chrisvoncsefalvay/vaers-outcomes huggingface dataset:
one vial of Arexvy was administered to a patient without reconstitution; last week an Arexvy vaccine was administered without reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one vial of Arexvy was administered to a patient without reconstitution) and inappropriate dose of vaccine administered (Verbatim: last week an Arexvy vaccine was administered without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The pharmacist called to report only one vial of Arexvy was administered to a patient without reconstitution but was unsure which one. Information about patient and vaccine were asked but caller stated had no details about event. During call HCP (health care professional) stated last week (from the date of reporting) an Arexvy vaccine was administered without reconstitution and when asked which vial was administered or if an unapproved diluent was used to reconstitute the antigen powder HCP answered did not have any information and requested medical information for both scenarios, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received FLUARIX QUADRIVALENT (batch number HZ723, expiry date 30th June 2016). On 9th October 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT .5 ml. On 10th October 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. The reporter considered the injection site pain and injected limb mobility decreased to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced injection site pain and was not able to lift her arm beginning the day after the vaccination. The pain was persisting almost 2 months later at the time of reporting. The patient was taking MOTRIN to treat the pain. The reporter was wondering if any other events of this type had been reported for this lot of vaccine.
Mother came to HD on 10/01/02 for child vaccine. Mother state child ran temp 100 -102 degrees F 2-3 days post last vaccine given on  07/29/01.State within 24 hours of vaccine, child stated crying nonstop for 2 days. Mother did not seek treatment for child. Child seen by MD on 08/03/02 and treated for ear infection.
Infection in a leg wound; Some soreness; This case was reported by a other health professional via interactive digital media and described the occurrence of wound infection in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wound infection (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the wound infection and pain were recovered/resolved.   It was unknown if the reporter considered the wound infection and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient received the 1st dose and was told to receive the 2nd dose after 2-6 months. The patient had some soreness lasting a couple of days. The patient would be going on a biologic once an infection in a leg wound clears up and wanted to know if he/she should get second shot of Shingrix before starting biologic. The patient asked was it better to get next dose at 2 months or wait a little longer.  Note: it was unknown if the patient had leg wound infection before or after 1st dose of Shingrix. Follow up information had been requested.
Initial and follow up information has been received from a physician and a registered nurse concerning a 16 year old female student with no drug allergies and reactive airway disease, who on 23-JUL-2007 was vaccinated intramuscularly in the right arm with a 0.5mL dose of Gardasil. Concomitant vaccination administered intramuscularly in the left arm included a dose of MENACTRA.  There were no illnesses at the time of vaccination. On 23-JUL-2007 for a period of "24 to 48 hours the patient experienced muscle weakness and droopiness of the face."  The patient sought unspecified medical attention.  The patient recovered spontaneously within 24-48 hours.  The physician did not know if her experiences were related to the MENACTRA or the Gardasil and was wondering if she should continue with the series.  On 05-AUG-2007 the patient was seen in the office and diagnosed with strep throat.  She was treated with amoxicillin for 10 days.  The patient recovered and it was reported that the sore throat was not related to the vaccination with Gardasil.  On 30-AUG-2007 the patient was seen after office hours at the emergency room for a sore throat.  A strep culture was performed and was negative.  The patient was started on KEFLEX but that was discontinued since the strep test was negative.  This was also unrelated to the vaccinations.  The patient recovered on an unspecified date. No product quality complaint was involved. Additional information is not expected.
Injection site welt/raised; Headache; Body aches; Injection site sore to touch; Fever; Injection site red; Chills; Fatigue; Injection site swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Injection site welt/raised), HEADACHE (Headache), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site sore to touch) and PYREXIA (Fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020 and Sinusitis on 01-Jan-2013. Concurrent medical conditions included Anxiety, GERD, Cholesterol (High cholesterol), Nausea, Depression (Mild depression), Drug allergy (Patient is allergic toAmoxicillin.) and drug allergy (Patient is allergic to bactrim). Concomitant products included ALPRAZOLAM (XANAX SR) from 01-Jan-2001 to an unknown date for Anxiety, ESCITALOPRAM OXALATE (LEXAPRO) from 01-Jan-2017 to an unknown date for Depression, OMEPRAZOLE from 01-Jan-2001 to an unknown date for GERD, SIMVASTATIN from 01-Jan-2010 to an unknown date for High cholesterol, PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) from 01-Jan-2010 to an unknown date for Nausea.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (Injection site welt/raised), HEADACHE (Headache), MYALGIA (Body aches), VACCINATION SITE PAIN (Injection site sore to touch), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Injection site red), CHILLS (Chills), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Injection site swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 10-Mar-2021, MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue) had resolved. On 11-Mar-2021, HEADACHE (Headache) had resolved. On 15-Mar-2021, VACCINATION SITE URTICARIA (Injection site welt/raised), VACCINATION SITE PAIN (Injection site sore to touch), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE SWELLING (Injection site swollen) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-052006 (E2B Linked Report). This case was linked to MOD-2021-119592 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event detail updated, medical history updated, concomitant medication list updated, second dose details updated; Sender's Comments:  MOD-2021-052006:Same reporter/unknown patients (Invalid case)
Patient was in office for well check-up. Had a fingerstick for CBC followed by 2 immunizations, GARDASIL and FLUZONE. Shortly after, patient experienced seizure-like movements observed by this nurse. Feet elevated above heart, supportive care given and pt. walked out of office independently with mother.
Side that I   received the vaccine on, side of neck blew up like a balloon. From my ear to the middle of my throat.  Too drink of orange juice and it burned like crazy on that side. Very painful to touch. Went down in 5 hours after applying cold wash cloth constantly.  Anything heavier hurt.  Slight fever
pt recv vax 2PM 23APR96 was currently on ATB;no fever;sustained achiness, chills; next 24hr went to ER dept ;25APR96 t98.6 on admission;discharge dx viral synd poss immunization rxn;
Patient admitted as inpatient on 12/26 due to COVID-19 pneumonia. Patient was tested for COVID-19 and was positive on 12/26.
Hives/rash on the bottom half of both of my legs, specifically near ankles. I still have the hives as of 4/2/2021.   I haven't implemented anything new, i.e. beauty products, detergents, food, medications, etc. I think it must be from the vaccine.
2 days post DTaP #4, temperature 103F, severe erythema and swelling of left upper arm. Arthus-type hypersensitivity reaction. Examined by ARNP 07/30/04. 08/03/04: Follow up swelling resolved. Child with tonsillitis. Treated with Rocephin 250mg IM.
Pt received shot at 1440, alerted staff at 1449 to difficulty breathing, globus, racing heartbeat. Pt given 1 Epi pen at 1449, second dose of epi given at 1455. Benadryl 50mg given at 1500. Patient transported 1508.
Breakthrough case admission after three vaccines  Pfizer 2/22/21 Lot# EN6200;  Pfizer 3/25/21 Lot# EN6199;  Pfizer 10/22/21 Lot# 320308D
pt mom reported finding pt unresponsive @ 10AM on 1APR98;911 was dispatched;pt was pronounced SIDS by medical examiner @ home;
Left back arm hot to the touch. Erythematous condition, unspecified, rash and other nonspecific skin eruption.
Patient presented to ED on 12/30/21 from (Privacy) due to uncontrolled pain from a MVA on 12/17/21. Patient full vaccinated and boosted with Pfizer on 3/2/21, 3/23/21, and 12/28/21. Patient was admitted on 12/30/21 and discharged to rehab facility on 1/6/22.
administered the first dose of Moderna then contracted COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (administered the first dose of Moderna then contracted COVID) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (administered the first dose of Moderna then contracted COVID). At the time of the report, COVID-19 (administered the first dose of Moderna then contracted COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wants to know whether safe to take her second dose . Concomitant medication use was unknown Treatment information was unknown; Sender's Comments: This case concerns  a female with unknown age with no reported relevant medical history , who experienced the unexpected event of Covid 19. This event occurred on an unknown date after the 1st dose of mRNA-1273 (Moderna) .  The rechallenge is  not applicable. The benefit-risk relationship of Moderna is not affected by this report.
Patient had red around (R) thigh where KINRIX vaccine and PCV 13 were administered only red around vaccine site.
Patient reported on 3/8/18 arm is red, swollen, and tender to the touch. Redness is also blotchy. patient was advised to take BENADRYL and Ibuprofen and to call MD. Also stated she had slight fever and chills on day of vaccination.
Pt recvd 3 dose of Engerix-B & did not respond when titer was checked; booster vax will be offered;
I had post nasal drip, clogged head, cough, chest congestion, feeling horrible all over, sore throat. I was prescribed 4 days z-pack. I get this every fall.
Severe muscle pain at injection site, pain so bad I still can't move my arm.  Stiff neck, chills and fever, nausea.
only received the adjuvant prior to mixing; only received the adjuvant prior to mixing; This case was reported by a other health professional via interactive digital media and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-Jun-2022 Reporters comment: This case was reported via interactive digital media. For Shingrix, reporter had a patient that had only received the adjuvant prior to mixing.  The reporter wanted to know that was there a time frame we must wait to start the series over. Additional Supportive Information: The patient received only the adjuvant prior to mixing which led to the inappropriate preparation of medication and inappropriate dose of vaccine administered. Follow up was not possible as no contact details available.
Headache first day, headache & fatigue second day, headache, severe fatigue, muscle aches, nausea and diarrhea third day, fatigue and slight headaches Fourth day, mild fatigue fifth day.
6 mos after vaccine mom brought to office with concerns of fatigue, costochondral chest pain, not sleeping well, weight gain. Mom believes has some depression. Believes all were caused by HPV and wanted reported. Have recommended counseling.
24 hours after receiving the vaccine patient developed a large welt on her left arm, it was present for 3-4 days before resolving
Patient reported to PCP that she was feeling like she had the flu again. She reported a sore/swollen arm, fever and "other flu like symptoms".
Developed swelling, erythema and heat in Rt thigh-site of injection ~ 24 hours post immunization no systemic signs. Tx'd with Motrin, Tylenol and ice.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. The nurse reported that the M-M-R II administered, reached a temperature outside the prescribing information. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Got the shot, got shingles again / Suspected vaccination failure; Shingles again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (reporter already had the shingles).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot, got shingles again / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles again). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2023 This case was reported by patient's friend via interactive digital media. This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
The morning after vaccine, the patient awoke with nausea and fever. By the afternoon, his temperature was 103, and he had shaking chills. He took ibuprofen. By 5/12/01, the fever was gone. He reported slight muscle tenderness at the site. As of 5/14/01, the patient reported feeling fine.
10-3-12 rec'd injection. 10-9-12 developed warm itchy, red, rash on left deltoid. Saw uc provider 10-10-12. Pt treated with azithromycin just in case. 10-12-12 dr who saw pt at uc stated this was a probable vaccine reaction. No fever temp 97.8 & 98 degrees F,
within 5 minutes of administration patient reported feeling dizzy, tunnel vision, and laid down on ground. Pt did not lose consciousness. I gave him a cup of water and a piece of candy to make sure low blood sugar was not a contributing factor. Patient rested on ground for 15 minutes, and reported feeling ok
soreness at injection site; redness at injection site; hardness at injection site; rash; heart palpatations; fever; headache; shivering; upset stomach; tired; difficulty sleeping; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. On 8th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping. On 11th July 2019, the outcome of the injection site induration, palpitation, fever, headache, shivering, tiredness and difficulty sleeping were recovered/resolved. On 13th July 2019, the outcome of the injection site pain, injection site erythema and rash were recovered/resolved. On 11th August 2019, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site induration, rash, palpitation, fever, headache, shivering, upset stomach, tiredness and difficulty sleeping to be related to Shingrix.  Additional information received were as follows: The patient experienced soreness at injection site, redness at injection site, hardness at injection site and heart palpatations. The patient planned to follow-up with her physician on an unknown date. The reporter consented to follow up.
Information has been received from a nurse concerning a 11 year old female who on 15-MAY-2008 was vaccinated with the first dose of GARDASIL IM (lot # 660391/0063X). The patient did not stay for the 15 minutes shot check, however called the office later (time unspecified) and stated that she was hallucinating, shaky and had a fever. The patient came to the office for any follow-up. Additional information has been requested.
Thrombocytopenia "clots" excreted from vagina-menstrual bleeding; bruising up and down UEs/LEs Narrative:
This spontaneous report as received from a physician refers to a currently 57 year old female patient with allergies to penicillin and clindamycin and a previous history of basal squamous cell carcinoma in unspecified locations of the body (date unspecified). On an unknown date, reported as over 1 year ago, the patient was vaccinated with a dose of ZOSTAVAX injection (lot# and expiry date were not reported), 0.65 ml subcutaneously, at an unspecified pharmacy. There were no concomitant therapies. On an unknown date, reported as soon after receiving ZOSTAVAX, the patient developed a lesion at the injection site that "never healed". The patient sought medical attention- she was seen in the physician's office on 21-MAR-2016 and was told to come back to have the area biopsied. The reporter stated that the patient returned to the office on 31-MAY-2016 to have the biopsy performed, and on an unknown date (approximately in 2016), the pathology report revealed basal squamous cell carcinoma in situ. The physician reported that the area was resected on an unknown date in 2016. The outcome of the event was reported as recovered on an unknown date in 2016. The relatedness between ZOSTAVAX and the event was not provided. Upon internal review, the event of basal squamous cell carcinoma in situ was considered to be medically significant. Additional information has been requested.
experienced Shingles 11 days after 1st dose of Shingrix; This case was reported by a physician via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number KX52G, expiry date 1st December 2021) and (batch number 9B23Y, expiry date 31st January 2022) for prophylaxis.   On 7th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In January 2020, 11 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient patient experienced Shingles 11 days after receiving 1st dose of Shingrix. The reporter was concerned about proceeding with 2nd dose of shingrix. The batch number for suspect was reported as KX526 however it was captured as KX52G as per sales data sheet. The reporter did not consent to follow up.
Received the Fluzone HD on the same day as PFIZER vaccination. Weakness, loss of bladder control.