chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within five minutes of receiving the vaccination part states that she did not  feel face got hot and jaw  got hot and hurting, was hlight headed heart, blood pressure went up and heart palpitation, tough swelling  and slightly fainted and she waited 45 minutes an tough went down jaw was hearting finger and feet swell and chest was hurting  like someone was sitting on her chest, stomach cramps and heart rate was at 100. Called the Dr. told to take Benadryl and Tylenol for pain. Told to take Benadryl and Tylenol before the second dose and was told to have a driver to take her. The second vaccination the jaw was hurting and chest was heavy and glad swelling and left side swelling on the leg and vision was blurry and lodes was swollen and a fainting spell that day.  Still have pressure in chest and extremely fatigue and vision is on and off blurry and nausea and diareeha.
I am a breastfeeding mom and for 48hrs after I received the shot my milk supply dropped and baby was more irritable.
IRREGULAR SHAPED RASH LARGER THAN 3 INCHES AND REPORTED 1 COLD SORE ON BOTTOM LIP.
improperly stored administered GARDASIL 9; No additional AEs; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.   Temperature excursion (product storage error) was reported on 05-MAY-2021 (first identified on 13-APR-2021). At that time, the customer erroneously stated no products were administered.The physician assistant reported improperly stored administered on an unknown date. The patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL injection, (dose number and route of adminstration was not provided) lot # 1691180, expiration date 15-NOV-2022, for prophylaxis.   Temperature: 28.8 F for 2 hours and 35 minutes and 31. 4 F for 0 hours and 15 minutes. There was not previous temperature excursion. The call was not because of a data logger.   No additional adverse events (AEs) or product quality complaint (PQC) were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1691180; expirationdate: 15-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Visual disturbances. Blurry vision, foggy could not read normal things I could previous day. Address labels, cell-phone, even did not drive a car.  I was seeing a blurry film in my vision.
aches; fever of 101.8 degrees F; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program regulatory authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced aches and fever of 101.8 degrees F. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
decreased appetite; GI symptoms starting 30-40 minutes after the injection; patient had to pull-over his car to the side of the road to vomit/proceeded to vomit multiple times that day; diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), DECREASED APPETITE (decreased appetite), GASTROINTESTINAL DISORDER (GI symptoms starting 30-40 minutes after the injection) and VOMITING (patient had to pull-over his car to the side of the road to vomit/proceeded to vomit multiple times that day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (diarrhea), GASTROINTESTINAL DISORDER (GI symptoms starting 30-40 minutes after the injection) and VOMITING (patient had to pull-over his car to the side of the road to vomit/proceeded to vomit multiple times that day). On 02-Feb-2021, the patient experienced DECREASED APPETITE (decreased appetite). At the time of the report, DIARRHOEA (diarrhea), DECREASED APPETITE (decreased appetite), GASTROINTESTINAL DISORDER (GI symptoms starting 30-40 minutes after the injection) and VOMITING (patient had to pull-over his car to the side of the road to vomit/proceeded to vomit multiple times that day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Info has been received from a physician and an RN concerning a 21 year old male employee, who on 10/28/02 was vaccinated with a 1st dose of Hep-B. Nine days, post vax, on 11/6/02, the pt developed swelling and weakness of his left wrist and shoulder pain and stiffness. Unspecified medical attention was sought. As of 11/6/02, the pt's experience had not abated. The physician noted that there was no previous history of an adverse reaction. Additional info has been requested.
MA had order from provider for Zoster vaccine. MA administered incorrect medication. MA retrieved vial for Varicella vaccine and drew up this vaccine. Varicella is what was administered to the patient instead of Zoster. Age of patient at time of event: 60 years.
After the 2nd dose of Pfizer on 3/22, on 4/3rd I notice my first experience of heart was strain, but I thought it was stemmed from school stress since it was Final exam month. Three days later (4/6th)  around 8 PM my heart started to race and I thought it was stemmed from the Adderall that I started to take, but I only took one 5 mg at 10 AM and the effects should already wear off. Ate something quickly and felt better. However, the heart palpitation returned again at 10 PM and subsided, and again at 2 AM. After surviving that rough night, my chest felt tender from all that and continued to feel tender till the end of April, also decided to quit taking Adderall for good. I had another episode of heart palpitation and now shortness of breath on May 4th made an appointment about my chest pain with my primary physician and found my EKG result came back abnormal with bradycardia (5/14). Later, was referred to a cardiologist and then was put on a Holter monitor on May 18th for two weeks. The entire two weeks was hard because I experienced countless stabbing sensation in the heart, shortness of breath, and it was so bad that I couldn't breathe while driving to do errands or sit through a movie, and it mostly happened around 8 PM, so I was fearful to go to sleep. Treated myself with allergies medicine and  steaming, hoping to open my airways. It helped some, but relief was short and temporary.  Later on requested to do a stress test (6/11). The result came back normal, and I notice my shortness of breath and chest pain began to subside by then. Been self treating with ibuprofen, turmeric milk, and ice/heating pad. Now I feel a lot better, but I do feel the symptoms on a mild side such as I can feel small hits or stabs at the heart but mildly or when I stretch when waking up I try to be cautious not to over do it. The whole experience has been traumatic.
Face was bright red raised warm rash 6pm took to ER 12/4/10 8pm.
sore arm; sinus problems; swollen lymph nodes; A spontaneous report was received from a consumer concerning a 45-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, sinus problems, swollen lymph nodes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sore Arm, Sinus Problems, Swollen Lymph Nodes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, sinus problems, swollen lymph nodes was unknown.
Arm pain/ rotator cuff contributes to arm pain; 1st dose in 2020, 2nd dose on 2023; Redness at injection site; Chills/ shivering; Fatigue; Heart palpitations; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on November 2020).   On 12th January 2023, the patient received the 2nd dose of Shingrix. On 12th January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 13th January 2023, the patient experienced pain in arm, injection site erythema, chills, fatigue and palpitation. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the injection site erythema, chills, fatigue and palpitation were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain in arm, injection site erythema, chills, fatigue and palpitation to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The patient was self-reported this case. The patient reported that she received first dose of Shingrix vaccine on November 2020 and the second dose was received on 12th January 2023. The patient reported that there was no adverse reaction after the first dose. The patient stated than on 13th January 2023, 1 day after received Shingrix vaccine she experienced arm pain, redness at injection site, chills, shivering, fatigue, and heart palpitations. The patient reported that the redness, chills, shivering, fatigue and heart palpitation are resolved after 2 days. The patient stated that the arm pain was ongoing.  The patient believed that she had a rotator cuff in need of replacement was a contributing to the arm pain, but also noted that they did not experience this type of pain when receiving other vaccinations in the same arm, nor did the pain with other vaccinations last for as many days. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Patient required hospitalization for COVID-19 Seen at an urgent care 2/24 for sore throat. Clinically dx'd w/strep and started on cefuroxime and prednisone Continued to decline with anorexia, dry cough , mild sore throat and weakness. Was taken to ED 2/27 and diagnosed with COVID pneumonia. Had mild hypoxemia requiring oxygen. She was admitted from 2/27-3/3. She was treated with 3 doses of IV dexamethasone and Remdesivir. Because of the length of time from second vaccination ID was consulted. They SARS-CoV-2 IgG testing. Pt was negative. Therefore the pt was treated with one unit of convalescent plasma on  3/1 for passive immunity. She was able to be weaned off oxygen on 3/1 and was discharged on 3/3 Additionally her SARS-CoV-2 nasal swab was sent to the health department for genetic sequencing
Severe lower back pain; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 21Feb2021 at 11:15 (at the age of 16-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) via an unspecified route of administration in the left arm on 20Mar2021 (at the age of 16-years-old), both as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to vaccination. Medical history was reported as none. 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 take any concomitant medications. The patient did not have any allergies to food, medications, or other products. On 18Mar2021, the patient experienced severe lower back pain. The event resulted in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of severe lower back pain and included treatment with unspecified pain medications. The patient underwent lab tests and procedures which included computed tomography (CT) scan, ultrasound and blood tests on an unknown date and the results were unknown. The clinical outcome of the event severe lower back pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
35 mm redness and swelling left arm denies any pain. 8/13/12 14:22- made reports redness and swelling almost completely gone- denies any pain.
She has itching that flared up on a daily bases that she didn't have before.; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She has itching that flared up on a daily bases that she didn't have before.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E214, 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Polycythemia vera.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-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 PRURITUS (She has itching that flared up on a daily bases that she didn't have before.). At the time of the report, PRURITUS (She has itching that flared up on a daily bases that she didn't have before.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She was having stronger negative symptoms of polycythemia vera cancer. Concomitant medication include Blood pressure medicines. No treatment information were provided.
CHILLS; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and FATIGUE (Feeling very tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CHILLS (CHILLS) and FATIGUE (Feeling very tired). At the time of the report, CHILLS (CHILLS) and FATIGUE (Feeling very tired) outcome was unknown. Not Provided          concomitant medicine: blood pressure pill and cholesterol pills Treatment information as not reported.
Woke up at 3:00 am about 14 hours after the injection.  Chills ,Fever 100.5 F, Heart Rate 95 ,Head Ache ,Fatigue ( fatigue malaise still present 01/06/2021 ) Upset stomach/pain. Took liquid gel Naproxen Sodium (OTC) 220 mg.  3 times, once an hour,  fever and chills subsided  temp at 8:00 am 98.8F. heart rate 85. General fatigue still present at the time of writing 01/06/2021  at 09:00.  No appetite.
Hair loss/bald spot, left side, @ 1 inch above left ear.  Received the 2nd vaccine dose on 3 MAY 21.  I dealt with the usual 48 hours of fatigue, body aches, etc with no other immediate issues.  On 13 May I went in for a hair cut.  Barber noticed the bald spot.  As of 17 May there is no return hair growth and the spot has grown in size from 1" to 1.5" across.
Redness noted at injection site on left anterior thigh a few hours post-immunization. Next morning red, raised bump developed on same thigh. Rash spreading, extending from knee to hip. Child also ran fever x 2 days max 101.6. No rash or redness on right thigh. No band-aids applied to either site. 5 days post-imms - redness and fever resolved. Rash still resolving. Mom reports same rash after Hib#1 given.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 27-JAN-2017, the health care worker administrated to the patient a dose of VARIVAX (lot # M033211, expiration date 13-SEP-2018) (Dose, route and anatomic location were not provided) for prophylaxis. The same date the patient was vaccinated with a dose of PROQUAD (Lot number, expiration date, dose, route and anatomic location were not provided) for prophylaxis (Accidental Overdose). The healthcare worker administered the two vaccines vaccines because did not realize that the PROQUAD vaccine was contained the VARIVAX. No adverse effects were reported.  Additional information has been requested.
Within approximately 30 minutes after vaccine (Thursday), patient presented with red rash to upper chest, severe headache, dizziness and nausea.  Was treated with Benadryl and Tylenol per anesthesia onsite. Symptoms remained throughout the day with minimal improvement. The following morning  (Friday) only headache remained. patient began having abdominal pain, and was admitted to hospital the next day (Saturday).  It is now Tuesday and patient is still hospitalized.  Unclear if this entire event is vaccine related.
Developed shingles (herpes zoster) thoracoabdominal dermatome onset 1 week post Moderna booster
Body rashing started around 9 pm the day I received the shot in addition to hot and cold chills with shaking. The rash started on my hips and went down to my feet. It was a very hot burning rash that would come and go during the day but was terrible when trying to lie down. At certain points my hip knee and ankle joints were neon pink. As of Thursday I went to urgent care and was prescribed a dexamethisone steroid pack that I just started yesterday with Zyrtec twice a day and Benadryl every 4 to 6 hours. Rash is improving and cold chills are less frequent but still occurring. Too soon to know if it will resolve since I just started oral dexamethisone yesterday
irritability; tinnitus; body temperature fluctuations with no fever; suicidal ideation; Extreme fatigue; depressed mood; brain fog; This is a spontaneous report from a contactable other hcp (patient). A 30-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced suicidal ideation, extreme fatigue, depressed mood, brain fog, irritability, tinnitus, body temperature fluctuations with no fever on 28Mar2021. The patient underwent lab tests and procedures which included body temperature: fluctuations with no fever on 28Mar2021. No treatment was received for the events. The reporter considered the events as non-serious. The event outcome was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Considering close temporal association, a possible contributory role of bnt162b2 to the reported events cannot be completely excluded. However the clinical course, relevant medical history and concomitant medications are pending for a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
tested positive for Covid a week after receiving the vaccine; tested positive for Covid a week after receiving the vaccine; patient stated that she was pregnant; patient stated that she was pregnant; patient stated that she was pregnant; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), via an unspecified route of administration on 18Dec2020 at left deltoid for Covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced tested positive for Covid a week after receiving the vaccine on 28Dec2020 (as reported), the patient stated that she was pregnant. The patient underwent lab tests and procedures which included Covid test: positive on 28Dec2020. The outcome of events was unknown.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information like confirmative virus genome /nucleic acid detection is needed for meaningful medical assessment.
Pfizer vaccine bivalent booster was order and administer by medical assistant. at around 1600 another MA was getting ready to work on another family and notice that vaccine vial was label with date 1/9/23 at 0909. Medical assistant immediately called LVN supervisor to huddle and determine if in fact vial was expire. on investigation it was determine that the vial was originally puncture on 1/9/23 at 0909 and it was passed the 12hrs. Provider was notified, and mother was notified. attempt to call Pfizer for guidance but office was close. we will call on 1/11/23
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # N008829 expiration date: 16-MAR-2019 (strength, dose, route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. It was stated by the reporter that the incorrect product storage had a time frame of 2 hours between  6° F and 14° F (6.3°F); and the call was given because of a data logger. Previous temperature excursions had not occurred. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1709USA008034:
1hr p/shot t104 ax,ear 102;crying & fussy, vomiting each time p/eating;lt thigh red, scrotum swollen to ER 18APR;mom states UA done MD felt allergic rxn to shots;following vax mom gave bath & APAP;sl diarrhea;pt fussy & irritable x 5 days;