chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; General not feeling well; This is a spontaneous report from a contactable nurse. This nurse reported similar events 6 patients. This is 4th of 6 reports. A 29-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm on 29Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported the patient had headache and general not feeling well. Patient received the vaccine on 29Dec2020. This patient started to experience these symptoms today (05Jan2021). Reporter talked to this patient earlier he said he had taken Tylenol and she has not heard from him since. Treatment included took Tylenol. Patient was not recovered from the events. The reporter considered the events Headache and General not feeling well was related to the drug.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
Woke up feeling okay, then body felt achy with flu-like symptoms, then dizziness set in and a headache developed.  Mid-afternoon chills developed and a fever of 101.
Coldness; Joints being painful/It comes and goes, knees feel painful, and elbows; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows). At the time of the report, FEELING COLD (Coldness) and ARTHRALGIA (Joints being painful/It comes and goes, knees feel painful, and elbows) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
No additional AE; an expired dose of VAQTA was administered to a patient.; This spontaneous report was received from Office coordinator and refers to a 2-year-old patient.  The patient's pertinent medical history, previous drug allergies/reactions and concomitant therapies were not reported.  On 23-MAR-2023, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (route of administration were not provided), 2nd dose, lot # W006214 and expiration date: 04-MAR-2023 (Lot number W006214 has been verified to be a valid lot number for hepatitis a vaccine, inactivated) administered for prophylaxis (Expired product administered).
Patient received first dose of Pfizer COVID-19 Vaccination 7/26/21, her menstrual period (previously regular, once a month) was due that week and never came. Second dose of Pfizer COVID-19 Vaccination 8/16/21, patient still experiencing secondary amenorrhea. Presented to OBGYN office for evaluation 9/14/21, reports she is virginal, urine and blood pregnancy test negative, still experiencing amenorrhea s/p vaccination.
Patient tested positive for COVID 19 after being fully vaccinated.  Moderna  1st dose: 12/23/2020 025J20A 2nd dose: 01/20/2021 030L20A
Pt into office for vaccine #3 reporting after vaccine #2 started having delusions which have continued. Is following with PCP & psych.
Narrative: 3/8- pfizer vaccine dose 1 3/27-pfizer vaccine dose 2 7/28- COVID+ swab, came in for test after exposure, sx included mild cough and headache, not feel well 7/31- dry cough but improving 8/6- resolved clinically
redness and heat at injection site in 4x5 size. patient still experiencing symptoms and is trying to use benadryl and an ice pack to alleviate. Patient said he would go to doctor if worsened or didn't improve by tomorrow.
Information has been received from a medical assistant concerning a 64 year old female who on an unspecified date was vaccinated SC with a 0.5 ml dose of varicella zoster virus vaccine live. Subsequently, the pt experienced an injection site rash measuring 7x3.5 cm and injection site swelling. Unspecified medical attention was sought. Subsequently, the pt recovered a week after vaccination. No product quality complaint was involved. Additional information has been requested.
Day after vaccine, had 6 days have low-grade temp (max 99.1), vomiting, diarrhea, epigastric pain.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 24-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016; dose and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient developed tightness in throat and chest; mucous production in throat; cough; change in voice; and palpitations. All symptoms started 10 minutes after influenza vaccine. Patient noted symptoms felt similar to reactions with bee stings/venom. Patient had been feeling well prior to event. On exam: Lungs clear, heart tachy; no oropharyngeal edema or stridor; no hives.
Facial flushing and  warm to touch day after injection with slight swelling and painful to touch.  Physician called and Treated with Benadryl orally and Tylenol.  The next morning  his face was extremely swollen and small blisters present and weeping. Face extremely painful. We went to hospital and diagnosed with allergic reaction and cellulitis. Treated with oral steroid taper,Pepcid and cephalexin. He continues to treat currently for both. Instructed by healthcare provider not to get the next injection.  On second steroid taper currently.
redness, swelling & hardness @ inj site on lt arm 13OCT95; fever on Saturday 14OCT95; took APAP for pain & saw PCP on 16OCT95;
Didn't feel well when  I got up the morning or 4/9, had chest discomfort, fluttering in the heart, numbness in the arms.  5pm same day got to feeling much worse.  Felt faint,  lose of eye site. called 911 and was transported by ambulance to hospital were I remained for 48 hours diagnosed with a mini stroke.  Released from hospital  4/11 @ 3pm.   Eyesite has recovered and feeling somewhat normal.
Sudden fever of 103. Could not control with febrile drugs. Discomfort/pain in various extremities. Nausea.  Red, swollen ring around inj. site.  ITCHY and still itchy with hard bump.
This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT (injection). On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were recovering/resolving. The reporter considered the pain in arm and mobility decreased to be possibly related to FLUARIX QUADRIVALENT. Additional information received: A nurse reported adverse events for 3 patients. Each patient was a female adult patient between 30 and 40 years of age. The patient's all received the flu vaccine from the same lot number. Each patient experienced extreme arm pain and limited arm mobility. The patients are recovering. The dose given was 0.5 mL for each patient. The field rep had no other information about the event. Additional information received on 07 April 2015: This case was reported for a 34-year-old female patient. Patient previously experienced idiopathic anaphylaxis reaction. On 10th January 2014, the patient experienced extreme arm pain and limited mobility in the arm.
The initial spontaneous report was received from a medical assistant refers to an unspecified number of patients of unknown ages and genders. On an unknown date, the patients were inadvertently vaccinated with improperly stored RECOMBIVAX HB injection (Dose, lot number and route not provided). A total of 5 doses were administered. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from an office manager concerning a 17 year old male patient who on 13-JUL-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 1), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information was received from the physician reporting that on 01-JAN-1993 the male patient was vaccinated with the first dose of RECOMBIVAX HB. On 02-MAR-1993, the patient was vaccinated with the second dose of RECOMBIVAX HB and on 08-JUL-1993 was vaccinated with the third dose of RECOMBIVAX HB. On 22-JUN-2010 serum hepatitis B surface antibody was <1. On 13-JUL-2010, the patient was vaccinated with a booster dose of RECOMBIVAX HB (lot# 789BA) On 13-AUG-2010 serum hepatitis B surface antibody screen was <1. This is one of several reports received from the same source. Additional information is not expected.
Patient received a dose of that was left out for 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of that was left out for 24 hours) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 033B21) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of that was left out for 24 hours). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of that was left out for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Fatigue which prevented in walking at normal speed on may 1 and followed by pain with stiffness in thighs on may 2 which prevented in walking normally. Nothing explains these unusual symptoms.
Uncontrollable shivering at 1AM (8 hours after vaccine). Fever of 101 degrees from 7AM-11AM. By 1PM I was fine.
High fever 104, screaming (excessive) for 5-6 hrs, bad cough, rash, diarrhea, vomiting, bronchitis; Dx adverse rxn to  DTP;
Little arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little arm soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced MYALGIA (Little arm soreness). At the time of the report, MYALGIA (Little arm soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided by reporter. Non drug medication include ice.   This case was linked to MOD-2021-291070 (Patient Link).
Info has been received from an RN concerning a 27 month old female who in 7/04, at one year of age, was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 10/17/05, the pt developed a generalized rash. It was noted that the pt was exposed to chickenpox in July 2005. On 10/19/05, the pt was seen by a physician, but no treatment was ordered. At the time of this report, the pt was recovering from the generalized rash. Additional info has been requested.
patient stated that she was having trouble swallowing, patient was monitored by doctor and was administered Benadryl and Decadron. patient was alert and verbal. called 911 and patient was sent to ER. patient was not admitted. provider also feels this was related to high anxiety about receiving vaccine
severe dizziness early next morning with nausea and slight headache.     took medicine for dizziness and nausea but symptoms continued for two days  still feel dizziness now and again
About two weeks after shot I was having intermittent pain in my shoulder that has progressed to tingly down my arm,  lack of mobility where I can't lift my arm above shoulder height without pain. I have used ice on and off with no help, I tried chiropractics and acupuncture to help alleviate pain b/c I can't take anti-inflammatory medications.
pt recvd vax & 17FEB94 & 18FEB94 mom noted small blisters on legs 730AM; mom states rash has moved up body & is now on face , arms, legs & body;
1st dose in Sept 2020, and didn't get the 2nd dose until 8/23/2021 (due to COVID).; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2020).   On 23rd August 2021, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not receive 2nd dose of Shingrix due to COVID pandemic situation, which led to social problem. The reporter stated that, the patient did not receive 2nd dose of Shingrix until 23rd August August 2021, batch number 9ZJ25, expiry date 23rd January 2023. The patient asked did need a 3rd dose. The reporter consented to follow up via email
In day of, fever, soreness of infection site, fatigue, cough. These continued for 2 days. On day 2, light spotting and period cramps occurred. It is not the time in my cycle for that. On day three, heavy bleeding started.
she lost her voice; she just can't talk; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EN6198) at the age of 74 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, Lot number: EL9261), for COVID-19 immunization. The following information was reported: APHONIA (non-serious) with onset 02Mar2021, outcome "not recovered", described as "she lost her voice"; MUTISM (non-serious) with onset 02Mar2021, outcome "not recovered", described as "she just can't talk". Additional information: It was reported that the patient had the shot and the first thing she did was she came home and went to bed, she lives by herself. The next day she was trying to sing, and she thought her voice doesn't sound right. She just thought she might better have it recorded, she has no other symptoms, she just can't talk. The patient said she does not know if it began the night of the vaccine on the 01Mar2021 because she came home and went to bed, she did not talk to anyone; she confirmed the first time she noticed it was 02Mar2021. The event was still ongoing and reported that the patient does not talk like this at all. The patient was not sure if it was related to the vaccine, she was not sure she just knew that it came on that quick. She has to say getting the shots could not been more pleasant from the moment she walked in to than when she left. The patient had no investigation assessment. The events were assessed as non-serious by the reporter. The relatedness of BNT162B2 to events/reactions with primary source reporter as the source of assessment and global introspection as method of assessment was unknown. No follow-up attempts are possible. No further information is expected.
Patient described symptoms of "brain fog" two days after receiving the vaccine and it lasted for about 4 weeks.  She said she was very forgetful and confused a lot of the time.
Right swollen, hot to touch, redness at site. Left arn swollen, hot to touch.
Inflamed armpit lymph node - very painful. could not apply deodorant or touch arm pit.
1ST DOSE MODERNA. COMPUTER LISTED 2ND DOSE TO BE PFIZER. IT PERSONNEL CHANGED 2ND DOSE TO MODERNA BUT DATE TO BE GIVEN NOR CHANGE MODERNA GIVEN @ 3 WEEKS
Aching in hips, legs, fever (101.7), chills, tiredness, headache.
vaccine administered was outside of the manufacturer's storage recommendation. specifically, it was refrigerated longer than recommended.
Redness, swelling, and pain (R) arm. BANOPHEN and prednisolone given.
SWELLING, ITCHING, HIVES,THROAT FELT TIGHT APPROX 20 HRS POST VACCINATION.  PT WENT TO ER, TEHN F/U W/ PCM ON 17 JUL.  PRESCRIBED STEROIDS, EPI-PEN, INSTRUCTED TO CONTINUE BENADRYL ALONG WITH STEROIDS.
Short of breath; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short of breath) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19). On 10-Apr-2021, the patient experienced DYSPNOEA (Short of breath) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Short of breath) and COVID-19 (Tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Two weeks after her first dose she got tested at the hospital and tested positive for COVID. Patient was short of breath and went to the emergency room on 10APR2021.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Information has been received from a Registered Nurse (R.N.) concerning a female patient with penicillin allergy who on 16-JUL-2007 was vaccinated IM into the right arm with a first dose of Gardasil lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. The patient recovered quickly. Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 10/12/2007. Initial and follow up information has been received from a Registered Nurse (R.N.) concerning a female student with penicillin allergy (rash) who on 16-JUL-2007, at 10:45 AM was vaccinated IM into the right deltoid with a first dose of GARDASIL lot #658490/0802U. The nurse reported that the patient went out to the waiting room and fainted after she got her first injection. In follow up it was reported that patient became dizzy, weak and had syncopal attack after the injection lasting few seconds. They gave client cold compress and took her blood pressure which was normal, and monitored her in the waiting room for 15 to 20 minutes. In follow up it was reported that her blood pressure (BP) was 100/68 and total heartbeat was 76. She was then watched for 15 minutes and then went home walking. The patient recovered quickly on 16-JUL-2007. Additional information is not expected.
Several hours after vaccination once patient went home, started to develop full body muscle aches, cramps, low grade fever, diaphoresis, and a debilitating migraine. Patient called the pharmacy the next day (5/5/21) to explain the situation. Her symptoms were still persisting and asked for advice. I told her to stay as well hydrated as possible and to take 500-1000 mg of APAP q6-8h and to monitor herself over next couple days for worsening of side effects.
Patient received COVID-19 vaccine. In the observation area, patient reported feeling weak and dizzy.  Patient continued in observation while staff got a stretcher; patient reported that her left side started to shake. A RRT was called and patient was transferred to the ED.
A rash and some swollen and itching has appeared on my right arm after 8 days of receiving the vaccine.
Cellulitis-like warm erythematous skin 1x9 cm in length below injection site.
pt. presented to the ED at hospital with SOB, that didn't resolve with inhaler, and generally not feeling well. ED note attributed to the COVID vaccine
Patient seen 4 Nov 2012 for suspected vaccine reaction from DTaP given 3 Nov 12. On 3 Nov 12 evening patient developed nausea, chills & not feeling well. No SOB, swelling lips or tongue. Patient (R) arm deltoid painful. On day of exam, patient still with (R)  deltoid pain 5x2cm swelling. No chills but did not feel well. No meds taken. Recommend BENADRYL 50mg at HS & CLARITIN 10mg or ZYRTEC QD x 7D.
Was at work when I noticed redness, site to touch and itched. Felt nauseous, weak, dizzy, and a headache. Sat for a little and drank water and it went away after about a couple of hours.
After receiving Covid vaccination patient complained of severe fatigue with severe bradycardia (pulse=36).  No history of any heart disease or bradycardia.  Referred to cardiology for pacemaker placement.
pt recv vax 23FEB98 & on approx 9MAR98 pt devel a fever of 104.5 x 5 days;
Patient presented for first Pfizer vaccine and received Pfizer Bivalent booster mistakenly, Patient was observed for 20 minutes and verified he was stable to no adverse outcome and released
rash on her arm; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program regulatory authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced rash on her arm on an unspecified date after the second dose. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain and swelling of hands and feet - mild but uncomfortable - no 1 or at  injection site inflammation swelling or discomfort no rash, fever or other symptoms.
Swelling in (L) arm up into neck, back of neck, redness and itching.