was half of the adult dose I decided to use the adult dose and had the prescriber write for a dose of 0.5ml. I had used this strategy to avoid having the vials of Hepatitis A expired not realizing the implications of excipients.
Patient received her vaccine, approximately 10 minutes into her waiting time afterwards she became nauseas, dizzy and slid off the couch onto the floor and passed out. She became tachypnic, clammy, unresponsive although later she said she never went completely unconscious as she could still "hear your voices". After the Physician assessed her and confirmed patient was not recovering in a satisfactory way as she remained nauseas and unsteady and our clinic does not offer long term monitoring as we are a walk in clinic. Patient agreed to be transferred to the hospital for a higher level of car.
2- 3 DAYS AFTER RECIEVING THE VACCINE, THE EMPLOYEE DEVELOPED A RASH OVER HER ENTIRE BODY WITH EXTREME ITCHING. AS OF 4/12/21 SHE STILL HAD THE RASH.
Dose error: patient received >18 y/o 0.1 ID dose of MPOX vaccine instead of 0.5 mL SQ at 1403 on 12/27/22. No s/sx or adverse effects.
Beginning at 9pm on 3/15/21, I had sharp pains in my chest and an elevated heart rate. Every day since, I have had chest pain/pressure, sharp pains in my head accompanied by a burning sensation throughout the top and back of my head and a burning sensation throughout my upper back and arms.
Nausea, chills, muscle aches, excessive sweating, fatigue, headache
Patient got fever on day 3(10/01/2022), on October 5th patients fever was 104 pt. was seen in ER , rash developed . X-ray showed mild cardiomegaly