chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive for COVID-19 on 08/24.  Was having fever with chills with a T-max of 102.9;Lost his sense of smell and taste today he was diagnosed with COVID-19 other associated symptoms include nausea without vomiting;was treated with empiric antibiotics and was given a dose of regeneron  With plans for him to discharge home.  However a CT angiogram of the chest revealed concerns for possible pulmonary embolism given this he was admitted for monitoring.He will be now discharged on Omnicef and azithromycin as well as Eliquis for full treatment x3 months of possible PE
Caller's mother was vaccinated but doesn't know if it was Pfizer vaccine/took Paxlovid for Covid; Caller's mother was vaccinated but doesn't know if it was Pfizer vaccine/took Paxlovid for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller's mother was vaccinated but doesn't know if it was Pfizer vaccine/took Paxlovid for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: took Paxlovid for Covid; Positive, notes: He found out three days ago that she had symptoms again for rebound case of Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Is report related to a study or programme was reported as No. Other Conditions was Not Provided. Investigations was Not Provided. Caller asks if she was supposed to report someone took Paxlovid and was using it to treat Covid and then got rebound case of Covid. Are we supposed to report like when someone gets Covid after having the Pfizer vaccine. Caller's mother, (Name with-held), took Paxlovid for Covid a week or so ago. He found out three days ago that she had symptoms again for rebound case of Covid. Also, he didn't know if supposed to report that or not. Caller does not think his mother required any treatment. Paxlovid NDC/LOT/Expiration was unknown. Description of Product Complaint: Description of complaint: Had Covid after unspecified Covid vaccine. Doesn't know if it was the Pfizer Covid vaccine. Caller declined to complete report. Full details unable to be obtained. Patient received treatment with Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Multiple reactions after the 2nd dose of the Pfizer vaccine.  Significant fever (104 degrees), body aches, chest pain and verified elevated heart rate, face flushing with small blister like rash on face.  We had a virtual appointment the day after the 2nd vaccine was given when my daughter complained of chest pain.  I manually took her pulse at the request of the doctor and it was elevated.  We were instructed to give her Advil and come in if the pain or sensation of a racing heart continued.  The fever and chest pain subsided by the next day (two days post vaccine).  The skin flushing and bumps on the cheeks did not subside and we went to physically see the doctor 3 weeks after the 2nd vaccine.  My daughter was diagnosed with Photo Dermatitis caused by the Pfizer Covid vaccine.  I have (in writing) that she had a baseline for the very rare disorder that was directly exacerbated by the Covid vaccine which has brought out constant symptoms on my daughters face and hands.  Since receiving the 2nd COVID vaccine my daughter has been allergic to the sun and diagnosed as such.
Had a generalized seizure lasting 30 minutes and requiring IV Atiran to stop. X ray need for soft tissue.
This case was reported by a physician and described the occurrence of ear pain in his wife who received hepatitis A inactivated and hepatitis B recombinant vaccine. On 10/27/03, the patient received the first dose of Twinrix. On an unspecified date in December 2003, approximately seven weeks later, the patient developed ear pain and was hospitalized. As of 12/22/03, the event was unresolved. The reporting physician considered the earaches to be unrelated to vaccination with Twinrix.
NDC: 80777-0273-99 I am post menopause in hormones, but started cramping and bleeding.  (Spotting, and painful cramps) 3 days Rash on spine mid -low back area 3 days ...typical sore arm, no fever or chills
Arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt a little). At the time of the report, PAIN IN EXTREMITY (Arm hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medications were reported.  No Treatment medications were reported.   This case was linked to MOD-2021-314861, MOD-2021-314862 (Patient Link).
Temp Excursion of 1.5 Degrees for a total of 34 minutes.   Vial was previously opened on 7/28/2023  No symptoms from patient.
medication leaking out of the syringe barrel, no AE; medication leaking out of the syringe barrel due to crack is in it, no AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old female patient who received a 0.5 mL INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ290AB, expiry date: 09-Jun-2020, via intramuscular route in unknown administration site on 20-Nov-2019.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Inappropriate dose of vaccine administered.  It was also a case of syringe leak.  It was reported that pharmacist was attempting to inject Fluzone High-Dose vaccine to a 78 year-old female. When he pressed down on the plunger, he noted the medication leaking out of the syringe barrel. The caller stated the needle had already pierced the patient's skin when this issue was discovered. He stopped and re-vaccinated with a different Fluzone HD pre-filled syringe  No adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
This spontaneous report was received from a nurse refers to an unspecified number of patients of an unknown age and gender. The concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the unspecified number of patients received improperly stored ROTATEQ (Lot number and dose were not reported) orally. No adverse effects were reported. Additional information has been requested.
Patient developed a rash on and around area where Band-Aid was applied. Also complained of extreme itching surrounding area. Swelling on and around injection site visible, within 24 hours of receiving vaccine.
pt was brought back to clinic 1 hr p/receiving vax w/c/o rash over entire body & itching; PE-multiple urticaria, wheezing; tx Epi; IMP; allergic reaction;
Shingles; Information was received from a lawyer regarding a case in litigation and refers to a 61 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of her receipt of zoster vaccine live(ZOSTAVAX), in April 2007, patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are pennanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Onset second morning after injection: headache, chills, nausea, loss of motor control in legs ( unable to stand or walk, unable to roll over to get out of bed), profuse sweating. About 1pm my wife assisted me to the bathroom toilet, where I passed out for approx 30 mins. These severe reactions finally started to recede about 6pm, although the sweating continued into Sunday.  Mild nausea, and mild headache continued into today Tuesday.
Severe allergic reaction; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001120.  A female 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
got really sick; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 experienced ILLNESS (got really sick) and PYREXIA (Fever). At the time of the report, ILLNESS (got really sick) and PYREXIA (Fever) outcome was unknown.   Action taken with mRNA-1273 in response to the events was not applicable    No concomitant medications provided Treatment information was not provided   This case was linked to MOD-2021-072952 (Patient Link).
Information has been received from a nurse, referring to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-FEB-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M018436 and expiration date on 13-APR-2018 (Strength, dose, anatomical location and administration route were not provided) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursions of an unspecified temperature (reported as more than 14 Fahrenheit (F) and less than 46 F) with a time frame of 3 hours. It was reported that no previous temperature excursions occurred and a digital data logger was involved. No product quality complaint (PQC) was involved Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date in 2015 (reported as since 29-JUN-2015), the unspecified number of patients were vaccinated with GARDASIL (route of administration, dose, lot# and expiration date not reported). The GARDASIL was improperly stored. There was no adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
COVID Positive>14 days post vaccine  Narrative: COVID positive >14 days post vaccine
He has well controlled focal epilepsy from old traumatic brain injury. Seizure free since 2015 on current medication. He reported to me today at routine visit that after first Covid-19 vaccine in Feb he had high fever, chills for 2 days. During that time he had a breakthrough focal seizure. No subsequent seizures with second vaccination, had milder side effects.
Pt presented 12/1/21 for first dose of pfizer vaccine. Second dose was administered 12/17/21. Vaccine doses were administered too close together. No know adverse events or side effects occurred.
Influenza vaccine administered at health fair at 9:45am,at 2:00pm developed swelling of eyelids,tightness in chest,cough.Benadryl 25mg po given coughing increased.Epinephrine 0.2ml given EMS called. Transported to ED.
ABOUT 15 MINUTES AFTER THE PATIENT RECEIVED A HIGH DOSE FLU SHOT (FLUZONE HD QUAD)  SHE WAS FEELING DIZZY AND HAD BLURRED VISION. SHE WAS GIVEN ORANGE JUICE BUT DID NOT SEEM TO GET BETTER. PARAMEDICS WERE CALLED AND SHE WAS TRANSPORTED TO THE HOSPITAL TO BE CHECKED. AFTER SHE WAS RELEASED FROM THE HOSPITAL SHE CAME BY THE STORE THE SAME DAY TO THANK EVERYONE FOR ACTING QUICKLY AND NOTHING BAD HAPPENED TO HER.
Mild fatigue; Rash at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Mild fatigue), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced FATIGUE (Mild fatigue), VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain at injection site). The patient was treated with ARNICA MONTANA (ARNICA (PLANTA TOTA) "WELEDA") for Pain, at an unspecified dose and frequency. On 10-Mar-2021, FATIGUE (Mild fatigue) had resolved. At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.        Treatment medcation included Arnica. No concomitant medications were reported   This case was linked to MOD-2021-067351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received  including Email address provided
No adverse effects reported. The patient came into the Pharmacy stating her prenatal physician wanted her to receive an RSV vaccine.  She stated that she was approximately 9 days from delivery. (35 weeks?) When the provider's office called to ask which RSV vaccine, it was determined that Abrexy, rather than Abrisvo was administered.
pt recv vax late OCT96 & devel an inj site rxn w/a quarter size welt w/redness & induration pt recovered;this is 1 of 5 pt;
Employee c/o dizziness, high blood pressure and nausea immediately after injection. Employee vomited and was assessed by MD.  Per MD on-site at clinic, the patient's BP was "elevated but WNL."  Received water and was monitored for an additional 45 minutes.
pt recvd Tetanus shot @ 1900 24SEP92; approx 2 hrs later felt dizzy & weak enough to leave work; hot & cold sensation & felt achy all over body; also felt nauseated;
My son had his physical for school on 8/16/17 and was in excellent health. The doctor recommended we give him the HPV vaccine. We asked him about the safety of it and he said it was safe. That night he started vomiting a little. 8/17/17 he said his stomach was upset and he had pain in his legs, that evening he said his stomach was sore, and vomited more that night. 8/18/17 he woke up and said his stomach hurt, as soon as the doctors office opened we called and they said it was probably just a reaction from the vaccine and to bring him in at 1:00 in the afternoon. We were there for 2 hours, then he sent us to the ER. At 9:30 they removed his appendix which had burst and the surgeon said had been burst for a while. He is still in the hospital, and probably will be the rest of this week 8/20-8/26. And they said he probably won't be able to start school next week. During his physical, the doctor felt and listened to his appendix and everything was fine. I mentioned several times to all the doctors involved during the last several days that he had the HPV vaccine and they were all saying it was unrelated, then I found a few documents stating that the HPV vaccine has directly caused appendicitis in .3% of cases. That information was not known to myself or the doctors, because when I showed them the information they said they never knew that. If we had known that possibility we would have called the doctor when his stomach first started hurting and the doctor probably would have sent us to the ER much earlier.
Diarrhea started 2 days after vaccination. Would experience diarrhea shortly after eating. At this time it is ongoing and has lasted for over a week (started 10/20/18 and today is 10/27/18).
diarrhea; back pain; feeling constantly cold; nausea; injection site pain; A spontaneous report was received from a pharmacist concerning a 47-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, backpain, diarrhea, nausea, and feeling constantly cold.   The patient's medical history was not provided.  Concomitant medications included Bystolic and Lexapro.  On 26 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 037K20A) in the right deltoid for prophylaxis of COVID-19 infection.   On 26 Dec 2020, the patient experienced injection site pain after taking the vaccine until 29 Dec 2020.  On 02 Jan 2021, the patient experienced backpain, diarrhea, nausea, and feeling constantly cold.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, injection site pain, was recovered on 29 Dec 2020.  The outcome of the events, backpain, diarrhea, nausea, and feeling constantly cold, was considered not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
severe singles outbreak on 06/17/21.   continues to be a severe problem after numerous RX and RX lotions.   severe pain the first  3 weeks.  finally was referred to a pain management DR and have obtained some relief.
PATIENT  LIGHTHEADED. PATIENT WAS LAID DOWN.  MOTHER AT HER SIDE.
Information has been received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 14-SEP-2018, the patient received improperly stored (-14 Celsius (C) degree to -10 C degree for 5 hours; there was no previous temperature excursion) VARIVAX (lot # R017636, expiration date auto-generated as 20-JUN-2020, also reported as 30-JUN-2018; strength, dose, frequency and route were not reported) for prophylaxis and was also reconstituted with sterile diluent (MERCK) (lot # R001089, expiration date 18-SEP-2020; strength, dose, frequency and route were not reported). No adverse effect was reported. It was not because of a data logger. Sender's Comments: US-009507513-1810USA011660: US-009507513-1810USA011661.
LETHARGY AND 101/102 FEVER FOR 24 HOURS INJECTION SITE RASH AFTER FEVER SUBSIDED
lightheaded, back pain, nauseated, chills-onset 2 hrs p/inj; pt went home felt well enough to drive;
Fatigue within 2 hours. next morning, headache, body and muscle aches, terrible lower back and leg pain. As day continued chills and cold bones, nightsweats. Sleeping for 10 hours at a time.  These symptoms lasted 48 hours. I still have residual back aches. I had the same symptoms in Dec- January when I was diagnosed positive with Covid. I felt like I was sick all over except in January I was sick for 10 days to 2 weeks
Nausea 2 days, headache 3 days, aches 5 days, fever one day (100.2), sniffles with clear drainage, rash over right eye across inter canthus to lower lid, redness inner right eye, and slight rash right nose.
This spontaneous report was received from a physician via a company representative refers to an unknown age and gender patients. Approximately in 2010 ("about 3 years ago" as reported) the patients were vaccinated with a dose of ROTATEQ (lot#batch# unspecified), formulation, route and dose unknown. The patients developed irritability, crying, loose and bloody stools after receiving the first and only dose of ROTATEQ. This was 2 of 2 cases reported for ROTATEQ. The patient had sought medical attention. On an unspecified date, the patient recovered from irritability, crying, loose and bloody stools. Additional information has been requested.
COVID-19; Sweating; Mobility decreased; Painful joints; Hangover; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19), HANGOVER (Hangover), HYPERHIDROSIS (Sweating), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Painful joints) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In January 2021, the patient experienced COVID-19 (COVID-19) and HYPERHIDROSIS (Sweating). In 2021, the patient experienced HANGOVER (Hangover), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Painful joints). In 2021, COVID-19 (COVID-19), HANGOVER (Hangover) and ARTHRALGIA (Painful joints) had resolved. At the time of the report, HYPERHIDROSIS (Sweating) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
A few hours later my arm was sore, lump in my left arm and went away and then in my lump left breast. I contacted a few weeks to my doctor.