chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body was aching; couldn't go to work for 3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as 1st dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "body was aching"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered", described as "couldn't go to work for 3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel a macular rash;JUL97 pt exp malaise, n/v, myalgia, fever 102, dec WBC count 2,0 & a dec platelet count 127;WBC down from 5.0 & platelet count down from 140;
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature was 34 Fahrenheit degree and the type of excursion was refrigerator (R). The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Pt recvd HIBTITER/DTP & devel hives next day, tx DPH;
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Medium, Systemic: Vomiting-Severe, Additional Details: none
Headache 4/10 left side.  Pt. stated that he still had a headache.  pt. informed that if symptoms persist or worsen to call 911.  Pt. told to follow up with primary care provider.  Pt. verbalized understanding.  Pt. A+Ox3.
Red itchy rash, redness swelling hot at injection site. Dx w/varicella on 3/23/11.
Major soreness in left arm, headache. Approximately 5-6 hours after injection At soreness, took 400mg ibuprofen, 50mg zinc supplement and 2tbsp of elderberry supplement. Overnight, fever with chills. Around midnight. No medicines taken. Fever had broken by morning.
I experienced COVID after my vaccine. My symptoms consisted of cough, difficulty getting air in, felt feverish, headache. I had chills, runny nose and very sore throat on Day 0.  I also lost my voice on Day 1.  On Day 2 my ears hurt and felt very weak. I had night sweats and swollen glands, weak hoarseness, very fatigued and achy legs on Day 4.  I took Tylenol for pain. I also Paxlovid on Day 1. I also took several rapid COVBID tests and did not go out of my house.   I still have some hoarsens in my voice that comes and goes and regard this as a change and my voice is minimal with sore throat.
Fever, Headache, Diarrhea, Fatigue, generally feeling bad After 9 days got covid test which was negative. Then went to doctor for diarrhea which was really bad( 4-6 times a day. Stool test diagnosed me with c diff. On antibiotic until March 20,2021, Diarrhea getting better but not back to normal
May 3rd 2021/first dose was given by error/vaccine had expired on 4/13/2021; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number EY93J, expiry date 13th April 2021) for prophylaxis.   On 3rd May 2021, the patient received the 1st dose of Shingrix. On 3rd May 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information was provided as follows:  On 3rd May 2021, the patient received 1st dose of Shingrix which was already expired on 13th April 2021. The reporter asked for side effect to report. The reporter consented to follow up.
Tenderness & swelling at injection sites. Also c/o headache, nausea and fever.
Systemic: Fainting / Unresponsive-Mild, Systemic: patient was anxious before the vaccine and is afraid of needles. 911 was called, emt arrived and assisted the patient. patient's vital signs were taken and were all within normal limits.-Mild
The day after the vaccine she experienced malaise, fever and chills.  That resolved.  Four days later she developed angio-edema that developed over the course of 6 hours with shortness of breath and weakness and confusion.  She had laryngeal edema.  she was treated with epinephrine, steroids and antibiotics.  symptoms improved within 24 hours and  resovled by 48 hours to 72  hours.  she was discharged after 3 days in the hospital
This spontaneous report as received from a office manager refers to patients of unspecified demographics. Reporter stated that doses of improperly stored ROTATEQ (units unspecified) (lot number, expiry date unspecified) were administered to unspecified patients on unspecified dates. No adverse events were reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
both breast became flaming red, red bridge between,  smooth rash  3 1/2 days
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The Nurse reports no adverse reactions or side effects to the Moderna COVID-19 vaccine.  No concomitant medication was reported. No treatment medications was reported.  It was reported that the vial was moved to refrigerator on 03-Mar-2022.Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022.Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit.
Feeling strange, kind of weird; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling strange, kind of weird), FATIGUE (Tiredness) and HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-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 05-May-2021, the patient experienced FEELING ABNORMAL (Feeling strange, kind of weird), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Feeling strange, kind of weird) and FATIGUE (Tiredness) outcome was unknown and HEADACHE (Headache) had resolved.            No concomitant medication were reported.  Patient  said that every evening around supper time he start feeling strange, kind of weird. He used to drink half a quart of water and eat and then felt good after 30min. He had headache earlier but that went away after a day or two.   No additional  treatment information was reported.   This case was linked to MOD-2021-089530 (Patient Link).
Information has been received from a certified medical assistant (C.M.A.) concerning a male who on 10-JAN-2000 was vaccinated with a dose of Varivax. In January 2006, the patient experienced a chickenpox breakthrough. No medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information was received on 05-JUL-2006 from the C.M.A. indicating that she is unable to provide any further information because no names were given at the time of the report. No further information is expected.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 04-JAN-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 14-AUG-2015, the patient was treated at a nursing center for a vesicular outbreak, which was diagnosed as shingles. The patient has been prescribed acyclovir and a topical ointment to manage his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
not yet received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th December 2020).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No reactions reported. The reporter consented to follow up.
On 11/17/08 received 2nd ROTATEQ, PREVNAR, DTaP, IPV, Hep B, Hib. Baby soon after developed liquid diarrhea. One with blood.  1/5/08 Reviewed PCP medical records of 11/20- FINAL DX: none provided Records reveal patient in good health on day of vaccination w/eczema over cheeks.  RTC 11/20 w/blood in stool x 2 days & hyperactive bowel sounds.  No further records available LABS: stool analysis w/many WBCs; no O&P; c/s neg.
Roaring in ears within 15 min of injection, Late night chills an aches with rash and swelling into collarbone the next day.
consumer received an extra dose of menquadfi in error with no reported adverse event; Initial information received from on 19-Oct-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age male patient, and reporter stated consumer received an extra dose of meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 25-Oct-2022, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot number, strength, expiry date: unknown) not reported via unknown route in unknown administration site for immunization. On 18-Oct-2023 he also received 0.5 ml total dose of the same vaccine (lot number, strength, expiry date: unknown) via unknown route in unknown administration site for immunization and consumer received an extra dose of menquadfi in error with no reported adverse event (extra dose administered) (latency: 11 months 24 days) following the first administration and (latency: same day) following the last administration of meningococcal A-C-Y-W135 (T CONJ) vaccine.  It was reported that a patient received the vaccine sooner that they should have. Patient received vaccine a little under 3 years and The clinic reported that the consumer received an extra dose of MENQUADFI in error described as getting a dose on 18Oct2023 that was not needed due to having their dose last year on 25Oct2022.   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 the 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 as received from a medical assistant (M. A.) refers to multiple unspecified patients. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not specified). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fatigue; Low back pain/lower back ache; Headache; Profuse cough; sore arm after the injection; throat was sore; glutes hurt; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program COVAX US Support. A female patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 01Apr2021 via an unknown route for Covid-19 immunization. Medical history included cough and fatigue. She mentioned that couple of days before receiving her second dose of the Pfizer COVID-19 vaccine she felt really fatigued "wiped out". Patient inquired if it was possible she had COVID-19 before she received her second dose, and inquired "Hypothetically speaking, if I did have COVID before that second dose [of the Pfizer COVID-19 vaccine] did I not need to get that dose or should I have still gotten it?"  Concomitant drug was not provided.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 for Covid-19 immunization. She mentioned that 3-4 days after her second dose, she experienced fatigue, low back pain, headache and profuse cough. It took 3 days before she got her energy back.  She reported that she had a cough for about a year and a half (as of 12Apr2021). She had seen a cardiologist, pulmonologist, gastroenterologist and her primary care doctor about this cough and no one care figure out why she had it, however, she stated that it did seem to have gotten worse since she had taken the second dose of the Pfizer COVID-19 vaccine. She further stated that she received her second dose and had a sore arm after the injection, but then 3 days later she reported that she felt really bad. She laid on the cough all day long, had a lower back ache and glutes hurt. She also states that her throat was sore.  Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
8/13/15 ER developed maculopapular rash on trunk, arms and legs. ER stated chicken pox. 8/16/15 ER again now with rash on face, under nose and upper mouth. ER states impetigo. Mom unable to reach by phone or certified letter. Lost to follow up.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age who on unknown date completed her three-dose series of GARDASIL (dose, lot# and expiration date were not reported), intramuscular. On unknown date reported as "2-3 months ago", the patient had Pap smear which came back with a positive HPV result. Genotype testing was performed in order to determine which strain of HPV the patient was diagnosed with but no results were available at the time of the report. On unknown date the patient sought medical attention by office visit with obstetric and gynecologist. At the time of the report, the outcome of human papilloma virus test positive was unknown. Additional information has been requested.
Pt passed out, BP-80/50, had numbness in feet and arms and legs, and tremors. Pt was taken to hospital. Hospital concluded it was an allergic reaction and referred pt to an allergist.
rash over upper arm, hot to the touch, itchy, painful, swollen cold compress used as treatment most symptoms cleared up within 72hrs; redness and mild swelling persist as of writing (10 days after first appearance)
Tested positive for covid on 3/8/23. Went on Paxlovid.
08/25/2021 (530pm) fuzziness , like in a daze a little bit. 08/25/2021 (8pm) headache started  08/25/2021 (9pm) feeling of sleepiness started  08/26/2021 (9am) woke up with left arm hurting couldn't lift 08/26/2021 (12pm) jaw started locking, hard to move jaw 08/26/2021 (3pm) had to call off work , couldn't lift arm still 08/26/2021 (5pm) severe headache started
Information has been received from a physician concerning a 12 month male with no pertinent medical history, a possible penicillin allergy, and who may have been on an "antibiotic" for "OM" when he was vaccinated on 23 FEB 2007, at 10:30 AM, subcutaneously into the left thigh with a first dose, a 0.5 ml, dose of ProQuad (Lot # 656550/1531F). Five days after vaccination, on 01 MAR 2007, the patient developed a diffuse, non-pruritic, measle like rash. The patient also had vomiting and diarrhea (viral gastroenteritis) and was on an antibiotic for "OM". The patient had a fever of 102 to 103F. In the beginning of March, patient was prescribed Augmentin and developed a rash. Medical attention was sought, at which time it was thought the patient may be allergic to penicillin. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered. No product quality complaint was involved. Further information is not expected.
This spontaneous report was received from the patient's friend via a company representative referring to a 15 year old non pregnant female patient. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unspecified date in 2009, (also reported as "sometime in the year 2009") the patient was vaccinated with the first dose of GARDASIL for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On the same date, after receiving the dose of GARDASIL the patient experienced a fever that lasted for one day. Furthermore, it was unknown whether the patient received treatment to the aforementioned event. At the time of the report, the outcome of pyrexia was reported as resolved. Additionally, the reporter did not provide causality assessment between the event and vaccination with GARDASIL.
This case was reported by a pharmacist via call center representative and described the occurrence of shivering in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included FLUAD for prophylaxis. On an unknown date, the patient received SHINGRIX and FLUAD. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shivering, fever, fatigue and gastrointestinal upset. On an unknown date, the outcome of the shivering, fever, fatigue and gastrointestinal upset were recovered/resolved. It was unknown if the reporter considered the shivering, fever, fatigue and gastrointestinal upset to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIS and FLUAD into arm. The pharmacist reported that she had given SHINGRIX to many people and followed up with each recipient. Additionally, she had given 2 patients FLUAD at the same visit as SHINGRIX (in opposite arms). The pharmacist stated that, most of the patient's reported shivering, gastrointestinal (GI) upset, fatigue or low-grade fever which was mild and resolve within 24 hours. The pharmacist stated that these 2 people did not report any different or more severe side effects compared to those who did not receive FLUAD and got SHINGRIX alone. The pharmacist said that, she did not feel like these adverse events were worthwhile to report, as they were all mild and self limiting. The patients that received FLUAD on the same day did not experience worse symptoms. This case has been linked to the US2018GSK177718 (unspecified number of patients who received only SHINGRIX) and US2018GSK177719 (the 2nd patient who received SHINGRIX and FLUAD both), reported by the same reporter.
Bone and joint pain, fever. Joint pain severe.  Headache. Lasted 48 hours.
This is a spontaneous case, initially received from other health professional (nurse) on 23-Oct-2018, concerning a 70-year-old, elderly, male patient. The patient's current condition included chronic lymphocytic leukemia (CLL) (reported as medical history) (diagnosed 7 to 10 years ago, as reported). On 23-Oct-2018, the patient was administered expired FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195215 and expiry date: 30-Apr-2018]. It was reported that the patient would revaccinate. At the time of this report, no adverse event was reported after vaccination. The reporter assessed this case as non-serious. Non-significant follow-up received from the reporter on 26-Nov-2018: The reporter confirmed that the patient was diagnosed with chronic lymphocytic leukaemia (CLL) 7 to 10 years ago. Also, it was confirmed that no adverse event was reported after the administration of expired vaccine. The narrative was amended accordingly.
About 5 minutes after vaccine administration the student vomited. Pale v/s 68/44 R 14 P 60 11:22. Had lunch-12:05 feels better B/P 94/70. Color good skin warm/dry. Mother present. Back to class.
Shoulder was very red, swollen, large area around the injection site was puffy, painful and itchy. Couldn't move shoulder for 2 days.
MOM REPORTED PATIENT WOKE UP ON 02/28/2019 WITH A RASH ON HER BODY (FACE, LEGS, ARMS, BACK, STOMACH). MOM REPORTED THIS HAS NEVER HAPPENED TO HER BEFORE AND SHE HAD NOT EATEN, DRANK, OR BEEN AROUND ANYTHING NEW. I REFERRED PATIENT TO HER DOCTOR. MOM STATED SHE WOULD TAKE HER IN TO HER DOCTOR SAME DAY.