chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administered to a patient 3 days after the expiration date; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 1st May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 4th May 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 4th May 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: The registered nurse stated that Rotarix was administered to a patient 3 days after the expiration date. The reporter consented to follow up via posta. Initials of patient and lot number not available at the time of the reporting.  Additional Supportive Information: The patient received Rotarix which was already expired, which led to expired vaccine used.
Patient was given vaccination, proceed to wait 15 minutes after given vaccination. Was seated in chair in waiting area, fell out of chair due to Vasovagal syncope. When patient came too he was disoriented but breathing on own and could answer simple questions of name, place etc. Checked pulse and %SpO2 both within normal. Patient was allowed to lye on floor for 5 minutes or so then propped up against wall for another 5 minutes. After observing for about 10 minutes pharmacist decided to call paramedics (just as a double check ) to make sure all ok. Paramedics came and checked BP/Pulse/%SpO2 all within normal. About 15 minutes go by and pharmacist drives patient home, and patient picks up car later. On drive home everything nothing observed abnormal.
Sore arm; Fatigued; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old patient with unspecified gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 15Mar2021 at 11:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 22Feb2021 at 13:00 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 15Mar2021 at 14:30, the patient experienced sore arm and fatigue. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm and fatigue was resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
On the day starting 6pm (injection +8.5 hrs/next day until 2pm: Severe headache, severe nausea/vomiting, dizziness, body ache, chills/hotflashes Two days later, mid afternoon: Nausea Five days later, lunchtime for several hours: severe headache Six days later, lunchtime for several hours: severe headache
Patient was given vaccine and in exam room for the 15 minute observation period. Patient states she began to feel dizzy and was trying  to get up from the chair to sit on the floor. At that time, patient had a syncopal episode. Patient was not conscious for approximately 20 seconds and was aroused. Patient was assessed by Nurse Practitioner and Nurse. Vital signs obtained multiple times. Patient remained lying on the floor due to continued dizziness when going from laying to seated, position. After some time patient was able to sit in the chair in exam room but still felt dizzy and slightly nauseous. Patient was laid down again. After some time patient was able to be seated again. Patient was advised to go to the local ED for further observation as a precautionary measure. Patient contacted spouse who came and picked her up, stating he would transport her to the hospital.
pt recvd vax & devel blotchy, raised rash on face which casued itching; did not spread to other parts of body-advised see MD; no reaction to Hep B # 1 & 2; 2FEB94 seen by MD given Epi & other rx's; rash cleared in 2 days;
Pt. have fever and irritability after vaccines. Pt. also had decreased po intake after shots.
fatigue; felt shakey/ felt like my sugar had dropped; feel nervous/buzzy feeling/nervousness; dizziness; Chills; muscle aches/body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (muscle aches/body aches), TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness) and DIZZINESS (dizziness) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cirrhosis liver (Medical history reported as cirrhosis of the liver.). Concurrent medical conditions included Diabetes (Medical history reported as diabetes.).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced CHILLS (Chills) and MYALGIA (muscle aches/body aches). On 24-Jan-2021, the patient experienced TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness) and DIZZINESS (dizziness). On 27-Jan-2021, the patient experienced FATIGUE (fatigue). At the time of the report, CHILLS (Chills), MYALGIA (muscle aches/body aches), TREMOR (felt shakey/ felt like my sugar had dropped), NERVOUSNESS (feel nervous/buzzy feeling/nervousness), DIZZINESS (dizziness) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Approximately 5-7 hours after receiving vaccine injection site became very painful, red, hot to touch. Over 24 hours patient developed chills and area of injection site remained red, blotchy approximately 5 in by 5 in. Pain subsided within 72 hours but injection site remains red.
Initial report was received from a healthcare professional on 04 February 2013. A 19-year-old female patient had received an injection of MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date of administration not reported) and an unspecified amount of time later became ill and was hospitalized on 01 February 2013. The patient was diagnosed with bacterial meningitis. The patient died on 03 February 2013. No additional information was provided. Outcome was fatal. Documents held by sender: None.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6203), on 19Mar2021 as dose 2, single (Lot number: EN6208), on 07Oct2021 as dose 3 (booster), single (Lot number: 30145819) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "non-alcoholic fatty liver" (unspecified if ongoing), notes: non-alcoholic fatty liver disease. Concomitant medication(s) included: AMLODIPINE, start date: Mar2021; FLUTICASONE, start date: May2022; ROSUVASTATIN, start date: May2022; OMEGA-3-ACID ETHYL ESTER, start date: Mar2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: repeat of COVID symptoms; Positive, notes: testing positive 11 days after Paxlovid dose ended. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies to patient. The patient received Paxlovid as a treatment for COVID-19 from 04Aug2022 to 09Aug2022. sore arm when vaccinated, repeat of COVID symptoms and testing positive 11 days after Paxlovid dose ended.  Follow-up attempts are completed. No further information is expected.
6mins post vaccination pt reported flushing/sweating, dizziness, and tunnel vision Vitals: 103/64, 76, 18, 100% SpO2 Pt given orange juice and crackers. Pt stable and released from the vaccination site.
For three days after vaccine I had severe pain at injection site and swelling (left arm). Two nights after injection I had body chills.  One week and one day after injection (1/19/2021) I developed 6x7inch red swelling, with irregular border at injection site. The area was itchy and very hot to the touch. No pain on palpation and no fever. I also experienced pain under my left arm pit. The next day (1/20/2021) the swelling has gotten larger with same symptoms.
Patients, ages 16 and 17 received the Moderna vaccine on April 1st; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patients, ages 16 and 17 received the Moderna vaccine on April 1st) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patients, ages 16 and 17 received the Moderna vaccine on April 1st). On 01-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patients, ages 16 and 17 received the Moderna vaccine on April 1st) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.   Reporter did not allow further contact
Pt went to sleep going home from office (did not even cry when given) but about 40-45 minutes, post vax, she woke up and screamed , unconsolable for almost one hour. She went to sleep and whimpered in sleep and every time pt moved, she screamed like severe pain.
Mom picked child up from school on 2/10/2000, at lunch time and she had a fever of 99.8, headache, both arms cold and numb, trembling, eye sight not clear and pale color. Mom thought daughter was having a hypoglycemic symptoms. Friday at 4:00 AM, on 2/11/2000, she had a fever of 101/8. Mom gave her Tylenol all day. Saturday morning at 7:00 AM her fever was 103. Gave Tylenol all day and she also had cough and congestion. Today, 2/17/2000, has cough and congestion but no fever after 2/12/2000. She ate well, crackers and tea.
Per MD, Pt c/o swelling in the roof of his mouth about 3 minutes after receiving the vaccine. No itching, no SOB.  Exam NAD 145/93 P88 O2sat 100%, Lungs CTAB This represents possible angioedema and I recommend that he forego the second dose of Pfizer. Pt provided with 25 mg of benadryl PO x1. He was d/ced home in stable condition. Cancelled 2nd dose and made appointment for Johnson & Johnson vaccine.
pain at injection site, lymph node pain, swelling in left arm pit, fatigued  Narrative: Woke 1/20/21 with pain at injection site, lots of pain in lymph node under L arm about size of tangerine, an very fatigued. Worked from home 1/20/21 swelling has decreased substantially, reports feeling better today
Re-emergence of vertigo that I had been suffering from on and off for about 15 months
I developed a deep cough on 09/04. I tested negative for COVID-19 on 09/05 and went to the urgent care that day. I was prescribed a cough medication. I tested positive on 09/06. I only have a cough but I'm still testing positive as of 9/15.
sudden onset chills, fever (101.3), body aches, headache. Mostly subsided 10 hours later.
EXTREME ACHES; NIGHT SWEATS; SEVERE CHILLS; FEVER 102; FATIGUE; THROBBING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced extreme aches, night sweats, chills, fever 102, fatigue, and throbbing headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever 102, chills, night sweats, extreme aches, fatigue, and throbbing headache. This report was non-serious.
Sore (mildly painful) area in armpit and down underside of arm.  Slightly swollen and tender to touch.  Took Advil twice a day to reduce soreness.  Felt gradually better and was fine after 4-5 days
Systemic: Dizziness / Lightheadness-Medium, Systemic: Difficulty breathing -Mild, Systemic: Nausea-Medium
In the few minutes (15 mins) following the administration FLUCELVAX vaccine, the patient complained of feeling warm then hearing diminished, felt light headed. Had patient lay down, given fluids and rest. Nurse practitioner at clinic examined her. BP fine/pt fine.
Patient received only liquid portion of Menveo without reconstitution; Patient received only diluent portion and also half dose due to leakage; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA641A, expiry date 30th June 2023) for prophylaxis.   On 9th May 2022, the patient received Menveo. On 9th May 2022, unknown after receiving Menveo, 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: 9-May-2022 Reporter's comments: On reporting day, the patient received half dose of only liquid portion of Menveo without being reconstituted due to leakage. The reporter consented to follow up.  Additional Supportive Information: The patient received half dose of only liquid portion of Menveo without being reconstituted, which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022075741:Initial Case
Patient brought to the ED by EMS on 11/19 for chest pain, fatigue, and dry cough. COVID-19 PCR test done in the ED resulted positive. In the ED, her O2 sats intermittently dropped to 88%, therefore she was given a dose of decadron and placed on O2 NC. In the ED, patient's troponin was found to be elevated, and cardiology was consulted who recommended admission. Ultimately patient admitted 11/19/22 - 11/22/22. Discharge diagnosis included acute hypoxia felt due to COVID-19 infection. Elevated troponin suspected to have been demand ischemia due to Afib RVR and possibly due to COVID-19 infection.
Information has been received from a licensed practical nurse concerning a male who, "a couple of weeks ago," on approximately 08/23/2001, was vaccinated with one dose (lot # 637095/0946K) of pneumococcal vaccine 23 polyvalent. Subsequently "within a day or two post-vaccination," on approximately 08/24/2001, the patient developed cellulitis. The patient sought unspecified medical attention. It was also reported that another patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent, from the same lot (lot #637095/0946K), and also developed cellulitis (WAES01090919). The reporter expressed a concern with the lot. The records of testing prior to release of this lot (637095/0946K) have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
seizure; A spontaneous report was received from a healthcare professional concerning a 63-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events seizure.  The patient's medical history was not provided. Concomitant medications reported were Phenytoin, Norvasc for drug use for unknown indication.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: not provided) via unknown route for prophylaxis of COVID-19 infection.  Lab parameters done was not provided.  On 1 Mar 2021, in the evening she went to bed and had a seizure. She was fine in the morning and her husband told her that she had a seizure last night. She is allergic to peanuts and peanuts oil. She has Epilepsy and take medications for that but didn't have a seizure for a long time.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), seizure was unknown.  Action taken with mRNA-1273 in response to the event was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates in 2014, reported as from 10-JUN-2014 to 18-JUL-2014, an unspecified number of patients were vaccinated with doses of ROTATEQ orally, (dose number, dose and lot number were not reported), which were improperly stored. No adverse events were reported. Concomitant medications were not specified. The action taken and outcome were not provided. Follow up information was received from the medical assistant on 06-AUG-2014. The medical assistant stated the temperature excursions occurred on two different dates: 10-JUN-2014, 51 degrees Fahrenheit for 5 minutes and on 18-JUL-2014, 48 degrees Fahrenheit for 24-minutes. The M.A. also stated she did not have patient identifiers, lot numbers, expiration dates, or dates of administration available at the time. Follow up information has been received on 06-AUG-2014 from medical assistant and refers to 5 month old patient of unknown gender who on 09-JUL-2014 was vaccinated with improperly stored dose of ROTATEQ oral, lot#K004468, expiration date 08-DEC-2015 (dose not reported). This is one of several reports received from the same source. Additional information is not expected.
Chest pressure, shortness of breath started 10 days after vaccination. Intermittent and associated with palpitations, pain is centrally located, not radiating, not associated with diet but gets worse with exercise and wakes her up from sleep. Diagnosed with high blood pressure and elevated lipids a year ago, controlled by diet and exercise. Seen in ER on 4/8/03, normal BP, ECG and ABGs. Chest x-ray also normal. Plans to see her primary physician and get full cardiac evaluation.
Caller did no get the second dose 36 days after the first; his mild tinnitus that only bothered him in one ear now developed into moderate tinnitus in both of his ears.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (his mild tinnitus that only bothered him in one ear now developed into moderate tinnitus in both of his ears.) and PRODUCT DOSE OMISSION ISSUE (Caller did no get the second dose 36 days after the first) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tinnitus since 2020.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced TINNITUS (his mild tinnitus that only bothered him in one ear now developed into moderate tinnitus in both of his ears.). On 19-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Caller did no get the second dose 36 days after the first). At the time of the report, TINNITUS (his mild tinnitus that only bothered him in one ear now developed into moderate tinnitus in both of his ears.) was resolving and PRODUCT DOSE OMISSION ISSUE (Caller did no get the second dose 36 days after the first) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No Treatment medications were provided. No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: updated action taken, updated event details and updated narrative On 12-Aug-2021: Fallow up received and contains no new information.
since 1st dose, no exacerbation of his conditions; This case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic drug effect in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included pseudogout and rheumatoid arthritis. Concomitant products included colchicine.   On 12th October 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced unexpected therapeutic drug effect. On an unknown date, the outcome of the unexpected therapeutic drug effect was unknown.   Additional Information: GSK Receipt Date: 13-JAN-2023 and 16-JAN-2023 Reporter's Comment: The reporter called at the time of reporting and stated that he had been diagnosed with rheumatoid arthritis and pseudo gout for over 12 years.  The reporter stated that since his diagnosis previously about every 8 to 12 days he had debilitating exacerbations of pain and swelling in his joints.  The reporter stated that since Shingrix he had not had a single exacerbation of his conditions.  Adverse event was filed. The reporter consented to follow up.  Additional Supportive Information: The reporter stated that since Shingrix he had not had a single exacerbation of his conditions, which led to unexpected therapeutic drug effect.
There was no reaction until 10 days after, then the arm was red swollen and hot and it?s larger than my hand.