chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; Vaccination site pain; Chills; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant adult female 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 07May2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any medication within two weeks of vaccination. The 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 16Apr2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 21:00, the patient experienced fever, injection site pain, chills and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with paracetamol (TYLENOL) on an unknown date. The clinical outcome of the event fever, injection site pain, chills and body aches was resolving at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
STARTING  AT 5 PM ON THE DAY OF THE VACCINATION, PT WAS DRIVING HOME.  SHE STARTED TO FEEL HER THOAT WAS CLOSING, SHE COULD SWALLOW,  FACE WAS GETTING PUFFY, EYE WERE FEELING SWOLLEN BUT COULD SEE.  SHE NOTICED HER RIGHT ARM WAS FEELING HOT.  LOOKING AT IT, THE RIGHT ARM AT THE INJECTION SITE WAS SWOLLEN AS LARGE AS A GRAPEFRUIT, RAISED AND BRIGHT RED. SHE ARRIVED HOME AT 630PM AND TOOK 25MG OF BENEDRYL PO.  A T 7PM SHE WENT TO THE LOCAL ER.  SHE WAS TRIAGED ,  VS WERE NORMAL.THE TRIAGE NURSE SAID TO SIT AND IF HER S/S WORSEN TO TELL SOMEONE RIGHT AWAY.  9PM SHE FELT BETTER AND DISCHARGED HERSELF WITH THE NOWLEDGE OF THE ER STAFF.  SUNDAY THE 5TH OF MARCH, HER ARM WAS BACK TO NORMAL.
nausea; vomiting; significant amount of diaphoresis; sudden onset of joint pain in upper torso involving fingers, elbows, and shoulders; Pain progressed into lower body; enlargement of the right supraclavicular lymph node; This is a spontaneous report from a contactable pharmacist(patient). A 37 years old female patient received second dose BNT162B2, Intramuscular on 05Jan2021 11:30 at the 37 years old at Arm Right at single dose for COVID-19 immunization. The medical history included Asthma and Seasonal Allergies. The concomitant medications were not reported. The patient previously took fist dose BNT162B2 on 16Dec2020 12:00 PM, Intramuscular at Arm Right at 37 years old for COVID-19 immunisation. The patient developed sudden onset of joint pain in upper torso involving fingers, elbows, and shoulders approximately 11 to 12 hours post immunization on 05Jan2021 23:00. Pain progressed into lower body throughout the night on 05Jan2021 23:00. The next morning, the pain increased to a point which caused severe nausea and vomiting on 06Jan2021. The patient received Toradol and Zofran to ease symptoms. After which, her husband was called to transport me home from work. The next 24 hours, the patient rested. During which, the patient experienced a significant amount of diaphoresis on 06Jan2021.  Forty-eight hours later, my symptoms are improving. I am sore, but functional. The only new occurrence is enlargement of the right supraclavicular lymph node in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not Allergies to medications, food, or other products. The outcome of events was recovering.  The information on the batch number has been requested.
10:25 am, felt faint, wanted to pass-out. 11:00 am, patient stated she is feeling much better. 92/57, HR 82, BS 120, 97/57, 100/62, O2Sat 99%.
Covid positive Jun2021; Covid positive Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL32646), in arm and on 05Feb2021 as dose 2, single (Lot number: FL9264) at the age of 58 years, in arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 01Jan1987 (ongoing); "T2 Diabetes", start date: 01Jan2017 (ongoing); "Bipolar Disorder", start date: 01Jan2019 (ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2021, outcome "unknown" and all described as "Covid positive Jun2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2021) Positive.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300026646 Same reporter/patient,different drug/dose/AE;US-PFIZER INC-202300026822 Same reporter/patient,different drug/dose/AE;US-PFIZER INC-PV202300127465 Same reporter/drug/patient, different dose.;
Moderna COVID?19 Vaccine EUA  About 8 hours after the shot, I had chills and developed swelling on the right side of my upper lip. In the morning the swelling and chills were gone, and I had a really stiff upper shoulder and up to my neck. I feel totally fine the next morning, but concerned about a worse reaction to the second shot.
Red rash developed on anterior chest area with blanching and refill with pressure. Doctor suspects allergic vasculitis but due to live vaccine prescribed antihistamine
The pt had a fever of 105 on 9/9/00. The pt had a fever and anorexia on 9/9/00 and 9/10/00. Tylenol was given as directed.
All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Redness at injection shot, warm 3 inchesx2 inches 9 days post vaccine
IMOVAX that was put in a freezer for an unknown duration of time with no reported  adverse event; administration after post excursion with no reported  adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited non-valid  non-serious case received from a pharmacist.  This case involved product storage error in which RABIES (HDC) VACCINE [IMOVAX RABIES] that was put in a freezer for an unknown duration of time with no reported  adverse event and it was administered post excursion with no reported adverse event.   On an unknown date, Imovax was put in a freezer for an unknown duration of time with no reported  adverse event (product storage error) (unknown latency). It was given to a patient (Poor quality product administered) (onset date : unknown) and (latency: same day). The caller was asking if this was rendered inactive and its safety after administration post-excursion. The reporter did not have the exact temperature reading . Information regarding batch/lot number requested, but not available at the time of call.   Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Guillain Barre Synd-progressive quadriparesis onset of weakness on 10Dec90, had febrile illness 1 wk prior this /w nausea & diarrhea treated /w Augmentin for a lt lower lobe infiltrate on CXR
8/14/21: patient presents to the ER with shortness of breath, cough, fever, weakness and malaise for several days.  He was seen in Urgent Care and tested positive for COVID-19.  He is now breathing better on supplemental FiO2 and denies any acute distress.  Of note, he received a Pfizer COVID vaccine earlier this year.  Tested positive for Covid on 8/15/21. Diagnosed with covid related pneumonia. Note: previously received Pfizer Covid-19 vaccine: First dose: 03/17/21 Lot Number EN6208; Second dose: 04/14/21 Lot Number EP7533 8/19/21: Discharged.
An RN reported that a 46 year old female RN with Addison's disease who on 1/20/00, was accidentally splashed in the eye with rubella virus vaccine live (second generation). The pre-assemble syringe was not tightened and the vax shot out where the needle and syringe are connected. Subsequently, the pts eye was burning and she flushed it out. The pt sought unspecified medical attention. On 01/24/2000 the pts eye "looked fine". Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 61-year-old female patient who received SHINGRIX (batch number Z9RR4, expiry date 15th November 2020) for prophylaxis. On 13th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. In July 2018, 28 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a pharmacy student. The pharmacy student reported that the patient developed shingles 4 weeks after getting SHINGRIX. The reported batch number for SHINGRIX 29RR4 did not exist and was updated from 29RR4 to Z9RR4 as per sales database.
Early menstruation occurred after dose 1 and 2, I didn't realize it was most likely the vaccine until after it happened again after second shot. Menstruation cycle is always regular and on time. each time with vaccine, bleeding started a day later and was a week early each time.
This spontaneous report as received from a nurse refers to unknown number of patients of unknown age and gender. On an unknown date unknown number of patients was vaccinated with GARDASIL (dose, route of administration and anatomical location unknown) which underwent an unsupported temperature excursion. No adverse effects reported. The outcome of the events was unknown. No further information provided. This case is linked to case # 1407USA005729, 1407USA005730, 1407USA005731 and 1407USA005736 via same reporter link. Additional information has been requested.
I began having transient vision loss and tinnitus. I had an eye exam revealing swelling of my optic nerve. Diagnosed with IIH.
Rec'd vaccine approx 11:15 AM today. At 7:45 PM reports swelling (starts arm double size), redness, pain and heat at site. No previous rxn to vaccines, only allergic to PCN, denied rash, breathing problems, dizziness or any other symptoms. Recommenced IBU, ice, BENADRYL and see a Dr.
Delayed hypersensitivity COVID arm; Arm was red; Arm was swollen/wewlt on arm at the site of injection; Felt like she was going to die/everything went fuzzy; Sweat pouring over me; Shivering; Everything went black; Had words but couldnt get them out of my mouth; A spontaneous report was received from a consumer (patient), concerning herself, a 31-year-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced everything went black (loss of consciousness), had words but could not get them out of my mouth (aphasia), felt like she was going to die/everything went fuzzy (feeling abnormal), sweat pouring over me (hyperhidrosis), delayed hypersensitivity COVID arm (vaccination site reaction), arm was red (vaccination site erythema), arm was swollen / welt on arm at the site of injection (vaccination site swelling), and shivering (chills).  The patient's medical history was not provided. Concomitant medications were not reported.  On 24 Feb 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection.   On the same day on 24 Feb 2021, within 3 minutes after receiving the vaccine, everything went blank for a minute. The patient had words but could not get them out of her mouth. The patient was observed and sent home. The patient was fine until the next day. The patient got up from bed around 07 00 AM on 25 Feb 2021, everything went black. The patient felt like she was going to die, like she was about to lose consciousness. Someone in her household, helped her put ice on her forehead and back on her neck. The patient also stated that she was shivering, sweat pouring over her. The patient was on the floor for 45 minutes; she could not get up. Twice, everything was fuzzy. The patient did not have strength to call emergency room (ER). The patient had no underlying medical conditions and not on any medications. The patient got a delayed hypersensitivity on COVID arm on 05 Mar 2021. The patient iced her arm for 2 to 3 hours because it was red and swollen. The patient thinks that it will become a ball on her underarm. There was a welt on her arm at site of injection. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the events was not reported.  The outcome of the events, everything went black, had words but could not get them out of my mouth, felt like she was going to die/everything went fuzzy, sweat pouring over me, delayed hypersensitivity COVID arm, arm was red, arm was swollen, welt on arm at the site of injection, and shivering were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
BODY ACHES; FEVERISH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not report, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, and feverish (all events in dose number series 2). The patient took tylenol 8hr arthritis pain because it said pain reliever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feverish, and the outcome of body aches was not reported. This report was non-serious. This case, involving the same patient is linked to 20220150541.
3-21-08 at 1am patient began vomiting, diarrhea, fatigue, no fever. Vomiting & diarrhea hourly until 7am. Diarrhea persisted, and patient developed fever & lethargy on 3-22-07 (T 101). Evaluated in physician's office afternoon of 3-22-07, 3pm. Diagnosis = viral illness, per office nurse.
pt recvd vax had inc fever; h/a & rash on abdo, chest, arms, legs then face; fever 103; went to er; in hosp for pneumonia; dx by MD's rxn to MMR;
heart attacks; bad immune system; lethargic; mild headache; feeling not well; soreness in the arm initially; may be dehydrated; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration at the age of 52-years, on 20Mar2021 at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that on 20Mar2021, he had the Pfizer covid vaccine and experienced lethargic, mild headache, feeling not well, soreness in the arm initially on an unspecified date. The patient also stated that he had heart attacks, has a bad immune system on an unspecified date and may be dehydrated. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Mother called clinic regarding her child seen on 5-17-16 that received DTap, Hep B, MMR and Varicella. Mother reports child had fever ranging from 100 to 102 on 5/25th-5/27th. Continued to learn child developed "bumps" on Saturday 5/28th that progressed from face and lower leg to back down to ankles. Mother reported "bumps" non welts on 5/31/16. Mother was advised to take child to pediatrician for evaluation.
Approximately 25 minutes after receiving the vaccine I developed numbness that started on the right side of my head that went to my face with the right side being more affected than the left.  My right eye closed and was difficult to open for a few minutes.  My right ear became painful as if I had an ear infection.  My breathing became tight for a few minutes and my right arm became mildly numb as did the fingers on my right hand, outer part of my right leg and some of the toes on my right foot.  I took Benadryl.  I continue to have residual numbness on the right side of my face and right arm and right leg and foot.
9/1/20: PATIENT CALLED PHARMACY APPROX 1 HR AFTER RECEIPT OF VACCINE AND ASKED IF IT WAS NORMAL FOR HIS MUSCLES TO BE SHAKIN ALL OVER. PHARMACIST ON DUTY STATED "NO" AND ADVISED PATIENT TO CONTACT HIS DOCTOR IMMEDIATELY. 9/3/20: RETURNED CALL TO DOCTOR @ THE HOSPITAL REACHED THE STAFF AND TOLD THE PATIENT WAS ADMITTED FOR SEPTIC SHOCK - NURSE STATED UN RELATED TO VACCINE.
Splotchy, circular red trash around injection site, hot to the touch with muscle stiffness and soreness at the rash site, beginning 8 days after injection.
Redness, hardness and itching in approx 2 in diameter around injection site. ?Covid Arm?
Patient reported experiencing a an uneasiness in the neck area by the ear lobe 4 days after the SHINGRIX vaccination. He said it's not pain but an uneasiness.
No additional AEs were reported; The healthcare worker reported that a patient received improperly stored vaccine.; This spontaneous report has been received from a health care worker, concerning a 4-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 18-AUG-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (valid lot number W004504 [expiration date 16-JUN-2023]) (valid lot number W002562 [expiration date 12-OCT-2023]) (the patient received only one dose, but the health care worker did not specify which actual lot the patient received), for prophylaxis, after a temperature excursion of 11.3 degrees Celsius (C) with a time frame of 34 minutes (min) (product storage error) (dose, vaccination scheme, and frequency were not provided). No previous temperature excursion was reported.   No additional adverse events (AE) were reported.
4 to 5 days aftrer the shot, I awoke with a soreness and swelling at the injection spot. There was a large red rash and itch. I applied cold and rubbed benadryl on the reas for the last 5 days. The swelling is almost gone and the itch is gone, but still a red rash. QUESTION-- I am scheduled for second shot on 3/3/21--DO I GET IT?
rash on right and left calf; This case was reported by a consumer via interactive digital media and described the occurrence of localised rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd January 2022, the patient received Shingrix. In January 2022, less than a week after receiving Shingrix, the patient experienced localised rash. On an unknown date, the outcome of the localised rash was unknown.   It was unknown if the reporter considered the localised rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingrix vaccine the day before reporting.  It was ok overall, but patient had developed a decent sized rash on right calf, and a tiny one on left calf.  It was not listed as a common side effect so wanted to know if patient need to call their physician the day after reporting. The follow-up would not possible as no contact details were available.
This was my 2nd shot.  (1st shot was 3 weeks prior).    Four days after 2nd shot, I developed wheezing and congestion.  On my 6th day, I had an asthma attack.    I obtain an albuterol inhaler and used it occasionally for the next 3 days. Today, after 11 days, I still have a slight cough but feel like I'm getting my energy back.
Mild redness and warmth in left lateral thigh at site of vaccine (VARIVAX and KINRIX). Redness measures approximately 6 cm around. Some tenderness at visit which was 2 days after administration of vaccine.
Mild itchy rash on right arm between elbow and wrist, with small blisters - reminiscent of urushiol (poison ivy/oak/sumac) exposure, but patient had no known exposure. Reporting only as precaution for data. Treated with spot application of OTC hydrocortisone cream, nearly resolved at 6 days.