chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started experiencing hot flashes, sweats, severe body aches, fever, sore throat, stuffy nose, severe headache, severe fatigue around 2am the next day of 2nd dose.
After patient received vaccine dose, they sat in a chair in the 15 minute observation area.  Patients spouse reported that they were not responding to verbal responses. Patient did not offer any verbal complaints.  Skin was cool and clammy/pale.  Pulse was irregular, pulse ox 95%.    Called 9-1-1.  Paramedics arrived and transported patient to local hospital. Patient was conscious and aware.
Zostavax(zoster vaccine)was given IM in left deltoid instead of SQ. Client called CCHD office on 8-19 with complaint of soreness in lt. arm at injection site, and also c/o limited mobility due to the soreness and stiffness in left arm. Client was questioned about pain relieve she had tried on own at home, stated was taking OTC pain medication and using heat. Staff suggested she use ice instead, to continue OYC medication and to use arm normally to work the soreness out. Client states she did not want to have to go to the dr. if she did not need to.
Hives. I had the Flu shot about 1400 and saw hives about 2200. Took 2 Benadryl at 0300 and was clear of hives about 0700.
got deathly ill from the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced illness (Verbatim: got deathly ill from the shot). The outcome of the illness was not reported.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.     It was unknown if the company considered the illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUL-2023 This case was received from patient's family member via interactive digital media. The reporter's mother in-law got deathly ill from the shot.
she told me she opened the PHN A immunization emergency kit  to give this patient 1 dose of diphenhydramine as patient was complaining of  tingling lips post COVID19 vaccination.   While I was was there, she asked patient if she was ok and patient verbalized  that she was fine.   Will notify clinical director & pharmacy chief, emergency kit box was restocked  appropriately & brought back to vaccination clinic.
Nausea , Headache, body ache, sore throat, runny nose, fever 100.2 F, soreness in L arm, palpitations.
Patient was alert and oriented with no signs or symptoms of sickness prior to immunization for 2nd dose of Pfizer COVID19 vaccine. Temperature 98.7. Patient under hospice care and DNR status for wound care (coccyx). Patient has no recollection of first dose, but no adverse reactions to first dose per her caregivers. Patient did not appear to have any adverse reactions to the vaccine after the 15 minute observation period. About 1 hr after vaccine administration, patient was reported deceased. No signs of swelling or allergic reaction at site of injection.
Interchange of vaccine products; On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Vaccination site pain; On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Pain in arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 10May2022, for COVID-19 immunisation, reaction(s): "her first two Covid vaccines were the J&J", "she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either", "her back was extremely painful and the pain radiated into right arm", "right arm was extremely painful and she couldn't move it either", "She had to stay in bed.", "injection it was a little sore for a couple of days"; Johnson and johnson covid vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Johnson and johnson covid vaccine (DOSE 2 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Vaccination site pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Pain in arm".  Additional information: She had the most recent Comirnaty 2023-2024 updated vaccine for adults, she did not provide the date received.  She had this injection and arm was sore for a couple of days, but not like the last time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305571 same patient, same product, different events (Dose 3);
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 15 years old adolescent patient and unknown gender. On 14-JUL-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Warmth and swelling up left arm, itchy / redness of eyes. Pt given Benadryl 25mg Po 9/3/09 at 1430.
Patient reported a mosquito bite sized red spot at administration site on 10/10/23. The redness migrated down below the administration site on the left upper arm by 10/11/23. No medical attention necessary. Redness has resolved.
Eyes became swollen, red and burning. Vision became blurry. Symptoms resolved about an hour after taking Benadryl. Mild redness and swelling continued for 2 days after vaccine and improved with Benadryl every 8 hours.
Shaky; feel lazy; doesn't feel wel; fever 99.1°F; Hyperglycemia; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Hyperglycemia), LAZINESS (feel lazy), MALAISE (doesn't feel wel), PYREXIA (fever 99.1°F) and CHILLS (Shaky) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidemia since an unknown date, Hypertension since an unknown date and Diabetes mellitus since an unknown date. Concomitant products included SITAGLIPTIN for Diabetes mellitus, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced HYPERGLYCAEMIA (Hyperglycemia). On 02-Feb-2021, the patient experienced LAZINESS (feel lazy), MALAISE (doesn't feel wel) and PYREXIA (fever 99.1°F). On an unknown date, the patient experienced CHILLS (Shaky). At the time of the report, HYPERGLYCAEMIA (Hyperglycemia), LAZINESS (feel lazy), MALAISE (doesn't feel wel), PYREXIA (fever 99.1°F) and CHILLS (Shaky) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 98.4°f fever 98.4°F. On 31-Jan-2021, Blood glucose abnormal: 1.68 (High) blood sugar levels high 1.68. On 01-Feb-2021, Blood glucose abnormal: 1.65 (High) blood sugar levels high 1.65. On 01-Feb-2021, Pyrexia: 98.4°f fever 98.4°F. On 02-Feb-2021, Blood glucose abnormal: 1.68. On 02-Feb-2021, Heart rate: 98 (Inconclusive) 98 heartbeat. On 02-Feb-2021, Pyrexia: 98.1 °f fever 98.1 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a other health professional via call center representatives and described the occurrence of incorrect storage of drug in a unk patient who received  KINRIX (batch number KJ924, expiry date 22nd October 2015). Co-suspect products included PEDIARIX (batch number L9L2K, expiry date June 2016) and (batch number 4M76D, expiry date October 2015) and PEDIARIX (batch number 4M78D, expiry date 9th October 2015). On an unknown date, the patient received KINRIX and PEDIARIX. On an unknown date, the dose was un unknown dose. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving KINRIX, PEDIATRIX and PEDIARIX, the patient experienced incorrect storage of drug. ON an unknown date, the outcome of the incorrect storage of drug was unknown. It was unknown if the reporter considered the incorrect storage of drug to be related to KINRIX, PEDIARIX AND PEDIARIX.  Additional information received: Per HCP, KINRIX and PEDIARIX were exposed to -0.5 deg C then subsequently administered to several pediatric patients. HCP is currently accumulating a list of patients that were given the vaccines that were considered unstable due to colder temperature excursion. PEDIARIX lot # L0L2K ex 6/5/16. PEDIARIX lot # 4M76D exp 10/9/15, KINRIX KJ924 exp 10/22/15.
generally ill; had to leave work; dizzy; nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (generally ill), IMPAIRED WORK ABILITY (had to leave work), DIZZINESS (dizzy) and NAUSEA (nauseous) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced MALAISE (generally ill), IMPAIRED WORK ABILITY (had to leave work), DIZZINESS (dizzy) and NAUSEA (nauseous). At the time of the report, MALAISE (generally ill), IMPAIRED WORK ABILITY (had to leave work), DIZZINESS (dizzy) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided by the reporter.  No treatment information provided   This case was linked to MOD-2021-383276 (Patient Link).
No additional AE reported.; an expired VAQTA was administered to a patient; This spontaneous report was received from a certified medical assistant (CMA) referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies was provided.  On 26-JUL-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) (0.5 milliliter (mL); lot # T014836 has been verified to be a valid lot number, expiration date reported and established as 17-JUL-2021; route and site of administration were not reported) for prophylaxis. The vaccine had no prior temperature excursions. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T014836; expirationdate: 17-JUL-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient developed a rash in entire body hours after receiving the Flu vaccine.  He was given to take a 50mg diphenhydramine pill to counteract the issues.
Wrist pain within  hour then gone;  2/24/21 thru 2/27/21   Pain in lower back and hips.
shingles; delay second dose; shooting pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (shooting pain), HERPES ZOSTER (shingles) and PRODUCT DOSE OMISSION ISSUE (delay second dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN (shooting pain). On an unknown date, the patient experienced HERPES ZOSTER (shingles) and PRODUCT DOSE OMISSION ISSUE (delay second dose). At the time of the report, PAIN (shooting pain) and HERPES ZOSTER (shingles) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (delay second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Bedridden  for 48 hours+ with overwhelming fatigue, fever, chills, severe headache, overall severe joint pain, sensation of swelling in L axilla although no actual swelling noted, pain at injection site, leg cramping, mouth pain (gums & teeth)
The first vaccine her mom had, she had seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 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: SEIZURE (medically significant), outcome "unknown", described as "The first vaccine her mom had, she had seizure". Therapeutic measures were taken as a result of seizure.  Clinical course: The first vaccine her mom had, she had seizure. So, her mom took seizure medication before getting the second one and did not experience a seizure.  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-202300002579 same patient/drug, different dose/event;
Information has been received from an office manager concerning a 59 year old female patient, who on 16-DEC-2004 was vaccinated with the first dose of PNEUMOVAX 23 (lot #, expire date and route not reported). On 01-NOV-2010 the patient received the second dose of PNEUMOVAX 23 (lot # 665903/1427Y) (expire date and route not reported). On 01-NOV-2010, the patient had a local and systemic reaction. She developed a fever of 102F, injection site swelling and lymphadenopathy. She was seen in the office but no treatment was recommended. At the time of the report, the outcome of the patient was unknown. On follow up information received from office manager reported that the patient was vaccinated with a dose of PNEUMOVAX 23 and the patient had a local reaction with fever. Office manager indicated that on an unspecified date, the patient recovered with no problems and also said that physician felt that the case was closed. This is one of several reports received from the same source. Additional information is not expected.
Nausea, vomiting, body aches, chills, severe shivering. Slept all day.
Difficulty breathing/like I can't breath; Still feeling the same inside my body/I feel desperate; Have something in my heart I can't explain; I got very dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (I got very dizzy), DYSPNOEA (Difficulty breathing/like I can't breath), FEELING ABNORMAL (Still feeling the same inside my body/I feel desperate) and CHEST DISCOMFORT (Have something in my heart I can't explain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included IRON for an unknown indication.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced DIZZINESS (I got very dizzy). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing/like I can't breath), FEELING ABNORMAL (Still feeling the same inside my body/I feel desperate) and CHEST DISCOMFORT (Have something in my heart I can't explain). At the time of the report, DIZZINESS (I got very dizzy), DYSPNOEA (Difficulty breathing/like I can't breath), FEELING ABNORMAL (Still feeling the same inside my body/I feel desperate) and CHEST DISCOMFORT (Have something in my heart I can't explain) had not resolved.            On 03 Jun 2021 patient had done tests on head, blood and urine and results were normal. On 08 Jun 2021 patient visited to primary health care provider and the events related details were unknown to them. Treatment medication was not provided.   This case was linked to MOD-2021-214535 (Patient Link).   Reporter did not allow further contact
Severe rash broke out; Numerous red dots all over the surface area of her back; she reported severe itchiness for 2-4 days; This is a spontaneous report from a contactable consumer. A 73-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 10Feb2021 14:30 (Batch/Lot Number: EN6201) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 16Feb2021 08:00, the patient experienced severe rash broke out, numerous red dots all over the surface area of her back, and she reported severe itchiness for 2-4 days. Therapeutic measures were taken as a result of the events (Benadryl tablets (oral) & hydrocortisone cream). The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Routine ZOSTAVAX given 4/30/2012 at physical. May 21, 2012 rash anterior & posterior neck. Neck burning pain in area 2 weeks before 5/21. Onset rash after burning.
This case was reported by a physician via call center representative and described the occurrence of fever in a elderly male patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and chills. On an unknown date, the outcome of the fever and chills were unknown. It was unknown if the reporter considered the fever and chills to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional was the patient. The patient experienced fever and chills that lasted for 4 to 5 hours. He reported that other patients in his office reported the same symptoms. The reporter did not have any additional patient information. The batch number for the suspect vaccine SHINGRIX was reported as 4402P, however it was changed to 4492P as per latest sales data sheet. This case has been linked with case US2018GSK068241, reported by the same reporter.
FATIGUE SORE MUSCLES LOSS OF APPETITE MIGRAINE LOW-GRADE FEVER DIZZY
21 minutes after the vaccine I experienced a wave of light-headedness, while I was driving home.  I have had headaches, relieved by Tylenol or Advil, and I have had an intermittent feeling like icy hot in my chest.
o Swollen raised small spot with a rash,  o Rash Spread from the size of a 50 cent piece to about 8 ? 10? o Location was very hot  o Tightness around the area o Walking ? off balance o Rise in Blood Pressure Treatment:  Ice,  benadryl, Cortizone 10 cream
Several days after patients were vaccinated, it was discovered that the refrigerator that housed the vaccine had temperatures ranging from 32 degrees-33 degrees F for 3-4 days. No adverse events noted and no abnormality note with vaccine itself, but manufacturer instructed facility to fill out VAERS form. Vial discarded and replaced.
Patient returned to observation area two hours post injection complaining of LA pain. Medic on site observed some swelling to the LA and proceeded to provide an ice pack. After further assesment patient did not appear in any distress and was instructed to stay in observation for an additional 30 min. At approximately 1300 the patient began scratching  the vaccinated arm and mumbling in a language we could not understand. Immediately the interpreter was called and we prepared for an adverse reaction. Two of our LPNs began taking vitals, One RN began assessing the site where we noted possible infiltration to the subcutaneous tissues. We then moved the patient to a private room.                    RN chart note: "Patient crying sitting in chair, complains of L arm pain. Left arm swollen, softball size, hard to touch, patient sensation remains intact, left radial pulse +2 and present, patient can wiggle all fingers on command. Patient initially denied Benadryl, however after educated with safety and calling 911, patient denied ambulance, and agreed to IV placement. 20 g IV placed in Right AC, 50 mg IV push Benadryl once for swelling and itching of arm spreading in size, 500mL LR bag hung, Patient A0x4 on room air answering questions appropriately. Patient denied ambulance service at this time. Patient states headache is stronger and chest pain decreased."  Patient then fell asleep and approximately  at 1400 awoke with red eyes, continued headache that had gotten worse. BP retaken and was 162/102. At this point we decided we would need EMS to respond. With the language barrier and poor past medical history, we did not find it appropriate to continue treating the patient on site. She was still A&Ox4, denied restricted airways or significant chest pain. Our medical director was alerted of the event and instructed us to call EMS despite patient refusal. EMS arrived by 1430 and assessed patient, she finally agreed to transport.
This spontaneous report received from a registered nurse, via company representative, refers to a 13 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 02-SEP-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9, lot # M009378 (dose, frequency, expiry date were not reported), for prophylaxis. The vaccine was purchased with private funds/ insurance. On 01-SEP-2016, temperature excursion of the vaccines occurred in the fridge and was not discovered until 26-SEP-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one the several reports received from  the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830.
Pt was found unresponsive at home by family taken to ER and pronounced dead. Autopsy report not available at this time.