chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunization administered, approximately 5 minutes later while being observed, patient was holding head and bending over - I went over to check on patient - she stated she was lightheaded, dizzy and ears were ringing. I stayed next to her as a team member got a cold bottle of water and used as a compress on back of neck. She stated it was intensifying.  I had the store manager call 911 she appeared to pass out for a second as she came around she said her tongue was sore. but no problems breathing, itching , hives or swelling of tongue.  the other symptoms reduced .  the EMS arrived and she was feeling better.  EMS took Blood pressure and heart rate - both were normal.  She refused to be transported and EMS waited until she could stand.  I recommended to call the primary care physician to discuss seconf dose and posssilby have the second dose at a mass vaccination site where there is a physician because it took 15 miuntes for EMS to arrive.
Had Prevnar-13 on 7/23/20 and Shingrex #1 on 8/3/20; By 8/11/20 developed petechiae over face, body & inside mouth.  Went to ER on 8/13/20 and platelets were at 6000.  It is unclear whether one or both of the vaccines so close together caused a severe autoimmune reaction.  No other conditions or issues surrounding this & was tested for many things in the ER.
Red face; Red neck; Tingling tongue; Tingling lips; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), ERYTHEMA (Red neck), PARAESTHESIA ORAL (Tingling tongue) and PARAESTHESIA ORAL (Tingling lips) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (Red face), ERYTHEMA (Red neck), PARAESTHESIA ORAL (Tingling tongue) and PARAESTHESIA ORAL (Tingling lips). At the time of the report, ERYTHEMA (Red face), ERYTHEMA (Red neck), PARAESTHESIA ORAL (Tingling tongue) and PARAESTHESIA ORAL (Tingling lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
102 degrees, headache, dizzy at least 90 lesions probably more in hairline.
hives, itching Tx: monitored, vs, Benadryl 50 mg, taken to ED -> monitored  ->hives resolved  1/11 allery eval -> 2nd dose given in ED monitoring test -> No adveRse  reaction
Post vax, her heart began racing, arm hurt and she had difficulty breathing. She went to ER and they treated her, run tests and told her it couldn't be from Hep-B and was probably a panic attack. These symptoms lasted 2 days, but she felt ill for 2 weeks.
Leg sore, not wanting to walk or stand day of shot and following day; on exam-slight pain and slight swelling.
6AUG92 unusual cry immed p/vax short, gasping like, lasting <2 mins; observation provided; 7AUG92 pc to parent pt cried 45-60mins that eve ok today;
No additional AEs; MMR II was administered by the intramuscular route and not the subcutaneous route; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 30-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 time dose, lot# T020656, expiration date 16-JUN-2022) via intramuscular instead of subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse event was reported.
Patient received a Moderna covid Vaccine, instead of a Pfizer covid vaccine.  Parent was made aware. Vaccinator was coached.
pt states she had fatigue, joint pain, fever and chills starting a couple of days after covid vax.  Pt is still having chills, fever, fatigue  and now has cough.  Fever ranges from 99.8- 101.0, it varies from day to day, comes and goes.  Pt has started taking Aleve to help w/ symptoms. Pt tried calling her PCP but office was closed so will try calling PCP again tomorrow.
Cellulitis in arm; Given into fatty part of the arm not the muscle; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and it was given to her in the fatty part of the arm, not the muscle and developed cellulitis in her arm .   The patient's medical history was not provided. Concomitant product use was not reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 23 Dec 2020, the reporter thinks that the patient was given the vaccine into the fatty part of her arm, not the muscle part.   On an unknown date, after vaccine administration, the patient developed cellulitis in her arm.  It was massive, red, and itchy. It started small and now 6-8 inches. Lot and expiration date unknown. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided .   The outcome of the event, cellulitis in arm, was not reported. The outcome of the event, given into fatty part of the arm, not the muscle, was considered resolved on 23 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 and concerns a female patient (unknown age), who experienced the event of cellulitis in her arm. The event occurred on an unknown date after a dose of mRNA-1273 vaccine administration. Based on the current limited available information and possible temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded and the event is assessed as possibly related.
Nurse reporting patient inadvertendly received unspecified dose of VARIVAX tah was improperly stored; no symptoms being reported; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent condition's drug and allergy history or concomitant medication's.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and route of administration) lot # S022758, expiration date 22-JUL-2021 for prophylaxis. The reporter stated that the sterile diluent (MRK) used was properly stored.  The doses of varicella virus vaccine live (oka/merck)(VARIVAX) were exposed to a temperature excursion of 22.7°Celsius (°C) during a time frame of 4 hours and 30 minutes. It was unknown if it was detected by the data logger or if there was a previous temperature excursion. No adverse effects were reported.  The reporter stated as a background that the completed stability assessment was provided on 12-DEC-2019, and varicella virus vaccine live (oka/merck)(VARIVAX) was placed into proper storage. Stability assessment provided was supported - used within 3 months.
Previously healthy 34-year old M was in his usual state of good health in JUL 2012. On 6 AUG 2012, patient received MGC, Typhoid and Tdap vaccinations. Prior to being immunized that day, patient sought evaluation for a 1-day history of right eye irritation with discharge noted that morning. He was evaluated by an optometrist and diagnosed with bacterial conjunctivitis. While waiting for his prescriptions, he received his vaccinations. Pt does not recall any significant and/or persistent local reactions at the vaccination sites. Within 12 hours of vaccine receipt, patient developed viral-type symptoms including generalized aching, including area of lower back, malaise, mild headaches and fevers. He self treated with NSAIDS. He measured his temperatures at home and noted elevations x 8 days, with the highest reading being 103. Patient sought evaluation for these symptoms but no additional recommendations were made. He continued follow up for his conjunctivitis and was seen by a ophthalmologist on 13 AUG, when he diagnosed with bilateral uveitis. At the time of his initial ophthalmological exam. Patient was not experiencing any discharge, pain or itching of his eyes, but did report a hazy glaze over his vision. His vision was not affected. Patient had been using TOBRADEX as prescribed on 6 AUG, but it did not help his symptoms. On 8 AUG, the TOBRADEX was discontinued and erythromycin drops were initiated and on 13 AUG, he was changed to 1% prednisolone acetate every 2 hours and homatropline 5% three times daily and ACULAR LS four time per day. Additional lab studies were completed, and patient was found to be HLA-B27 positive. Other than his ocular symptoms, patient was feeling well on the day of vaccine receipt. He denies any recent infections, including upper respiratory, gastrointestinal or genitourinary infections. He denies a history of previous eye conditions, except he was diagnosed with a stye in his right eye in APR 2012. He denies a history of chronic back pain, chronic skin conditions or chronic gastrointestinal symptoms. IMPRESSION AND PLAN per dr on 13 AUG 2012: Nongranulomatous anterior uveitis OU. We discussed this diagnosis at length and a complete review of systems was obtained. He does have a history of stray cat exposure approximately a year to a year and half ago..., we obtained extensive blood work and he will try to obtain that as soon as possible. For now, I prescribed DUREZOL four times q.i.d. OU to help quiet his anterior inflammation. Given the fact that he has had multiple flare-ups indicative of his coreneal endo-pigment and posterior synechiae, a thorough work up is indicated. Patient was referred for a rheumatology evaluation and imaging studies, which are pending.
She was fine the day of injection. But, upon awakening the next morning, she developed symptoms. They included numbness from her elbow down through her hand. Her hand also felt swollen. The numbness has continued off and on and every day since then.
5cm of swelling and redness on left arm around immunization site. Tested with Benadryl and Keflex resolved.
Information has been received from a nurse practitioner concerning a 17 year old female patient, who received the full series of GARDASIL (Lot # not reported) on 21-JUL-2008, 29-SEP-2008 and 27-JAN-2009. The nurse reported that on 07-FEB-2011 the patient tested positive for high risk HPV on a screening test performed. A PAP smear was performed and the results were not abnormal and the patient had no symptoms. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
warm to the touch.; small red mark; tchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch.), VACCINATION SITE ERYTHEMA (small red mark) and VACCINATION SITE PRURITUS (tchy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch.), VACCINATION SITE ERYTHEMA (small red mark) and VACCINATION SITE PRURITUS (tchy). At the time of the report, VACCINATION SITE WARMTH (warm to the touch.), VACCINATION SITE ERYTHEMA (small red mark) and VACCINATION SITE PRURITUS (tchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information were reported.
Suspected vaccination failure/Shingles after 2nd dose of Shingrix; Shingles; little Skin rash; Itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, rash and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 23-Dec-2022 Reporter's comment: A pharmacist reported about the development of shingles after the administration of the second dose of Shingrix.  The reporter mentioned that after the administration of Shingrix patient suffered from little skin rash and itchiness.  The reporter did not share information about the patient and the Shingrix vaccine.  The reporter did not consent to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
2/22 6 days after vaccination, patient presented with red rash on upper arm below vaccination site. She also had 1 spot below her breasts and an itchy stomach per pt. The next day rash had spread on arm - very red visible spot 2/25 on stomach and cheeks were red - pt went to dr received KENALOG shot and was told to take BENADRYL or ALLEGRA. Dr thought it was a rxn to the PREVNAR.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Hives on arms, back of neck and chest tightness one hour after FIRST PFIZER Covid Vaccine .Patient took Benedryl at home and shortly after the symptoms resolved.
Pt recvd 3 doses of Engerix-B; titer checked 4 months p/3rd dose; titer result was a low positive result;
Information has been received from the mother (who is also a registered pharmacist) of a female pt with no medical history who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Seven days post-vaccination, the pt developed a mild case of the chickenpox. Unspecified medical attention was sought and it was unknown what treatment was provided. No diagnostic lab tests were performed. It was unknown if the pt had recovered. No product quality complaint was involved. Additional information has been requested.
Began having nose bleeds, progressively more frequently appx 1 month after  COVID VACCINE #2.
cycle began again (that's 7 days earlier); This is a spontaneous report from a contactable Other HCP (patient). A 48-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 02Apr2021 18:00 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization and on 09Apr2021, the patient experienced Menstrual cycle dysregulated, Delayed period, and Bled very heavily and outcome was not recovered. On an unspecified date, the patient experienced cycle began again (that's 7 days earlier). The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Headache, Myalgia, NauseaVomiting, tinnitus Narrative: pt c/o COVID like symptoms 2 hours after receiving vaccination. encouraged to monitor for further symptoms, seek COVID team should further sx develop.
4 Hrs. after the vaccination I was getting Dizzy, now since having the virus I had experiencing Dizziness, fatigue and headaches, but now what was happening was constant waves of dizziness, one right after another. This went on for 2-3 hrs. when I just laid down and fell asleep until the next morning. When I rose I found that both my arms from the elbows down thru my hands and every finger was extremely painful. When I went to move my hands, something a muscle, tendons who knows  I could hear in both arms that I could feel and hear what sounded like they were snapping over bone in my forearm. As the day went on this extreme soreness went thru my entire body. I felt like I had the virus over again but 10 times worst. This went on into the third day when finally it went away.
Pt has localized reaction at Anthrax injection site (right deltoid) about 2 days after administration. Some erythema and mild swelling with some warmth was noted. Dx'd as mild cellulitis and pt was given 10 day course of Keflex po. Pt was in no distress and no systemic Rxn noted.
Pain/soreness at injection site, left armpit swollen and sensitive, slight headache, tired, general feeling unwell, left shoulder/scapula area sore/tired
Message from patient on 01/13/2023 at 11:09 AM states "I?ve been experiencing intense should pain since the injection of my HPV vaccine on Wednesday. It hurt quite a bit during injection but I didn?t think that much of it. Since then it?s gotten progressively worse to the point where I now can?t raise my arm over my head, sleep on that side, or move it in other normals ways."
1 week after dose 4 I had rash, swollen eyes and itchiness. I took Zyrtec and it went away.  On the 28th of May the right side of by body had a rash and face was swollen.  I went to urgent care and was prescribed Benadryl and steroids. I took my medication for a week and it did help. I still have itchiness and rash and I am still taking Zyrtec.  I went to an allergist on June 21st and told me to continue Zyrtec and return in a couple weeks.  He was not able to give me any explanation as to what was going on. I have continued to take Zyrtec every other day and it does help with the itchiness.
This spontaneous report was received from a certified medical assistant, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored PNEUMOVAX 23, single-dose vials, lot # L019835, expiry date 23-MAR-2017. It was reported that the vaccines were exposed to temperature of 12.6 degree Celsius for 2 hours and 9 minutes because of data logger. No previous temperature excursion was reported. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of three reports received from the same reporter. Additional information has been requested.
SORE SPOT AT THE VACCINATION, ABOUT THE SIZE OF A QUARTER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sore spot at the vaccination, about the size of a quarter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore spot at the vaccination, about the size of a quarter. This report was non-serious. This case, involving the same patient is linked to 20221234779. This case, from the same reporter is linked to 20221234943 and 20221235149.
Student (patient) complained of "scratchy" and slightly swollen throat 5 minutes after flu shot given. Some cough with no wheezing - given. BENADRYL 25 mg by mouth and epinephrine auto injector 0.3mg. Temperature 98.6 degrees F and oxygen saturation 100%.
This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose and route not reported) and developed shingles. No concomitant medications were reported. The nurse did not have any patient specific data at the time of the call. The nurse did not know when the patient received the ZOSTAVAX or how soon after vaccination with ZOSTAVAX the patient developed shingles. The nurse believed the patient got the shingles at least a year ago. No treatment information was reported. It was unspecified if the patient had sought medical attention. On an unknown date, the patient had recovered from shingles. Additional information is not expected.
Gave PNUE 23 to pt lt arm pt said it bothered her every. Went to clinic in town with pain and swelling of arm. Clinic sent her to the ER.
Fever; Chills and shivering; Malaise; Sore throat; Headache; Flu-like symptoms Symptoms lasted about 24 hours and were self-limiting.
the third dose of Pentacel was administered incorrectly to a patient/No AE; Initial information was received on 18-Aug-2020 regarding an unsolicited valid non-serious case from an other health professional .  This case involves patient with unknown demographics who received third dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] [lot number and expiry date not reported] incorrectly via an unknown route at an unknown administration site, on an unknown date for prophylactic vaccination (Incorrect dosage administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was also a case of actual medication error due to inappropriate age at vaccine administration. (Latency: at the same time of vaccination)  At the time of report, 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 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.
Report 20000302321 describes hallucinations in a male "child" who received Engerix-B. Allergies, medical history, and concomitant medications are not specified. In October 1999, the vaccinee received his first dose of Engerix-B. In December 1999, the vaccinee experienced hallucinations and high fever. The vaccinee's mother does not wish the vaccinee to receive additional doses of Engerix-B because the vaccinee's pediatrician was relating the adverse events to Engerix-B. As of 10/02/2000, the outcome of the events is unknown.
Pt recvd 2 doses of vax & pt exp no adverse events p/dose 1; reporter indicated shortly p/dose 2 administered discomfort began in the rt upper quadrant; sx eventually resolved & the pt fully rexpects to complete;