chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling of outer area of both eyes; Left eye worse: sore, tender to touch and feels like a little fluid buildup.; Left eye worse: sore, tender to touch and feels like a little fluid buildup.; This is a spontaneous report from a contactable consumer (Patient). A 51-year-old female patient not pregnant patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 11Feb2021 13:00 (Lot Number: EN5318) as single dose (at age of 51-year-old), for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient had no known allergies (NKA) nor food allergies. First dose of bnt162b2 (BNT162B2), was received via an unspecified route of administration, administered in Arm Left on 21Jan2021 13:00 (Lot Number: EL1283) (at age of 51-year-old), for covid-19 immunisation. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and the patient has not been tested for COVID-19 post vaccination. On 12Feb2021 at 16:00 patient experienced swelling of outer area of both eyes. Left eye worse: sore, tender to touch and feels like a little fluid buildup. No treatment was received. Patient had not recovered from the events, at the time of the report.
she got sick after the second dose; diarrhea; throwing up; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she got sick after the second dose), DIARRHOEA (diarrhea), VOMITING (throwing up) and CHILLS (chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     The patient had no known drug or food allergies.  Concurrent medical conditions included Latex allergy (some medication sensitivities including latex).   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ILLNESS (she got sick after the second dose), DIARRHOEA (diarrhea), VOMITING (throwing up) and CHILLS (chills). On 07-Mar-2021, ILLNESS (she got sick after the second dose), DIARRHOEA (diarrhea), VOMITING (throwing up) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: abnormal (abnormal) She had gained 25 lbs, since she had been sitting in the house since COVID-19 began..         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-355964 (Patient Link).
CUSTOMER STATED before vaccine given that she gets very nervous of needles. after receiving the vaccine she stated she was still nervous and then she vomited.  i gave her a cold pack and after about 20 minutes she said she still felt nauseated  and vomited again . after a few more minutes she said she felt better and  continues to sit with her rep.  Then after a few more minutes she  decided  to sit on the floor . she said she felt lightheadiness so  i ask if she would lay on her back and i elevated her feet and got another cold pack. she stayed on her back for about 20 minutes and then set up  and said she felt better and her rep went and got her car and they left. she said thanks for everything. i offered to call paramedics twice but rep stated no because she does this when needles are involved.
Large red, warm/hot and swollen mark on my arm. Still there 3 days later. Still warm, red, swollen and sore to touch.   Along with uncontrollable shivering and body aches from the afternoon of day 1 throughout day 2.    By the beginning of day 3 with OTC excedrin the body aches had cleared.  The shivering and cold only lasted the whole of the first night.  The tenderness in the arm at the injection site continues currently.  The red swollen area is about 3?x2? on my upper arm.  We so sore the first day/night it was impossible to sleep on that side.   There were no side effects from the first shingrix shot.
This is a spontaneous report from a contactable consumer reported for herself. A 42-year-old female patient (non-pregnant) received third (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot#30145BA), at the age of 42, intramuscularly, in right arm, Oct 4, 2021, at 20:00, single dose, for COVID-19 immunisation. The patient's medical history included ulcerative colitis. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL3247), at the age of 42, intramuscularly, in right arm, Feb 22, 2021, at 11:30, single dose; and dose 2, on Mar 15, 2021, at 11:30, for COVID-19 immunisation. On Oct 6, 2021, at 06:00, patient experienced swollen lymph nodes (right-side). No treatment received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has not tested for COVID-19. At the time of report, the outcome of the event: recovering. Follow-up attempts completed. No further information expected.
Choking sensation, difficulty breathing Given 0.3 epi at 1319 Transported to ER via Rescue Squad Evaluated in ERx4 hours
Patient experienced a non-itching, non-blanching petechial rash across bilateral arms, trunk, and back beginning 5 days after vaccination. Biopsy revealed underlying vasculitis with eosinophils. The rash clears up with use of oral prednisone. Patient has also experienced edema and ulcers of the lower extremities believed to be caused by microeboli associated with vasculitis.
pacemaker surgery; weak; carpel tunnel; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION COMPLETED, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: CARDIAC PACEMAKER INSERTION (medically significant), outcome "unknown", described as "pacemaker surgery"; ASTHENIA (non-serious), outcome "unknown", described as "weak"; CARPAL TUNNEL SYNDROME (non-serious), outcome "unknown", described as "carpel tunnel". The patient underwent the following laboratory tests and procedures: tested: Unknown results, notes: I was tested for carpel tunnel & more; carpel tunnel, notes: I was tested for carpel tunnel & more.  Clinical information: Description of event outcome your video was not functioning and I have heard some PSA's about the generalities about is. I would like to know more. The photo shown was someone holding a section of their leg and the four points highlighted were strong Indicator as to what I have been dealing with. I have doctor's follow ups after my pacemaker surgery from last Feb, emergency, weak after receiving my COVID booster. now there are more issues arising that are of further concern. I was tested for carpel tunnel & more. No medical inquiry asked.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
A non-serious spontaneous report of administration to pregnant female was received from a health professional concerning a 27-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 28-Sep-2011, a pregnant female received FLUMIST. There was no adverse event associated with this pregnancy. Treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX concomitantly with a dose of influenza virus vaccine (unknown if AFLURIA). About 1 month ago, in approximately September 2013, the patient developed Guillain-Barre Syndrome. The patient was admitted to an unspecified hospital. The patient's outcome was unknown. The causal relationship was not provided. Upon internal review, Guillain-Barre Syndrome was considered medically significant. Additional information has been requested.
Itchiness started in my scalp on Dec 3rd, 11 days after I received the Moderna booster. Over the next few days, I had full body itchiness, hives on my neck and eyes, eye swelling, red/hot ears and dermatographia. I went to urgent care and got steroids and Hydroxyzine. That day a pink circle formed around my eye and my entire chest, it was scary. I started feeling intense chest pain that would wake me up. One night it was so painful I went to the ER and was told I likely had acid reflux. Dr. said the chest pain could potentially be lung spasms, so he gave me an Albuterol inhaler. He started me on a Zyrtec/Allegra/Pepcid combo. The chest pain became much less severe and went away after a week and a half. I ended up testing positive for Covid on 12/18 and only having cold-like symptoms with no new allergic reactions. I still have full body itchiness and dermatographia. I only had temporary reactions (lasting less than 24hrs) to the first two Moderna shots.
Information has been received from a Certified Medical Assistant (C.M.A) concerning multiple unspecified patients of unknown age and gender. On unknown dates the patient were inadvertently vaccinated with improperly stored GARDASIL 9, lot # L018351 with expiration date 11-AUG-2017 (dose and route unspecified), which was exposed to temperature excursion 47.78 Fahrenheit degree (F) for 22 hours 44 minutes or 15 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
In October 2021 not long after my booster shot, I was out on a walk and noticed I had a 'squiggle' that went across my vision.  I realized it was blood.  I visited the ophthalmologist and confirmed I had a vitreous detachment in my right eye.  I now just have floaters.  After dose 4, in June 2022, I noticed I was dizzy, and my blood pressure was high.  I was traveling.  In February 2023, while in another country, I was having spiking blood pressure episodes.  I was dizzy with urges to go to the bathroom.  I went to the emergency department.  I also had a grinding sensation in my abdomen with chills.  This happened again after I returned home.  I went to the emergency department again.  No one could explain this reaction in my abdomen.  On another day it happened, and it was also shortness of breath and chest pain.  I saw the doctor next day.  I was told I just may have hypertension.  I am now on a blood pressure medication.
5/14/04:Vaccine received in 5/13/04. Received TC 5/14/04 at 10 am. Pt complained of sore throat, "felt like throat closing" evening of 5/13, pt did not contact anyone, took sleeping pill and went ot bed. This am, c/o sore throat on left, going up to left ear, weakness, denies fever. I pt to see MD today. This clinic contacted regional immunization report from  DOH.
Information has been received from a 36 yr old female health professional with no medical history and no allergies who on 18Jun01 was vaccinated IM in the left arm with a first dose of varicella virus vaccine live (lot632044/0947K). There was no concomitant medication. On 01Aug01 a second dose of varicella virus vaccine live was given. A titer done on 02Jan06 showed no varicella antibodies. A third dose of varicella virus vaccine live was given on 13Feb06 and resulted in arm soreness that day. The following week, on approx 20Feb06 the pt experienced stomach symptoms and one week later on approx 27Feb06, the pt experienced a cold and earache. It was reported that her arm continues to be sore and she is not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 15 month old patient of unknown gender. The concurrent conditions, drug reactions/allergies and medical history of the patient were not reported. On 19-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis, which was stored at 1.1 Celsius degrees (°C) for 27 minutes, 0.7 °C for 19 minutes, 1.1 °C for 36 minutes, 0.7 °C for 29 minutes, 1.3 °C for 17 minutes, 1.1 °C for 20 minutes, 0.9 °C for 26 minutes, 0.7 °C for 31 minutes and 1.2 °C for 24 minutes. There was no previous temperature excursion. Moreover, the temperature excursions were detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments:  US-009507513-1701USA007921: US-009507513-1701USA007910: US-009507513-1701USA004148: US-009507513-1701USA003168: US-009507513-1701USA007912: US-009507513-1701USA007922: US-009507513-1701USA007881: US-009507513-1701USA007913: US-009507513-1701USA007882: US-009507513-1701USA004150: US-009507513-1701USA007958: US-009507513-1701USA007906: US-009507513-1701USA007895: US-009507513-1701USA007896: US-009507513-1701USA007923: US-009507513-1701USA004152: US-009507513-1701USA007883: US-009507513-1701USA007897: US-009507513-1701USA007905: US-009507513-1701USA007884: US-009507513-1701USA007924: US-009507513-1701USA007925: US-009507513-1701USA007847: US-009507513-1701USA007885: US-009507513-1701USA007908: US-009507513-1701USA007909: US-009507513-1701USA007898: US-009507513-1701USA007914: US-009507513-1701USA007916: US-009507513-1701USA007848: US-009507513-1701USA007849.
This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "cardiac disorder" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too.; "APS" (unspecified if ongoing), notes: Caller also stated she has APS and is a cardiac patient too. Concomitant medication(s) included: INFLUENZA VACCINE. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: Unknown), for COVID-19 Immunization, reaction(s): "nausea", "vomiting". The following information was reported: NAUSEA (non-serious), outcome "recovered"; VOMITING (non-serious), outcome "recovered".  Additional information: She mentioned she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul. She mentioned she is concerned about getting the Omicron vaccine and that she is allergic to something vaccine. Caller asked if in stoppers or syringes may have latex. Caller also mentioned she just recently received a Flu shot and asked how long should she wait to get the new Omicron vaccine. Caller also stated she has APS and is a cardiac patient too. She asked if the Pfizer Product get into the valves of the heart. Caller also mentioned her last booster was in Jul2022 and asked when can she receive the bivalent vaccine. Caller mentioned she is vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul. She mentioned she is concerned about getting the Omicron vaccine and that she is allergic to something vaccine. Caller asked if in stoppers or syringes may have latex.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child, age 8 mo, 13 days came to clinic for 6 mo vaccines. ROTATEQ is part of 6 mo vaccines but should not be given after 8 mo. This child was 13 days beyond 8 months.
got covid Virus after receiving the 1st dose; got covid Virus after receiving the 1st dose; This is a spontaneous report received from a contactable consumer (patient wife) via a Pfizer-sponsored program . This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that, the patient got covid Virus after receiving the first dose of vaccine on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021195278 same reporter/drug/event, different patient
Roughly 8 hours after vaccination I had fever to 100.0 and fatigue for about 24 hours.  Mild muscle aches.  Extremely tender shoulder for 48 hours
fever; waking up sweating; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support. A contactable female consumer (patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history concomitant medications were not reported. Historical vaccine includes BNT162B2 on an unspecified date for covid-19 immunisation. The patient reported took the second dose of the vaccine and got symptoms last night, having fever and waking up sweating on an unspecified date, and asked if she can take Tylenol. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 11/10/00, the pt developed pink, reddened swollen area on the left deltoid. Tender to the touch. Treated with hydrocortisone cream and Tylenol.
This initial spontaneous report was received from a registered medical assistant referring to an unspecified number of patients of unknown ages and genders. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On unspecified dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX injection (lot # K018960 with expiration date 15-OCT-2016; dose and route were not provided). No adverse effect was reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Tingling and numbness on right hand; Tingling and numbness on right hand; warm sensation on inner side of right leg near foot.; warm sensation on inner side of right leg near foot.; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 05Jan2022 13:15 (Lot number: FJ8757) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing); "PUD" (ongoing); "Insomnia" (ongoing); "Constipation" (ongoing); "GERD" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); SPIRONOLACTONE (ongoing); TRELEGY; OMEPRAZOLE taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2590, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 27Oct2021, when the patient was 34 years old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 07Jan2022 12:00, outcome "not recovered" and all described as "Tingling and numbness on right hand"; BURNING SENSATION (non-serious), FEELING HOT (non-serious) all with onset 07Jan2022 12:00, outcome "not recovered" and all described as "warm sensation on inner side of right leg near foot.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, burning sensation, feeling hot.  Additional Information: It was unknown if the patient received any other vaccine in four weeks. The patient did not have covid prior vaccination and the patient was tested for COVID post vaccination. There were no known allergies. There were no relevant test done for thromboembolic events with thrombocytopenia   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200047545 Same reporter/patient/drug, different dose/events
No adverse event; Patient received the monovalent booster instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported. It was that moment they did not have the bivalent vaccine. They received the bivalent vaccine on 04-Oct-2022. No treatment medications were reported.. This case was for 5th patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656478, PR-MODERNATX, INC.-MOD-2022-656480 (E2B Linked Report). Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-656478:Patient 3 PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-655231:Patient 1
Extreme pain in left shoulder where vaccination was administered. Limited mobility due to pain. Have been to oncology office, chiropractor and physical therapist and symptoms have not improved. Have been prescribed oxycodone for the pain. The pain continues.
Pt vax 3 doses; did not convert.  Titer indicated no HBSAB.