chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site vesticle - Information has been received from a physician concerning a 15 month old male patient with no known allergies who no known allergies who on 24 Apr 2000 was vaccinated in the right deltoid with the first dose at varicella virus vaccine live (lot 632616/16883) Concomitant vaccine that same day included the fourth dose of diphtherin toxioid (+) aceliular pertussis (+) tetanus toxoid in the left arm Lot u0163ca.  Concomitant therapy also included amoxicillin for otitis media at the time of vaccination.  On 04 May 2000 the patient developed fluid filled vesicles in a ring at the injection site around where the varicella virus vaccine live was given.  He was afebrile and the vesicles wee non pruritic.  On 13 May 2000 the patient's mother noted that she saw 2 rings of vesicles.  On 15 may 2000 the patient was seen by a physician who reported seeing only one ring with the vesicles resolving and fading hyperpigmented area where the vesicles reportely were.  on an unspecified date the patient recovered.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On 20-NOV-2015, the patient was vaccinated with improperly stored adult dose of VAQTA (lot # reported as L027735, expiration date: 12-JAN-2017) (dose and route of administration were not reported) and improperly stored dose of GARDASIL 9 (lot# L013429, expiration date: 21-JUL-2017 or lot# reported as L020015, expiration date: 16-AUG-2017 or lot# L0257373, expiration date: 28-JUL-2017) (dose and route of administration were not reported). No adverse effect was reported. There was no product quality complaint. This is one of several reports from the same reporter. Additional information has been requested.
rash at the injection site; pain in shoulder; This is a spontaneous report from a contactable consumer (patient) received via Pfizer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he developed rash at the injection site after getting the shot and has pain in shoulder. The clinical outcome for the events was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous report was received from a physician refers to an unspecified number of patients of an unknown age and gender. the patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with first dose of GARDASIL 9 injection (lot number/expiry date and dosage not reported). On an unknown date, the patients were late in receiving the second dose of GARDASIL 9 injection (lot number/expiry date and dosage not reported). No adverse symptoms reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
2 nights p/vax t103, inconsolable crying, screaming, no social behavior, opening & closing hands, staring off into space; on 30SEP temp dropped 94.4-no communication;child holding stomach as in pain
I contracted COVID-19 after exposure to my husband who tested positive on 06/21/2022. He was quarantining in isolation in the house when I became symptomatic with a sore throat that would not go away. My sore throat began on 06/24/2022. I had a fever of 101 degrees F., chills, night sweats, and had trouble swallowing. I also had swollen glands and my neck was sensitive to the touch. I received the monoclonal antibody infusion on 06/28/2022. My symptoms resolved completely on 07/05/2022. My husband's symptoms were different, where he had a persistent dry cough that he could not control. His symptoms lasted until 08/05/2022. He had no fever and no sore throat. He was vaccinated against COVID-29 with his 4th booster.
Flu like symptoms; maybe coming down with cold but not serious but its there; just not feeling well; having chills but not terrible; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (maybe coming down with cold but not serious but its there), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (just not feeling well), CHILLS (having chills but not terrible) and FATIGUE (feeling tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included RA (Rheumatoid Arthritis). Concomitant products included CELECOXIB (CELEBREX) for Pain, METHOTREXATE for RA, PREDNISONE for an unknown indication.    On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (maybe coming down with cold but not serious but its there), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (just not feeling well), CHILLS (having chills but not terrible) and FATIGUE (feeling tired). At the time of the report, NASOPHARYNGITIS (maybe coming down with cold but not serious but its there), MALAISE (just not feeling well), CHILLS (having chills but not terrible) and FATIGUE (feeling tired) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.   This case was linked to MOD-2021-269189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Event outcome updated for flu like symptoms as recovered/resolved.
Prolonged on & off  fatigue for 10 days with on & off chills.
I have been bloating since the time I got the vaccine. I have gone to the hospital, bloating was that bad, they did scan with contrast, blood work, stool sample, breathing test everything comes back negative. So far no one can find the reason for my bloating,
PATIENT EXPERIENCED SWELLING AND ERYTHEMA AT INJECTION SITE, SHE WAS LATER DIAGNOSED WITH CELULITIS AND PUT ON ORAL ANTIBIOTICS
Client started to turn pale and clammy and stated that he was not feeling well. Stated he felt like he needed to throw up and was nauseated. Client began to have dry heeves, but did not vomit.  Client then appeared like he was going to pass out, so laid client on the floor with feet up.
Started croupy cough at 3am,followed by fever. Was fine during the day but at 9:50pm,awakened from sleep stidorous,dyspneic,tachypneic, intercostal and supraclavicular muscle retraction---called 911--brought to ER--admitted to PICU for Severe Croup r/o Tracheitis. Discharged within less than 24 hrs of admission Final Diagnosis: Influenza B, Croup.  10/26/09:  Hospital Records and Discharge Summary received for dates of service 10/19/09 to 10/20/09.  Dx: Croup, Influenza B.  Assessment:  Presents with fever and respiratory distress, mild rhinorrhea, throat pain, hoarse voice, T max 102.  Mother describes stridor increased WOB and writhing.  Treated in the ED with 2 racemic epinepherine nebs and decadron.  Wheezing was noted and he was given 2 combination albuterol/atrovent nebs followed by 1 hr. of continuous albuterol with excellent response.  There was a concern of bacterial tracheitis, so the pt. was given ceftriaxone.  Continued on cool mist overnight and continued to have barky cough.     ICD 9 Codes:  487.1, 382.9.
1.23~starting with stomach ache and lots of elimination which turned into diarrhea. 1.24~awful diarrhea and stool was black for a few eliminations.  Fever, Chills, Nausea, arm sore, headache, fatigue, body ache 1.25 ~ symptoms continued 1.26 ~ more black stool.  Dr. advised me to go to ER.  They did find blood in stool. 2.1~finally had normal bm and started to feel better
Breakthrough case admission after 3 vaccines Pfizer 3/1/21 Lot# EN6199;  Pfizer 4/1/21 Lot# ER8733;  Pfizer 12/11/21 Lot# FJ8757
Night of (4/8/21, 8:00pm), I experienced notable fatigue.  Day after (4/9/21, beginning 9:30 AM), began to feel dehydrated, dizzy, hot flashes, and nauseated.
EXTREME LETHARGY; HEAD PAIN AND PRESSURE; NAUSEA AND LOSS OF APPETITE- THESE LASTED FOR ABOUT 36 HOURS SORENESS OF INJECTION SITE FOR 2-3 DAYS
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 09Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative, notes: testing negative and finishing Paxlovid anti-viral pills. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
THE PFIZER BI-VALENT FOR AGES 5 YEARS OLD TO LESS THAN 12 YEARS OLD WAS ADMINISTERED TO THIS PATIENT INSTEAD OF THE ADULT DOSE.
Some vaccine leaked out during vaccination; Some vaccine leaked out during vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Some vaccine leaked out during vaccination) and UNDERDOSE (Some vaccine leaked out during vaccination) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (Some vaccine leaked out during vaccination) and UNDERDOSE (Some vaccine leaked out during vaccination). At the time of the report, DEVICE CONNECTION ISSUE (Some vaccine leaked out during vaccination) and UNDERDOSE (Some vaccine leaked out during vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment medications provided by the reporter.
7 year old was given Kinrix, which is only indicated for 4-6 year old. No adverse event
Muscular pain in the shoulder, arm and neck through the evening and following day, enough that it limited my lifting my arm.   Further I began feeling extremely itchy on my arms, hands, and face. Checking later in the evening, I did have red blotches all over both arms and shoulders.  Took a benadryl and by morning the red blotches were gone as well as the itching.
Information has been received from a healthcare worker concerning a 65 year old female who on 11-SEP-2009 was vaccinated with "just one time shot" of ZOSTAVAX (Merck) (Lot # 664091/0140Y). It was reported that it was a vaccine failure with ZOSTAVAX (Merck). On 26-MAY-2010 the patient got shingles. It was a rash on her back and it was diagnosed as shingles. She was prescribed NEURONTIN and VALTREX which was given to treated it. "It was a mild case." It was reported that the patient was fine and recovered from shingles. The patient sought unspecified medical attention. Additional information has been requested.
After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down.  Few seconds later, my heart beat increased faster and faster, my neck turned red.  I called for help, they gave me some apple juice to drink and talked to me.  About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color.  I only had a little vertigo symptom but I was able to manage myself.  About 2 hours later, symptoms disappeared and I was back to my normal health
Headache / migraine medicine did not help; Chest pain; Pain at the injection site; Chest congestion / better but would come and go; Sore throat; Runny nose; Fever of 99.2 / her temperture normally runs low; Sinus pressure / Sinus issues; Sinus pain / Sinus issues; Scratchy throat; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine and allergy.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than 2 weeks after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation. On 20th November 2020, the patient experienced chest pain and injection site pain. On 22nd November 2020, the patient experienced headache. The patient was treated with antimigraine preparations (Generic Migraine Medicine (Name Unknown)). On 10th December 2020, the outcome of the lung congestion, sinus pressure, sinus pain and throat irritation were recovered/resolved. On an unknown date, the outcome of the chest pain, injection site pain, headache, sore throat, runny nose and fever were unknown.   It was unknown if the reporter considered the lung congestion, chest pain, injection site pain, headache, sore throat, runny nose, fever, sinus pressure, sinus pain and throat irritation to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. Next day after receiving Shingrix, the patient had chest pain and pain at the injection site. The patient also had a headache that her migraine medicine did not help. The patient also experienced sore throat, runny nose, fever of 99.2-degree F, sinus pressure and sinus pain and chest congestion. The patient had as covid test which was negative. On 04th December 2020, scratchy throat, sinus issues and chest congestion better but would come and go. The events lasted until 10th December 2020. The patient mentioned that her temperature normally ran low at 96.8-degree F. The reporter provided permission to follow up with healthcare professional. For the tolerance of 2nd dose, refer linked case US2021AMR019262.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR019262:Same reporter.
Last 4 weeks I have lost my sense of taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Last 4 weeks I have lost my sense of taste) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Last 4 weeks I have lost my sense of taste). At the time of the report, AGEUSIA (Last 4 weeks I have lost my sense of taste) outcome was unknown.            Concomitant medication not provided. Patient reported to have changed medication with the time span of the vaccine.  Patient reported his last dose date was 08 March. Treatment information not provided.
Late evening/early morning patient reported severe headache, sweats and fever that lasted approx. 24 hours. He also experienced severe joint and muscle pain in his shoulders, arms, legs and back. This pain lasted 2 full days and has started to improve on the third day. It was so severe that he was unable to walk or barely move for 2 days.
Moderate to strong muscle soreness and tenderness to the touch around injection site, redness and slight swelling below injection site, dull headache, cold chills, felt lethargic, mostly noticeable upon waking the following morning. Took TYLENOL the following night, felt much better the next morning. The side effects were much stronger than I expected. I am in good health, normal weight range, walk on treadmill approximately 15-20 miles per week, nonsmoker, had chickenpox in early teens. Even though I still have some soreness and redness, I indicated that I recovered.
Lipomas - were removed June 2, 2021 at Hospital.  Got bacterial infection.  Still healing.  Right leg.   Muscle and nerve pain in upper left and right arms and/ upper left and right thighs.  Lasts several weeks but continues to return.
HANDS TINGLING; NAIL BED BLUE; This spontaneous report received from a patient concerned a 64 year old 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 08-APR-2021 in Left Deltoid for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced hands tingling. On 08-APR-2021, the subject experienced nail bed blue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hands tingling, and nail bed blue. This report was non-serious.
Rapid COVID-19: Negative. He had meningitis B vaccine and HPV vaccine yesterday -- discussed that he is likely having a reaction to one or both of these. He states his mother told him he used to have reactions to vaccines when he was younger as well. No signs of an anaphylactic or localized reaction. ER precautions reviewed at length. Advised him to rest, stay well hydrated, bland snacks/meals throughout the day, alternate ibuprofen/Tylenol per manufacturer's instructions. Notify us tomorrow of how he is feeling. If sx's persist/worsen/new sx's arise, discussed having him re-tested for COVID-19. He took today off work and may need to be off tomorrow as well. He declines needing a work note. He should be fever free for 24 hours before returning.
THE INDIVIDUAL RECEIVED LESS THAN 0.5ML OF THE JANSSEN COVID-19 VACCINE AS A BOOSTER DOSE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient received covid-19 vaccine from unspecified manufacturer (form of admin, batch number and expiry were not reported) dose was not reported, 1 in total, administered (dose number in series 1) for prophylactic vaccination. It was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A expiry: 11-APR-2022), 0.3 ml, 1 in total, administered (dose number in series 2) to left arm on 01-DEC-2021 for prophylactic vaccination which was an off label use as patient received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose (LLT: Vaccine underdose). No concomitant medications were reported. As per the report, the HCP withdrew 8 doses of the Janssen Covid-19 vaccine from 5 vials and 7 doses from 1 vial which injected into 48 individuals. When the caller had a discussion with that HCP, mentioned that he/she injected 0.5mL but the caller mentioned that the math (she arrived at that by dividing 2.5mL by 5 doses) did prove that they received approximately around 0.3mL."(dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the individual received less than 0.5ml of the Janssen covid-19 vaccine as a booster dose and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211210684, 20211210197, 20211210409, 20211210067, 20211209551, 20211210160, 20211210058, 20211209843, 20211209775, 20211210549, 20211210610, 20211210159, 20211210555, 20211210733, 20211210408, 20211209880, 20211210133, 20211209816, 20211209782, 20211212088, 20211212082, 20211209740, 20211209706, 20211209798, 20211209874, 20211209884, 20211209921, 20211209976, 20211210019, 20211210106, 20211210107, 20211210141, 20211210112, 20211210143, 20211210165, 20211210180, 20211210334, 20211210350, 20211210385, 20211210585, 20211210588, 20211210590, 20211210670, 20211210824, 20211210662 and 20211209912.
Large (7 cm x 6 cm)  area of redness, swelling, heat and discomfort onset within 24 hs after vaccine and pt report of hives on face with sl swelling of left cheek.
This spontaneous report was received from a pharmacist via Pfizer, referring to a female patient on her 30's with a history of pneumonia and current condition of asthma. No drug reactions were reported. On an unknown date, the patient was vaccinated with PREVNAR 13 administered in left deltoid, intramuscularly and was given instead of PNEUMOVAX 23 (wrong drug administered). There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
Lt leg (anterior thigh) 10 x 10 cm erythematous warm plaque with blanching.
started breaking into hives within 10  minutes of receiving the vaccine she received 50 mg of diphenhydramine
Immediately after vaccination, developed lingering sharp but short lasting chest pains. I also had what the internet calls 'COVID arm' where my arm was very red, hot, itchy, and swollen. Chest pains seemed to subside some around November (2 months later). However, mid-January, developed heart palpitations, cannot determine if this was due to having had COVID or the vaccine or the combination. Am presently taking a low dose of a medication daily, though palpitations persist. I am an otherwise healthy 39 year old, active woman.
The patient was admitted to the hospital on 7/31/2021 with worsening shortness of breath, lightheadedness, and abdominal pain. COVID-19 PCR test was ordered as a part of admission requirements. A chest x-ray shows signs of a right middle lobe infiltrate. Patient is not wheezing. Following the COVID-19 result, the patient was administered dexamethasone and remdesivir on 7/30/2021. At the time of this report, the patient is in stable condition.
Evening after receiving vaccine, felt "fuzzy, full feeling in tongue and throat".  No breathing issue.  Fever (101 degree)  and rash (all over body, red, flat petechiae) developed 24 hours after vaccine with diaphoresis and general skin flushing, body aches and, severe local arm reaction.  All symptoms resolved after 48 hrs.
Became very sleepy 8 hours post, slept 12 hurs straigt, awoke with cough, wheezing, tightness of chest, red painful eyes with blurry vision, copious discharge from nose similar to severe respiratory allergic reaction
8pm started to feel nauseous with headache.  Headache became stronger, sweating, increased respiration (45/min), fever 100.9, dizziness, SOB between 2200-0000.  14 weeks pregnant with chronic hypertension. eDD
blisters on the tongue, followed by itching, and anaphylactic shock from 11:30pm to 12:30am. benadryl and 2 epi pens were used and then at the hospital steroids and IV benadryl were utilized. Benadryl was used for the next 24 hours and then steroids were prescribed outpatient