chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reconstituted lyophilized component with 1 percent Xylocaine; Reconstituted lyophilized component with 1 percent Xylocaine and administered the dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number L4472) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix. In FEB-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted lyophilized component with 1 percent Xylocaine) and inappropriate dose of vaccine administered (Verbatim: Reconstituted lyophilized component with 1 percent Xylocaine and administered the dose ). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-MAR-2023 The licensed practical nurse reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient back in early February 2023. The reporter mentioned for each patient was attempt at first dose of Shingrix. The reporter was unable to provide any vaccine or patient details. The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that, they reconstituted Shingrix lyophilized component with 1 percent Xylocaine and administered the dose to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023034623:same reporter US-GSK-US2023034626:same reporter
tested positive after first dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive after first dose) 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced COVID-19 (tested positive after first dose). At the time of the report, COVID-19 (tested positive after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, SARS-CoV-2 test: positive (Positive) tested covid-19 positive on 06'march..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-044057, MOD-2021-046748 (Patient Link).
pain in shot arm 1st day, woke up 2nd day feeling achy, about 30 hrs after the shot real achy and tired, that night about 40hrs after shot went to bed.. woke up 5 hrs later exhausted, 102.5 fever, whole body felt like I was hit by a truck then a train, sore arm, swollen gland under shot arm..  this was after my 1st Moderna shot. I had covid , very mild in March/April 2020,
Unprecedented heart palpitations - pounding and skipping beats. Occurred most nights for about 3  weeks .
Patient was experiencing chest pain 30-40 mins after shot and we called 911 and his vitals were: BP: 91/60, HR: 78 and Oxygen:97. He was alert and was able to speak.
started to have headache day of vaccine 4 days after vaccine patient felt chest pain like weight on chest - someone trying to squeeze chest See at outside ED with troponin elevated to transferred to CHCO for echo and serial troponin monitoring
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 01-SEP-2014 (reported as "one or two days ago"), the patient was vaccinated with ZOSTAVAX, subcutaneous, in the arm (dose, strength, frequency and lot number were not reported). Concomitant therapies included influenza virus vaccine (unspecified), hydroxyzine hydrochloride (manufacturer unknown) for anxiety and BENADRYL for an unknown indication. Hydroxyzine hydrochloride (manufacturer unknown) and BENADRYL were initiated sometime prior the administration of ZOSTAVAX. The pharmacist reported that a physician called him and stated that the patient had developed an injection site reaction of redness and itching in the arm where the ZOSTAVAX vaccine was applied. This has spread to the back of the patient's arm and it was extending down the patient's arm. The patient had no symptoms in the arm that received the influenza virus vaccine (unspecified). The outcome of the events was reported as not recovered. It was reported that the patient went to an immediate care center. Additional information has been requested.
Expired vaccine given on accident due to pharmacy given us 3 different expiration dates.  We used not knowing it was expired.
patient reports dizziness on and off. denies any difficulty breathing or cutaneous symptoms. Dizziness persisted greater than 15 minutes so patient brought to medical tent for evaluation. blood pressure 122/91 HR 83. Patient was instructed to drink water and lie down until improvement in symptoms. patient left medical tent after dizziness subsided, aproximately 45 minutes spent under evaluation and it was considered safe for her to drive home.
PATIENT CALLED ON  07092021 TO REPORT SWOLLEN AND SORE ARM NEAR INJECTION SITE
Pt reported injection site swelling within hrs developed local swelling on arm the size of a baseball.
first dose twinrix second dose engerix; first and third dose twinrix second dose engerix; This case was reported by a pharmacist via and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B, the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and incomplete course of vaccination. On an unknown date, the outcome of the wrong vaccine administered and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported for Engerix B and not applicable for Twinrix. The reporter stated that the patient administrated with a first dose of Twinrix, second dose as Engerix-b, which led to wrong vaccine administered and third dose as Twinrix. Till the time of reporting, the patients did not received 3rd dose of Twinrix, which led to incomplete course of vaccination. The healthcare professional thought could be multiple patients involved. No adverse event was reported. No batch number and expiry date reported. No patient details were reported. The reporter consented to follow-up.
Patient reported rash on left arm below the injection site.  The rash felt swollen and warm.  The rash was discovered the morning following vaccination.  She took Benadryl 50mg that morning, 25mg in the evening and 25mg the next morning.  Symptoms resolved after 3 doses of Benadryl.
pt recv hep B instead of TB Mantoux 7OCT97 & pt exp initial burning @ inj site;
received a dose of the vaccine from a vial that was left 30 hs out of the fridge; received a dose of the vaccine from a vial that was left 30 hs out of the fridge; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) and PRODUCT STORAGE ERROR (received a dose of the vaccine from a vial that was left 30 hs out of the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Patient developed numbness in (R) upper arm after injection given. He did have a syncopal episode. He waited in the clinic for 30 min; after 15 minutes he passed out. LOC for a few seconds after he recovered (15 min) he still complained of arm numbness. This has happened x2 both injections of GARDASIL caused same reaction.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-SEP-2015, the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
accidentally administered an expired tenivac vaccine to a patient yesterdaywith no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves an unknown age and unknown gender patient and reporter stated that expired tenivac vaccine administered accidentally to a patient yesterday with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Oct-2022, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection total (lot U6831AA, expiry date 08-Oct-2022) (with an unknown strength, dose, route, administration site) for Immunization.  On 13-Oct-2022 the patient accidentally administered with an expired tenivac vaccine yesterday with no reported adverse event (expired product administered) same day following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  No lab data reported.  Action taken was not applicable.   At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
had fever of 102.3F by noon the following day after injection, including headache and body pain all over, most symptoms were gone the following day after. needed 500mg-750mg doses of acetaminophen to mostly counteract symptoms, a warm shower followed by bed rest over a 24hr period, then patient was mostly back to normal.
On January 16. ( 7 days after the injection) I noticed a hard lump, some swelling , warmth and itching on my right arm. On January 19th the rash spread to approx 5 1/2 ? long  to 5? in width - still warm and itching , January 20 th rash is still there but doesn?t itch.
onset of local itching on rt upper arm 2-3 days p/inj;also devel a hard, red, warm area 4" in diameter that reamins 1wk p/inj;pt using hydrocortisone oint to area for itchign;
Customer came in for a flu vaccine, I used an Inject-Safe-Barrier Bandage. Customer left the vaccine area to shop for groceries but returned 10-15 minutes later and said the injection site had bled out of the bandage. I brought her into our immunization room and took off the Inject-Safe-Barrier Bandage and cleaned her injection site and placed a regular bandage over the injections site after the bleeding stopped. Patient stated she had just recently started a new blood thinner and had been rotating her arm while shopping to work out any soreness.
Varicella rash (about 20 lesions) developed on 4/4/03.
Persistent and sporadic return of chest pains, stabbing stomach pains, nausea, aches, pains, fever, eye discomfort, swollen eyelids, chest pressure, shortness of breath,  myocarditis diagnosis by cardiologist- needs anti inflammatory medicine and no exercise for 6-8 weeks.  A previously healthy male nowhas myocarditis for indefinite period of time and in the care of a cardiologist.  The boosters are unsafe for him and doctor informed we MUST REFUSE FURTHER BOOSTERS MANDATED.
PRONOUNCED LOCAL REACTION WITH SWELLING AND REDNESS FROM BICEP DOWN TO MIDDLE OF UPPER ARM.
vomited 3 times in car on way home 30 minutes after shot, no rash or swelling at site
Tiredness Extreme Menstrual Cycle Cramping for 2 days Extreme Menstrual Cycle Clots for 2 days
Severe onset painful armpit swelling which did not resolve. Swelling would increase and decrease, but remain. Began to have hot flashes, shakiness which continued to March 22, 2022 when developed severe tachycardia. Tachycardia at >140bpm for 24h, resulted in 4mm bilateral pitting edema in legs and enlarged heart. Sought treatment March 24 2022 in ER. Diagnosed acute onset hyperthyroidism, started on propanolol and methimazole. Graves Disease diagnosis ~1 week, presenting without ocular symptoms. Symptoms rapidly under control with methimazole, propanolol stopped ~3 weeks. Cardiac symptoms never returned, set to stop methimazole @ 1 year mark March 2023.
Dose administered to patient after improper storage and handling; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anaemia, Penicillin allergy and Allergy to antibiotic (Amoxicillin). Concomitant products included FERROUS SULPHATE [FERROUS SULFATE] from 18-Aug-2021 to an unknown date for Anaemia.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  It was reported that patient was given vaccine that was thawed, frozen and thawed.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Additional information included patient details, medical history, concomitant and event.
Development of erythema, warmth, pain and swelling at right deltoid region where shot was administered.  9-cm diameter area of mild erythema at injection site, no purulent drainage noted, patient afebrile.  Cellulitus Dx, treated with Keflex 500mg every 6hrs for 10 days.  F/U scheduled for 04/04/2013.
localized red and painful area about 1.5 inches in diameter; localized red and painful area about 1.5 inches in diameter; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced localized erythema and pain. On an unknown date, the outcome of the localized erythema and pain were unknown.   It was unknown if the reporter considered the localized erythema and pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shringrix 36 hours before the time of reporting  The patient had localized red and painful area about 1.5 inches in diameter, about 1 inch below injection site. Injection site was clear.
06/08/05 Symptoms started with pain at injection site of right deltoid. 6/9/05 Redness, heat, itchy at injection site.
Sore throat, fever, stiff muscles and joints. Swollen glands and swelling of free on cheeks. She now has a rash on cheeks, arms, and back.
Administered expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Covid-19 vaccine) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported by the reporter.  Treatment medication was not provided by the reporter.  The vial was initially stored in the refrigerator on 06 Jul 2021 and the vaccine vial had not undergone any temperature excursions. It was reported that the patient did not report any other adverse events. It was unknown which arm the patient received the Moderna covid-19 vaccine in.  This case was created for 5th patient out of 17 patient's   This case was linked to MOD-2022-489263 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Feb-2022: Upon internal review on 22-Feb-2022, significant correction was performed. The report type was updated from Invalid case to Spontaneous and case narrative was updated accordingly
Initial information received on 25-Feb-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 72 years old female patient who experienced allergy to tetanus toxoid vaccine, while received vaccine Tetanus Toxoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Tetanus Toxoid (lot number and Expiry date unknown) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus toxoid vaccine (allergy to vaccine) (Unknown latency) following the administration of Tetanus Toxoid. (Other relevant tests included no lab data.) Final diagnosis was allergy to tetanus toxoid vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy. List of documents held by sender: none.
Patient complains of soreness of left arm. Arm is warm to touch. VHC notified at 10:30. VHC provider evaluated patient and gave instructions: Alternate warm-cold compress for 48 hrs. Take Motrin for pain.
Pt arrived to med obs #1 via wheelchair with ODI c/o dizziness, lightheadedness, and diaphoresis. Pt has holter monitor in place, placed yesterday (5/3/21) by pt cardiologist for ongoing s/s of palpitations and dizziness per her report. Pt also c/o tingling to bilateral hands and abdomen, and "strange sensation" in throat. Denies difficulty swallowing, soreness, or tightness of throat. Pt cannot elaborate further on the way her throat feels. Pt accepted water, declined snack. Pt began c/o worsening dizziness, placed in trendelenburg position with relief. Orthostatic VS obtained. Pt reports her BP tends to run low at baseline. VSS. Pt declined wheelchair to exit, escorted by staff with pt son to exit. VS are as follows: 1640: BP 128/55, HR 81, RR 12, O2 sat 96% on RA 1650: BP 117/60, HR 74, RR 14, O2 sat 96% on RA 1655 (lying): BP 110/55, HR 72, RR 16, O2 sat 95% on RA 1657 (sitting): BP 119/62, HR 83, RR 16, O2 sat 97% on RA 1659 (standing): BP 115/55, HR 77, RR 16, O2 sat 97% on RA
Information has been received from a pharmacist and a 69 year old female patient with thyroid disorder and high blood pressure and no drug allergy who on 11-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z). Concomitant therapy included NAFTIN, LAMISIL, unspecified thyroid medication and unspecified high blood pressure medication. A few days after the vaccination (also reported as on 11-MAR-2011) the patient experienced small blister on both arms/a rash on both arms. No lab test was performed. The patient had sought medical attention by calling pharmacy. The patient also said she would be visiting the next day. At the time of reporting, the patient had not recovered from the adverse event. Additional information has been requested.
patient complained of arm heaviness, lightheadedness, dizziness after receiving 2nd dose of COVID vaccine - her blood pressure was elevated as well - she reports she had not taken her blood pressure medication prior to the vaccine.  Patient received Acetaminophen and Lisinopril in Emergency Dept afterwards and discharged home.
Information has been received from a pharmacist concerning a 19 year old female patient who on 12-NOV-2009 was vaccinated with the first dose of GARDASIL. The patient experienced headache, stomachache and felt tired, weak, light headed and nauseous after received GARDASIL. The patient sought unspecified medical attention. It was unspecified if lab tests were performed. At the time of the report, the patient had not recovered. No further information is available.
Post vax of Hep-B, I asked child if she was "ok", as she was quite fearful. She shook her head and replied "yes". She then leaned towards other nurse and had a seizure, lasting < 1 minute. Client was pale, skin cool and moist. HR-62 and even. Within 2-3 minutes, she was aware of person, place and time. Pupils were sluggish and reactive to light. On 5/15/01, mother stated, she has not been ill previously, on no medications and has no previous history of seizures. Physician paged at 17:30. Call returned at 18:00 by physician on call and stated "doubtful vaccine responsible for seizure; possibly caused by fear". Told to send home and have mother call PCP in the AM with an update. Conversation relayed to mother who verbalized understanding. Follow-up call made on 5/15/01 at 09:30 AM to mother. She reported she had been fine, just tired and quieter than normal. Mother had not called doctor yet but intended to call shortly. Recommended remaining Hep-B shots be given at doctor's office.
Received HPV, MENACTRA, FLUMIST on 9/20/12. Felt sick the next day (9/21/12) - headache, sore throat, decreased appetite. Developed fever 9/23 -> 9/26.