chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8/6/21: soreness at injection site lasting approximately 24 hours.  8/23/21: noticed soreness at injection site returned. I had been exposed to covid the day before and assumed the pain meant the vaccine was working.  9/5: Quarantine ended, I tested negative throughout. Pain gradually intensified.  8/23/21-9/14/21: soreness gradually spread throughout left arm starting at the shoulder. Pain level gradually intensified, but is not severe. It has become difficult to hold objects in my left hand.  9/14/21: called Dept of Health for guidance about getting the 2nd shot. Was instructed to report the incident here and see my physician.
Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022; Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 02 Oct 2021 and was administered on 13 Oct 2021) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Oct-2022 and removed from the fridge on 13-Oct-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Reportedly, the vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that one vial was taken out at a time and thawed as they did not thawan entire box.  Vaccine was removed from the fridge on 13 Oct 2021.   Treatment information was not provided.
Fever (low grade, then 103 to 104 F); Feeling kind of ill; Arm was really sore; Sluggish; Body aches; Nausea; Vomiting; Diarrhea; Hurting chills; Muscle aches; headache; This is a spontaneous report from a contactable consumer (patient's mother).  A 17-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 21Aug2021, at the age of 17 years old, as 1st single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient woke up the following morning, on 22Aug2021, and started feeling kind of ill, his arm was really sore, he was just sluggish, with low grade fever, body aches, and as the days progressed the symptoms kept getting worse, he had nausea, vomiting, diarrhea, hurting chills, body aches, muscle aches, headache, and for 2 or 3 days he started running fever like a 103 F to 104 F and then fever 100-101F. According to the patient, no treatment was needed for the events. The outcome of the events was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101281780 similar report from same reporter
11/05/09 Headache. 11/06/09 Hot flashes, felt like fever, lethargy-mild. Took ibuprofen before taking temperature.
Information has been received from a physician, via a company representative, concerning an approximately 14 year old ("14 or 15" years), female patient, who on an unknown date was vaccinated with the first dose of Gardasil (Lot # not provided), and subsequently fainted. At the time of this report, the patient had recovered from the event (date and duration not specified). The patient sought unspecified medical attention. Additional information has been requested.
This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 20May2021 at 05:15 (at the age of 67-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and the patient had a history of allergy to codeine. Concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 at 03:00, the patient experienced nausea, body aches, earache, sore throat, eyes burning, fever, extreme fatigue and heaviness in chest. It lasted 48 hours. 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, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of nausea, body aches, earache, sore throat, eyes burning, fever, extreme fatigue and heaviness in chest were recovered on an unknown date in May2021.
The patient had his vaccines on 12/20/00.  He slept a lot for approximately 2 days, since then more subdued.  The patient used to talk more, and laugh more now he requires stimulation to laugh.  The patient is quiet unless he is hungry, needs a diaper change, or is stimulated by the mom, he was always easy going but now more so. No virus in the house.
PATIENT FELT HOT AND FAINTISH ABOUT 2 MINUTES AFTER RECEIVING THE IMMUNIZATION. PATIENT MOM SAID HE KEPT LOOKING AT THE BLOOD AND THEN THE SYMPTOMS CAME ON. DURING THE OBSERVATION, THE PATIENHAD ON A SWEAT SHIRT, SKULL HAT AND HEAD BAND. ALL THREE ITEMS WERE REMOVED, PATIENT LIED DOWN ON THE FLOOR WITH FEET UP IN A CHAIR FOR 10 -15 MINUTES. AND A COLD COMPRESS  TO THE NECK. PATIENT NEVER LOST CONSCIENCE AND ALWAYS KNEW HIS NAME A DOB WHEN ASKED. MOM AND SON SAID HE STARTED FEELING THIS WAY WHEN HE LOOKED AT THE BLOOD ON HIS BANDAGE. THE PATIENT NOR HIS MOM WANTED US TO SEEK MEDICAL 911 ATTENTION AND WALKED OUT ON HIS OWN LATER.
Later in the day I saw a brownish discharge in my underwear. The next day it was the same thing. The next day I wore a pad, and it was much more of the discharge. I am post-menopausal, so I knew I was not supposed to have a discharge.  That Friday, I called my doctor because the discharge was worse. I went in and had Uterine Biopsy on 09/19/2022- which was Negative. The doctor told me to get a trans abdominal and transvaginal ultrasound which is scheduled for tomorrow. He asked me to restart the Premarin Vaginal Suppository. The discharge has stopped but I am still experiencing abdominal pain. I also have to have a Metabolic Panel drawn next week.
-Redness at injection site has spread into about a 3 inch circle (length and width). Started as about a 1 inch circle. -The area is hot to the touch -Swelling and hardness  I have iced the area on and off, it does not seem to help. Benadryl does not seem to help.
Worst headache of life. COVID diagnosis 2/24/2022, and received monoclonal ab treatment on 2/27/2022.  New subarachnoid hemorrhage from brain mass.
This spontaneous report was received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history, drug reactions/ allergies and concomitant medications. On 12-OCT-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml, once, subcutaneously, (lot # and expiry date not reported). Subsequently, on the same day, the patient experienced redness and swelling at the injection site. Therefore, the patient sought medical attention - seen in the pharmacy. However, no treatment was given for the events and no lab diagnostics were performed. At the time of report, the patient was recovering from the events. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Significant changes to my menstrual cycle . Experiencing heavier than normal bleeding, longer than normal bleeding and irregular cycles. Also much more severe cramps with my period as well as increased pms symptoms
Severe tinnitus in left ear.  On going since the 10 day mar.  At 42 days second shot was administered as tinnitus had subsided mostly.  Day 3 after second shot tinnitus came back strong.
Reconstitution with sterile water; Reconstitution with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 05-Apr-2022 Reporter's comment: Registered pharmacist reported that one of their providers reconstituted Shingrix with sterile water for injection and administered it to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter had no details regarding patient or product but agreed to follow up.
The use of telehealth was discussed with the patient who understands that telehealth services are provided by an Emergency provider at a distant site, not in the same room with the patient. The patient understands that his/her medical information will be discussed during the telehealth service. The patient consents to any additional persons on the patient?s end of the service hearing this information and is aware that he/she may exclude persons on their end of the communication if they so wish. The patient understands that at times the information and assessment gathered during a telehealth service may be insufficent given the nature of being remote from the patient, and that there could be equipment failures or security failures leading to a breach in privacy. A written consent was not obtained due to the nature of this telehealth visit as screening for COVID-19. Patient Location: ED Waiting   Verbal consent obtained: Yes Patient Location: ED Waiting  HPI and Screening  Patient is a 77 y.o. male who presents asthma, pneumonia, sarcoid, on home oxygen, dm, htn, ttp, ulcer, presents after going to receive a Covid vaccine. After taking the Covid check he began to have central chest pain. He describes the pain primarily as discomfort or burning. This is his first Covid shot. Felt like when he had contrast dye in the past. He does have a documented contrast allergy. He states that his breathing in general is better today. But that was prior to vaccine administration. No itching hives difficulty swallowing. His speech is normal. No fevers chills sweats cough or cold no loss of taste or smell. Nausea vomiting or diarrhea.
Fever (that was usual) and left arm where shot was given was stiff and achy. NOT the injection site but the actual shoulder/neck area. Saw my PCM on 10/01/2012 after the pain was persistent, not improving, swollen and hot. Was told it was and infection and started treatment, a course of antibiotics (CEPHALEXIN 500MG) for 10 days. Still taking antibiotics but swelling has gone and most of my range of motion has returned. Occasional weakness and pain still.
None. Pt received PEDIARIX and Hep B single dose on 11/12/2008.
Slightly pink (R) upper arm tender slightly swollen covering 50% of mid upper arm.
Sore arm, chills, severe aching body, no energy, unable to go to work.
adverse affect was on 1/12 and was diagnosed by her PCP with Shingles. Today, 1/20, remains with Shingles, with rash, itchy and pain.
Large rash area on my right arm showed up a week after the shot. It was very itchy, burning and felt like I had been punched in the arm and left with a bruise like feeling. It was very sensitive to the touch. My lymph nodes have also become swollen.
pt stated a couple of days after taking the 2nd covid vax, she woke up with pressure and tingling in the top part of her should and around the breast plate, causing SOB.  She had pressure around her head like a band was around it causing her to have a severe headache. She took Aleve and Excedrin Migraine for these symptoms.  Pt went to Urgent Care on 10/4/21 via ambulance.  She took blood  work and did EKG.  Test results were normal.  They asked her is she felt like she was having a panic attack, which she knew it was not the case.  They hold her FU w/ a PCP but she is still waiting to get into see one.  The headaches lasted about three days but had flu symptoms about nine days.
The normal arm being sore began later that evening, Tuesday October 1, 2013. The pain continued to get worse and I was unable to have the full use of my arm from that point till now. I was at the doctor for a routine checkup and asked her about my arm ant the pain and lack of full use and she began to run tests. At this time, there have been no exact diagnosis. The pain is beginning to travel from the injection site to my elbow. I am scheduled this Saturday, February 1st for a MRI for further testing. I am very careful what I try to do with this arm because of the pain and weakness. I am left handed and the injection was in my left arm. At this point, I am continuing treatment to find out the damage done and will continue to follow up with VAERS as to the findings.
"HIGH RISK" FOR BEING ON TREMFYA  AND RECEIVING THE COVID VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received combination product guselkumab (solution for injection in pre-filled syringe, route of admin not reported, batch number: unknown) dose, frequency, and therapy dates were not reported for an unspecified indication. Product constituent parts included .The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the subject experienced "high risk" for being on tremfya and receiving the covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with guselkumab was not reported. The outcome of "high risk" for being on tremfya and receiving the covid vaccine was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
Coughing, Vomiting, Diarrhea, fever, chills, lethargic, pale.
Patient called pharmacy and reported a rash on her Left arm where her SHINGRIX was administered 2 days ago. Patient was recommended to see her physician.
24 hr after vaccine, I had fatigue and generalized body aches and left arm pain at site of injection. I took tylenol.  Those stopped by the second day morning (day after vaccine). However, in the second morning ( day after vaccine) I started having pain on left side of neck and on Trapezius muscle on left shoulder blade - and had that pain for three more days. Range of motion for neck restricted for three days. All symptoms improved after four days. I took Lidocaine patch and Tylenol for neck and shoulder blade pain.
Body Muscle pains through out the body it started on 12/20/2020 The muscles were swollen  One day I had a slight fever I also had dehydration.  Virtual appointment with my doctor
INJECTION SITE SWELLING; ITCHING AT THE SITE OF INJECTION; INFLAMMATION AT THE SITE OF INJECTION; HEADACHE; LOW GRADE FEVER; This spontaneous report received from a patient via a company representative concerned an adult female. The patient's weight, height, and medical history were not 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 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced itching at the site of injection. On 06-APR-2021, the subject experienced inflammation at the site of injection. On 06-APR-2021, the subject experienced headache. On 06-APR-2021, the subject experienced low grade fever. On 09-APR-2021, the subject experienced injection site swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and low grade fever on 09-APR-2021, was recovering from itching at the site of injection, and inflammation at the site of injection, and the outcome of injection site swelling was not reported. This report was non-serious.
This spontaneous report has been received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 24-MAY-2018,the patient was vaccinated with and expired dose of PNEUMOVAX 23 (lot # M032635 and expiration date 05-MAY-2018) (dose, frequency and route of administration were not provided) for prophylaxis.
Pt recvd 3 doses of Engerix-B vax & it was determined that pt did not seroconvert; 4th dose of Engerix-B vax was administered;
tested positive for COVID; tested positive for COVID; pretty sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000004911, 2022NVX-US-000004910.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID"; ILLNESS (non-serious), outcome "unknown", described as "pretty sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: It was reported that on 19Dec2022, it was reported that a patient stated treatment on an unspecified date with Pfizer BioNTech COVID-19 vaccine unspecified dose for Covid-19 immunisation. It was reported the patient tested positive for COVID. The individual was reported to be pretty sick even though they were fully vaccinated with Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
A nurse reported that a 48 year old female received Pnu-Imune 23 vaccine on 10/8/01. The injection was given in her left upper arm; however, it seemed lower than the deltoid muscle. Subsequent to immunization, she developed a "severe" injection site reaction characterized by swelling, redness, induration and pain. The area of induration measured 6" to 7". She also had developed swelling in her whole left arm and pain in her arm, shoulder and chest wall. No additional information was available as of the date of this report.
Labored breathing; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: OP7553) on 01Apr2021 at 17:00-18:00 in right arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetic which diagnosed 19 years before. No family medical history relevent to events. Concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No event following prior vaccinations. Patient stated she had been having labored breathing since having the vaccine and fatigue in Mid Day on 04Apr2021. Patient clarified if she moves around too much, she gets tired and breathless and can't hardly breathe. Patient didn't think it was from the Pfizer vaccine at first, she had a cardiac catheterization done at first in Apr2021 and that was normal so they ordered a CT (Computerised tomogram) of her lungs and that was done on 14Apr2021 and it was normal. The only thing that she had done differently was she had the Pfizer vaccine. Events resulted a visit to Emergency Room and Physician Office on 07APR2021, she first went to the doctor's office, she ended up in the ER the next day and they wanted her to see a cardiologist and that was when she ordered the cardiac catheterization, since she was diabetic, the cardiologist was surprised she did not have any blockage, he said most have a little bit, but hers was normal, so he ordered a CT Scan of her Lungs to see if there was a blockage, blood clot or cancer and they were both fine.  No treatment received for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from from a RN concerning a 9 year old white female with no known medical history or allergies who on 02/01/00 was vaccinated SQ with a dose of varicella virus vaccine live. Concomitant vaccination that day included an IM fifth dose of diphtheria toxoid + pertussis vaccine+ tetanus toxoid.  There was no illness at the time of vaccination . On 11/15/2004 the pt developed a HA that lasted 3 days and chickenpox with pimples over her back and head that were itchy. The same day the pt was seen in the doctors office and a PE was performed which showed her ears, nose, chest, and cardiac to be within normal limits. TX included Sx relief and the pt was to return to the office as the occasion required. Subsequently on 11/20/04 the pt recovered from the chickenpox. There was no product quality complaint involved. Additional information is not expected.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received first vaccine and now tested positive for Covid; received first vaccine and now tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of vaccine and now  (unspecified date) tested positive for COVID. She wanted to know how long would she have to wait after testing positive to get the 2nd dose. Outcome of events was unknown.  Information on the lot/batch number has been requested.