chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot. Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752091A, A0752092A, A0752093A, A0752094A and A0752095A. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 27-year-old female subject who was vaccinated with TWINRIX, (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). On 9 October 2008, at an unspecified time after vaccination with TWINRIX, the subject experienced injection site stinging, injection site burning and product complaint. On 9 October 2008, the events were resolved. The physician considered the events were related to vaccination with TWINRIX. The physician associated the events to possible irritating substance in lot AHABB128AB. The lot was removed from vaccination circulation.
Fever 101.2 for 2 days, severe headache, pain at base of my neck. Injection site is swollen almost 3 inches in diameter with blisters in the middle, its bright red, hard and itches. Spoke to a nurse practitioner who said it was an allergic reaction to injection and called it "Covid Arm"
Pt developed scattered lesions (approximately 20) representing all 3 stages (lesion, vesicle, crusted vesicle). No fever was experienced.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 64 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. It was reported that the patient was 64 years and rarely got sick. She was previously treated with rubella vaccine for prophylactic vaccination (it did not stick with her).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry date: unknown) dose was not reported, 1 total administered in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-AUG-2021, the patient developed the symptoms of Covid-19 infection for first time that included feeling aches, cough and fatigue (suspected clinical vaccination failure). The symptoms lasted for about a week or two, but she still felt fatigue at time of reporting. She did not receive medical help but had bed rest for 2 weeks. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected Covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210857250- Covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Fever, chills, 12 hrs after injection on 2 days later when finally able to get dressed noticed red splotches with blister on shoulder. Splotching can be seen on shoulder going down back and on arm. Photos available
Information has been received from a pharmacist concerning an unknown age and gender patient who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# 665524/1374Y). In June 2010, the patient reported a reaction which included redness, swelling and inflammation. It was noted that the patient's relevant history, concomitant medications and past drug history were unknown. It was unspecified if lab tests were performed. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Came home and around 3PM arm became swollen (about size of golfball) - Shortly after, missed a step, passed out, scraped knee. At scheduled appt, Dr said knee was healing. Had cramps, blood in urine, felt sick and vomited. Doing good now. Took PHENERGAN. Started taking new Pxsd Med (Methadone) AM of 9/18/09.
ACHING/ DULL PAIN, CERTAIN MOTIONS TRIGGER PAIN, MUSCLE PAIN, CLOSE TO INJECTION SPOT. BEEN TAKING IBUPROFEN/TYLENOL. PAIN STARTED NEXT DAY. INJECTION SITE IS LEFT UPPER ARM (DELTOID).
sudden death noc of 8FEB-9FEB <24 hrs p/vax;
MMR and Varicella ordered for 1 year old. MMR/V and Varicella given. Therefore, extra dose of Varicella given. Employee thought she had picked MMR and instead gave MMRV.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a healthy female with no past medical history who on 8/3/95 was vaccinated with 1 dose of varicella virus vaccine live (site unknown) (lot 608589/0416B). There was no concomitant medication. On 12/23/01, the pt developed varicella which was described as lesions on the whole body and mouth. The pt was afebrile. The pt was seen in the office on 12/24/01 and was noted to have 285 lesions. The pt was treated with Benadryl, avena (Aveeno Bath) and Tylenol as needed. Additional information has been requested.
Sore arm but in May started to feel vertigo like symptoms and was nauseous and couldn?t lay on one side of body. Day she died shortness of breath.
This spontaneous report was received on 14-JUL-2017 from a pharmacist (Pharm D) and refers to a 67-year-old male patient. Concomitant medication was simvastatin (manufacturer not reported). No information about the patient's medical history, concurrent conditions, drug reactions or allergies was provided. The pharmacist reported that on 11-JUL-2017, the patient was administered PNEUMOVAX 23, (Lot number reported as N000463, expiration date reported as 19-OCT-2018) (dose, route, and site of administration were not reported) to prevent pneumonia and developed redness and pain at the injection site "few hours later". The patient was treated with ice and ibuprofen at an urgent care center on the same day. Patient has recovered. No additional information was provided. Additional information has been requested.
dose 1 and 2: Moderna, Dose 3 and 4: Pfizer; COVID; COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) and on 11May2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Feb2023, outcome "recovered" (2023) and all described as "COVID"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "dose 1 and 2: Moderna, Dose 3 and 4: Pfizer". Clinical course: COVID on 06Feb2023 and quarantined for 5 days. No further medical issues.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200922255 same patient/drug; different dose/events;
Felt tired; Soreness on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and VACCINATION SITE PAIN (Soreness on the arm of the injection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Felt tired) and VACCINATION SITE PAIN (Soreness on the arm of the injection). At the time of the report, FATIGUE (Felt tired) and VACCINATION SITE PAIN (Soreness on the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no relevant treatment and concomitant medication provided.
Vertigo, Nausea, Clammy, Tingling in fingers, HA, neck tension.
Nauseous and felt like I could pass out. Laid down for 40 minutes until the feeling passed. Fatigued the remaining of that afternoon/evening.
Pt recvd 3rd dose of vax & exp palpitations, lightheadedness, & fatigue; feeling of nausea; mild-sever upper abdo pain/spasm 30MAR93; heavy weight on chest & abdo spasm persisted; weight fluctuations of plus & minus 5 lbs; ketonuria;
Site: Redness at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Heart Attack-Severe
Dizzy, tired, weak, nausea, joint pain. I am resting and still feeling the effects. But slowly getting better.
Pain in arm, nausea, fatigue, fever, body ache beginning 2-3 hours after shot, peaking around 2am. Day 2, intense body ache all day. Evening of day 2, itchiness, redness, pain and mild swelling at injection site, two possible hives on chest area. Day three, continued itching, redness, pain and mild swelling at injection site. Day 4, same as day 3.
fluzone HD was administered to children age 8 year old without any reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 8-years-old female patient who administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] without any reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant(s): no other vaccines  On 11-Oct-2023, patient received 0.7 mL dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (Frequency: Once; Strength: Standard) (batch number: U8138CA; expiry date: 30-Jun-2024) via intramuscular route in the right deltoid for Immunization, to children age 8 year old without any reported adverse event (product administered to patient of inappropriate age) (same day latency).  Action taken: not applicable.  Treatment: None  At time of reporting, the outcome was Unknown for the event.  No additional information at the time of the report.  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 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.; Sender's Comments:  US-SA-2023SA317312:01802208
shortness of breath; severe aspiration; A spontaneous report was received from a consumer who was a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe shortness of breath/dyspnea and severe aspiration/aspiration.  The patient's medical history included chronic obstructive pulmonary disease (COPD). No relevant concomitant medications were provided.  On 13 Feb 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA (Lot number:unknown ) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, patient experienced severe aspiration and called paramedics.  She received a breathing treatment when they arrived at her house but she did not go to the hospital.  Then, on 05 Mar 2021, the patient reported that her breathing got very bad again so she drove herself to the hospital.  She was given magnesium and another medication (she was unable to recall the name) as well as a five day course of prednisone.  On 10 Mar 2021, she followed up with her primary physician and he prescribed another week of prednisone with an increased dose.   No laboratory data was provided.   Treatment for the event included a breathing treatment by the paramedics,  magnesium, an unknown medication and prednisone.  On 15 Mar 2021, she was scheduled to receive second vaccine dose.   Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of the events, severe shortness of breath and severe aspiration,  were considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored   RECOMBIVAX HB. No adverse symptoms reported. At the time of the report the action was not reported. All telephone attempts to obtain follow-up information have been unsuccessful.  Additional information was received from a registered nurse concerning a 1 day male patient. Patient's birth weight was 6 lb 7 oz with 0 siblings. Patient was vaccinated with RECOMBIVAX HB the same day that he was born (19-MAY-2014) at 08:50 AM. Lot number J012520; Exp. Date: 30-JAN-2016.  The vaccine storage temp dropped to 0-1 degrees on 18 different episodes between May 14th and July 21st (unspecified year) according to min/max. All recorded temps are within 2-8 degrees. Additional information is not expected since all follow ups requested to complete the case were received.
My joints, knees, hips, shoulders, and neck were all hurting. When I tried to sit it would hurt. I couldn't barely get out of bed because of the pain. I took a bath one night and couldn't get out of it because of the pain. I went to my doctor, and she prescribed pain and anti-inflammatory medicine.  I see a rheumatologist. I had inflammation of 186 when the normal range is 15 to 30. I was very inflamed, so the doctor started me on prednisone 80mg, and then she added in a methotrexate medication. She was trying to reduce the prednisone dosage but when she does my symptoms would come back so she would have to bring it back up. I was diagnosed with polymyalgia rheumatica. I'm still having pain in my hips and knees while still on medication. I will be on medication as long as I have it because if I stop it comes right back.
Abdominal pain that lasted about an hour. Did not feel well, went to sleep, the pain was gone when I awoke.
Small macular-papular rash on chest, legs, abdomen, arms, face, neck, and behind both ears.  Bilateral pinna of both ears swollen and red.  Post cervical lynphadenopathy present.  Buccal mucosa-small half centimeter white bumps.  Bloodshot eyes.  Lethargy.
A non-serious, spontaneous report of positive for type A influenza virus, productive cough, sore throat, runny nose, chills, body ache and malaise was received from a nurse concerning a 24 year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 29-Sep-2008. On 05-Oct-2008 the patient developed symptoms of productive cough, sore throat, runny nose, chills, body ache and malaise. He was evaluated on 09-Oct-2008 and an influenza test was positive for type A influenza virus. The outcome for the reported adverse events was not reported.
Lightheadedness/dizziness after left office following vaccination on 8/9/21. That evening, c/o abdominal pain and "black slush" stools that continued intermittently through night to next day.
Red (3-3.5cm) area. Erythematous w/o induration. DLF checked area at office 04/18/2005. Will f/u in office PRN.
Stomach ache, nausea, dry heaves, headache fever(101.3) chills body aches, headache, brain fog
2 days of hyporesponsiveness- fed, but dec nursing, pale color. Was not limp. Slept & difficult to awaken. Seen 6May92 & had returned to nl nursing, color & response.
pt presents to ED with difficulty breathing; duration approximately 1 wk; positive for COVID; admitted with AHRF secondary to COVID PNA; cough; given dexamethasone; pt out of the window for baricitinib; experienced A Fib; pt's condition worsened; he was transitioned to comfort care and passed away in the hospital
pt had t104 & sz w/in 24 hrs p/vax; had eye rolling back & tremors;
Appearance of itchy red rash located on both the left front of the knee and red rash around the mouth that an esthetician identified as possible eczema. Never previously experienced before the vaccine.  Hydrocortisone OTC used since 5/9/21 and the  rash is still occurring.
No adverse event; Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (071B22A and first dose) on 13-Feb-2023. Past adverse reactions to the above products included No adverse event with Spikevax.    On 24-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 24-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received booster shot on 24-Mar-2023 instead of getting their second dose of the primary.).    No concomitant information was reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. It was reported that patient did not reported any adverse reaction. No treatment information was provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 3:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 3:12 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.55.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, temperature was 32, at 10 AM, temperature was 32, at 11 AM, temperature was 32, at 2 PM, temperature was 35, at 3 P, temperature was 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 9-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).