chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client vaccinated at 1545 by LPN and sat for 15-minute observation, without incident. At approximately 1605, client was sitting outside with her mother and started feeling dizzy. Upon assessment, client was sitting in the chair, she noted she started to feel dizzy, and she last ate three hours ago. She denies any c/o pain or blurred vision, client did not fall. Vitals: B/P-100/65, R- 20, O2- 99%-RA, HR-67, and client has no known allergies. EMS contacted at 1609. EMS arrived at 1626 and check clients blood glucose (106). EMS stated, ?She is fine and just needs to rest.? Client?s mother did not want her to be transported. Client sat in the chair for an additional 20 more minutes, but still felt dizziness. Client?s father came to pick her up and client's mother accompanied her to the car.
Breakthrough COVID infection. Patient tested positive on 11.9.2021. Patient was fully vaccinated on 1.21.2021.
chest pain when swallowing; left arm pain; POTS syndrome; muscle contractions; Swelling in her right thumb; Entire body pain; both knees were swollen and hot; both knees were swollen and hot/swelling in her right thumb and it was hot; swollen throat; swelling in her right thumb, it was red; Pain; Initial information was received on 22-Apr-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry number: 00573551).  This case involves a 20 year old female patient who experienced pots syndrome (postural orthostatic tachycardia syndrome), left arm pain (pain in extremity), muscle contractions (muscle contractions involuntary), swelling in her right thumb (peripheral swelling), pain, entire body pain (pain), chest pain when swallowing (chest pain), both knees were swollen and hot (joint swelling), swollen throat (pharyngeal swelling), swelling in her right thumb, it was red (erythema) while received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 19-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number: UJ477AB, expiry date: 30-Jun-2021] via an unknown route at an unknown administration site for prophylactic vaccination.  On 03-NOV-2020 the patient developed a non-serious pots syndrome (postural orthostatic tachycardia syndrome), left arm pain (pain in extremity), muscle contractions (muscle contractions involuntary), swelling in her right thumb (peripheral swelling), pain, entire body pain (pain), chest pain when swallowing (chest pain), both knees were swollen and hot (joint swelling), swollen throat (pharyngeal swelling), swelling in her right thumb, it was red (erythema) 15 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory test results included:  Cardiac stress test - On an unknown date: [Result: heart rate got up to 201] Heart rate - On an unknown date: [Result: Rapid heart rate]  Other relevant tests were not reported.  She was taken to the ER and treated with steroids.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the patient was not recovered for the event postural orthostatic tachycardia syndrome and recovered from all the remaining events.
Mother states that rash noticed around 12:00 PM on 4/15/03. Red, raised areas on face, trunk, and extremities. Rash clearing and then reappearing on other areas of the body. While in office Urticaria rash on areas highlighted on body diagram. Patient also noted to have ear infection today. Atarax syrup given for allergic reaction. Zithromax given for Otitis Media.
Patient developed hives and swelling, redness on (R) thigh within 5 minutes of receiving DTaP and IPV. Patient was given BENADRYL and kept in office for observation. Sent home after responding to BENADRYL.
This spontaneous report was received from a medical assistant concerning a 6 year old patient of unknown gender. No information regarding patient's concurrent conditions and medical history was provided. On 28-SEP-2015, the patient was inadvertently vaccinated with ZOSTAVAX (dose and route were not reported, lot # L015416, expiration date: 01-AUG-2016). No concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
Shingrix reconstituted with normal saline; Shingrix reconstituted with normal saline; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 96-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 5th October 2023) for prophylaxis.   On 15th September 2022, the patient received Shingrix. On 15th September 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-SEP-2022 Reporter's comment: HCP (Health Care Professional) reported that patient received the Shingrix reconstituted with normal saline. No reactions were reported. The reporter consented to follow-up via email. Additional Supportive Information: The patient received Shingrix reconstituted with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
back pain / the patient reports the back pain may be due to potential kidney pain; was unable to stand; the patient reports the back pain may be due to potential kidney pain; the patient reports after vaccination he felt light headed; This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) subcutaneously (strength, dose, frequency, site of administration, lot # and expiration date were not reported) for prophylaxis.  All information was provided by the pharmacist, who conveyed what the patient reported. On an unknown date, after the patient received the suspect vaccine, he left facility and walked across the street. The patient reported that after vaccination he felt light headed, had back pain and was unable to stand. Emergency Medical Services (EMS) were called and he felt better 10-15 minutes later. The patient reported that the vitals were normal per Emergency Medical Technicians (EMT) and he did not need transport. The patient reported that back pain might have been due to potential kidney pain caused from the vaccine.  The outcome of the events of feeling light headed, back pain, being unable to stand and kidney pain was unknown.  The reporter did not provide causality between the events of feeling lightheaded, back pain, kidney pain, being unable to stand and Pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).
At approximately 7:15 pm on 5/7/21 administered a COVID19 (Janssen) vaccine to the patient. Immediately the patient began to complain of feeling "sick" and slumping forward in chair. immediately lowered patient to the ground and placed in a supine position. Called 911 and waited outside for EMS to arrive. Patient remained conscious and pulse was noted as strong but breathing  was shallow and rapid. Pt was encouraged to focus on breathing but began to complain of muscle tightness in the hands and back. at approximately 7:25 EMS arrived and were able to calm patient using breathing exercises. EMS attributed the incident to an panic disorder which was reported to have occurred  once before approximately 10 years prior when receiving a flu vaccine.  The patient denied ambulatory care to the hospital for further evaluation.
fever; more exhausted; This spontaneous case was reported by a consumer and describes the occurrence of fever and FATIGUE in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 088021A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced fever and FATIGUE. At the time of the report, fever and FATIGUE outcome was unknown.            Concomitant products included INHALERS for COPD.  No Treatment informations were reported.   This case was linked to MOD-2021-310917, MOD-2021-311057, MOD-2021-310917 (Patient Link).
About 2 hours after he received the Pfizer booster vaccine he was going to the bathroom and became unresponsive. He was "coded" and did become responsive and breathing again and the ambulance took him to Hospital. It may have been a vasovagal response or something else. He has an extensive medical history so I'm not sure if it is vaccine related or not. I have not heard from  hospital at this time to know what his diagnosis is.
rash around neck on 18OCT92; arms on the 20OCT92; abdomen 21OCT92; non pruritic; seen by MD on 20OCT92; dx poss vax related exanthem;
have 99.98 fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On 13th November 2020, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever 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 selected as adult as per the vaccine indication. The patient received Shingrix and had Fever. The reporter asked how long would fever last after getting the shot.
patient is late for her second dose of Imovax vaccine by 11 days; Initial information received on 08-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 19 years old female patient who was vaccinated with a first dose of a 0.5 ml RABIES (HDC) VACCINE [IMOVAX RABIES] (lot NIK303N and Exp. Date 08-Dec-2019) via intramuscular route in the left deltoid on 26-Jun-2019 and was late for her second dose of Imovax vaccine by 11 days.  The patient's medical history not reported and no other vaccines or medications were given that day.  It was an actual medication error case due to inappropriate schedule of vaccine administered as patient was late for her second dose of Imovax vaccine by 11 days.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Lightheadedness; Accelerated heart rate; Chest pain; Adverse event NOS; This serious initial spontaneous safety report was received by Novavax on 27-AUG-2022 from a consumer.     A female of 41 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 1 on 16-JUL-2022, and intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 2 on 19-AUG-2022.  The following secondary suspect medications were reported: Hepatitis B [Hepatitis B Vaccine] on 10-AUG-2022.  No medical history was reported.  No concomitant medications were reported.  On 19-AUG-2022, after vaccination, the individual experienced adverse event nos (PT: Adverse event) (Serious: Medically Significant). On 19-AUG-2022, three hours after vaccination, the individual experienced lightheadedness (PT: Dizziness) (Serious: Medically Significant) and accelerated heart rate (PT: Heart rate increased) (Serious: Medically Significant). On 19-AUG-2022, the individual also experienced chest pain (PT: Chest pain) (Serious: Medically Significant) in the center of the chest. The individual went to emergency room on 20-AUG-2022 for continued symptoms. Symptoms lasted for several days.  Relevant lab tests included: Heart rate (Result: up to 100-120 bpm, baseline is reported as 80 bpm; 19-AUG-2022).  At the time of reporting, the event outcomes of Adverse event, Dizziness, Heart rate increased and Chest pain were recovering/resolving.; Sender's Comments: This female of an unspecified age experienced: Adverse event, Chest pain, Dizziness and Heart rate increased after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Adverse event, Chest pain, Dizziness and Heart rate increased were reported as serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events were assessed as Possible.
rebound covid 4 days following the last dose; rebound covid 4 days following the last dose; Moderna/ Pfizer / BioNTech; Moderna/ Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FG3527) and on 07Jul2022 as dose 4 (booster), single (Lot number: FD7150), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 16Jan2021 as dose 1, single (Lot number: 011J20A) and on 13Feb2021 as dose 2, single (Lot number: 024M20A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "rebound covid 4 days following the last dose"; OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown" and all described as "Moderna/ Pfizer / BioNTech". Therapeutic measures were taken as a result of drug ineffective, covid-19.
pt recv vax 6JUN96 & w/in 48hr post vax pt exp myalgia & neuralgia @ the rt deltoid inj site & the rt shoulder area;MD visit was required;tx Ibuprofen & Percocet;sx have persisted & are aggravated by certain arm & shoulder movements;
patient felt faint and hot approximately 10 minutes after vaccine administration - required an ice pack after administration - the patient left with a caregiver, she did not want an ambulance called
A report was received from a health care professional on 06Jan04 concerning an adult vaccinee of unknown gender who inadvertently received two 0.5ml doses of Fluvirin vaccine, one dose on 23Dec03 and a second dose on 06Jan04. The vaccinee was inadvertently administered two doses of Fluvirin two weeks apart. The nurse who administered the vaccine was confused due to the 0.25ml marking on the Fluvirin pre-filled syringes and did not realize until after the second dose was administered that each pre-filled syringe contained 0.5ml. The vaccinee did not experience any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
patient developed Bell's Palsy within 24 hours of  flu vaccine being adminsitered. pt went to ER and they determined it was likely caused by her flu shot. Patient called the pharmacy, where the shot was administered, the following week just to inform us of incident. pt was given prednisone, valacyclovir and gabapentin at ER. pt was slowly recovering at time of conversation.
Patient recieved a regular pfizer 12+ vaccine as a booster dose instead of the Bivalent Pfizer Booster
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Patient fell out of chair. Regain conciousness, fluttering eyes. Heart rate 35 , O2 was 98. Heart rate went up to 51 once paramedics arrived. O2 remained 95-98. Patient was brought to hospital by EMS.
Developed blood clot; Sever pain in his stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016L20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Sever pain in his stomach) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Developed blood clot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Apr-2021 to 04-May-2021 due to ABDOMINAL PAIN UPPER and THROMBOSIS. The patient was treated with Surgery (leading to two and half feet of his small intestine removed) for Thrombosis. At the time of the report, THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) outcome was unknown.            Patient started having severe pain in his stomach on 27-Apr-2021. He was taken to the hospital on 28-Apr-2021, patient's doctor said that he had a clot in his intestine and that caused the pain, was operated removed to two and half feet of his small intestine. Patient was discharged from the hospital on 04-May-2021.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company Comment : Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
A spontaneous report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. The patient reported ADMINISTRATION OF EXPIRED DOSE which started on 22-Jan-2014. The outcome of the event of ADMINISTRATION OF EXPIRED DOSE is unknown. The report was considered to be non-serious by the reporter.
episode of pallor, taken to ER 10NOV95;pallor & hypotonic x 45mins;
Vaccine was expired for 8 days. Given inadvertently due to confusion in extended dates. vaccine stored in refrigerator and not ultra-cold. Used ultra-cold extended date instead of 10 week expiration date.
I received 2nd dose Moderna Vaccination on 4/2/21. I had mild side effects of exhaustion and body aches.  On 4/9/21 and 9/10/21 I had back pain and it was sting-itchy. On  4/11/21 the itchy patch began to blister wrapping around my left side of body from spine to sternum. On 4/12/21 I met with Dr. and she diagnosed me with shingles.
PATIENT FELT USUAL ADVERSE EFFECTS FROM FLU IMMUNIZATION SORENESS WHERE THE SHOT WAS GIVEN, HEADACHE AND ACHES.
I had flu-like symptoms with chest pains and syncope. I went to ER on 01/06/2022 and blood work, EKG, CATA, and Urinalyses was done. My EKG discovered a long QT wave (referred to cardiologist) Blood work (normal, except d-dimer) Urinalyses and CATA (normal). Follow up and referral given, nothing prescribed or treatment given. I went to my PCP to follow up and it was discussed for which cardiologist to see and possible long haul Covid. I had an initial meeting with Cardiologist and was put on a 24hr heart monitor at the end of March, (TBD) and discussed test and labs to be done. Angiogram to be done next month and follow up with cardiologist in May.
Information has been received from a LVN concerning 8 children from different families who on unspecified dates were vaccinated with one dose of varicella virus vaccine live. Subsequently, the children developed varicella with a large number of lesions of 100 or more for each child. The children sought unspecified medical attention. Also reported were other patients who were vaccinated and experienced similar events. Additional information has been requested.
Red spot on both arms. Red ring at sight of injection, still noticeable 11 days after injection.
Based on information received on 24-Aug-2018, the report previously considered as non-valid became valid (as number of patient identified). Initial information received on 23-Aug-2018 regarding an unsolicited non-valid non-serious case received from a non-health care professional (office staff), This case involves 37 child patients (gender unknown) who were vaccinated with dose of PENTACEL and ADACEL (batch number, expiration date, dose, route and site of administration was not reported for both vaccines) on an unspecified date. The patients medical history and concomitant medications were not reported. It was an actual medication error case due to incorrect product storage. It was reported that that there were several temperature excursion reached -0.33C for 30 minutes for PENTACEL and ADACEL and the vaccines were given to 37 children. It was unknown whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. Follow up information received on 24-Aug-2018 from a non-health care professional (office staff). Added number of patient, as reported and confirmed validly of case. List of documents held by sender- none.