chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever in excess of 102; Body aches; Swelling at injection site; Bruising at injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and cholesterol. The patient was allergic to to mycin drugs. The patient had received unspecified concomitant medications within 2 weeks of vaccination. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Mar2021 at 00:00, reportedly experienced fever in excess of 102 for over two days, body aches, swelling and bruising at injection site. Caused me to miss work both times I had the immunization. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 16Mar2021 at 00:00, the patient underwent body temperature and the result was 102. The clinical outcome of the event of fever was recovered on 18Mar2021, with the duration of two days. The clinical outcome of the events of body aches swelling at vaccination site and bruising at vaccination site was recovered on an unknown date in 2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
GIVEN 2 BIVALENT DOSES 09/20/2022 03/23/2023  NO SYMPTOMS
Swollen red arm. Big oval at injection site a week after the first injection.  Arm extremely itchy.  Lasted about a week. I took Benadryl before bed.  Could not take when at work. Put ice on it  as well.
pt recv vax 29DEC97 & 8-10hr p/vax pt exp 99 temp & chills;7JAN98 pt c/o strep pharyngitis;
The patient was vaccinated and around 25 minutes later they advised me that the syringe was empty, meaning that they had not really administered the vaccine, but they did not show any evidence of this.
Diarrhea began about 4:30 pm on 3/1/2021, continued intermittently for 4-5 hours.  Significant loss of energy and headache began around 8:00 pm on 3/1/2021, and persisted with gradually decreasing intensity until 3/5/2021.
On 11/27/2017, patient received two vaccinations, PNEUMOVAX 23 and FLUZONE HD. Patient states that shortly after receiving the vaccinations he started to feel shortness of breath. Patient did not come back to pharmacy due to concern about groceries he had purchased. Patient left home and was taken to the hospital an hour later by ambulance where he had a hospital stay of two days. Patient believes it was an allergic reaction to PNEUMOVAX 23 as he has had the Flu vaccination in the past.
Possible administration of Bexsero, Hiberix, Menveo and Boostrix / exposed to -11.9°F for 2 hours; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th May 2021, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Hiberix, Menveo, Boostrix and Boostrix Pre-Filled Syringe Device. On 11th May 2021, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Hiberix, Menveo, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The age at vaccination was not applicable for this report. The reporter was a medical assistant.  The reporter had called to report possible administration of Menveo, Boostrix, Hiberix, and Bexsero exposed to minus 11.9 degree farenheit for 2 hours on 11th May 2021. No further events were reported. The agent tried to give time to the healthcare professional to recollect information but could not retrieve at the moment of the call.  The agent tried several times to reach the healthcare professional to retrieve information but reached voicemail every time.  The reporter did not decline nor accepted to follow up.
Child came in 6/24/10 for dizziness, went to ER -all tests normal. In for ROV - 7/20/10 - c/o dizziness on that day; rec'd MENACTRA, Tdap and Hep A. - returned 2 days later c/o fainting episodes that required at 911 call - denied h/a, c/o diff moving legs; bradycardia noted, racing heart. No previous hx, sent to Neurology.
Vaccine is placed in refrigerator on 18Oct2021 and administered on 20Oct2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 18Oct2021 and administered on 20Oct2021) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 18Oct2021 and administered on 20Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine is placed in refrigerator on 18Oct2021 and administered on 20Oct2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported.  There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned No Treatment information was reported.
Patient presented to the Emergency Department at our facility with approximately 4 hours of vomiting and nausea after receiving the second vaccination for Covid yesterday.  She was monitored and treated with Phenergan, Toradol, and Benadryl prior to discharge back home.
Around 3/28/22 I noticed more numbness & tingling bilateral in my hands and feet, then couple of day later sensation progressed up arms, included feet & legs, and could no longer feel hot/cold in finger tips. I also became easily fatigued with routine tasks.
bodyaches & fever (unk); has red blister rash around waist of rt sides-burning pain-rash about 3 wks p/vax; did not go to PMD;  dx shingles caused by flu shot;
Upon waking the day after vaccination, I experienced vertigo severe enough I did not feel safe driving a motor vehicle or carrying my 2 year old child. I have continued to have the same amount of vertigo since. I have never had vertigo before.
Moderate itchy feeling on skin extending from lower left ear area to middle of throat on face/neck. Nothing obvious visually but itching is very similar to mild poison ivy. Local ointments (benadryl, hydrocortisone, etc) have zero effect.
Fever; tested positive for rapid tests and molecular tests; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (parent) reported that a 17-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Lot number was not reported), via an unspecified route of administration on 09Apr2021 (at the age of 17-year-old) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The consumer called on behalf of her daughter who received Pfizer meningococcal group b rlp2086 (TRUMENBA) vaccine on the 09Apr2021 and developed a fever on unspecified date in 2021. This morning she was relieved, and the fever was gone. She tested positive for rapid tests and molecular tests on unspecified date in 2021. The patient recovered from fever on unspecified date in 2021. The outcome of the remaining event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed painful red swelling lower R arm. Taken to Emergency Room and prescribed antibiotics for cellulitis.
About 10 minutes after the vaccine, the patient's arm went numb and then became painful. Patient got dizzy and had tunnel vision. This resolved after 5 minutes of sitting down. The next morning (Friday, 10/8), patient woke with a bad headache and remained home from school. Tylenol was taken throughout the day. Friday evening, patient complained that it was difficult to breathe and there was a pain in the center of her chest. Patient took 2 puffs of Albuetrol, which did not resolve the symptoms. After 30 minutes, patient took Benadryl. An hour later, breathing was better but patient indicated it felt like her chest was being squeezed. Saturday morning, patient woke with headache and a feeling of the chest being squeezed and not being able to get enough air. Doctor was consulted via phone and advised to give ibuprofen, to use a heating pad on the chest, and to limit activity. Ibuprofen would help with the pressure feeling but would need to be given every 4-5 hours to prevent the feeling. This continued all through Sunday and Monday (patient missed school again). On Tuesday, the patient woke with no headache but still had the uncomfortable pressure (which was slightly better). Patient returned to school after taking ibuprofen. Gradual improvement was seen Wednesday and Thursday. Patient is still taking ibuprofen as the pressure pain comes and goes. Patient indicated that there have been a couple of episodes of her vision getting blurry in school since returning.
Patient experienced Angioedema. Started on Claritin, Kenalog and Prednisone.
Gotten COVID-19; gotten COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (176967). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "gotten COVID-19".  Clinical course: Reporter stated she had gotten COVID-19 after being vaccinated with the Pfizer covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The pt states he felt immediate pain at the injection site and continued to have pain and then had difficulty with mobility of left shoulder. He presented to MD on 12/6/01 to evaluate. Pt dx'd with a frozen shoulder. No redness or swelling at the site. Pt sent to physical therapy.
ITCHY RASH ON BACK AND TORSO REGION.  VISIBLE SIGNS OF RASH SUBSIDED AFTER 3 DAYS BUT ITCHINESS PERSISTS.  ALL MOLES AND SKIN ABNORMALITIES ON BACK REGION PRESENT WITH SCABS.   PERSISTENT NAUSEA,   HEADACHE AND EXTREME LETHARGY AND TIREDNESS; ONGOING (7 DAYS) THUS FAR.  UNABLE TO  PERFORM DAILY TASKS OR WORK FOR MORE THAN A FEW MINUTES AT A TIME.
Information has been received from a nurse via a company representative referring to herself. Medical history of the patient was not reported. On 27-MAR-2015, while withdrawing M-M-R II vaccine (lot# reported as K018990, expiration date unspecified) from the vial, for an unspecified patient, that the needle "exploded" which caused a small amount of the vaccine to splash in the nurse's right eye and on her face. The nurse stated that she was using a Tuberculin syringe, and while withdrawing the vaccine from the vial, that the pressure caused the vacine to squirt out at the point where the needle connected to the syringe. PQC was involved. The nurse stated that she was experiencing a headache, but felt it is not related to the vaccine exposure. Nurse stated that she consulted with an unspeciifed physician was not involved in any topical vaccine exposure due to this event, and that the patient received a dose that was newly drawn up. The outcome of headache was unknown. Additional information has been requested.
pt recv vax & exp hives, swollen lip, tongue, sore arm; given DPH
little chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (little chilly) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Headache recurrent (Suffers from continuous headaches) and Arthritis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ACETAMINOPHEN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (little chilly). At the time of the report, CHILLS (little chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported she takes 500 mg aspirin and acetaminophen concomitantly for her continuous headaches and Arthritis, but now is taking 250 mg acetaminophen and 250 mg aspirin instead.
Patient c/o sensation down L arm shortly after injection, also c/o lightheadedness. Patient's mother had an anxiety reaction on 11/6/09.
Vertigo, nausea and loss of hearing in right ear starting April 28, 2021.  I took a Claritin thinking that might help with the vertigo, it did not.  I contacted my doctor April 29th and he prescribed over the counter Mecilizine, which I took but it did not help with the vertigo. I made an appointment to see an MD, as my MD was out of the office, on Monday May 3rd. He prescribed Fluticasone, sinus rinse, and mucinex.  I took these for 7 days with no relief from the dizziness or hearing loss.  I contacted my MD again and he scheduled a hearing test which showed Moderate hearing loss in right ear.
A non-serious report of "we gave a partial (1/2) of H1N1 Vaccine to 5" was received from a physician concerning a ten-year-old female. The patient's medical history was not provided. On 20-Oct-2009, the patient was inadvertently administered half of H1N1 dose. There was no adverse event associated with this administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; coviD-19 vaccine (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 was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 30Apr2022, outcome "recovered" (15May2022), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: Tuesday 03May upon receipt of positive PCR results; (10May2022) Negative, notes: Negative rapid antigen test on Tues 10May; (14May2022) Positive, notes: On Sat 14May had cold symptoms & fatigue & positive rapid antigen test; (15May2022) Negative, notes: The next day (Sun 15May) felt normal again & rapid was negative. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The patient took Paxlovid treatment for COVID 19, treatment start date was 03 May 2022 and stop date was 08 May 2022. Paxlovid was rebound. Patient had COVID symptoms flu like fatigue body aches chills etc it started on sat 30 Apr then started 5 day course of Paxlovid. Symptoms had been improved over course of treatment and days following.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Medium, Systemic: pain raidiates down towards hand-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Severe
Severe sharp pain from injection site up to base of neck and down to wrist. Inability to raise arm for 24 hours after injection, starting 3 hours after injection.
Onset of Tinnitus, ears ringing all the time, it?s especially noticeable in quiet environment.
This spontaneous report referring a 71 years old female patient, was received from a pharmacist (also the patient's husband) and the patient. The patient's medical history and concurrent conditions were not reported. In 2007, the patient was vaccinated with ZOSTAVAX 19400 PFU injection (dose, lot number, expiration date, route and anatomical location of administration were not reported). The patient had no concomitant therapies. On approximately 01-AUG-2016 (reported as "1 week ago today/last Monday") the patient started feeling itchy and developed shingles (herpes zoster). On approximately 03-AUG-2016 (reports as "by Wednesday"), a spot appeared in the middle of her chest, then a cluster on the top of her right shoulder, then on the right side of her skull into her right ear, then it spread to the side of her jaw on the right side, afterwards a mirror image appeared on her left side of her face into her left ear (herpes zoster oticus). The right side of her shoulder was the worst area. The patient sought medical attention with a physician and on 06-AUG-2016 (reported as "on Saturday") was prescribed with valacyclovir, 1 gram, orally, three times per day as treatment. No laboratory diagnostics were performed. On 07-AUG-2016 (reported as "by Sunday"), she had an area 4 inches long under her left breast and the left shoulder area was drying up, but still had classic signs and continued to have outbreak areas. She felt no pain, only itching at all sites. The patient was requesting that her physician be provided with a courtesy supply of ZOSTAVAX (two doses) one for herself and one for her husband to prevent shingles from reoccurring in the future. No product quality complaint was involved. At the time of reporting, the outcome of the events was reported as not recovered. The causal relationship between the events and ZOSTAVAX was not reported. Upon internal review, the herpes zoster oticus was considered to be medically significant. Additional information has been requested.
headache; dizziness; This is a spontaneous report received from a contactable consumer (patient's parent). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); via an unspecified route of administration on 08Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); vaccine on 18Mar2021 for Covid-19 immunization. On an unspecified date patient experienced headache and dizziness. Reporter wanted to know if this is normal and how long should this last. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023; No Adverse Event; 4 patients were administered with doses BUD on 23-Jan-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Patient had no known relevant medical history/conditions, allergy, concomitant diseases and risk factor. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023).    Concomitant medication was not provided.   The dose administered was Initial Booster.  Vaccines were stored in the fridge since 21-Dec-2022.  Treatment information was not provided.
Raised swollen area right glute at site of injection. Pt. complained of fever chills and dizziness. Area of redness measuring 6 by 3 inches.
11 year old patient was administered MenB vaccine rather than the age-indicated MenACWY.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (lot# unspecified) series on an unspecified date and the second dose of the GARDASIL (lot# unspecified) series in approximately January 2013("about 1 year ago"). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that the patient was in the office to receive the third dose(lot# unspecified) on 09-JAN-2013. No adverse effects reported. Additional information has been requested.
Patient called stating she has been experiencing shoulder pain since she received her flu shot. She stated it feels sore and hurts to move her arm and she doesn't want to move it due to the pain. Patient is going to follow up with her primary care physician.