chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DERMATOLOGY RELATED SKIN ISSUES; FLARE UP; RASH; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company concerned a 39 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not having any known allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, administered 1 in total, first dose on 25-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 39 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The patient received booster dose of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 2) (form of admin unknown, intramuscular, batch number and expiry was not reported) dose and frequency were not reported on 01-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date, the patient experienced dermatology related skin issues, flare up, and rash following vaccination with elasomeran (Moderna vaccine) (Dose number in series 2). It was unknown if patient was enrolled in covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s, adalimumab, and elasomeran was not applicable. The outcome of the rash, dermatology related skin issues, flare up and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Vaccine given In Left Deltoid.   Patient anxious about getting vaccine. Discussed and gave words of support. Patient wanted vaccine. After vaccine patient felt shakey. Took vital signs BP 162/100 per electronic BP cuff, Temp 97.9 F, P:100 SP02 99%. Patient stated she took medication today but did not eat yet. Given water, gave words of support and performed manual BP 10 min later and BP was 142/82. Patient stated she felt better has history of HTN was going to eat lunch and would call emergency if she starts experiencing Chest pain SOB or any concerns or will call provider if starts to have questions or concerns. Encouraged to follow up with provider. Patient stated she felt better and wanted to Continue to work. Supervisor present and aware of situation .
This medically confirmed report (initial receipt 30-Nov-2012) concerns a 31-year-old female patient. The patient was enrolled in a randomized controlled clinical trial. The patient had a medical history of frequent infections over the last year. She experienced impetigo a year ago and 2 episodes of methicillin-resistant staphylococcus aureus (MRSA) abscesses. She also had a B12 deficiency. on 24-Oct-2012, the patient received CSL influenza (batch number not specified). On 16-Nov-2012 (3 weeks and 3 days following vaccination) the patient presented to the emergency department (ED) with a severe headache. It was a preliminary case of viral meningitis. Spinal fluid revealed clear, colorless fluid. Total white cells were 33 in the 1st tube count and 39 in the 2nd. Percent lymphocytes were 88% in the 1st tube and 96% in the 2nd. Cerebrospinal fluid (CSF) ependymal cells were seen in both tubes, 6 in the 1st and 2 in the 2nd. CSF glucose was 47, peripheral glucose was 94 and CSF total protein was 89. It was felt that this was consistent with aseptic meningitis as the patient had a total white count in the periphery of 4.5, hemoglobin of 15, hematocrit of 43, platelet count of 209 with 60 segs, 28 lymphs and 7 monos on dip. The patient was admitted and placed on a broad spectrum of antibiotics to treat bacterial meningitis and acyclovir. Immunoglobulin (Ig) levels revealed IgG as 629 and IgM was 52 both only slightly low and IgA as 120 which was normal. The patient had a deficiency which would benefit from immunology consultation. The patient's mean cell volume (MCV) level was elevated at 101-103. A nasopharyngeal swab was negative for influenza A and B. Brain CT on 16-Nov-2012 questioned a mildly bulbous appearance of the anterior communicating artery. A small aneurysm could not be excluded. A final CSF culture was negative for bacterial meningitis. Her intravenous (IV) antibiotics were stopped per the direction of infectious diseases (ID) the day before discharge. The patient was feeling much better and after discussion with ID acyclovir was stopped. On 20-Nov-2012 she was discharged, at this time all viral studies were pending. Discharge medications included ondansetron 4mg orally (po) every 6 hours as needed (prn) for nausea and vomiting, PERCOCET 5/325 one to two po every 4 hours prn for pain, DIFLUCAN 150mg po x 1 prn for vaginal candidiasis, sennosides plus docusate 2 tablets po twice a day (bid) if taking narcotics, TORADOL 10 mg po every 4-6 hours prn for pain, and acetaminophen 325-650mg po every 6 hours for pain. The subject completed her diary card and reported minimal local symptoms and no general symptoms. The subject fully recovered and completed participation in the study.
Seen at Urgent Care on 5/23/12 at 9:06pm for swollen (L) thigh with redness at site of injection & diagnosed with cellulitis no fever. Child seen in office on 5/24/12 with swollen (L) thigh which has decreased as per guardian. Currently taking SEPTRA 200mg/40mg/5mL 7.5 cc PO BID x 10 days as per urgent care.
Tinnitus in left ear and hasn't stopped YET! I've had numerous tests done and everything is coming back normal.
Patient experiencing limited range of motion in shoulder socket, beyond typical soreness in deltoid. Concerned vaccine given too high.
On the day of the vaccination, a few minutes later (8 approximately) I felt mild dizziness, then the next day pain in the area of the vaccine (it was given on May 6), on Wednesday, May 12, when I woke up I began to feel very dizzy. Frequent at all times, at the moment today Friday 1:31 am I feel dizzy and nauseated, fatigue.
administration of expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Number of doses/vials 10-dose vial. Date the vial was initially stored in the refrigerator: 02-Sep-2021.  Number of doses/vials: 14 doses, which were administered  Date the vial was initially stored in the refrigerator: 30-Sep-2021.  No concomitant medication information were provided. No treatment information was provided.   This case was linked to MOD-2021-345448, MOD-2021-345472, MOD-2021-345642, MOD-2021-345457, MOD-2021-345456, MOD-2021-345619 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up information received on 08-Oct-2021: Significant follow-up appended, Reported added and Batch No. updated.
Kinrix administered to patient for her 3rd DTaP and 3rd IPV.
On 1/27/00, the pt developed a vesicular rash. The pt was seen by a physician 3 days after the rash began. The rash consisted of approximately 50 lesions over his trunk, arms, legs, neck, in scalp and on face. It was reported that the pt presented with a "full blown case of chickenpox that consisted of greater than 50 lesions. Four weeks after the rash began. The pt recovered.
Rec'd Menveo, HPV, Bexsero & after HPV became dizzy, pale, felt faint. BP dropped. Had eaten breakfast prior to visit
Injection site swelled up to size of an orange and was red and itchy (per pt); pt took MOTRIN and the swelling went down to pinpoint within 1-2 days.
got shingles shot and 3 month later I got Shingles/suspected vaccination failure; shingles, almost lost my eyesight; almost lost my eyesight; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and profound vision impairment, one eye (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and profound vision impairment, one eye were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and profound vision impairment, one eye to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles shot and got shingles so bad that almost lost left eyesight and still have problem with left eye at the time of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. This case is linked with case US2021AMR156120 for comment response.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156120:Comment response
an unspecified physician "drew titers" and the results came back "negative and she did not have any titers"; injection site reaction; bruising; itching; erythema; injection site hurts when I rub up against it; This spontaneous report was received from a 56-year-old female patient who was also a pharmacist, referring to herself. The patient's concurrent condition included 30-40 pounds overweight. She did not have any drug reactions/allergies (reported as none). Concomitant medications included a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dosage regimen, route, lot # and expiration date were not provided), as prophylaxis on the opposite arm (on 27-APR-2020).  On an unspecified date in 2007 (reported as "13 years ago"), she was vaccinated with a dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) (manufacturer unknown) (reported as unspecified MMR vaccine). Then, on an unknown date, an unspecified physician "drew titers" and the results came back "negative and she did not have any titers" (antibody test negative).  On 27-APR-2020, the patient was vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin) rHA (M-M-R II) (dosage regimen was not provided), administered subcutaneously (SC) as prophylaxis (reported as "vaccine"), lot # S020161 has been verified to be a valid lot number for measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live and expiration date as 30-JUN-2021; Other suspect therapies included: sterile diluent (MERCK STERILE DILUENT) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On the same date, the patient had injection site reaction which was 5 inches length and more than 2 inches width with erythema (injection site erythema), bruising (injection site bruising) and inching (injection site pruritus) in the measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) site arm vaccination; also, her injection site hurts when she rub up against it (injection site pain). However, she did not have any injection site reaction on the opposite arm. No treatment was given for the events, and the patient did no sought medical attention. The outcome of antibody test negative was unknown. The outcome of the events of injection site reaction, injection site pain, injection site erythema, injection site pruritus and injection site bruising was reported as not recovered.  The causal relationship between all reported events and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) for antibody test negative was not related and for the reaming events was unknown. The causal relationship between measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live  (manufacturer unknown) for antibody test negative was unknown and for the remaining events was not related.
Pt. Had a vasovagal symptom at 1410, Laid down pt elevated legs and took BP, which  was 110/70 followed by 120/81 at 1420 and 1415 respectively, pt recovered immediately without difficulties, have pt sit , drink water. ER precaution was given for both pt and parent, who was with the pt. Pt and Parent acknowledge understanding. Pt was put for another observation for 15 minutes and was let go after acknowledgment with no sign of dizziness and full recovery.
Information was received from a registered nurse who reported that on unknown dates, multiple unknown patients received improperly stored VARIVAX lot # M036292, expiration date 17-AUG-2018 and lot #M042858, expiration date 21-JAN-2018; diluent lot #N007932, expiration date 06-MAY-2018 (dosages and routes of administration not provided). Temperature: 12F-15F Time frame: once every 24 hours for < 60 minutes for an unspecified number of days. Previous temperature excursion: No Data logger involved: No. Additional information has been requested.
An itchy rash (around 150 spots) all over the body occured ten days after the vaccine was administered and lasted for four days. Preceding the rash was a mild fever that lasted two days.
Red rash that spread out 1.5 inches from injection site. Arm that was injected warm to touch at injection site DTaP was given.
PATIENT WAS GIVEN HEP A CHILD . HE IS AN ADULT. HE WAS MADE AWARE. NO REACTION OCCURRED FROM THE WRONG DOSE.
Swollen left eyelid, left ptosis, conjunctival injection. left eyeball pain, left enophthalmos
Patient called vaccine clinic on 12/22/20 to report loss of bowel function.  He reported that it happened on 12/21/20 on the way to work.  The patient could not make it to the bathroom in time and soiled his pants.  On 12/22/20 in the morning it happened again on the way to work and the patient soiled his pants.  At this point the patient called the vaccine clinic with this information.  The nurse at the clinic did inform the patient that there are some GI side effects that have been reported with the vaccine.  She also recommended the patient get tested for Covid since GI side effects are also reported with Covid and the vaccine has not had enough time to offer immunity yet.
experiences a week long illness; Initial information received on 16-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA354038 (same reporter)  This case involves a 47 years old female patient who experienced a week long illness (ill-defined disorder), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Past vaccination included INFLUENZA VACCINE (Flu Shot) with 2 years in a row. Medical history, medical treatment and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and other dosing details were not reported] via unknown route in unknown administration site.  On an unknown date, the patient experienced a non-serious a week long illness (ill-defined disorder) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  Final diagnosis was ill-defined disorder.  It was not reported if the patient received any corrective treatment.  Event outcome is was Unknown for ill-defined disorder.  Information on the batch number was requested.
This spontaneous report was received from the patient's mother referring to a 17 year old female patient. The patient's pertinent medical history included ear tube insertion (reported as "tubes in ears"). Her concurrent conditions included Sulfa based medications allergy. The patient had not concomitant medications. In November 2017, the patient was vaccinated with the first dose of GARDASIL 9 "1 x 0.5-mL dose at 0, 2 and 6 months", intramuscularly, for prophylaxis (lot # and expiration date were not reported). On an unspecified date in 2017 (reported as "about two weeks after receiving her first dose"), the patient experienced warts on her fingers (skin papilloma). An unspecified treatment was given to the patient. On an unknown date, the patient's dermatologist removed one wart to analyzed it (papilloma excision). At the time of reporting, the outcome of the events was reported as recovered on an unspecified date. The causality assessment between the events and GARDASIL 9 was not provided. This one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA006350.
Chills, Aches, Nauseated for 24-36 hours and arm swollen, red, and painful for 7 days.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a child patient (gender not reported) who was vaccinated only with HIB portion of PENTACEL which was activated with sterile water diluent on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate reconstitution technique. It was not reported whether the patient experienced any adverse events following the vaccination. 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 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. Documents held by sender: none.
Severe stomach flu symptoms...vomiting and explosive diarrhea.. and headache I  could not hold down even water for several hours on 4/15
Redness 6 1/2 by 5 in. soreness, swollen arm. Patient felt all down arm. Redness below injection site on arm.
his co-worker tested positive for COVID-19 after returning from a trip to country. He had received the full 2 dose of the Pfizer COVIS-19 Vaccine prior to going to country; his co-worker tested positive for COVID-19 after returning from a trip to country. He had received the full 2 dose of the Pfizer COVIS-19 Vaccine prior to going to country; This is a spontaneous report from a contactable consumer. A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration, on an unknown date, as dose 1 and dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for COVID-19 after returning from a trip a (Withheld). He had received the full 2 doses of the Pfizer COVID-19 Vaccine prior to going to (Withheld). It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19, Since the vaccination, the patient been tested for positive COVID-19. Treatment for adverse event was unknown. The outcome of the event was unknown.  Information on batch/lot number has been requested.
This spontaneous report was received from an office manager via a company representative who refers to a patient of unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history were not reported. The reporter stated that on 08-MAY-2017 the patient was vaccinated with a 4th dose of unidentified Merck hpv vaccine administered (name, strength, route, dose, lote number and expiration date were not provided) for prophylaxis (product use issue). The reporter did not specify if it was GARDASIL or GARDASIL 9. The patient's concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
Patient is COVID positive 11/17/2021.  Fully vaccinated.  Presented to the ED for dizziness and "not acting himself"  + for leukocytosis. Decision to discharge patient.  Patient told to return to ED for any worsening symptoms.
A few weeks after my second dose I began to feel slight chest pain/pressure discomfort in the mediastinal area in different spots. The symptoms progressively got worse as time went on. By 06/01/2021 my symptoms included strong heart palpitations, irregular beat tachycardic episodes, chest pressure/pain mediatinally and chest area surrounding my lungs mostly anteriorly and slightly posteriorly. My breathing also began to feel different as I felt I was unable to take deep breaths feeling SOB. After my third vaccine dose my symptoms worsen severly. Eventually, a CT of my lungs showed bilateral distal ground glass infiltration and granuloma formation which previous CXR failed to show.  Since the CT scan a bronchoscopy was performed and treatment plan was started after all results came back from procedure. Steroid and antibiotic was perscribed. Treatment showed evidence of positive progresssion, but not complete recovery. Symptoms are not as severe which include heart palpitations, lower chest pressure and slight SOB. Any exertion and my symptoms worsen, mostly SOB. Trying to take very deep breaths very often and severe sinus pressure/inflammation (more left sided) has also been symptoms throughout this entire process.
I woke up early feeling achy and had a headache. I took a home test which came back positive. I isolated and stayed home until the 20th. 06/20, I went back to work and I didn't feel bad at the beginning of the day as the day went on I started feeling run down and just wanted to crawl into bed. Body aches, headaches, fatigue, shortness of breath. Called the doctor and they sent me to the hospital for the antibody infusion for the next day. 06/21, Went and did the infusion, shortness of breath, chest congestion, flu like symptoms. This day was by far the worst day while having COVID-19. 06/22, I started to feel much better and was on isolated for the rest of the week. 06/27, I went back to work with no issues and I had fully recovered from the illness.