chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Complications: Next morning after SHINGRIX shot I found a engorged deer tick on inside of left arm above elbow. I immediately took one Doxycyline tablet. It was shortly after that, that I started feeling a tingling pin prick sensation over my back. I went to the Walk-in clinic mentioned above and Dr thought it was the a reaction to the doxycycline. This, despite, having taken doxycycline (years) before without adverser reaction. The tingling sensation turned into a rash expression of hives, polka dots all over my body, very itchy, with a blister on my right hand. Now taking prednisone at 2-20 mg  (first day) which seems to be doing something. Redness seems to be receding.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).A male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CHILLS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "body aches"; ILLNESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sick twice"; DECREASED APPETITE (non-serious) with onset 25Feb2021, outcome "unknown", described as "doesn't want to eat".Additional Information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The reporter was asking if the patient should get the second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine approved for 18 years of age and older was given to 17 year old patient.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered (after 30 day Use By Date)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination. No Medical History information was reported. In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered (after 30 day Use By Date)). In January 2022, EXPIRED PRODUCT ADMINISTERED  (Expired doses administered (after 30 day Use By Date)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant Drug details were reported. No Treatment information was provided.
Approximately 5-10 minutes following injection I became extremely dizzy and lightheaded and was unable to see clearly.  Voices were muffled and seemed distant.  My family helped me into our home where I lied down for approximately 20-30 minutes.  After that time, I was still stomewhat lightheaded but was beginning to feel somewhat better.  I have received flu vaccination for the past 8 years and have never had any experience remotely similar.
the patient appeared with a swollen face when the morning shift arrived at 7 am . no signs of respiratory concerns, vitals within normal limits . face swollen and warm to the touch.  the patient was taken to urgent care by her POA. clinic transferred the patient to a local hospital where she admitted to be observed overnight. The Resident returned back to the facility the next day (1/21/21).  Reported received verbal notification from POA that the patient's primary physician is recommending to not receive the second dose of the Moderna vaccine.
lot could be: (HG74629) I got the vaccine on 9/15/23, I had a lot of itching in the area of the vaccine, and then developed a large hard, red area around the vaccination site. It was itchy, I thought it would go away, and it did go away some, but then on 9/17/23, in the afternoon, I started getting an itchy feeling starting between my shoulder blades, then spread to the shoulders itself- on the back. Then it started spreading further down my back, and then out just above the buttocks out on either side with itching. The next day, that night, it started spreading to my buttocks, my buttocks was itching. Then I slept through the night, I did take a non drowsy antihistamine, but the next morning, my upper arms, my chest, just above my breast and then my breast was itching. The only thing that does not itch, are my legs. I took another non drowsy antihistamine before I called you.
we already had the COVID; we already had the COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, 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: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "we already had the COVID". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information available, there is causal association between the events drug ineffective, covid-19 and the suspect drug BNT162b2 cannot be excluded . The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200020676 same drug/event, different patient;
4/22/2021 PATIENT NOTICED LIPS WERE DRY, RED, AND PEELING 4/23/2021 PATIENT LIPS STARTED ITCHING AND BUMPS DEVELPED IN THE CORNERS OF HER MOUTH 4/24/2021 LIPS GETTING WORSE WITH BUMPS, TICHING, AND REDDNESS.  STARTED TAKING ABREVA FOR CORNER BUMPS 4/25/2021 LIPS GETTING PUFFY, SORE, TINGLY, AND MORE BUMPS NOTED 4/26/2021 LIPS VERY SWOLLEN, UPPER WORSE THAN LOWER.  OUTER RIM OF LIPS VERY RED.  BUMPS NOTED AS HIGH AS                            HALFWAY BETWEEN NOSTRILS AND UPPER LIP  LOOKING BACK ON START OF PFIZER COVID VACCINE SERIES (3/30/2021) PATIENT ALSO REPORTS ECZEMA GOT WORSE ESPECIALLY ON TOP OF HANDS.  HAS ITCHINESS ALL OVER BODY SINCE MID APRIL.  LASTLY, AFTER DOSE 1 SHE DEVELOPED A COLD SORE 3 DAYS AFTER DOSE 1 AND STARTED GENERIC VALTREX.  COLD SORE RESOLVED A FEW DAYS LATER.  SHE HAS STARTED BENADRYL ON A NIGHTLY BASIS AND RESTARTED GENERIC VALTREX ON 4/26/2021.  SHE ALSO HAS BEEN APPLYING LAVENDER AND PEPPERMINT LIP BALM THAT SHE MAKES HERSELF (AND HAS USED FOR A LONG TIME), CURELL LOTION, ANTI-ITCH CREAM, AND ICE PACKS.  NOTHING SEEMS TO BE PROVIDING MUCH RELIEF AT THIS POINT.
Expired Havrix administered; subcutanoues route of adminstartion; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old female patient who received HAV (Havrix adult) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th December 2022, the patient received Havrix adult (subcutaneous) and Havrix Pre-Filled Syringe Device. On 27th December 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and intramuscular formulation administered by other route. On an unknown date, the outcome of the expired vaccine used and intramuscular formulation administered by other route were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022193700   Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's comments: The Healthcare Professional (HCP) had reported that a female patient was administered an expired dose of Havrix on 27 December 2022, which was expired on 16 December 2022. The reporter had consented to follow-up via regular mail. Additional supportive information: At the time of reporting, the patient had received an expired dose of Havrix adult vaccine via subcutaneous route, which led to expired vaccine used and Intramuscular formulation administered by other route.; Sender's Comments:  US-GSK-US2022193700:Same reporter / FU1
Narrative:  Patient is a 68 yo M with a PMH significant for HLD, multiple sclerosis, vitamin B12 deficiency, rosacea, HTN, disorder or rotator cuff an lower back pain who had received Herpes Zoster (Shingles) Vaccine on 2/8/22 in right deltoid. Next day, patient developed generalized muscle pain. Patient reported "everything from neck down hurts, it started after shingles vaccine at clinic". Per EMR, the CDC RISKS OF VACCINE REACTION for Shingles was read to patient over the phone. He stated he was experiencing all of them (tired, muscle pain, feeling cold, decreased appetite. Unsure about fever since he had no thermometer). According to patient, "it hurt to even lay down". He states he took one 800mg Ibuprofen with minimal effect He was informed this could last 2-3 days per CDC vaccine info statement. Patient was instructed to continue to hydrate, take ibuprofen as needed and call back if symptoms became unbearable. No reports of patient received first dose of Shingles in August of 2021 and called clinic ~3 days later for c/o hypotension and decreased appetite for a couple weeks following vaccine administration. No further complaints were made thereafter.
arm pain; hurts when lift; pain in the muscle at the back of the armpit; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN (hurts when lift), MYALGIA (pain in the muscle at the back of the armpit) and ARTHRALGIA (shoulder pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (oesophageal), Seizure and Cholesterol. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), ZOLPIDEM TARTRATE (ZOLPIDEM TARTATE) for Cholesterol, LEVETIRACETAM for Seizure.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm pain), PAIN (hurts when lift), MYALGIA (pain in the muscle at the back of the armpit) and ARTHRALGIA (shoulder pain). At the time of the report, PAIN IN EXTREMITY (arm pain), PAIN (hurts when lift), MYALGIA (pain in the muscle at the back of the armpit) and ARTHRALGIA (shoulder pain) outcome was unknown.            Treatment information was not provided.
diarrhea; This case was reported by a physician via other manufacturer and described the occurrence of bloody diarrhea in a 2-month-old female patient who received Rota (Rotarix) for prophylaxis.   On an unknown date, the patient received Rotarix (oral). On an unknown date, less than a month after receiving Rotarix, the patient experienced bloody diarrhea (serious criteria GSK medically significant). On an unknown date, the outcome of the bloody diarrhea was unknown.   It was unknown if the reporter considered the bloody diarrhea to be related to Rotarix.  Additional details were provided as follows: The patient received Rotarix at 2 months of age and experienced bloody diarrhea. The reporter called to find out if that was a typical adverse event for that vaccine or he could rule out if that was cause or if something else was going with the patient.
Slightly swollen at injection site; Red at injection site; Slightly swollen from middle of fore arm down the arm; Red from middle of forearm down the arm.; arm a little warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Slightly swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site), PERIPHERAL SWELLING (Slightly swollen from middle of fore arm down the arm), ERYTHEMA (Red from middle of forearm down the arm.) and VACCINATION SITE WARMTH (arm a little warm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025a21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Slightly swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site), PERIPHERAL SWELLING (Slightly swollen from middle of fore arm down the arm), ERYTHEMA (Red from middle of forearm down the arm.) and VACCINATION SITE WARMTH (arm a little warm). At the time of the report, VACCINATION SITE SWELLING (Slightly swollen at injection site), VACCINATION SITE ERYTHEMA (Red at injection site), PERIPHERAL SWELLING (Slightly swollen from middle of fore arm down the arm), ERYTHEMA (Red from middle of forearm down the arm.) and VACCINATION SITE WARMTH (arm a little warm) outcome was unknown.            Treatment information was not provided.
Patient inadvertently given first dose of Moderna  Covid 19 vaccine and is under age 18.  Patient received 2nd dose of Moderna on 03/05/2021.  2nd dose was approved be,  Chief  and  Medical Director.
small dots on skin that look a bit like Petechiae. This is on her left mid-thigh. She also had very itchy nose and ears.
I started having mid-sternal chest pain at 2 PM on the 15th.  I went to the hospital at 2 am on the 16th where I was diagnosed with an MI in progress.  I had angiography on the 17th, and a four vessel Coronary Artery Bypass Graft on the 21st.
pt recv vax & as later as 7 days p/vax pt devel localized rash @ inj site & erythema;
fever; pink; 3x5 patch around the injection site; warm on injection site; itchiness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm on injection site), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (pink), VACCINATION SITE RASH (3x5 patch around the injection site) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE WARMTH (warm on injection site), VACCINATION SITE PRURITUS (itchiness) and VACCINATION SITE RASH (3x5 patch around the injection site). On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (pink). On an unknown date, the patient experienced PYREXIA (fever). The patient was treated with BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]) at an unspecified dose and frequency and VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm on injection site), VACCINATION SITE PRURITUS (itchiness), VACCINATION SITE ERYTHEMA (pink) and VACCINATION SITE RASH (3x5 patch around the injection site) had not resolved and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This spontaneous report was received from a Registered Nurse refers to a 5 year old female patient. No pertinent medical history was reported. On 10-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (lot # K004860 and expiration date 04-OCT-2015 also reported as 10-APR-2016) (dose and route were not reported). No adverse effects reported at that time. This is one of the two reports from the same source. Additional information has been requested.
This spontaneous report as received from the mother of the patient consumer refers to a currently 6 year old male patient. The patient had no pertinent medical history or allergies. On 2008, when the patient was 2 years old, he was vaccinated with the first dose of VARIVAX (Merck). A week after receiving the shot, the patient developed a rash around the injection site. The patient sought medical attention going to an unspecified physician. The patient was treated with acyclovir (manufacturer unspecified). The patient did not undergo any lab test. It was reported that on an unspecified date the patient recovered from the event. At the time of the report the patient has not yet received the second dose of VARIVAX (Merck) and his mother was unsure if the patient would get the second dose. Additional information has been requested.
hives afternoon day of vaccine, next day, stomach ache, fever ( T 100.0) , chills, vomiting, headache, dizziness, hazy feeling and nosebleed.   Symptoms slowly improved over 5 days and returned to work.
Chest pain, shortness of breath, dizziness, fatigue.  Abnormal EKG signaling Left Atrial Enlargement.  Emergency Room visit with similar EKG findings.  Am on anti-inflammatory medication to control pain while pending an ECHO as well as a follow up with a cardiologist to bring my heart back to a healthy state.
Pain at injection site, through the second day so far (I've never felt a vaccine this much and have had many to be able go to location a few years ago).  A short amount of time after the vaccine the veins in my left arm through my fingers were extremely swollen feeling and visibly larger than my right arm.  It was enough to make me not be able to work at all afterwards.  In the pharmacy I mainly felt the injection location, then walked home for a short distance, shortly afterwards the pain and pressure grew, including the beginnings of joint swelling as well.  Massaging the muscles around it seemed to make it worse, so I stopped after a short while (muscles also inflamed feeling) I took a nap, and woke up with some circulation issues but some of the vein symptoms had receded.  Today (second day) there is still a feeling of inflammation in my hands and left forearm, and the area around the injection site (about 5" in diameter) is warm, painful and makes full range of motion not possible.
About 5 min after vaccine given, patient had a syncopal episode.  BP 59/35.  Taken to ED.  Noted with a fear of needles and had not eaten that morning.  In ED, BP 125/82, respirations 20, HR 84.  Remained stable with no further hypotension.
This case was reported by a physician via market research programs and described the occurrence of immune-mediated adverse reaction in a adult patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis. On an unknown date, the patient received Hz/su + AS01B at an unknown dose. On an unknown date, unknown after receiving Hz/su + AS01B, the patient experienced immune-mediated adverse reaction (serious criteria death and GSK medically significant). On an unknown date, the outcome of the immune-mediated adverse reaction was fatal. The reported cause of death was immune-mediated adverse reaction. The reporter considered the immune-mediated adverse reaction to be possibly related to Hz/su + AS01B. Additional details were provided as follows: This case was reported via interactive digital media. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The physician posted, a closed doctors forum that it was funny to see this post here after I had 2 cases of death following SHINGRIX vaccination. Both were devastating. It was lucky that your patient only got the rash. The physician was reported to Centers for Disease Control and Prevention (CDC). Cause of death did not seem infection related but more so of a exacerbated immunologic response to the vaccination. The physician written them up as case report. The physician would advise against giving this vaccination to any the patients who were receiving immunotherapy for either oncologic or rheumatologic conditions. The famous last words the heard from their documents were but they were not live virus. Reported Cause(s) of Death: Immune-mediated adverse reaction.
tightness in throat, chest discomfort, felt throat was closing off, difficulty swallowing
Upper arm swelled on the inside of the arm from a couple of inches below the armpit to elbow, turned red, was hot to the touch. Applied cool compresses.
I went to the Fairgrounds to get my 2nd shot of Covid. I waited for 15 minutes. I went home and was fine. The next day I had a fever and had the flu symptoms. I recovered from those symptoms. A couple of months later I started having the Afib problems. I went to see my PCP to get it checked. I am on medication currently and still being treated for A-fib. I do not have the A-fib under control with all the medication. I have had more over than 64 episodes of the A-fib.
covid 19; covid 19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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 "covid 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19  and The suspected drug cannot be ruled out.
severe lt lower abo pain, weight loss & over all weakness are reported in pt who recvd fluogen; pt underwent a biopsy & colonoscopy which revealed some type of organism; felt faint while driving & woke up in the hospital;
I woke up about 12 hours after my shot with leg pain (2:30am on Saturday. It came and went over the course of a few days and then was gone for maybe a day or so. It returned on Tuesday and continued to worsen and spread some. I was seen and had an elevated d-dimer test. They did an ultrasound for blood clots. Currently, I'm on day 7 and have aching, cramping, tingling, burning and cool sensations in both legs and a bit in my arms.